UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 or 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

 

Report on Form 6-K dated April 9, 2019

 

(Commission File No. 001-31269)

 


 

Alcon Inc.

(Name of Registrant)

 

Rue Louis-d’Affry 6

1701 Fribourg

Switzerland

(Address of Principal Executive Offices)

 


 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

Form 20-F: x

 

Form 40-F: o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes: o

 

No : x

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes: o

 

No : x

 

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes: o

 

No : x

 

 

 


 

Exhibit

 

 

Number

 

Description

 

 

 

99.1

 

Separation and Distribution Agreement by and between Novartis AG and Alcon Inc., dated as of April 8, 2019

99.2

 

Tax Matters Agreement by and between Novartis AG and Alcon Inc., dated as of April 8, 2019

99.3

 

Employee Matters Agreement by and between Novartis AG and Alcon Inc., dated as of April 8, 2019

99.4

 

Forward Manufacturing and Supply Agreement by and between Novartis Pharma AG and Alcon Inc., dated as of April 8, 2019

99.5

 

Reverse Manufacturing and Supply Agreement by and between Novartis Pharma AG and Alcon Inc., dated as of April 8, 2019

99.6

 

Transitional Services Agreement by and between Novartis AG and Alcon Inc., dated as of April 8, 2019

99.7

 

Patent and Know-How License Agreement by Novartis AG for the benefit of Alcon Inc., dated as of April 8, 2019

99.8

 

Patent and Know-How License Agreement by Alcon Inc. for the benefit of Novartis AG, dated as of April 8, 2019

99.9

 

Brand License Agreement by Novartis AG for the benefit of Alcon Inc., dated as of April 8, 2019

99.10

 

Brand License Agreement by Alcon Inc. for the benefit of Novartis AG, dated as of April 8, 2019

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

Alcon Inc.

 

 

 

 

 

 

Date: April 9, 2019

By:

/s/ David J. Endicott

 

Name:

David J. Endicott

 

Title:

Authorized Representative

 

 

By:

/s/ Royce Bedward

 

Name:

Royce Bedward

 

Title:

Authorized Representative

 

3


Exhibit 99.1

 

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 

 

SEPARATION AND DISTRIBUTION AGREEMENT

 

 


 

CONTENTS

 

Clause

 

 

Page

 

 

 

 

1.

THE SEPARATION

 

3

2.

THE ALCON TRANSFERRING ASSETS

 

5

3.

THE NOVARTIS TRANSFERRING ASSETS

 

7

4.

LOCAL SEPARATION AGREEMENTS

 

8

5.

THE DISTRIBUTION

 

9

6.

GLOBAL CONDITIONS

 

10

7.

BRAZIL

 

12

8.

TRANSFERRING CONTRACTS

 

12

9.

MATTERS GOVERNED EXCLUSIVELY BY ANCILLARY AGREEMENTS

 

12

10.

INTERCOMPANY ARRANGEMENTS

 

14

11.

ACCOUNTS PAYABLE AND RECEIVABLE

 

15

12.

CREDIT SUPPORT

 

16

13.

MUTUAL RELEASE AND INDEMNIFICATION

 

17

14.

ASIA INVESTIGATION

 

20

15.

LIABILITIES AND ADDITIONAL MATTERS

 

21

16.

CLAIMS

 

24

17.

ACCESS TO INFORMATION; BOOKS AND RECORDS

 

26

18.

INSURANCE

 

32

19.

SEPARATION COMMITTEE

 

33

20.

SWITCH RIGHTS

 

34

21.

PUURS

 

36

22.

BRAZIL SITE

 

37

23.

APL/NOAG INTERFACE

 

38

24.

WARRANTY AS TO CAPACITY

 

38

25.

WRONG POCKETS

 

38

26.

FURTHER ASSURANCES

 

41

27.

TERMINATION

 

42

28.

CONFIDENTIALITY

 

42

29.

ANNOUNCEMENTS

 

43

30.

ASSIGNMENT

 

43

31.

COSTS

 

44

32.

NOTICES

 

44

33.

CONFLICT WITH OTHER AGREEMENTS

 

45

34.

WHOLE AGREEMENT

 

45

35.

WAIVERS, RIGHTS AND REMEDIES

 

46

36.

COUNTERPARTS

 

46

37.

VARIATIONS

 

46

38.

INVALIDITY

 

47

39.

NO THIRD PARTY ENFORCEMENT RIGHTS

 

47

40.

GOVERNING LAW

 

47

41.

DISPUTE RESOLUTION

 

47

 

2


 

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

 

49

SCHEDULE 2 TRANSFERRING CONTRACTS

 

71

SCHEDULE 3 BRAZIL

 

76

 

 

EXHIBITS REFERRED TO IN THIS AGREEMENT

 

Exhibit 1 : Transferors and Transferees

 

Exhibit 2 : Separation Steps Plan

 

Exhibit 3 : Distribution Steps Plan

 

Exhibit 4 : Continuing Intercompany Arrangements

 

Exhibit 5 : Existing Counsel

 

Exhibit 6: Brazil Products

 

Exhibit 7: IT Contract Costs

 

AGREED FORM DOCUMENTS REFERRED TO IN THIS AGREEMENT

 

Books and Records Plan

 

Cash Settlement Plan

 

IT Assets List

 

Properties List

 

Novartis Prospectus Statements List

 

Puurs Separation Plan

 

Product List

 

3


 

SEPARATION AND DISTRIBUTION AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

1.                                       Novartis AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland ( Novartis ); and

 

2.                                       Alcon Inc. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland ( Alcon ),

 

(together the Parties , and each a Party )

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

Whereas:

 

A.                           At the date of this Agreement, Alcon is a direct, wholly owned Subsidiary of Novartis. Novartis, acting through its Subsidiaries, currently conducts, among other businesses, the Alcon Business.

 

B.                           The majority of the Alcon Business is conducted through the Alcon Transferring Entities. The Alcon Business also comprises certain additional assets — the Alcon Transferring Assets — and associated liabilities that are held by the Alcon Asset Transferors.

 

C.                           The majority of the Novartis Business is conducted by the Novartis Transferring Entities and certain other existing Subsidiaries of Novartis that are not the Alcon Transferring Entities. The Novartis Business also comprises certain additional assets — the Novartis Transferring Assets — and associated liabilities that are held by the Novartis Asset Transferors.

 

D.                           The Parties have approved the separation of the Alcon Business from the Novartis Business into Alcon pursuant to the following steps:

 

i.                       the transfer of the Alcon Transferring Assets and the Alcon Transferring Entities to the Alcon Asset Transferees and the Alcon Share Transferees, respectively;

 

ii.                    the transfer of the Novartis Transferring Assets and the Novartis Transferring Entities to the Novartis Asset Transferees and the Novartis Share Transferees, respectively; and

 

iii.                 the assumption by the Novartis Group of the Novartis Liabilities and the assumption by the Alcon Group of the Alcon Liabilities,

 

together, the Separation .

 


 

E.                            The Alcon Transferring Entities and Novartis Transferring Entities, respectively, will be (or have already been) transferred as part of the Separation together with all of their respective assets and liabilities, including, in the case of the Alcon Transferring Entities, the shares held in the Alcon Indirect Transferring Entities. In contrast the Separation comprises the transfer of only certain assets and associated liabilities held by the Alcon Asset Transferors. Clause 2 ( The Alcon Transferring Assets ) and Clause 3 ( The Novartis Transferring Assets ) of this Agreement sets out the details of the Alcon Transferring Assets and Novartis Transferring Assets that will be (or have already been) transferred in each Asset Sale Jurisdiction and the Novartis Retained Assets and Alcon Retained Assets that will be (or have already been) excluded from the transfer in each Asset Sale Jurisdiction.

 

F.                             Exhibit 1 ( Transferors and Transferees ) of this Agreement sets out a list of (i) the Alcon Asset Transferors and Alcon Asset Transferees, and the Alcon Transferring Entities, Alcon Share Transferees and Alcon Share Transferors; and (ii) the Novartis Asset Transferors and Novartis Asset Transferees, and the Novartis Transferring Entities, Novartis Share Transferors and Novartis Share Transferees.

 

G.                           The Separation Steps Plan included in Exhibit 2 ( Separation Steps Plan ) of this Agreement sets out the legal steps through which the Separation will be (or has already been) effected.

 

H.                          Prior to the date of this Agreement, the Parties have implemented the steps required to be effected before Separation pursuant to the Cash Settlement Plan.

 

I.                               Following completion of the Separation:

 

i.                        Alcon will (a) own and conduct, directly and indirectly, the Alcon Business; (b) be the ultimate Parent Company of, among other Persons, each Alcon Transferring Entity; and (c) be responsible for all the Alcon Liabilities; and

 

ii.                     Novartis will (a) own and conduct, directly and indirectly, the Novartis Business; (b) be the ultimate Parent Company of, among other Persons, the Novartis Transferring Entities; and (c) be responsible for all the Novartis Liabilities.

 

J.                               The Novartis shareholders have further resolved, on the terms contemplated hereby, that Novartis shall be authorised to transfer the entire issued and outstanding share capital of Alcon held by Novartis as of immediately prior to the Distribution (the Listing Shares ) by means of a distribution of an extraordinary dividend of the Listing Shares to holders of Novartis Shares on a pro rata basis out of distributable reserves (the Distribution ) and for such Listing Shares to be admitted to listing on each of the SIX and the NYSE.

 

K.                           Clauses 5 ( The Distribution ) and 6 ( Global Conditions ) and the Distribution Steps Plan included in Exhibit 3 ( Distribution Steps Plan ) of this Agreement set out the terms and conditions applicable to the Distribution.

 

L.                            The remainder of this Agreement sets out the other terms and conditions on which the Separation and the Distribution are to be implemented.

 

2


 

IT IS AGREED:

 

1.                    THE SEPARATION

 

1.1                                The Separation. The Parties acknowledge that the Separation is intended to result in:

 

(a)                                  Alcon directly or indirectly owning the Alcon Business, including the Alcon Transferring Entities (together with all of their assets) and the Alcon Transferring Assets, and bearing the Alcon Liabilities; and

 

(b)                                  Novartis directly or indirectly owning the Novartis Business, including the Novartis Transferring Entities (together with all of their assets) and the Novartis Transferring Assets, and bearing the Novartis Liabilities,

 

in accordance with the terms of this Agreement.

 

1.2                                The Separation Date . To the extent not already completed in any jurisdiction prior to the date of this Agreement, the Separation shall take place on 8 April 2019 (the Separation Date ).

 

1.3                                Transfer of Alcon Transferring Assets and Alcon Transferring Entities.

 

(a)                                  To the extent not transferred prior to the date of this Agreement, subject to Clauses 7 ( Brazil ) and 8 ( Transferring Contracts ), on the Separation Date and in accordance with the Separation Steps Plan, Novartis and Alcon shall procure that:

 

(i)                   each Alcon Share Transferor shall transfer to each Alcon Share Transferee, and each Alcon Share Transferee shall accept, all of such Alcon Share Transferor’s direct or indirect rights, title and interest in and to each Alcon Transferring Entity for which it is identified as the respective Alcon Share Transferor or Alcon Share Transferee (as applicable) in Part A ( Alcon Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) (together with all of its assets); and

 

(ii)                each Alcon Asset Transferor shall transfer to each Alcon Asset Transferee, and each Alcon Asset Transferee shall (A) accept all of such Alcon Asset Transferor’s direct or indirect rights, title and interest in and to each Alcon Transferring Asset for which it is identified as the respective Alcon Asset Transferor or Alcon Asset Transferee (as applicable) in Part C ( Alcon Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and (B) assume all Alcon Liabilities relating to such Alcon Transferring Assets pursuant to Clause 1.4 ( Assumption of Alcon Liabilities ).

 

(b)                                  Novartis and Alcon shall procure that the shares (and other equity interests) in each Alcon Transferring Entity to be transferred pursuant to Clause 1.3(a)(i) shall be transferred with all rights attaching to them, including the right to receive all distributions and dividends declared, paid or made in respect of the relevant shares (and other equity interests) after the Separation Date.

 

3


 

1.4                                Assumption of Alcon Liabilities.

 

(a)                                  Subject to Clauses 7 ( Brazil ) and 13.1 ( Ancillary Agreement Liabilities ), each Party shall procure that on and from the Separation Date, Alcon (and/or the applicable Alcon Asset Transferee) shall assume and be responsible for all Alcon Liabilities, regardless of when or where such Alcon Liabilities arose or arise, or whether the facts on which they are based occurred prior to, at or after the Separation Date, regardless of where or against whom such Alcon Liabilities are asserted or determined (including any such Alcon Liabilities arising out of claims made by Novartis’s or Alcon’s respective Affiliates or by Representatives of Novartis or Alcon or their respective Affiliates against either Party or any of its Affiliates) or whether asserted or determined prior to, at or after the Separation Date, and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of any Applicable Law, fraud, misrepresentation or otherwise by either Party or any member of its Group or any of their respective Representatives.

 

1.5                                Transfer of Novartis Transferring Assets and Novartis Transferring Entities.

 

(a)                                  To the extent not transferred prior to the date of this Agreement, subject to Clause 8 ( Transferring Contracts ) on the Separation Date and in accordance with the Separation Steps Plan, Novartis and Alcon shall procure that:

 

(i)                   each Novartis Share Transferor shall transfer to each Novartis Share Transferee, and each Novartis Share Transferee shall accept, all of such Novartis Share Transferor’s direct or indirect rights, title and interest in and to each Novartis Transferring Entity for which it is identified as the respective Novartis Share Transferor or Novartis Share Transferee (as applicable) in Part D ( Novartis Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) (together with all of its assets); and

 

(ii)                each Novartis Asset Transferor shall transfer to each Novartis Asset Transferee, and each Novartis Asset Transferee shall (A) accept all of such Novartis Asset Transferor’s direct or indirect rights, title and interest in and to each Novartis Transferring Asset for which it is identified as the respective Novartis Asset Transferor or Novartis Asset Transferee (as applicable) in Part E ( Novartis Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and (B) assume all Novartis Liabilities relating to such Novartis Transferring Assets pursuant to Clause 1.6 ( Assumption of Novartis Liabilities ).

 

(b)                                  Novartis and Alcon shall procure that the shares (and other equity interests) in the Novartis Transferring Entities to be transferred pursuant to Clause 1.5(a) shall be transferred with all rights attaching to them, including the right to receive all distributions and dividends declared, paid or made in respect of the relevant shares (and other equity interests) after the Separation Date.

 

1.6                                Assumption of Novartis Liabilities

 

(a)                                  Subject to Clause 13.1 ( Ancillary Agreement Liabilities ), each Party shall procure that on and from the Separation Date, Novartis (and/or the applicable Novartis Asset Transferee) shall assume and be responsible for all Novartis Liabilities, regardless of when or where such Novartis Liabilities arose or arise, or whether the facts on which they are based occurred prior to, at or after the Separation Date, regardless of where

 

4


 

or against whom such Novartis Liabilities are asserted or determined (including any such Novartis Liabilities arising out of claims made by Novartis’s or Alcon’s respective Affiliates or by Representatives of Novartis or Alcon or their respective Affiliates against either Party or any of its Affiliates) or whether asserted or determined prior to, at or after the Separation Date, and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of any Applicable Law, fraud, misrepresentation or otherwise by either Party or any member of its Group or any of their respective Representatives.

 

2.                                       THE ALCON TRANSFERRING ASSETS

 

2.1                                The Alcon Transferring Assets. Subject to and in accordance with the terms of this Agreement and the Ancillary Agreements, including Clauses 2.2 ( The Novartis Retained Assets ), 8 ( Transferring Contracts ) and 9 ( Matters Governed Exclusively by Ancillary Agreements ), the Alcon Transferring Assets to be transferred by each Alcon Asset Transferor in each Asset Sale Jurisdiction shall comprise the following (if any held by such Alcon Asset Transferor):

 

(a)                                  the Alcon Business Contracts;

 

(b)                                  the Alcon Part of all Shared Contracts, in accordance with Schedule 2 ( Transferring Contracts );

 

(c)                                   the Alcon Inventory;

 

(d)                                  the Alcon Properties (including the Alcon Puurs Site);

 

(e)                                   any Artwork located at an Alcon Property as at the Separation Date;

 

(f)                                    the Alcon IT Assets;

 

(g)                                   subject to and in accordance with the MA Transfer Agreement, the Alcon Transferring Marketing Authorisations;

 

(h)                                  to the extent transferable under Applicable Law, the Alcon Business Permits;

 

(i)                                      subject to and in accordance with Clause 17 ( Access to Information; Books and Records ), the Alcon Transferring Books and Records;

 

(j)                                     subject to and in accordance with the Intellectual Property Agreements, any Intellectual Property Rights allocated to Alcon in accordance with the Intellectual Property Agreements;

 

(k)                                  subject to and in accordance with the Employee Matters Agreement, any rights and assets related to Employees and/or Employee Benefits to the extent transferred in accordance with the Employee Matters Agreement;

 

(l)                                      subject to and in accordance with the Third Party Claims and Investigations Management Agreement, all rights of any Alcon Asset Transferor to causes of action, lawsuits, judgements, claims or demands to the extent Exclusively Related to the Alcon Business; and

 

(m)                              subject to and in accordance with Clause 11 ( Accounts Payable and Receivable) , the benefit of all Alcon Accounts Receivable.

 

5


 

2.2                                The Novartis Retained Assets. Notwithstanding anything in this Agreement to the contrary, the following assets (the Novartis Retained Assets ) shall be excluded from the transfer of the Alcon Transferring Assets in each relevant Asset Sale Jurisdiction:

 

(a)                                  all assets of the Novartis Business (as more specifically described in Clause 3 ( The Novartis Transferring Assets );

 

(b)                                  the Novartis Part of all Shared Contracts and all Third Party Supply Agreements (as defined in the Transitional Services Agreement(s));

 

(c)                                   all land, real estate and freehold or leasehold property, together with all interests therein (including all the Novartis Properties and the Novartis Puurs Site), other than the Alcon Properties;

 

(d)                                  any Artwork located at a Novartis Property as at the Separation Date;

 

(e)                                   all information technology equipment and assets, other than the Alcon IT Assets (including all the Novartis IT Assets);

 

(f)                                    any Intellectual Property Rights other than those allocated to the Alcon Group in accordance with the Intellectual Property Agreements;

 

(g)                                   subject to and in accordance with the Employee Matters Agreement, any rights and assets related to Employees and/or Employee Benefits to the extent transferred in accordance with the Employee Matters Agreement;

 

(h)                                  any product and any Permits in respect of any products, or any applications therefor, other than the Alcon Products, Alcon Transferring Marketing Authorisations and the Alcon Business Permits (including, for the avoidance of doubt, the Novartis Transferring Marketing Authorisations);

 

(i)                                      all cash, marketable securities and negotiable instruments, and all other cash equivalents, including any bank deposits;

 

(j)                                     any company seal, minute books, charter documents, stock or equity record books of any Alcon Asset Transferor and any Books and Records other than the Alcon Transferring Books and Records;

 

(k)                                  subject to and in accordance with the Third Party Claims and Investigations Management Agreement, any right of the Novartis Group to be indemnified by a Third Party in respect of any Novartis Liabilities and any other causes of action, lawsuits, judgements, claims or demands arising in relation to any Novartis Liabilities;

 

(l)                                      any rights of the Novartis Group under any of its Intercompany Arrangements, which Intercompany Arrangements are dealt with in accordance with Clause 10 ( Intercompany Arrangements );

 

(m)                              any equity interest in any Person other than an Alcon Transferring Entity;

 

(n)                                  all rights of the Novartis Group under this Agreement (including, for the avoidance of doubt, any right of the Novartis Group to be indemnified in respect of the Alcon Liabilities) and any other Transaction Document; and

 

6


 

(o)                                  without prejudice to Clause 18 ( Insurance ), all policies of or agreements for insurance and interests in insurance pools and programs (in each case including self-insurance and insurance from members of the Novartis Group) and all rights of any nature with respect to any of the foregoing, including in each case all recoveries thereunder and rights to assert claims seeking any such recoveries and any claim that was declared thereunder prior to the Separation Date (collectively,  Insurance Arrangements ).

 

3.                    THE NOVARTIS TRANSFERRING ASSETS

 

3.1                                The Novartis Transferring Assets. Subject to and in accordance with the terms of this Agreement and the Ancillary Agreements, including this Clause 3.1 ( The Novartis Transferring Assets ), Clause 8 ( Transferring Contracts ) and Clause 9 ( Matters Governed Exclusively by Ancillary Agreements ), the Novartis Transferring Assets to be transferred by the Novartis Asset Transferor shall comprise the following (if any held by such Novartis Asset Transferor):

 

(a)                                  the Novartis Business Contracts;

 

(b)                                  the Novartis Part of all Shared Contracts, in accordance with Schedule 2 ( Transferring Contracts );

 

(c)                                   the Novartis Inventory;

 

(d)                                  all land, real estate and freehold or leasehold property, together with all interests therein (including all the Novartis Properties), other than the Alcon Properties;

 

(e)                                   any Artwork located at a Novartis Property as at the Separation Date;

 

(f)                                    all information technology equipment and assets, other than the Alcon IT Assets (including all the Novartis IT Assets);

 

(g)                                   subject to and in accordance with the MA Transfer Agreement, the Novartis Transferring Marketing Authorisations;

 

(h)                                  to the extent transferable under Applicable Law, the Novartis Business Permits;

 

(i)                                      subject to and in accordance with Clause 17 ( Access to Information; Books and Records ), the Novartis Transferring Books and Records;

 

(j)                                     any Intellectual Property Rights other than those allocated to the Alcon Group in accordance with the Intellectual Property Agreements

 

(k)                                  any rights and assets related to Employees and/or Employee Benefits other than those allocated to the Alcon Group in accordance with the Employee Matters Agreement;

 

(l)                                      subject to and in accordance with the Third Party Claims and Investigations Management Agreement, all rights of any Novartis Asset Transferor to causes of action, lawsuits, judgements, claims or demands to the extent Exclusively Related to the Novartis Business; and

 

(m)                              subject to and in accordance with Clause 11 ( Accounts Payable and Receivable) , the benefit of all Novartis Accounts Receivable.

 

7


 

3.2                                The Alcon Retained Assets. Notwithstanding anything in this Agreement to the contrary, the following assets (the Alcon Retained Assets ) shall be excluded from the transfer of the Novartis Transferring Assets in each relevant Asset Sale Jurisdiction:

 

(a)                                  all assets of the Alcon Business (as more specifically described in Clause 2 ( The Alcon Transferring Assets );

 

(b)                                  the Alcon Part of any Shared Contract;

 

(c)                                   the Alcon Properties;

 

(d)                                  any Artwork located at an Alcon Property as at the Separation Date;

 

(e)                                   the Alcon IT Assets;

 

(f)                                    any Intellectual Property Rights allocated to the Alcon Group in accordance with the Intellectual Property Agreements;

 

(g)                                   any rights and assets related to Employees and/or Employee Benefits other than those transferred in accordance with the Employee Matters Agreement;

 

(h)                                  the Alcon Products, Alcon Transferring Marketing Authorisations and the Alcon Business Permits;

 

(i)                                      all cash, marketable securities and negotiable instruments, and all other cash equivalents, including any bank deposits;

 

(j)                                     any company seal, minute books, charter documents, stock or equity record books of any Novartis Asset Transferor and any Novartis Transferring Books and Records;

 

(k)                                  subject to and in accordance with the Third Party Claims and Investigations Management Agreement, any right of the Alcon Group to be indemnified by a Third Party in respect of any Alcon Liabilities and any other causes of action, lawsuits, judgements, claims or demands arising in relation to any Alcon Liabilities;

 

(l)                                      any rights of the Alcon Group under any of its Intercompany Arrangements, which Intercompany Arrangements are dealt with in accordance with Clause 10 ( Intercompany Arrangements );

 

(m)                              any equity interest in any Person other than a Novartis Transferring Entity; and

 

(n)                                  all rights of the Alcon Group under this Agreement (including, for the avoidance of doubt, any right of the Alcon Group to be indemnified in respect of the Novartis Liabilities) and any other Transaction Document.

 

4.                    LOCAL SEPARATION AGREEMENTS

 

4.1                                Execution of Local Separation Agreements. To the extent not executed prior to the date of this Agreement, Novartis and Alcon shall, and shall procure that each relevant member of their respective Groups shall, execute such agreements, transfers, conveyances and other documents, as required pursuant to Applicable Law in each applicable jurisdiction and otherwise as may be agreed by Novartis and Alcon (including with respect to the form thereof) to memorialise and effect the Separation in accordance with the Separation Steps

 

8


 

Plan (such agreements and any such agreements executed prior to the date of this Agreement, the Local Separation Agreements ).

 

4.2                                Inconsistencies with Local Separation Agreements. To the extent that the provisions of a Local Separation Agreement are inconsistent with or additional to the provisions of this Agreement:

 

(a)                                  the provisions of the Local Separation Agreement shall prevail in respect of the scope of, and details of, the assets transferred pursuant to such Local Separation Agreement and in respect of the transfer of title of such assets;

 

(b)                                  the provisions of this Agreement shall otherwise prevail, including in respect of the allocation and assumption of Liabilities; and

 

(c)                                   so far as permissible under Applicable Law, Novartis and Alcon shall cause the provisions of the relevant Local Separation Agreement to be amended, solely to the extent necessary under Applicable Law to give effect to the provisions of this Agreement or, to the extent this is not permissible, Novartis and Alcon shall cooperate with each other and use Commercially Reasonable Efforts to ensure that each applicable Party (or the relevant member of its Group) shall receive the rights benefits and interests, and be responsible for such liabilities, as the case may be, that such Party (or the relevant member of its Group) would have received or been responsible for had such Local Separation Agreement been governed solely by the terms of this Agreement.

 

4.3                                Local Separation Agreement Claims. Each Party shall not (and shall cause each member of their Group not to), bring any claim against the other Party or any member of its Group in respect of or based upon the Local Separation Agreements or in respect of the Separation based upon or pursuant to any relevant Applicable Law in the relevant jurisdiction, in each case except to the extent necessary to implement the Separation as contemplated by this Agreement or the assumption of the Alcon Liabilities or Novartis Liabilities as contemplated by this Agreement or otherwise to implement the terms of this Agreement. All such claims (except as referred to above) shall be brought and be subject to the provisions, rights and limitations as set out in this Agreement and no Person shall be entitled to recover damages or obtain payment, reimbursement, restitution or indemnity under or pursuant to any of the Local Separation Agreements or in respect of the Separation based upon or pursuant to any relevant Applicable Law in the relevant jurisdiction (but without prejudice to the establishment of the existence of the claim hereunder). To the extent that either Party (or a member of its Group) does bring a claim in breach of this Clause 4.3 ( Local Separation Agreement Claims ), such Party shall indemnify the other Party (and each member of its Group) against all Liabilities which the other Party (or the relevant member of its Group) may suffer through or arising from the bringing of such a claim.

 

5.                    THE DISTRIBUTION

 

5.1                                Novartis Discretion to Implement the Distribution . Subject to Applicable Law, Novartis shall, in its sole and absolute discretion, determine:

 

(a)                                  whether and when to proceed with all or part of the Distribution; and

 

(b)                                  all terms of the Distribution, as applicable, including the form, structure and terms of any transaction(s) and/or offering(s) to effect the Distribution and the timing of and

 

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any additional conditions (in addition to, or in place of, those referred to in Clause 6 ( Global Conditions )) to the consummation of the Distribution.

 

If Novartis determines to proceed with the Distribution, Novartis may, subject to Applicable Law, at any time and from time to time until the completion of the Distribution abandon, modify or change any or all of the terms of the Distribution, including by accelerating or delaying the timing of the consummation of all or part of the Distribution.

 

5.2                                Implementation of the Distribution. Subject to Clause 6 ( Global Conditions ), if Novartis determines, in accordance with Clause 5.1 ( Novartis Discretion to Implement the Distribution ), to implement the Distribution, Novartis and Alcon shall procure that the Distribution shall be implemented by Novartis and Alcon in accordance with the Distribution Steps Plan (as may be modified by Novartis in its absolute discretion) and the terms and conditions determined by Novartis in accordance with Clause 5.1 ( Novartis Discretion to Implement the Distribution ).

 

6.                    GLOBAL CONDITIONS

 

6.1                                Global Conditions . Implementation of the Distribution pursuant to Clause 5 ( The Distribution ) shall, subject to Applicable Law, be conditional on the following Global Conditions having been fulfilled (or waived by Novartis, in whole or in part, in its sole discretion). It is understood that the following Global Conditions are to be interpreted in accordance with the respective conditions stated in the resolution of the general meeting of shareholders of Novartis of 28 February 2019 approving the Distribution, which shall prevail in case of any inconsistency:

 

(a)                                  the Novartis shareholders shall have authorised and approved the Distribution, and not withdrawn such authorisation and approval, in accordance with Swiss law;

 

(b)                                  the Listing Shares shall have been admitted to listing on the SIX and the NYSE as from the ex-dividend date (subject to technical deliverables only) ;

 

(c)                                   the Commission shall have declared effective the Registration Statement, no stop order suspending the effectiveness of this Registration Statement shall be in effect and no proceedings for that purpose shall be pending before or threatened by the Commission;

 

(d)                                  no Order, injunction or decree issued by any Governmental Entity of competent jurisdiction or other legal restraint or prohibition preventing consummation of the Separation and/or the Distribution shall be in effect, and no other event outside the control of Novartis shall have occurred or shall have failed to occur that prevents the consummation of the Separation and/or the Distribution (including, but not limited to, the Novartis Group not being able to complete the internal transactions required to effect the Separation due to elements outside of its reasonable control); and

 

(e)                                   no other events or developments shall have occurred prior to the ex-dividend date for the Distribution that, in the judgment of the Novartis board of directors, would result in the Separation and/or the Distribution having a material adverse effect (including, but not limited to, material adverse Tax consequences or risks) on Novartis or its shareholders.

 

6.2                                Efforts to Satisfy Global Conditions. Each Party shall, at its own cost, use Commercially Reasonable Efforts to ensure that each of the Global Conditions is fulfilled as

 

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soon as practicable after the date of this Agreement (to the extent not already fulfilled prior to the date of this Agreement).

 

6.3                                Steps to Satisfy Global Conditions. Without prejudice to the generality of Clause 6.2 ( Efforts to Satisfy Global Conditions ), to the extent not completed prior to the date of this Agreement:

 

(a)                                  Alcon shall, and shall cause the other members of the Alcon Group to, cooperate in all respects with Novartis and any member of the Novartis Group to accomplish the Distribution, including in connection with the registration under the Securities Act or the Exchange Act of the Listing Shares, including the filing and publication of any necessary documents pursuant to the Securities Act or the Exchange Act, including the Registration Statement;

 

(b)                                  Novartis and Alcon shall take all such action as may be necessary or appropriate under the securities or blue sky Applicable Laws of the states or other political subdivisions of the United States of America, Switzerland or any other jurisdiction in connection with the Distribution; and

 

(c)                                   Alcon shall prepare and file, and shall use Commercially Reasonable Efforts to have approved prior to the Separation Date, an application for the listing of the Listing Shares on each of the SIX and the NYSE, subject to official notices of issuance, as applicable.

 

6.4                                Information Sharing. Each Party shall provide the other Party with any necessary Information and documents reasonably required for the purpose of making any submissions, notifications and filings to any such Governmental Entity in respect of any Global Condition.

 

6.5                                Conditions for the Benefit of Novartis. The foregoing Global Conditions are for the sole benefit of Novartis and shall not give rise to or create any duty on the part of Novartis to waive or not waive such Global Conditions or in any way limit:

 

(a)                                  the right of Novartis pursuant to Clause 5.1 ( Novartis Discretion to Implement the Distribution ) to determine, in its sole and absolute discretion, whether and when to proceed with all or part of the Distribution and all terms of the Distribution; or

 

(b)                                  the right of Novartis to terminate this Agreement as set forth in Clause 27 ( Termination ) or alter the consequences of any such termination from those specified in Clause 27 ( Termination ).

 

Any determination made by Novartis concerning the satisfaction or waiver of any or all of the Global Conditions shall be conclusive and binding on the Parties.

 

6.6                                Shareholder Register. Immediately prior to the date of the Distribution, Novartis shall provide Alcon with the full shareholder data contained in the register of shareholders of Novartis and in the ADR register kept by JPMorgan Chase Bank, N.A. in an appropriate manner, in order to facilitate Alcon to effect prompt shareholder registration after the Distribution (unless such provision has been prohibited by the concerned shareholders). After the date of Distribution and upon request by Alcon, Novartis shall provide further information that is reasonably required or desirable to facilitate such registration and reasonably cooperate with Alcon for that purpose.

 

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7.                    BRAZIL

 

The provisions of Schedule 3 ( Brazil ) shall apply.

 

8.                    TRANSFERRING CONTRACTS

 

8.1                                Non-Required Consents . The Parties acknowledge that it is their intention that, in such cases where the transfer of any applicable Transferring Business Contract or the Alcon Part or Novartis Part (as applicable) of any Shared Contract as part of the Separation is subject to a Third Party Consent and such Third Party Consent has not been obtained prior to the implementation of the Separation in any jurisdiction, the Separation shall proceed in such jurisdiction without the transfer of any such Transferring Business Contract or Alcon Part or Novartis Part (as applicable) of a Shared Contract and the provisions of this Clause 8 ( Transferring Contracts) and Schedule 2 ( Transferring Contracts ) shall apply.

 

8.2                                Transferring Contracts . The provisions of Schedule 2 ( Transferring Contracts ) shall apply, subject to the terms of any relevant Ancillary Agreement:

 

(a)                                  if and to the extent that the transfer, assignment, sub-licence of the benefit and / or burden of (x) any Alcon Business Contract to the relevant member of the Alcon Group; or (y) any Novartis Business Contract to the relevant member of the Novartis Group:

 

(i)                   requires obtaining an agreement of novation or transfer, a consent, approval, waiver or the like from a Third Party (including any Governmental Entity) (such agreement of novation, transfer, approval, waiver or consent, a Third Party Consent ) to such assignment, sub-license, transfer or change of control; or

 

(ii)                is prohibited by Applicable Law: and

 

(b)                                  with respect to any Shared Contract.

 

9.                    MATTERS GOVERNED EXCLUSIVELY BY ANCILLARY AGREEMENTS

 

9.1                                Matters Governed Exclusively by Ancillary Agreements . Each of Novartis and Alcon agrees on behalf of itself and the members of its respective Group that, except as expressly provided in this Agreement or any Ancillary Agreement:

 

(a)                                  the Employee Matters Agreement shall govern the matters governed thereby, including the allocation of all rights, assets and liabilities related to Employees and/or Employee Benefits related matters, including:

 

(i)                   the allocation of employment and service-related Liabilities (including wages, salaries, employer’s Liabilities in respect of associated Taxes and other periodic outgoings);

 

(ii)                the existing equity plans with respect to employees and former employees of members of both the Novartis Group and the Alcon Group; and

 

(iii)             the allocation of pensions liabilities and workers’ compensation liabilities, including the retention of certain pensions liabilities and related assets by the Novartis Group;

 

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(b)                                  the Transitional Services Agreement shall govern the matters governed thereby, including all matters related to the provision of certain identified transitional services to be provided by one Party (and/or any member of its Group) to the other following the Separation Date;

 

(c)                                   the Tax Matters Agreement shall govern the matters governed thereby, including the allocation of Taxes and certain other Tax matters;

 

(d)                                  the Intellectual Property Agreements shall govern the matters governed thereby, including the allocation of Intellectual Property Rights and the use of the “Alcon” name;

 

(e)                                   the Manufacturing and Supply Agreements and related agreements shall govern the matters governed thereby, including all matters related to the provision of certain identified manufacturing services;

 

(f)                                    the Transitional Distribution and Services Agreement and related Promotional Services Agreement shall govern the matters governed thereby, including all matters related to the provision of certain identified distribution and promotional services;

 

(g)                                   the Pharmacovigilance Agreement and Pharmacovigilance Services Agreement shall govern the matters governed thereby, including all matters relating to pharmacovigilance and related services;

 

(h)                                  the Third Party Claims and Investigations Management Agreement shall govern the matters governed thereby, including the conduct of Third Party Claims and Investigations;

 

(i)                                      the Information Access Agreement shall govern the terms on which the Parties (or the relevant members of their Group) shall access Retained Records;

 

(j)                                     the MA Transfer Agreement shall govern matters relating to the Alcon Transferring Marketing Authorisations and the Novartis Transferring Marketing Authorisations; and

 

(k)                                  the Quality Agreements shall govern the matters governed thereby.

 

9.2                                Ancillary Agreement Conflicts.

 

(a)                                  If there is any conflict between the terms of this Agreement and any Ancillary Agreement:

 

(i)                   the terms of the relevant Ancillary Agreement shall prevail (as between the parties to this Agreement and as between any members of the Novartis Group and any members of the Alcon Group); and

 

(ii)                nothing in this Agreement is intended to limit or exclude the rights and/or obligations of any party under any Ancillary Agreement.

 

(b)                                  If there is any conflict between the terms of any two or more Ancillary Agreements, drafting in any Ancillary Agreement that deals expressly with any issue, matter or circumstance shall prevail over any drafting in another Ancillary Agreement that deals generally with such issue, matter or circumstance.

 

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10.             INTERCOMPANY ARRANGEMENTS

 

10.1                         Termination of Intercompany Arrangements . Subject to Clause 10.2 ( Continuing Intercompany Arrangements ) and Clause 10.3 ( Settlement of Intercompany Accounts ), Novartis and Alcon shall procure, and shall procure that each member of their respective Groups shall procure, to the extent not terminated prior to the date of this Agreement, that:

 

(a)                                  all Intercompany Arrangements between such Persons and in effect or accrued as of the Separation Date shall be terminated effective as of immediately prior to the Separation Date, but without prejudice to any Intercompany Accounts outstanding as at the Separation Date;

 

(b)                                  no such terminated Intercompany Arrangement (including any provision thereof that purports to survive termination) shall be of any further force or effect after the Separation Date. Each Party shall, at the reasonable request of the other Party, take, or cause to be taken, such other actions as may be necessary to effect the foregoing. The Parties, on behalf of the members of their respective Groups, hereby waive any advance notice provision or other termination requirements with respect to any Intercompany Arrangement; and

 

(c)                                   each member of the Alcon Group shall cease to be a party to any Novartis Cash Management Arrangements prior to the Separation Date.

 

10.2                         Continuing Intercompany Arrangements . The provisions of Clause 10.1 ( Termination of Intercompany Arrangements ) shall not apply to any of the following Contracts, agreements, arrangements, commitments or understandings, each of which shall remain in place and continue in full force and effect notwithstanding this Agreement and the Separation:

 

(a)                                  this Agreement and the Transaction Documents (and each other Intercompany Arrangement or Intercompany Account expressly contemplated by this Agreement or any Transaction Document to be entered into by either Party or any other member of its Group);

 

(b)                                  any agreements, arrangements, commitments or understandings to which any Third Party or any non-wholly owned Subsidiary of Novartis or Alcon (as the case may be) is a party; and

 

(c)                                   the Continuing Intercompany Arrangements.

 

10.3                         Settlement of Intercompany Accounts . Without limiting the termination of the Intercompany Arrangements described in Clause 10.1 ( Termination of Intercompany Arrangements ), each of Novartis and Alcon shall procure that:

 

(a)                                  any Intercompany Trading Accounts outstanding on the Separation Date are settled in the ordinary course of business, and in any event by not later than 60 days after the Separation Date (and, for the avoidance of doubt, it shall be possible for members of the Novartis Group and the Alcon Group, respectively, to set-off amounts owed to and from each other, on an entity by entity basis); and

 

(b)                                  as contemplated in the Cash Settlement Plan, any Intercompany Non-Trading Accounts outstanding as of the close of business on the Business Day immediately prior to the Separation Date are settled on a net basis (whether via a dividend, a capital contribution, a combination of the foregoing or as otherwise agreed), in each case as of the close of business on the Business Day immediately prior to the

 

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Separation Date (and, for the avoidance of doubt, it shall be possible for members of the Novartis Group and the Alcon Group, respectively, to set-off amounts owed to and from each other, on an entity by entity basis).

 

11.             ACCOUNTS PAYABLE AND RECEIVABLE

 

11.1                         Payment of Accounts Payable and Receipt of Accounts Receivable . From and after the Separation Date:

 

(a)                                  the relevant Alcon Asset Transferor shall pay any Alcon Accounts Payable and shall use Commercially Reasonable Efforts to procure receipt of any Alcon Accounts Receivable of such Alcon Asset Transferor in the ordinary course of business, consistent with past practice; and

 

(b)                                  the relevant Novartis Asset Transferor shall pay any Novartis Accounts Payable and shall use Commercially Reasonable Efforts to procure receipt of any Novartis Accounts Receivable of such relevant Novartis Asset Transferor in the ordinary course of business, consistent with past practice.

 

11.2                         Re-imbursement of Accounts Payable .

 

(a)                                  If at any time after the Separation Date, any member of the Novartis Group pays any monies in respect of any Alcon Accounts Payable, then the relevant member of the Alcon Group shall pay or procure payment to the relevant member of the Novartis Group, by no later than 10 Business Days after the end of the calendar month in which the Alcon Group is notified of such amount having been paid, the amount paid, plus any Tax or other costs actually suffered or incurred by the Novartis Group which would not have arisen but for the payment of such monies (less the amount of any Tax or other benefits actually received by the Novartis Group).

 

(b)                                  If at any time after the Separation Date, any member of the Alcon Group pays any monies in respect of any Novartis Accounts Payable, then the relevant member of the Novartis Group shall pay or procure payment to the relevant member of the Alcon Group, by no later than 10 Business Days after the end of the calendar month in which the Novartis Group is notified of such amount having been paid, the amount paid, plus any Tax or other costs actually suffered or incurred by the Alcon Group which would not have arisen but for the payment of such monies (less the amount of any Tax or other benefits actually received by the Alcon Group).

 

11.3                         Pass-back of Accounts Receivable .

 

(a)                                  If at any time after the Separation Date, any member of the Novartis Group actually receives any monies in respect of any Alcon Accounts Receivable, then the relevant member of the Novartis Group shall pay or procure payment to the relevant member of the Alcon Group, by no later than 10 Business Days after the end of the calendar month in which such amount is received, less any Tax or other costs actually suffered or incurred by the Novartis Group which would not have arisen but for the receipt of such monies (less the amount of any Tax or other benefits actually received by the Novartis Group).

 

(b)                                  If at any time after the Separation Date, any member of the Alcon Group actually receives any monies in respect of any Novartis Accounts Receivable, then the relevant member of the Alcon Group shall pay or procure payment to the relevant

 

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member of the Novartis Group, by no later than 10 Business Days after the end of the calendar month in which such amount is received, less Tax or other costs actually suffered or incurred by the Alcon Group which would not have arisen but for the receipt of such monies (less the amount of any Tax or other benefits actually received by the Alcon Group).

 

12.             CREDIT SUPPORT

 

12.1                         Intragroup Credit Support Instruments . Each Party shall, and shall procure that each member of its respective Group shall, use Commercially Reasonable Efforts to procure that, unless otherwise agreed in writing between the Parties, effective on or prior to the Separation Date:

 

(a)                                  each member of the Alcon Group is released from any Novartis Intragroup Credit Support Instruments and such Novartis Intragroup Credit Support Instruments are replaced with alternate arrangements that do not require any credit support from any member of the Alcon Group; and

 

(b)                                  the beneficiaries of such Novartis Intragroup Credit Support Instruments provide written releases to Alcon (which in the case of a letter of credit or bank guarantee may be effective upon surrender of the original Novartis Intragroup Credit Support Instrument to the originating bank and such bank’s confirmation to Alcon of cancelation thereof) indicating that Alcon or the relevant member of the Alcon Group shall, effective upon the consummation of the Separation, have no liability with respect to such Novartis Intragroup Credit Support Instruments, in a form reasonably satisfactory to Alcon;

 

(c)                                   each member of the Novartis Group is released from all Alcon Intragroup Credit Support Instruments and such Alcon Intragroup Credit Support Instruments may be, in the sole discretion of Alcon, replaced with alternate arrangements that do not require any credit support from any member of the Novartis Group; and

 

(d)                                  the beneficiaries of such Alcon Intragroup Credit Support Instruments provide written releases to Novartis (which in the case of a letter of credit or bank guarantee may be effective upon surrender of the original Alcon Intragroup Credit Support Instrument to the originating bank and such bank’s confirmation to Novartis of cancelation thereof) indicating that Novartis or the relevant member of the Novartis Group shall, effective upon the consummation of the Separation, have no liability with respect to such Alcon Intragroup Credit Support Instruments, in a form reasonably satisfactory to Novartis.

 

12.2                         Third Party Credit Support Instruments . Each Party shall, and shall procure that each member of its respective Group shall, use Commercially Reasonable Efforts to procure that, unless otherwise agreed in writing between the Parties, prior to, or as soon as reasonably practicable after, and in any event by no later than three months after the Separation Date:

 

(a)                                  each member of the Alcon Group is released from all Novartis Third Party Credit Support Instruments and such Novartis Third Party Credit Support Instruments are replaced with alternate arrangements that do not require any credit support from any member of the Alcon Group; and

 

(b)                                  the beneficiaries of such Novartis Third Party Credit Support Instruments provide written releases to Alcon (which in the case of a letter of credit or bank guarantee

 

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may be effective upon surrender of the original Novartis Third Party Credit Support Instrument to the originating bank and such bank’s confirmation to Alcon of cancelation thereof) indicating that Alcon or the relevant member of the Alcon Group shall, effective upon the consummation of the Separation, have no liability with respect to such Novartis Third Party Credit Support Instruments, in a form reasonably satisfactory to Alcon;

 

(c)                                   each member of the Novartis Group is released from all Alcon Third Party Credit Support Instruments and such Alcon Third Party Credit Support Instruments may be, in the sole discretion of Alcon, replaced with alternate arrangements that do not require any credit support from any member of the Novartis Group; and

 

(d)                                  the beneficiaries of such Alcon Third Party Credit Support Instruments provide written releases to Novartis (which in the case of a letter of credit or bank guarantee may be effective upon surrender of the original Alcon Third Party Credit Support Instrument to the originating bank and such bank’s confirmation to Novartis of cancelation thereof) indicating that Novartis or the relevant member of the Alcon Group shall, effective upon the consummation of the Separation, have no liability with respect to such Alcon Third Party Credit Support Instruments, in a form reasonably satisfactory to Novartis.

 

12.3                         Credit Support Indemnities. With effect from the Separation Date

 

(a)                                  Novartis shall indemnify on demand and hold harmless Alcon and each member of the Alcon Group and their respective directors, officers, managers, members, agents and employees against and in respect of all Liabilities actually suffered or incurred by any of them after the Separation Date under or by reason of any Novartis Intragroup Credit Support Instrument and/or Novartis Third Party Credit Support Instrument that is not released on or prior to the Separation Date; and

 

(b)                                  Alcon shall indemnify on demand and hold harmless Novartis and each member of the Novartis Group and their respective directors, officers, managers, members, agents and employees against and in respect of all Liabilities actually suffered or incurred by any of them after the Separation Date under or by reason of any Alcon Intragroup Credit Support Instrument and/or Alcon Third Party Credit Support Instrument that is not released on or prior to the Separation Date, including, without limitation, any payment obligations or other Liabilities arising from Novartis (or the relevant member of its Group) to the relevant bank or credit card provider in respect of credit cards used or held by, or provided to, members of the Alcon Group or their respective directors, officers, managers, members, agents and employees.

 

For the avoidance of doubt, the provisions of Clause 15.1 ( Threshold for Indemnity Claims ) shall not apply to the indemnities contained in this Clause 12.3 ( Credit Support Indemnities ).

 

13.             MUTUAL RELEASE AND INDEMNIFICATION

 

13.1                         Ancillary Agreement Liabilities. Clause 1.4 ( Assumption of Alcon Liabilities ), Clause 1.6 ( Assumption of Novartis Liabilities ) and the remaining provisions of this Clause 13 ( Mutual Release and Indemnification ) shall not apply in relation to any Liabilities that are otherwise expressly allocated between the Parties (and/or their respective Groups) in any Ancillary Agreement, such that, for example, Employee related liabilities that are allocated between the Parties (and/or their respective Groups) pursuant to the Employee Matters

 

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Agreement shall not be released or recoverable pursuant to this Clause 13 ( Mutual Release and Indemnification ).

 

13.2                         Exceptions to the Mutual Release and Indemnification . Nothing in this Agreement or any Transaction Document:

 

(a)                                  shall operate to transfer :

 

(i)                   any of the Novartis Retained Assets to any member of the Alcon Group or make any member of the Alcon Group liable for any of the Novartis Liabilities;

 

(ii)                any of the Alcon Retained Assets to any member of the Novartis Group or make any member of the Novartis Group liable for any of the Alcon Liabilities;

 

(b)                                  shall impair any right of any Person to enforce, or release any Person from Liability under, this Agreement or any Transaction Document, or any Intercompany Arrangement or Intercompany Account referred to in Clause 10.2 ( Continuing Intercompany Arrangements ), or any other Contract or Liability specified as continuing notwithstanding the Separation in any Ancillary Agreement, in each case in accordance with its terms;

 

(c)                                   shall impair any right of any Person to enforce, or release any Person from Liability under, any Contract or other agreement, arrangement, commitment and/or undertaking entered into between any member of the Novartis Group, on the one hand, and any member of the Alcon Group, on the other, after the Separation Date; or

 

(d)                                  shall release:

 

(i)                   Novartis or any member of the Novartis Group from honouring its obligations existing immediately prior to the Separation Date to indemnify any director, officer or employee of Alcon or any other member of the Alcon Group who was a director, officer or employee of Novartis or any other member of the Novartis Group on or prior to the Separation Date, to the extent such director, officer or employee was entitled in such capacity to such indemnification pursuant to obligations existing immediately prior to the Separation; provided that if a director of Alcon or any other member of the Alcon Group receives indemnification payments from Novartis or Alcon, as the case may be, with respect to a particular Liability for which such director is entitled to indemnification, such director shall not be entitled to receive indemnification payments from the other Party with respect to the same Liability to the extent of the indemnification payments previously received by such director from Novartis or Alcon, as the case may be, and provided, further, that to the extent the events underlying an indemnification claim would give rise to an Alcon Liability, the liability of the relevant member of the Novartis Group to such director, officer or employee shall be treated as an Alcon Liability for the purposes of Clause 13.8 ( Alcon Indemnity ); or

 

(ii)                Alcon or any member of the Alcon Group from honouring its obligations existing immediately prior to the Separation Date to indemnify any director, officer or employee of Novartis or any member of the Novartis Group who was a director, officer or employee of Alcon or any member of the Alcon Group on prior to the Separation, to the extent such director, officer or

 

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employee was entitled in such capacity to such indemnification pursuant to obligations existing immediately prior to the Separation; provided that if a director of Novartis or any member of the Novartis Group receives indemnification payments from Novartis or Alcon, as the case may be, with respect to a particular Liability for which such director is entitled to indemnification, such director shall not be entitled to receive indemnification payments from the other Party with respect to the same Liability to the extent of the indemnification payments previously received by such director from Novartis or Alcon, as the case may be, and provided, further, that to the extent the events underlying an indemnification claim would give rise to a Novartis Liability, the liability of the relevant member of the Alcon Group to such director, officer or employee shall be treated as a Novartis Liability for the purposes of Clause 13.7 ( Novartis Indemnity ).

 

13.3                         Release of Novartis Group . Subject to the terms of this Clause 13 ( Mutual Release and Indemnification ) and Clause 10 ( Intercompany Arrangements ), Alcon shall, and shall procure that all members of the Alcon Group shall, with effect from the Separation Date and to the fullest extent permitted by Applicable Law, release and discharge Novartis, each member of the Novartis Group and their respective successors and assigns and, save in respect of any Liabilities arising as a result of fraud or other criminal conduct, all Persons who are, or at any time prior to the Separation Date have been shareholders, directors, officers, managers, members, agents or employees of any member of the Novartis Group (in each case, in their respective capacities as such), and their respective heirs, executors, administrators, successors and assigns, from all Alcon Liabilities.

 

13.4                         No Claims by Alcon Group . Alcon shall not, and shall procure that no member of the Alcon Group shall, make, any claim or demand, or commence any proceedings asserting any claim or demand, including any claim of contribution or any indemnification, against Novartis or any other member of the Novartis Group, or any other Person released pursuant to Clause 13.3 ( Release of Novartis Group ), with respect to any Liabilities released pursuant to Clause 13.3 ( Release of Novartis Group ).

 

13.5                         Release of Alcon Group . Subject to the terms of this Clause 13 ( Mutual Release and Indemnification ) and Clause 10 ( Intercompany Arrangements ), Novartis hereby, and shall procure that all members of the Novartis Group shall, with effect from the Separation Date and to the fullest extent permitted by Applicable Law release and discharge Alcon, each member of the Alcon Group and their respective successors and assigns and, save in respect of any Liabilities arising as a result of fraud or other criminal conduct, all Persons who are, or at any time prior to the Separation Date have been shareholders, directors, officers, managers, members, agents or employees of any member of the Novartis Group (in each case, in their respective capacities as such), and their respective heirs, executors, administrators, successors and assigns, from all Novartis Liabilities.

 

13.6                         No Claims by Novartis Group . Novartis shall not, and shall procure that no member of the Novartis Group shall, make, any claim or demand, or commence any proceedings asserting any claim or demand, including any claim of contribution or any indemnification, against Alcon or any other member of the Alcon Group, or any other Person released pursuant to Clause 13.5 ( Release of Alcon Group ), with respect to any Liabilities released pursuant to Clause 13.5 ( Release of Alcon Group ).

 

13.7                         Novartis Indemnity. Subject to the terms of this Clause 13 ( Mutual Release and Indemnification ) and Clause 15 ( Liabilities and Additional Matters ), Novartis shall, with effect from the Separation Date and to the fullest extent permitted by Applicable Law, indemnify on demand and hold harmless Alcon and each member of the Alcon Group and

 

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their respective directors, officers, managers, members, agents and employees against and in respect of all Liabilities actually suffered or incurred by any of them to the extent arising out of or resulting from any Novartis Liabilities, including the failure of Novartis or any other member of the Novartis Group or any other Person to pay, perform or otherwise promptly discharge any Novartis Liability in accordance with its terms.

 

13.8                         Alcon Indemnity. Subject to this Clause 13 ( Mutual Release and Indemnification ) and Clause 15 ( Liabilities and Additional Matters ), Alcon shall, with effect from the Separation Date and to the fullest extent permitted by Applicable Law, indemnify on demand and hold harmless Novartis and each member of the Novartis Group and their respective directors, officers, managers, members, agents and employees against and in respect of all Liabilities actually suffered or incurred by any of them to the extent arising out of or resulting from any Alcon Liabilities, including the failure of Alcon or any other member of the Alcon Group or any other Person to pay, perform or otherwise promptly discharge any Alcon Liability in accordance with its terms.

 

14.             ASIA INVESTIGATION

 

14.1                         Novartis Asia Investigation Indemnity. Novartis shall indemnify on demand and hold harmless Alcon and each member of the Alcon Group against any Monetary Penalty agreed with, imposed by, or ordered in proceedings brought by, the United States Department of Justice ( DOJ ) and/or the Commission, to the extent that such Monetary Penalty results from or arises out of the Asia Investigation.

 

14.2                         Exclusions to the Novartis Asia Investigation Indemnity. The Parties agree that the indemnity in Clause 14.1 ( Novartis Asia Investigation Indemnity ) shall not cover, and neither Party nor any member of their respective groups shall have any claim under any Transaction Document, notwithstanding any other provision of any Transaction Document, in respect of:

 

(a)                                  any Monetary Penalty agreed with, imposed by, or ordered in proceedings brought by, any entity other than DOJ or the Commission in connection with the matters that are the subject of the Asia Investigation;

 

(b)                                  any Liabilities resulting from or arising out of any civil claims threatened or brought by any party claiming to have suffered loss as a consequence of the Asia Investigation and/or of the matters that are the subject of the Asia Investigation;

 

(c)                                   any Liabilities resulting from or arising out of: (i) the appointment of a monitor; or (ii) any undertakings, prohibitions or restrictions imposed or required by, or agreed to with, any party, in either case in connection with, or as a result of, the Asia Investigation;

 

(d)                                  any Liabilities arising in connection with the Asia Investigation that are special, indirect, derivative or consequential or result from or arise out of:

 

(i)                   any threatened or actual termination of, or suspension, debarment or disqualification from bidding or tendering for, any contract or other commercial arrangement with any Third Party;

 

(ii)                any alleged or actual damage to business or reputation, or the loss of, or adverse effect on, cash flow, assets, goodwill, results of operations, business prospects, profits or business value; and/or

 

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(iii)             the termination of, or the ability to obtain or continue, financing for current or future business activities or projects; or

 

(iv)            the Asia Investigation Costs (except under Clause 14.3 ( Asia Investigation Costs )).

 

14.3                         Asia Investigation Costs . The Asia Investigation Costs shall be paid on the following basis:

 

(a)                                  Novartis shall pay any fees and disbursements payable to the Existing Counsel, and any experts they engage, in connection with the Asia Investigation;

 

(b)                                  the engaging Party shall pay any fees and disbursements payable to any counsel other than the Existing Counsel, and any experts that counsel engages, in connection with the Asia Investigation;

 

(c)                                   the Party who employs or engages, or who last employed or engaged, any current or former director, officer, manager or employee (each a “ Relevant Person ”), shall pay:

 

(i)                   any fees and disbursements payable to any counsel or expert engaged by or on behalf of the Relevant Person, other than the Existing Counsel, in connection with the Asia Investigation; and

 

(ii)                any costs and expenses incurred by or in relation to the Relevant Person in connection with the Asia Investigation — for example, acting as a witness.

 

(d)                                  any other costs or expenses in connection with the Asia Investigation not included within sub-paragraphs (a) to (c) above shall be paid by the Party by whom they are incurred.

 

15.             LIABILITIES AND ADDITIONAL MATTERS

 

15.1                         Threshold for Indemnity Claims. Subject to Clause 15.2 ( Applicability of Threshold for Indemnity Claim ), no Indemnifying Party shall be liable for any Indemnity Claim unless the amount of the Liability which may be recoverable pursuant to that single Indemnity Claim (and, for these purposes, a number of Indemnity Claims arising out of the same subject matter, facts, events or circumstances may be aggregated and form a single Indemnity Claim) exceeds $500,000 (in which case the Indemnitee shall be entitled to claim for the full amount of the Indemnity Claim, not just the excess).

 

15.2                         Applicability of Threshold for Indemnity Claim .

 

(a)                                  Notwithstanding Clause 15.1 ( Threshold for Indemnity Claims ), if Novartis (or any member of the Novartis Group), on the one hand, or Alcon (or any member of the Alcon Group), on the other hand, accepts that a relevant Third Party Claim constitutes in its entirety, or in any part, its Liability, under clause 11 ( Notification and Classification of Third Party Claims ) of the Third Party Claims and Investigations Management Agreement, then Novartis or Alcon, as applicable, shall be liable for the full amount of such Third Party Claim (or the relevant part in respect of which Liability is accepted), even if the amount of the Liability actually arising from such Third Party Claim is equal to or less than $500,000.

 

(b)                                  The terms of Clause 15.1 ( Threshold for Indemnity Claims ) shall not apply to:

 

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(i)                   any payment required to be made pursuant to Clause 11 ( Accounts Payable and Receivable );

 

(ii)                any Claim arising under Clause 14 ( Asia Investigation ); or

 

(iii)             any payment or transfer required pursuant to Clause 25 ( Wrong Pockets ).

 

15.3        Recovery from Third Parties.

 

(a)                                  The Parties intend that any Liability subject to indemnification or reimbursement pursuant to this Agreement shall be net of:

 

(i)       Insurance Proceeds that actually reduce the amount of, or are paid to the applicable Indemnitee in respect of, such Liability; and/or

 

(ii)      other amounts recovered from any Third Party, net of any costs or expenses incurred in the collection or litigation thereof and net of any Taxes resulting from the receipt thereof, that actually reduce the amount of, or are paid to the applicable Indemnitee in respect of, such Liability ( Third Party Proceeds ).

 

(b)                                  Accordingly, the amount that an Indemnifying Party is required to pay to any Person entitled to indemnification or reimbursement pursuant to this Agreement (an Indemnitee shall be reduced by any Insurance Proceeds or Third Party Proceeds theretofore actually recovered by or on behalf of the Indemnitee from a Third Party in respect of the related Liability.

 

(c)                                   If an Indemnitee receives an Indemnity Payment and subsequently receives Insurance Proceeds or Third Party Proceeds in respect of such Liability, then the Indemnitee shall pay to the Indemnifying Party an amount equal to the excess of the Indemnity Payment received over the amount of the Indemnity Payment that would have been due if such Insurance Proceeds or Third Party Proceeds had been received, realised or recovered before the Indemnity Payment was made.

 

(d)                                  An insurer that would otherwise be obligated to pay any claim shall not be relieved of the responsibility with respect thereto or have any subrogation rights with respect thereto by virtue of the indemnification provisions hereof, it being expressly understood and agreed that no insurer or any other Third Party shall be entitled to a “wind-fall” (i.e., a benefit it would not be entitled to receive in the absence of the indemnification provisions) by virtue of the indemnification provisions of this Agreement.

 

(e)                                   Subject, and without prejudice, to Clause 18 ( Insurance ), each Indemnitee shall use Commercially Reasonable Efforts to seek to collect or recover any Insurance Proceeds and any Third Party Proceeds to which such Indemnitee is entitled in connection with any Liability for which such Indemnitee intends to make an Indemnity Claim, prior to making an Indemnity Claim; provided, however, that:

 

(i)                   such Indemnitee’s inability to collect or recover any such Insurance Proceeds or Third Party Proceeds shall not limit the Indemnifying Party’s obligations hereunder; and

 

(ii)                an Indemnifying Party may not delay making any indemnification payment required under the terms of this Agreement, or otherwise satisfying any indemnification obligation, pending the outcome of any actions to collect or

 

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recover Insurance Proceeds, and an Indemnitee need not attempt to collect any Insurance Proceeds prior to making a claim for indemnification or contribution or receiving any Indemnity Payment otherwise owed to it under this Agreement or any Ancillary Agreement.

 

15.4        Subrogation . In the event of payment by or on behalf of any Indemnifying Party to any Indemnitee of any Third Party Claim, such Indemnifying Party shall be subrogated to and shall stand in the place of such Indemnitee as to any events or circumstances in respect of which such Indemnitee may have any right, defence or claim relating to such Third Party Claim against any claimant or plaintiff asserting such Third Party Claim or against any other Person. Such Indemnitee shall, and shall procure that its Affiliates shall, cooperate in good faith with, and provide such assistance as may be reasonably required by, such Indemnifying Party, at its cost and expense, in prosecuting any subrogated right, defence or claim. This Clause 15.4 ( Subrogation ) shall not apply to Insurance Arrangements that are dealt with in Clause 18 ( Insurance ).

 

15.5        Duty to mitigate. Prior to making any Indemnity Claim, Novartis or Alcon, as applicable, shall, and shall procure that the relevant members of its respective Group shall, subject to the terms of any Ancillary Agreement, including the Third Party Claims and Investigations Management Agreement, use Commercially Reasonable Efforts to avoid or mitigate any Liabilities for which such Person intends to seek indemnification.

 

15.6        No Double Recovery and No Double Counting. A Party shall be entitled to make more than one claim under this Agreement arising out of the same subject matter, fact, event or circumstance but shall not be entitled to recover under this Agreement or any relevant Transaction Document or otherwise more than once in respect of the same Liabilities suffered or amount for which the Party is otherwise entitled to claim (or part of such Liabilities or amount), regardless of whether more than one claim arises in respect of it. No amount (including any relief) (or part of any amount) shall be taken into account, set off or credited more than once under this Agreement or any relevant Transaction Document or otherwise, with the intent that there will be no double counting under this Agreement or any Transaction Document or otherwise.

 

15.7        Specific Performance. In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement. The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy. The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived. Any requirements for the securing or posting of any bond with such remedy are waived.

 

15.8        Timing of Payments . Indemnity Payments or contribution payments in respect of any Liabilities for which an Indemnitee is entitled to indemnification or contribution under this Agreement shall be paid reasonably promptly (but in any event within sixty (60) days of the date on which the Parties agree the amount that the Indemnitee is entitled to indemnification or contribution under this Agreement or on which such amount is determined in accordance with Clause 41 ( Dispute Resolution ) by the Indemnifying Party to the Indemnitee as such Liabilities are incurred upon demand by the Indemnitee, which demand shall be accompanied by reasonably satisfactory documentation setting forth the basis for the amount of such

 

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Indemnity Payments or contribution payments, including documentation with respect to calculations made and consideration of any Insurance Proceeds that actually reduce the amount of such Liabilities. The indemnity and contribution provisions contained in this Agreement shall remain operative and in full force and effect, regardless of (i) any investigation made by or on behalf of any Indemnitee; and (ii) the knowledge by the Indemnitee of Liabilities for which it might be entitled to indemnification or contribution hereunder.

 

15.9        Covenant Not to Sue . Each Party hereby covenants and agrees that neither it nor any member of its Group or any Person claiming through it shall bring suit or otherwise assert any claim against any Indemnitee, or assert a defence against any claim asserted by any Indemnitee, before any court, arbitrator, neutral mediator or administrative agency in any jurisdiction, alleging that:

 

(a)                                  the acquisition or transfer of any Alcon Transferring Assets and/or Novartis Transferring Assets, as applicable, on the terms and conditions set forth in this Agreement and the other Transaction Documents is void or unenforceable for any reason;

 

(b)                                  the assumption of any Alcon Liabilities and/or Novartis Liabilities, as applicable, on the terms and conditions set forth in this Agreement and the other Transaction Documents is void or unenforceable for any reason; or

 

(c)                                   the provisions of Clause 13 ( Mutual Release and Indemnification ), Clause 14 ( Asia Investigation ) or this Clause 15 ( Liabilities and Additional Matters ) are void or unenforceable for any reason.

 

15.10      Remedies Cumulative. The remedies provided in Clause 13 ( Mutual Release and Indemnification ) shall be cumulative and shall not preclude assertion by any Indemnitee of any other rights or the seeking of any and all other remedies against any Indemnifying Party.

 

15.11      Survival of Indemnities. The rights and obligations of each of Novartis and Alcon and their respective Indemnitees under Clause 13 ( Mutual Release and Indemnification ) and Clause 14 ( Asia Investigation ) shall survive the Distribution and the sale or other transfer by any Party or its Affiliates of any assets or businesses or the assignment by any Party or its Affiliates of any Liabilities, or the change of form or change of control of any Party.

 

15.12      Term of Indemnities . The obligation of Novartis to indemnify under Clause 13.7 ( Novartis Indemnity ) and Clause 14 ( Asia Investigation ) and the obligation of Alcon to indemnify under Clause 13.8 ( Alcon Indemnity ), together with the related obligations of both parties under this Clause 15 ( Liabilities and Additional Matters ), shall lapse ( verjähren ) upon expiry of the 10 (ten) year term pursuant to article 127 of the Swiss Code of Obligations, which shall start to run on the date on which the obligation of Novartis to indemnify under Clause 13.7 ( Novartis Indemnity ) or the obligation of Alcon to indemnify under Clause 13.8 ( Alcon Indemnity ), as applicable, becomes due, such due date being the date on which the relevant indemnified Party actually suffers or incurs a relevant Liability.

 

16.     CLAIMS

 

16.1        Restrictions on Claims. Any Claim shall, to the extent applicable, be subject to the applicable provisions of this Clause 16 ( Claims ) and Clause 15 ( Liabilities and Additional Matters ) and, where applicable, the terms of the Third Party Claims and Investigations Management Agreement.

 

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16.2        Notice of Claims.

 

(a)                                  If a Party (the Claimant Party ) wishes to make a Claim against another Party (the Defendant Party ), the Claimant Party shall, subject to the terms of the Third Party Claims and Investigations Management Agreement to the extent such a Claim arises from a Third Party Claim or an Investigation, as soon as reasonably practicable after becoming aware of the facts or circumstances giving rise to such Claim (including any written demand or claim that is asserted against the Claimant Party by a Third Party), give written notice to the Defendant Party (the Claim Notice ) containing reasonably specific details of the Claim, including such Information as is available to the Claimant Party (or its Affiliates) to assess the Claim and, to the extent reasonably practicable, the Claimant Party’s estimate (on a without prejudice basis), on the basis of the Information then available to the Claimant Party, of the amount of the Liabilities which are, or are to be, the subject of the Claim (if known) and the method of computation thereof. To the extent a reasonable estimate and/or method of computation cannot reasonably be provided in the Claim Notice, the Claimant Party shall provide such Information to the Defendant Party as soon as reasonably practicable thereafter.

 

For the purposes of this Clause 16 ( Claims ), “Affiliates” of each of Alcon and Novartis shall include the respective current and former shareholders, directors, officers, managers, members, agents and employees who are entitled to indemnification pursuant to Clause 13 ( Mutual Release and Indemnification ).

 

(b)                                  Following the delivery of a Claim Notice pursuant to Clause 16.2(a), the Defendant Party shall have a period of forty-five (45) days within which to object to any such notice, stating whether it disputes the existence or scope of an obligation to indemnify the Claimant Party, and describing in reasonable detail the basis for its objection thereto. If the Defendant Party does not so respond within such forty-five (45)-day period stating that the Defendant Party disputes its liability for such Claim, the Defendant Party shall be deemed to be disputing such Claim.

 

(c)                                   If, the parties are disputing a Claim following the procedure outlined above, the provisions of Clause 41 ( Dispute Resolution ) shall apply.

 

(d)                                  The regime provided for in this Clause 16.2 ( Notice of Claims ) shall be in lieu of, and not in addition to, any Claimant Party’s duty to immediately inspect and notify the Defendant Party in accordance with article 201 CO.

 

16.3        Third Party Claims and Investigations Management Agreement. The terms of the Third Party Claims and Investigations Management Agreement shall apply as set out therein, including in respect of any Claim arising from a Third Party Claim or an Investigation. Any acceptance by Novartis or Alcon, respectively, that a relevant Third Party Claim constitutes in its entirety, or in any part, its Liability, under clause 11 ( Notification and Classification of Third Party Claims ) of the Third Party Claims and Investigations Management (whether by electing to take conduct for the purposes of clause 11 ( Notification and Classification of Third Party Claims ), or otherwise), shall be binding on the Parties for the purposes of this Agreement and the other Transaction Documents.

 

16.4        Exclusion of Matters Covered by the Ancillary Agreements. For the avoidance of doubt, this  Clause 16 ( Claims ) shall not apply to Claims which are dealt with expressly under any of the Ancillary Agreements.

 

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17.     ACCESS TO INFORMATION; BOOKS AND RECORDS

 

17.1        Transferring Books and Records.

 

(a)                                  To the extent not transferred prior to the date of this Agreement:

 

(i)       Novartis shall, and shall procure that each relevant member of the Novartis Group shall, transfer, or procure the transfer of, the Alcon Transferring Books and Records to Alcon or the relevant member of the Alcon Group; and

 

(ii)      Alcon shall, and shall procure that each relevant member of the Alcon Group shall, transfer, or procure the transfer of, the Novartis Transferring Books and Records to Novartis or the relevant member of the Novartis Group,

 

in each case, in accordance with the Books and Records Plan and as soon as reasonably possible after the Separation Date.

 

(b)                                  Neither Party shall have any obligation to re-write, edit, amend, translate, re-formulate, re-format, take inventory of, or take any other action in connection with Transferring Books and Records that it is transferring to the other Party, other than to transfer them in the form that they are in or, at the discretion of the transferor, in another data format that is reasonably accessible by the other Party.

 

(c)                                   Where Transferring Books and Records are to be transferred by physical delivery at or after the Separation Date, Novartis or Alcon (as applicable) shall procure that such Transferring Books and Records are available for collection at the location at which such Transferring Books and Records are being stored at that time (such that there shall be no requirement on either Party to move Transferring Books and Records from one location to another in order to effect the transfer) or as otherwise agreed between the Parties.

 

(d)                                  From the point at which any Transferring Books and Records have been transferred to the Alcon Group or the Novartis Group (as applicable), in the manner described in paragraph (c) above, no member of the Novartis Group or Alcon Group (as applicable) shall have any further obligations to the other Party or its Group in connection with such Transferring Books and Records.

 

17.2        Retention of original Transferring Books and Records.

 

(a)                                  Subject to Clause 17.2(b), the original Alcon Transferring Books and Records shall transfer to the Alcon Group, and the original Novartis Transferring Books and Records shall transfer to the Novartis Group, in accordance with this Clause 17 ( Access to Information; Books and Records ), provided that:

 

(i)                   the Novartis Group and Alcon Group (as applicable) shall have the right to retain copies of any Transferring Books and Records:

 

(A)                                if required under Applicable Law; or

 

(B)                                in order to evidence their respective compliance with their obligations under this Agreement or the relevant Transaction Document; or

 

(C)                                as otherwise agreed by the Parties;

 

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(ii)                if any member of the Novartis Group or Alcon Group, as applicable, is required under Applicable Law to retain the original versions of any Transferring Books and Records or may not transfer the original versions of any Transferring Books and Records under Applicable Law, Novartis or Alcon (as applicable) shall provide one copy of such Transferring Books and Records to the other Party, to the extent permitted by Applicable Law; and

 

(iii)             if either of Novartis and Alcon (or any members of their Groups) are required under Applicable Law to provide originals of any Transferring Books and Records to a Tax Authority or any other Governmental Entity, the Parties shall cooperate in good faith to ensure that each relevant Party is able to comply with its obligations under Applicable Law or any request from a Tax Authority or any other Governmental Entity with respect to such Transferring Books and Records.

 

(b)                                  In the event that:

 

(i)                   Alcon elects not to have the Alcon Transferring Books and Records transferred to it; or

 

(ii)                Novartis elects not to have the Novartis Transferring Books and Records transferred to it,

 

then such Transferring Books and Records shall be deemed to be Waived Books and Records and the holding Party shall have no further obligation to the other Party with respect to such Waived Books and Records, including any obligations to provide access to such Waived Books and Records under the IAA.

 

17.3        Retained Records.

 

(a)                                  The Retained Records shall be retained by the current holder of the Retained Records and held for the Retention Period, unless the holding Party reasonably considers such period to be burdensome, in which case the holding Party may elect to transfer the relevant Retained Records to the other Party (if permitted under Applicable Law) and the Parties shall discuss in good faith the most practical means of affecting any transfer on this basis.

 

(b)                                  The Retained Records do not need to be held by the Parties in their current form, and the holding Party shall, at its discretion, have the option to decommission and archive any Retained Records.

 

(c)                                   The holder of the Retained Records shall be entitled (but shall not be obliged) to delete and/or destroy any Retained Records after the expiry of the Retention Period, at the holding Party’s cost, provided that the other Party has not provided written notice (in accordance with paragraph (d) below) that it wishes the Retained Records to be retained for a longer period of time, in which case such Retained Records shall be deemed to be Waived Books and Records.

 

(d)                                  If either Party wishes the Retained Records to be retained for a longer period than the Retention Period:

 

(i)                   it shall, at least three (3) months prior to the expiration of the applicable Retention Period, provide notice identifying which Retained Records should be retained and the relevant additional Retention Period requested; and

 

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(ii)                the holding Party may either:

 

(A)                                retain the Retained Records for the additional period at the requesting Party’s cost; or

 

(B)                                transfer the Retained Records to the requesting Party at the requesting Party’s cost (if such transfer is permitted under Applicable Law).

 

(e)                                   Each Party shall be entitled to request access to the Retained Records held by the other Party (or its Group) in accordance with the terms of the Information Access Agreement and for the period specified in the Information Access Agreement.

 

17.4        Books and Records required in connection with the operation of Ancillary Agreements. To the extent that any Books and Records are required by the holder of the relevant Books and Records in connection with the operation of any Ancillary Agreement, the relevant Books and Records will be retained by that Party and, upon termination or expiry of either the Ancillary Agreement or, in the case of Books and Records required in connection with the provision of services under the Transitional Services Agreement, the applicable service term under the Transitional Services Agreement, will either be (i) transferred (as Transferring Books and Records for the purposes of this Agreement); or (ii) made available on the terms of the Information Access Agreement (as Retained Records for the purposes of this Agreement and the Information Access Agreement), in each case as set out in the relevant Ancillary Agreement and/or the Books and Records Plan.

 

17.5        Excluded Books and Records. The following Books and Records (the Excluded Books and Records ) shall not constitute Transferring Books and Records to be transferred by either Party (or member of their Group):

 

(a)                                  Books and Records that do not contain Business Information related to the Novartis Business (in respect of Novartis Transferring Books and Records) or the Alcon Business (in respect of Alcon Transferring Books and Records), as applicable;

 

(b)                                  secondary business information (including copies, disaster recovery backups);

 

(c)                                   technical system data/backups (unless related to transferring and un-wiped IT assets);

 

(d)                                  transient information (including Outlook calendar invites, text message, personal notes), unless otherwise agreed in the Books and Records Plan;

 

(e)                                   training confirmations/reports;

 

(f)                                    compliance and audit reports;

 

(g)                                   the Waived Books and Records; and

 

(h)                                  any other Books and Records which the parties agree in writing should be treated as Excluded Books and Records.

 

17.6        Costs Relating to Books and Records. The costs relating to Books and Records shall be borne as follows:

 

(a)                                  Transferring Books and Records : Subject to any specific provisions on costs in any Ancillary Agreement, including information technology and other separation costs set

 

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out in the Transitional Services Agreement, the cost of separation (including the cost of modification, transformation and/or redaction, if necessary) and transfer of

 

(i)                   the Alcon Transferring Books and Records that are identified by the Parties prior to the Separation Date and set out in the Books and Records Plan, shall be borne by Novartis (notwithstanding that such separation or transfer may occur after the Separation Date in accordance with the Books and Records Plan); and

 

(ii)                all other Alcon Transferring Books and Records (including those identified by either Party on or after the Separation Date) shall be borne by Alcon;

 

(iii)             the Novartis Transferring Books and Records shall be borne by Novartis; and

 

(b)                                  Retained Records . Subject to any specific provisions on costs in any Ancillary Agreement:

 

(i)                   the cost of retaining and storing of:

 

(A)                                any Alcon Retained Records held by Novartis shall be borne by Novartis; and

 

(B)                                any Novartis Retained Records held by Alcon shall be borne by Alcon;

 

(ii)                the cost of providing access to:

 

(A)                                any Alcon Retained Records held by Novartis shall be borne by Alcon, in accordance with the Information Access Agreement; and

 

(B)                                any Novartis Retained Records held by Alcon shall be borne by Novartis, in accordance with the Information Access Agreement.

 

17.7        Compliance with Applicable Law and Confidentiality .

 

(a)                                  In complying with their respective obligations, and exercising their respective rights, under this Clause 17 ( Access to Information; Books and Records ), each of Novartis and Alcon agrees that it will only process personal data provided to it by the other Group in accordance with and will at all times be subject to and act in accordance with all Applicable Law, including but not limited to applicable privacy and data protection law obligations (including any applicable privacy policies of the Novartis Group, as the case may be) and will implement and maintain at all times appropriate technical and organisational measures to protect such personal data provided to it by the other Group against unauthorised or unlawful processing and accidental loss, destruction, damage, alteration and disclosure.

 

(b)                                  In addition, each Party agrees to provide reasonable assistance to the other Party in respect of any obligations under privacy and data protection legislation affecting the disclosure of such personal data to the other Party and will not knowingly process such personal data in such a way to cause the other Party to violate any of its obligations under any applicable privacy and data protection legislation.

 

(c)                                   Each Party shall implement appropriate technical and organisational measures, including information barriers protocols or other operational measures, to ensure the

 

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confidentiality of any information relating to the other Party and to ensure that applicable antitrust and regulatory requirements are complied with.

 

17.8        Ownership of Information . Any Information owned by one Group that is provided to the requesting Party hereunder or in connection with the transactions contemplated hereunder shall be deemed to remain the property of the providing Party. Except as specifically set forth herein, nothing herein shall be construed as granting or conferring rights of license or otherwise in any such Information.

 

17.9        Liability in Respect of Information. Each of Novartis and Alcon acknowledges that the data provided by the other will be provided in their current form and may be inaccurate, incomplete or contain errors. Neither Novartis nor Alcon shall have any Liability to the other Party in the event that any Information exchanged or provided pursuant to this Agreement is found to be inaccurate in the absence of wilful misconduct or Gross Negligence by the providing Party.

 

17.10      Accounting and Reporting Cooperation .

 

Alcon and Novartis shall cooperate with each other (and shall procure that their respective Affiliates shall cooperate with each other) in order to enable each member of the Alcon Group and each member of the Novartis Group to comply with the financial reporting and other reporting obligations under Applicable Law, including:

 

(a)                                  until the end of the first full fiscal year occurring after the Distribution (and for a reasonable period of time afterwards as required by Applicable Law for Novartis to prepare consolidated financial statements or complete a financial statement audit for any period during which the financial results of the Alcon Group were consolidated with those of Novartis), Alcon shall use Commercially Reasonable Efforts to enable:

 

(i)                   Novartis’s management to assess the effectiveness of its disclosure controls and procedures and its internal control over financial reporting as required under Applicable Law;

 

(ii)                Novartis’s auditors to timely complete their annual audit and quarterly reviews of financial statements; and

 

(iii)             Novartis to meet its timetable for dissemination of its financial statements.

 

As part of such efforts, to the extent reasonably necessary for the preparation of financial statements or completing an audit or review of financial statements or an audit of internal control over financial reporting:

 

(A)                                Alcon shall authorise and direct its auditors to make available to Novartis’s auditors, within a reasonable time prior to the date of Novartis’s auditors’ opinion or review report, both (x) the personnel who performed or will perform the annual audits and quarterly reviews of Alcon and (y) work papers related to such annual audits and quarterly reviews, to enable Novartis’s auditors to perform any procedures they consider reasonably necessary to take responsibility for the work of Alcon’s auditors as it relates to Novartis’s auditors’ opinion or report, and

 

(B)                                until all governmental and statutory audits are complete, Alcon shall provide reasonable access during normal business hours for

 

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Novartis’s auditors, counsel and other designated representatives to (x) the premises of the Alcon Group and all Information (and duplicating rights) within the knowledge, possession or control of the Alcon Group and (y) the officers and employees of the members of the Alcon Group, so that Novartis may conduct reasonable audits relating to the financial statements provided by the Alcon Group; provided, however, that such access shall not be unreasonably disruptive to the business and affairs of the Alcon Group.

 

(b)                                  Until the end of the first full fiscal year occurring after the Distribution (and for a reasonable period of time afterwards as required by Applicable Law), Novartis shall use Commercially Reasonable Efforts to enable:

 

(i)                   Alcon’s management to assess the effectiveness of its disclosure controls and procedures and its internal control over financial reporting as required under Applicable Law;

 

(ii)                Alcon’s auditors to timely complete their annual audit and quarterly reviews of financial statements; and

 

(iii)             Alcon to meet its timetable for dissemination of its financial statements and to enable.

 

As part of such efforts, to the extent reasonably necessary for the preparation of financial statements or completing an audit or review of financial statements or an audit of internal control over financial reporting:

 

(A)                                Novartis shall authorise and direct its auditors to make available to Alcon’s auditors, within a reasonable time prior to the date of Alcon’s auditors’ opinion or review report, both (x) the personnel who performed or will perform the annual audits and quarterly reviews of Novartis and (y) work papers related to such annual audits and quarterly reviews, to enable Alcon’s auditors to perform any procedures they consider reasonably necessary to take responsibility for the work of Novartis’s auditors as it relates to Alcon’s auditors’ opinion or report, and

 

(B)                                until all governmental audits are complete, Novartis shall provide reasonable access during normal business hours for Alcon’s auditors, counsel and other designated representatives to (x) the premises of the Novartis Group and all Information (and duplicating rights) within the knowledge, possession or control of the Novartis Group and (y) the officers and employees of the members of the Novartis Group, so that Alcon may conduct reasonable audits relating to the financial statements provided by the Novartis Group; provided, however, that such access shall not be unreasonably disruptive to the business and affairs of the Novartis Group.

 

17.11      Separation Date Balance Sheet .

 

(a)                                  Alcon shall provide such assistance as Novartis (or the auditors it appoints for such purposes) may reasonably request in order to allow Novartis (or the auditors it appoints for such purposes) to prepare an audited, stand-alone statutory balance sheet of Alcon as at: (i) the last day of the month immediately prior to the month in which

 

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the Distribution occurs; or, if later, (ii) the day after the date on which the transfer of the Alcon Transferring Entities to Alcon is completed (the Separation Balance Sheet ), which shall be prepared in accordance with the methodologies and accounting principles used to prepare the Alcon Carve-out Balance Sheet and shall be delivered to both Alcon and Novartis as soon as reasonably practicable following the Distribution.

 

(b)                                  In respect of the preparation of the Separation Balance Sheet, any costs incurred by Alcon or Novartis (or their respective external auditors) in preparation and/or audit of the Separation Balance Sheet shall be borne by Novartis.

 

17.12      General Information and Knowledge Sharing.

 

(a)                                  Subject to paragraph (b) below, for a period of one year after the Separation Date, Novartis shall use Commercially Reasonable Efforts during normal business hours to provide any information, Know-How, guidance and assistance reasonably requested by Alcon to the extent that such information, Know-How, guidance or assistance relates to the operation of the Alcon Business, in each case at Alcon’s expense.

 

(b)                                  Novartis shall not be obliged to provide any information, Know-How, guidance or assistance pursuant to paragraph (a) above if doing so would be likely to be unreasonably disruptive to the business and affairs of the Novartis Group.

 

(c)                                   Subject to paragraph (d) below, for a period of one year after the Separation Date, Alcon shall use Commercially Reasonable Efforts during normal business hours to provide any information, Know-How, guidance and assistance reasonably requested by Novartis to the extent that such information, Know-How, guidance or assistance relates to the operation of the Novartis Business, in each case at Novartis’s expense.

 

(d)                                  Alcon shall not be obliged to provide any information, Know-How, guidance or assistance pursuant to paragraph (c) above if doing so would be likely to be unreasonably disruptive to the business and affairs of the Alcon Group.

 

(e)                                   For the avoidance of doubt, this Clause 17.12 ( General Information and Knowledge Sharing ) shall not give either Party (or any member of their Group) any right to access any Books and Records of the other Party (or any member of its Group).

 

17.13      Privilege and Litigation . Notwithstanding the forgoing or any of the provisions of the Agreement, neither Party shall be required to disclose any documents or communications protected by the attorney-client privilege, the work product doctrine or any other legal privilege if doing so would result in the loss of any applicable privilege or other protection. The rights conferred under the Agreement shall not affect in any manner either Party’s rights to discovery in any litigation and shall not create any rights for Third Parties to access the documents, employees or information of either Party.

 

18.             INSURANCE

 

18.1        No cover under the Insurance Arrangements from the Separation Date. Each Party agrees that with effect from the Separation Date:

 

(a)                                  Other than pursuant to this Clause 18 ( Insurance ), no member of the Alcon Group (including any Alcon Transferring Entity) shall have, or be entitled to, the benefit of any insurance policies of the Novartis Group in respect of any event, act or omission

 

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that takes place after the Separation Date and it shall be the sole responsibility of Alcon to ensure that adequate insurances are put in place in relation to the Alcon Business with effect from the Separation Date; and

 

(b)                                  Novartis shall not be required to maintain any Insurance Arrangements for the benefit of any Alcon Transferring Entity or in respect of any Alcon Transferring Asset.

 

18.2        Run-off D&O Insurance.

 

(a)                                  Novartis shall use Commercially Reasonable Efforts to arrange, with effect from the Separation Date, run-off director and officer insurance coverage in respect of the directors, officers and other relevant individuals who were covered by Novartis director and officer insurance policies immediately prior to the Separation Date of each of Alcon and each Alcon Transferring Entity on such terms as may be agreed between Novartis and Alcon (the Run-Off D&O Insurance ) .

 

(b)                                  The cost of the Run-Off D&O Insurance shall be borne by Alcon.

 

18.3        Post-Separation Claims Under the Run-off D&O Insurance.

 

(a)                                  Novartis shall use Commercially Reasonable Efforts, upon the request of Alcon, to pursue claims against the relevant insurers for recovery for any loss, liability or damage identified by Alcon that may be recoverable under the Run-off D&O Insurance, to the extent that the terms and conditions of the Run-off D&O Insurance provides coverage therefor.

 

(b)                                  Any claim by Novartis against the relevant insurers under the Run-off D&O Insurance shall be treated as an Affirmative Claim under the Third Party Claims and Investigations Management Agreement.

 

18.4        General Insurance Provisions

 

(a)                                  This Agreement is not intended as an attempted assignment of any policy of insurance or as a Contract of insurance and shall not be construed to waive any right or remedy of any member of Novartis Group in respect of any Insurance Arrangement or any other Contract or policy of insurance.

 

(b)                                  Nothing in this Clause 18 ( Insurance ) shall limit Novartis’s ability to operate any policy of insurance of Novartis Group (including any Insurance Arrangement) for the benefit of the Novartis Business.

 

19.             SEPARATION COMMITTEE

 

19.1        Separation Committee . Prior to the Separation Date, the Parties shall establish a Separation Committee (the Separation Committee ) that shall consist of an equal number of members from Novartis and Alcon. The Separation Committee shall be responsible for the overall monitoring and management all matters related to any of the transactions contemplated by this Agreement or any Ancillary Agreements. The Separation Committee shall have the authority to:

 

(a)                                  establish one or more subcommittees from time to time as it deems appropriate or as may be described in any Ancillary Agreements, with each such subcommittee comprised of one or more members of the Separation Committee or one or more

 

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employees of either Party or any of its Subsidiaries, and each such subcommittee having such scope of responsibility as may be determined by the Separation Committee from time to time;

 

(b)                                  delegate to any such committee any of the powers of the Separation Committee; and

 

(c)                                   to combine, modify the scope of responsibility of, and disband any such subcommittees, and to modify or reverse any such delegations.

 

19.2        Separation Committee Procedures . The Separation Committee shall establish general procedures for managing the responsibilities delegated to it under this Clause 19 ( Separation Committee ), and may modify such procedures from time to time.  All decisions by the Separation Committee or any subcommittee thereof shall be effective only if mutually agreed by both Parties. The Parties shall utilise the procedures set forth in Clause 41 ( Dispute Resolution ) to resolve any matters as to which the Separation Committee is not able to reach a decision.

 

20.             SWITCH RIGHTS

 

20.1        Alcon Switch Rights . Novartis shall, and shall procure that the relevant members of the Novartis Group shall,  with effect from the Separation Date, grant to Alcon (for and on behalf of the Alcon Group) the right to (i) switch Patanol, Pataday, Patanase and/or Pazeo (and any product having substantially the same formula as any of the foregoing) from Prescription Products to Over-the-counter Products and (ii) to Develop, Manufacture and/or Commercialise Patanol, Pataday, Patanase and/or Pazeo (and any product having substantially the same formula as any of the foregoing) as an Over-the-counter Product in any jurisdiction (the Alcon Switch Rights ), exercisable upon written notice by Alcon to Novartis in accordance with Clause 20.2 ( Switch Process ).

 

20.2        Switch Process . If Alcon wishes to exercise its Alcon Switch Right in any jurisdiction:

 

(a)                                  Alcon shall give written notice of its request to Novartis (a Switch Notic e);

 

(b)                                  if the jurisdiction in which Alcon wishes to exercise its Alcon Switch Right is the United States of America, the Switch Process shall commence from the date specified by Alcon in the Switch Notice;

 

(c)                                   if the jurisdiction in which Alcon wishes to exercise its Alcon Switch Right is outside of the United States of America:

 

(i)                   the Switch Process shall not commence unless and until Novartis gives its written consent (in its sole discretion) to Alcon’s request to initiate the Switch Process in the relevant jurisdiction; and

 

(ii)                where consent is granted by Novartis pursuant to Clause 20.2(c)(i), the Switch Process shall commence from the date notified by Novartis in such notice; and

 

(d)                                  once the Switch Process has commenced in any jurisdiction:

 

(i)                   Alcon shall have control of the Switch Process, including preparing and submitting any application or registration information to the relevant

 

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Governmental Entity as necessary to obtain Marketing Authorisation to Commercialise  the relevant product as an Over-the-counter Product, provided that Alcon shall consult with Novartis in respect of such Switch Process and shall provide Novartis with drafts of any submissions to be sent to such Governmental Entity in relation to the Switch Process a reasonable period of time in advance of their submission and shall incorporate any such comments as may be reasonably required by Novartis on such documentation;

 

(ii)                if the Switch Process results in the successful registration of a relevant product as an Over-the-counter Product:

 

(A)                                in jurisdictions where it is possible to sell the product (or any product having substantially the same formula as the product) simultaneously as a Prescription Product and as an Over-the-counter Product, Novartis shall retain the right to sell the product as a Prescription Product and Alcon shall have the right to sell the product as an Over-the-counter Product; and

 

(B)                                in jurisdictions where it is not possible to sell the product simultaneously as a Prescription Product and as an Over-the-counter Product, Alcon shall have the right to sell the product as an Over-the-counter Product and Novartis shall cease to sell the product; and

 

(iii)             the Parties shall negotiate in good faith to agree the terms of:

 

(A)                                a transitional agreement between Alcon and Novartis to govern (I) the Switch Process and the transfer (where applicable) of the Development, Manufacture and Commercialisation of the product to Alcon; (II) the transfer (where applicable) of any Marketing Authorisations to Alcon; and (III) any other actions reasonably required in order to give effect to the Alcon Switch Rights granted to Alcon pursuant to this Clause 20 ( Switch Rights );

 

(B)                                if and to the extent reasonably required from a regulatory or safety perspective, an agreement governing the ongoing relationship between Novartis and Alcon (and the respective members of their Groups) in connection with interactions required between the Parties on regulatory and safety grounds for products that may be linked from a regulatory or safety perspective including as a result of (I) being sold under the same trademarks; (II) sharing the same active pharmaceutical ingredient(s); (II) relying on the same Marketing Authorisation Information controlled by the other Party; or (IV) relying on a Marketing Authorisation held by the other Party; and

 

(C)                                any amendments to the schedules to the Patent and Know-How Licence Agreement and/or Brand Licence Agreement such that, to the extent the Intellectual Property Rights are owned or controlled by Novartis as of the Separation Date and are necessary to give effect to the Alcon Switch Rights granted to Alcon pursuant to this Clause 20 ( Switch Rights ), then Novartis, subject to any encumbrances of, or contractual terms that relate to, any such Intellectual Property Rights, between Novartis and a Third Party from time to time (including all relevant Third Party royalty or other payment obligations to the

 

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extent that they relate to those Intellectual Property Rights in which case Alcon agrees to be responsible for any applicable royalty or other payment obligations to the relevant Third Party as if it were a party to the relevant contract or arrangement), shall grant such rights to Alcon on the terms of the Patent and Know-How Licence Agreement and/or the Brand Licence Agreement, as applicable, at no additional cost to Alcon.

 

21.             PUURS

 

Puurs Sites

 

21.1        Notice of a potential Puurs Transfer . Novartis and Alcon shall each procure that if the relevant member of its Group wishes to transfer, sell, or dispose of any right or interest in its Puurs Site (a Puurs Transfer ), the entity intending to implement the Puurs Transfer (the Puurs Seller ) shall first give the other Party, or a member of the other Party’s Group nominated by the other Party for such purposes, (the Puurs Continuing Party ) notice of the proposed potential Puurs Transfer as soon as reasonably practicable after commencing negotiations (and in any event within 5 days after commencing negotiations) with the relevant third party purchaser (the Third Party Purchaser ).

 

21.2        Puurs ROLL Notice. Novartis and Alcon shall procure that before the Puurs Seller completes any Puurs Transfer to the Third Party Purchaser, the Puurs Seller shall first give the Puurs Continuing Party notice of the proposed Puurs Transfer (a Puurs Right of Last Look Notice ), which shall include the purchase price and fully described terms and conditions of the proposed Puurs Transfer and the identity of the Third Party Purchaser. A Puurs Right of Last Look Notice shall be irrevocable.

 

21.3        Puurs ROLL Exercise . Novartis and Alcon shall procure that on receipt of the Puurs Right of Last Look Notice, the Puurs Continuing Party shall have the right to buy the Puurs Seller’s Puurs Site at the price, and on substantially the same terms, set out in the Puurs Right of Last Look Notice by giving notice to the Puurs Seller within 30 days of receiving the Puurs Right of Last Look Notice.

 

21.4        Third Party Puurs Transfer . Novartis and Alcon shall procure that if the Puurs Continuing Party does not exercise its right to buy under Clause 21.3 ( Puurs ROLL Exercise ) the Puurs Seller may only transfer the Puurs Seller’s Puurs Site to the Third Party Purchaser identified in the Puurs Right of Last Look Notice at the price and on substantially the same terms specified in the Puurs Right of Last Look Notice and not to a different Third Party Purchaser and/or at a different price or on different terms.

 

21.5        Puurs Transfer Completion . Novartis and Alcon shall procure that the Puurs Continuing Party shall be bound to buy (and the Puurs Seller shall be bound to sell) the Puurs Seller’s Puurs Site on giving the Puurs Seller notice that it is exercising its right under Clause 21.3 ( Puurs ROLL Exercise ). In such event, completion of the sale and purchase of the Puurs Seller’s Puurs Site shall take place within 90 days of giving notice.

 

21.6        Puurs Separation .

 

(a)                                  Alcon:

 

(i)                   shall have control of the implementation of the separation of the Alcon Puurs Site from the Novartis Puurs Site, and shall use Commercially Reasonable

 

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Efforts to implement such separation in order to achieve the outcomes, and the finished separation state, set out in the Puurs Separation Plan; and

 

(ii)      shall (or shall procure that the relevant member of the Alcon Group shall) bear all capital expenditure paid or incurred by the Alcon Group or the Novartis Group (whether before, on, or after the Separation Date) in connection with such separation.

 

(b)                                  Novartis shall (or shall procure that the relevant member of the Novartis Group) shall cooperate reasonably with Alcon (or the relevant member of the Alcon Group) in order to effect the separation referred to in paragraph (a) above.

 

Innova Equipment Line

 

21.7        Notice of a potential Innova Line Transfer . Novartis shall procure that if the relevant member of its Group wishes to transfer, sell, or dispose of any right or interest in the Innova Line (a Innova Line Transfer ), the entity intending to implement the Innova Line Transfer (the Innova Line Seller ) shall first give Alcon, or a member of the Alcon Group nominated by Alcon for such purposes, (the Innova Line Offeree ) notice of the proposed potential Innova Line Transfer as soon as reasonably practicable after commencing negotiations (and in any event within 5 days after commencing negotiations) with the relevant Third Party Purchaser.

 

21.8        Innova Line ROLL Notice. Novartis shall procure that before the Innova Line Seller completes any Innova Line Transfer to the Third Party Purchaser, the Innova Line Seller shall first give the Innova Line Offeree notice of the proposed Innova Line Transfer (an Innova Line Right of Last Look Notice ), which shall include the purchase price and fully described terms and conditions of the proposed Innova Line Transfer and the identity of the Third Party Purchaser. An Innova Line Right of Last Look Notice shall be irrevocable.

 

21.9        Innova Line ROLL Exercise . Novartis and Alcon shall procure that on receipt of the Innova Line Right of Last Look Notice, the Innova Line Offeree shall have the right to buy the Innova Line at the price, and on substantially the same terms, set out in the Innova Line Right of Last Look Notice by giving notice to the Innova Line Seller within 30 days of receiving the Innova Line Right of Last Look Notice.

 

21.10      Third Party Innova Line Transfer . Novartis and Alcon shall procure that if the Innova Line Offeree does not exercise its right to buy under Clause 21.9 ( Innova Line ROLL Exercise ) the Innova Line Seller may only transfer the Innova Line to the Third Party Purchaser identified in the Innova Line Right of Last Look Notice at the price and on substantially the same terms specified in the Innova Line Right of Last Look Notice and not to a different Third Party Purchaser and/or at a different price or on different terms.

 

21.11      Innova Line Transfer Completion . Novartis and Alcon shall procure that the Innova Line Offeree shall be bound to buy (and the Innova Line Seller shall be bound to sell) the Innova Line on giving the Innova Line Seller notice that it is exercising its right under Clause 21.11 ( Innova Line Transfer Completion ). In such event, completion of the sale and purchase of the Innova Line shall take place within 90 days of giving notice.

 

22.             BRAZIL SITE

 

22.1        Notice of a potential Brazil Transfer . Novartis shall procure that if the relevant member of its Group wishes to transfer, sell, or dispose of any right or interest in the Novartis

 

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Brazil Site (a Brazil Transfer ), the relevant member of the Novartis Group (the Brazil Seller ) shall first give Alcon notice of the proposed potential Brazil Transfer as soon as reasonably practicable after commencing negotiations (and in any event within 5 days after commencing negotiations) with the relevant Third Party Purchaser.

 

22.2        Brazil ROLL Notice . Novartis shall procure that before the Brazil Seller completes any Brazil Transfer to the Third Party Purchaser, the Brazil Seller shall first give Alcon notice of the proposed Brazil Transfer (a Brazil Right of Last Look Notice ), which shall include the purchase price and fully described terms and conditions of the proposed Brazil Transfer and the identity of the Third Party Purchaser. A Brazil Right of Last Look Notice shall be irrevocable.

 

22.3        Brazil ROLL Exercise . Novartis shall procure that on receipt of the Brazil Right of Last Look Notice, Alcon or any member the Alcon Group nominated by Alcon for such purposes (the Brazil Continuing Party ) shall have the right to buy the Novartis Brazil Site at the price, and on substantially the same terms, set out in the Brazil Right of Last Look Notice by giving notice to the Brazil Seller within 30 days of receiving the Brazil Right of Last Look Notice.

 

22.4        Third Party Brazil Transfer . Novartis shall procure that if the Brazil Continuing Party does not exercise its right to buy under Clause 22.3 ( Brazil ROLL Exercise ) the Brazil Seller may only transfer the Novartis Brazil Site to the Third Party Purchaser identified in the Brazil Right of Last Look Notice at the price and on substantially the same terms specified in the Brazil Right of Last Look Notice and not to a different Third Party Purchaser and/or at a different price or on different terms.

 

22.5        Brazil Transfer Completion . Alcon shall procure that the Brazil Continuing Party shall be bound to buy (and the Brazil Seller shall be bound to sell) the Novartis Brazil Site on giving the Brazil Seller notice that it is exercising its right under Clause 22.3 ( Brazil ROLL Exercise ). In such event, completion of the sale and purchase of the Novartis Brazil Site shall take place within 90 days of giving notice.

 

23.             APL/NOAG INTERFACE

 

Novartis and Alcon shall use Commercially Reasonable Efforts to implement a systems interface between the SAP system of Alcon Pharmaceuticals Limited and the JDE system of Novartis Ophthalmics AG, in accordance with the plan agreed between Novartis and Alcon, the costs of which implementation shall be borne by Novartis.

 

24.             WARRANTY AS TO CAPACITY

 

Each Party has obtained all corporate authorisations and (other than to the extent any such consent, license or authorisation constitutes a Global Condition) all other governmental, statutory, regulatory or other consents, licences or authorisations required to empower it to enter into and perform its obligations under this Agreement where failure to obtain them would adversely affect to a material extent such Party’s ability to enter into or perform its obligations under this Agreement.

 

25.             WRONG POCKETS

 

25.1        Non-transferred Assets. Subject to Clause 7 ( Brazil ), Clause 8 ( Transferring Contracts ), Clause 9 ( Matters Governed Exclusively by Ancillary Agreements ), Clause

 

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17 ( Access to Information; Books and Records ), Schedule 2 ( Transferring Contracts ) and Schedule 3 ( Brazil ), and except as otherwise expressly provided for in this Agreement or any Ancillary Agreement, if, following the Separation Date:

 

(a)                                  any property, right or asset forming part of the Alcon Business (other than any property, right or asset expressly excluded from the Separation under this Agreement or any Ancillary Agreement) has not and should have been transferred to Alcon, or to another member of the Alcon Group, pursuant to this Agreement or any Ancillary Agreement or otherwise, Novartis shall use Commercially Reasonable Efforts to procure that all right, title and interest in such property, right or asset (and any related liability which is an Alcon Liability) is assigned and transferred to Alcon (or another member of the Alcon Group as Alcon may nominate reasonably acceptable to Novartis) as soon as practicable and at no cost to Alcon (or any member of its Group), and such member of the Alcon Group shall accept such transfer or assume such assignment in accordance with the terms of this Agreement. Pending such transfer and subject to Applicable Law, Novartis shall cause such property, right or asset to be held on trust and provide to Alcon or its designated assignee all of the benefits associated with such property, right or asset (in accordance with Schedule 2 ( Transferring Contracts ), if applicable); or

 

(b)                                  any property, right or asset forming part of the Novartis Business (other than any property, right or asset expressly excluded from the Separation under this Agreement or any Ancillary Agreement) has not and should have been transferred to Novartis, or to another member of the Novartis Group, pursuant to this Agreement or any Ancillary Agreement or otherwise, Alcon shall use Commercially Reasonable Efforts to procure that all right, title and interest in such property, right or asset (and any related liability which is a Novartis Liability) is assigned and transferred to Novartis (or another member of the Novartis Group as Novartis may nominate reasonably acceptable to Alcon) as soon as practicable and at no cost to Novartis (or any member of its Group), and such member of the Novartis Group shall accept such transfer or assume such assignment in accordance with the terms of this Agreement. Pending such transfer and subject to Applicable Law, Alcon shall cause such property, right or asset to be held on trust and provide to Novartis or its designated assignee all of the benefits associated with such property, right or asset.

 

25.2        Incorrectly Transferred Assets. Subject to Clause 7 ( Brazil ), Clause 8 ( Transferring Contracts ), Clause 9 ( Matters Governed Exclusively by Ancillary Agreements ) and Clause 17 ( Access to Information; Books and Records ), Schedule 2 ( Transferring Contracts ) and Schedule 3 ( Brazil ), and except as otherwise expressly provided for in this Agreement or any Ancillary Agreement, if, following the Separation Date:

 

(a)                                  any property, right or asset not forming part of the Alcon Business (other than any property, right or asset expressly included in the sale under this Agreement or any Ancillary Agreement) is found to have and should not have been transferred to Alcon or another member of the Alcon Group pursuant to this Agreement or any Ancillary Agreement, Alcon shall transfer (or procure the transfer of) such property, right or asset as soon as practicable to the transferor or another member of the Novartis Group nominated by Novartis reasonably acceptable to Alcon at no cost to the Novartis Group; or

 

(b)                                  any property, right or asset not forming part of the Novartis Business (other than any property, right or asset expressly included in the sale under this Agreement or any Ancillary Agreement) is found to have and should not have been transferred to Novartis or another member of the Novartis Group pursuant to this Agreement or any

 

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Ancillary Agreement, Novartis shall transfer (or procure the transfer of) such property, right or asset as soon as practicable to the transferor or another member of the Alcon Group nominated by Alcon reasonably acceptable to Novartis at no cost to the Alcon Group.

 

25.3        Timing of Wrong Pockets Transfer. Any transfer pursuant to this Clause 25 ( Wrong Pockets ) shall be treated by the Parties for all purposes as if it had occurred on the Separation Date, except as otherwise required by Applicable Law.

 

25.4        Additional Asset Transfers . Subject to Clause 7 ( Brazil ), Clause 8 ( Transferring Contracts ), Clause 9 ( Matters Governed Exclusively by Ancillary Agreements ), Clause 17 ( Access to Information; Books and Records ), Schedule 2 ( Transferring Contracts ) and Schedule 3 ( Brazil ), and except as otherwise expressly provided for in this Agreement or any Ancillary Agreement, if either of the Parties identifies:

 

(a)                                  any property, right or asset that is an Alcon Transferring Asset or is Exclusively Related to the Alcon Business (other than any property, right or asset expressly excluded from the Separation under this Agreement or any Ancillary Agreement and excluding any Novartis Retained Asset) that has not been transferred to Alcon, or to another member of the Alcon Group, pursuant to this Agreement or any Ancillary Agreement or otherwise, or is held by a member of the Novartis Group after the Separation Date, then:

 

(i)       the Parties shall use their respective Commercially Reasonable Efforts to procure that the holder of such property, right or asset shall be deemed to be an Alcon Asset Transferor for the purposes of this Agreement;

 

(ii)      Alcon shall nominate a member of the Alcon Group (acceptable to Novartis, acting reasonably) as the Alcon Asset Transferee for such property, right or asset and such member of the Alcon Group shall be deemed to be an Alcon Asset Transferee for the purposes of this Agreement; and

 

(iii)             the provisions of Clause 25.1 ( Non-transferred Assets ) shall apply to such property, right or asset; or

 

(b)                                  any property, right or asset that is a Novartis Retained Asset or is Exclusively Related to the Novartis Business (other than any property, right or asset expressly excluded from the Separation under this Agreement or any Ancillary Agreement and excluding any Alcon Transferring Assets), that has not been transferred to Novartis, or to another member of the Novartis Group, pursuant to this Agreement or any Ancillary Agreement or otherwise, or is held by a member of the Alcon Group after the Separation Date, then:

 

(i)                   the Parties shall use their respective Commercially Reasonable Efforts to procure that the holder of such property, right or asset shall be deemed to be a Novartis Asset Transferor for the purposes of this Agreement;

 

(ii)                Novartis shall nominate a member of the Novartis Group (acceptable to Alcon, acting reasonably) as the Novartis Asset Transferee for such property, right or asset and such member of the Novartis Group shall be deemed to be a Novartis Asset Transferee for the purposes of this Agreement; and

 

(iii)             the provisions of Clause 25.1 ( Non-transferred Assets ) shall apply to such property, right or asset.

 

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25.5                         Compensation for Wrong Pockets Transfers. Following the transfer of any property, right or asset pursuant to this Clause 25 ( Wrong Pockets ) from any entity that is not party to a Local Separation Agreement, or where otherwise required under Applicable Law, Novartis (in respect of any property, right or asset transferred by any member of the Novartis Group) or Alcon (in respect of any property, right or asset transferred by any member of the Alcon Group) shall compensate the relevant member of its Group for the fair market value of such property, right or asset.

 

25.6                         Books and Records . For the avoidance of doubt, the provisions of this Clause 25 ( Wrong Pockets ) shall not apply to Books and Records, in respect of which the provisions of Clause 17 ( Access to Information; Books and Records ) shall apply.

 

25.7                         Wrong Pockets IP Licence

 

(a)                                  Except to the extent otherwise addressed in this Agreement or an Ancillary Agreement, if following the Separation Date Alcon identifies any Intellectual Property Rights owned or controlled by Novartis or a member of its Group as at the Separation Date that were used in the Alcon Business and have not been licensed to Alcon pursuant to the terms of the Patent and Know-How License Agreement or the Brand License Agreement, then Novartis shall use Commercially Reasonable Efforts to license or cause its relevant Group member to license the relevant Intellectual Property Rights to Alcon on the same terms as provided under the Patent and Know-How License Agreement or the Brand License Agreement, as applicable, as soon as practicable and at no cost to Alcon.

 

(b)                                  Except to the extent otherwise addressed in this Agreement or an Ancillary Agreement, if following the Separation Date Novartis identifies any Intellectual Property Rights owned or controlled by Alcon or a member of its Group as at the Separation Date that were used in the Novartis Business and have not been licensed to Novartis pursuant to the terms of the Patent and Know-How License Agreement or the Brand License Agreement, then Alcon shall use Commercially Reasonable Efforts to license or cause its relevant Group member to license the relevant Intellectual Property Rights to Novartis on the same terms as provided under the Patent and Know-How License Agreement or the Brand License Agreement, as applicable, as soon as practicable and at no cost to Novartis.

 

26.             FURTHER ASSURANCES

 

26.1                         Further Acts and Documents. Subject to the express limitations in this Agreement, each of the Parties shall, at such Person’s sole expense, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or reasonably required to implement and give effect to this Agreement.

 

26.2                         Obligations of Agreement on Affiliates. Each of Novartis and Alcon shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

26.3                         Ratification of Past Actions. On or prior to the Separation Date, Novartis and Alcon, in their respective capacities as direct and indirect shareholders of their respective Subsidiaries, shall each ratify any actions that have been taken by the Parties (or any member of their Group) prior to the date of such ratification and/or which may be reasonably necessary or desirable to be taken by Alcon or any other Subsidiary of Novartis, as the case

 

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may be, after such date, in each case to effectuate the transactions contemplated by this Agreement and the other Transaction Documents.

 

27.             TERMINATION

 

27.1                         Novartis Termination Right. This Agreement may be terminated by Novartis at any time, in its sole discretion, prior to the Distribution. In the event of any termination of this Agreement prior to the Distribution, neither Party (nor and of their respective Representatives) shall have any Liability or further obligation to the other Party under this Agreement or any Transaction Document.

 

27.2                         No Additional Termination Rights. Other than pursuant to Clause 27.1 ( Novartis Termination Right ), no Party shall be entitled to rescind or terminate this Agreement in any circumstances whatsoever (whether before or after the Separation and/or Distribution). This shall not exclude any liability for (or remedy in respect of) fraudulent misrepresentation.

 

28.             CONFIDENTIALITY

 

28.1                         Confidentiality Obligation . Each of Novartis and Alcon shall, and shall procure that each member of their respective Groups shall, hold, and cause its Representatives to hold, in strict confidence and not release or disclose, with at least the same degree of care that Novartis applies to its own confidential and proprietary Information pursuant to policies in effect immediately prior to the Separation (but no less than a reasonable degree of care), all Information concerning the Alcon Business (in respect of the obligations of the members of the Novartis Group) or the Novartis Business (in respect of the obligations of the members of the Alcon Group) that is either in its possession (including Information in its possession prior to the Separation and including the Retained Records) or furnished by the other Group or its respective Representatives at any time pursuant to this Agreement or any Ancillary Agreement, and shall not use any such Information other than for such purposes as shall be expressly permitted hereunder or thereunder, except, in each case, to the extent that such Information is:

 

(a)                                  in the public domain through no fault of any member of the Novartis Group or the Alcon Group, as applicable, or any of its respective directors, officers, employees, agents, accountants, counsel and other advisors and representatives,

 

(b)                                  lawfully acquired from other sources by any member of the Novartis Group or the Alcon Group, as applicable, or any of their respective Representatives, which sources are not themselves bound by a confidentiality obligation to the knowledge of Novartis or Alcon, as applicable;

 

(c)                                   independently generated without reference to any proprietary or confidential Information of the Novartis Group or the Alcon Group, as applicable, or

 

(d)                                  required to be disclosed by Applicable Law or the lawful requirements of any Governmental Entity; provided, however, that the Person required to disclose such Information shall give the applicable Person prompt, and to the extent reasonably practicable, prior notice of such disclosure and an opportunity to contest such disclosure and shall use Commercially Reasonable Efforts to cooperate, at the expense of the requesting Person, in seeking any reasonable protective arrangements requested by such Person.

 

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28.2                         Exceptions to Confidentiality Obligation . Notwithstanding the foregoing, each of Novartis and Alcon (and the members of their respective Group) may release or disclose, or permit to be released or disclosed, any Information concerning the Alcon Business (in respect of the obligations of the members of the Novartis Group) or the Novartis Business (in respect of the obligations of the members of the Alcon Group):

 

(a)                                  to their respective Representatives who need to know such Information (who shall be advised of the obligations hereunder with respect to such Information) and

 

(b)                                  to any nationally recognised statistical rating organisation as it reasonably deems necessary, solely for the purpose of obtaining a rating of securities or other debt instruments upon normal terms and conditions; provided, however, that the Party whose Information is being disclosed or released to such rating organisation is promptly notified thereof.

 

29.             ANNOUNCEMENTS

 

29.1                         No Announcement Without Approval . From and after the date of the Distribution, neither Party (nor any of their respective Affiliates) shall, without the prior written approval of the other Party (such approval not to be unreasonably withheld, conditioned or delayed), make any public announcement or other communication about or in connection with the subject matter of this Agreement (or any other Transaction Document) or the Alcon Business (in the case of Novartis) or the Novartis Business (in the case of Alcon) or any Covered Claims and Investigations within the scope of clause 18.1 of the Third Party Claims and Investigations Management Agreement, or in relation to the Asia Investigation (or the matters that are the subject of the Asia Investigation or any Related Claim or Related Investigation (each as defined in the Asia Investigation Management Agreement)), that contains any information, statement, fact or opinion that is not either (i) in the public domain prior to the date of this Agreement through no fault of any member of the Novartis Group or the Alcon Group, as applicable, or any of its respective directors, officers, employees, agents, accountants, counsel and other advisors and representatives; or (ii) disclosed in the Listing Prospectus, the Registration Statement or any document publicly filed in connection therewith.

 

29.2                         Required Announcements . The restriction in Clause 29.1 ( No Announcement Without Approval ) shall not apply to the extent that the announcement or other communication is required by Applicable Law, any stock exchange or any regulatory or supervisory body or authority of competent jurisdiction. If this exception applies, Novartis or Alcon (as applicable) shall, in advance of the announcement or other communication being made by the relevant Party, use its Commercially Reasonable Efforts to consult in good faith with the other Party in advance as to the form, content and timing of such announcement or other communication and to take into account any reasonable comments of the other Party in respect of such announcement or other communication.

 

30.             ASSIGNMENT

 

30.1                         No Assignment Without Consent. Unless Novartis and Alcon agree in writing, no Person shall assign, transfer, charge or otherwise deal with all or any of its rights under this Agreement nor grant, declare, create or dispose of any right or interest in it. Any purported assignment in contravention of this Clause 30 ( Assignment ) shall be void.

 

30.2                         No Increased Liabilities. If an assignment is made in accordance with this Clause 30 ( Assignment ), the liabilities of the members of the Novartis Group to the Alcon Group, and

 

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the Alcon Group to the Novartis Group, as applicable, under this Agreement shall be no greater than such liabilities would have been if the assignment had not occurred.

 

31.             COSTS

 

31.1                         Legal and Financial Advisor Fees . Novartis shall bear all fees, charges and other expenses payable to any legal counsel or financial advisor appointed by Novartis in relation to the Separation and/or the Distribution, including all fees, charges and other expenses payable to Freshfields Bruckhaus Deringer LLP, Cravath, Swaine & Moore LLP, Bär & Karrer AG, Hogan Lovells LLP, Bank of America Merrill Lynch, and UBS Group AG.

 

31.2                         Costs. Subject to Clause 31.1 ( Legal and Financial Advisor Fees ) and except as otherwise provided in this Agreement or any Ancillary Agreement or as otherwise agreed in writing between the Parties, Novartis and Alcon shall each be responsible for its own costs, charges and other expenses (including those of members of their respective Groups) incurred in connection with the Separation and the Distribution.

 

32.             NOTICES

 

32.1                         Form of Notice . Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it (in the case of notice by e-mail, a notice signed electronically or a scanned copy of a signed original notice shall suffice). It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Novartis shall be deemed notice to all members of Novartis Group, and any notice to Alcon shall be deemed notice to all members of Alcon Group.

 

32.2                         Effectiveness of Notice . A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

32.3                         Notice Details . The addresses and e-mail addresses of the Parties for the purpose of Clause 32.1 ( Form of Notice ) are:

 

Novartis and each member of the Novartis Group

 

For the attention of: Head Legal M&A (Novartis International AG)

Novartis Campus
Fabrikstrasse 18-2.47
4056 Basel

Switzerlandjonathan.emery@novartis.com

 

Alcon and each member of the Alcon Group

 

For the attention of: General Counsel

Alcon Inc
Rue Louis-d’Affry 6,
1701 Fribourg,
Switzerland

royce.bedward@alcon.com

 

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32.4                         Change of Notice Details . Novartis and Alcon shall each notify the other Party in writing of a change to its details in Clause 32.3 ( Notice Details ) from time to time.

 

33.             CONFLICT WITH OTHER AGREEMENTS

 

Subject to Clauses 4.2 ( Inconsistencies with Local Separation Agreements ) and 9.2 ( Ancillary Agreement Conflicts ), if there is any conflict between the terms of this Agreement and any other agreement, this Agreement shall prevail (as between the parties to this Agreement and as between any members of the Novartis Group and any members of the Alcon Group) unless (i) such other agreement expressly states that it overrides this Agreement in the relevant respect and (ii) Novartis and Alcon are either also parties to that other agreement or otherwise expressly agree in writing that such other agreement shall override this Agreement in that respect.

 

34.             WHOLE AGREEMENT

 

34.1                         In this Clause 34 ( Whole Agreement ) the Transaction Parties shall mean Novartis, Alcon and each Alcon Asset Transferor, Alcon Asset Transferee, Alcon Share Transferor, Alcon Share Transferee, Novartis Asset Transferor, Novartis Asset Transferee, Novartis Share Transferor and Novartis Share Transferee, and each of them shall be a Transaction Party .

 

34.2                         This Agreement and the other Transaction Documents together set out the whole agreement between the Transaction Parties in respect of the Separation and the Distribution and supersede any previous draft, agreement, arrangement or understanding, whether in writing or not, relating to the Separation and/or the Distribution. It is agreed that:

 

(a)                                  no Transaction Party has relied on or shall have any claim or remedy arising under or in connection with any statement, representation, warranty or undertaking made by or on behalf of any other Transaction Party (or any of its Representatives) in relation to the Separation and/or the Distribution that is not expressly set out in this Agreement or any other Transaction Document;

 

(b)                                  except as expressly set out in this Agreement or any other Transaction Document, no Party is: (i) representing or warranting to any other Party in any way as to (A) the Alcon Transferring Entities, Alcon Transferring Assets, Novartis Transferring Entities, Novartis Transferring Assets, Alcon Liabilities or Novartis Liabilities; (B) any approvals or notifications required in connection therewith or otherwise in connection with this Agreement; or (C) the value or freedom from any security interests of, or any matter concerning, any assets of such Transaction Party; (D) the absence or presence of any defences to or right of setoff against or freedom from counterclaim with respect to any proceeding or other asset, including any accounts receivable, of any Transaction Party; or (E) the legal sufficiency of any Local Separation Agreement or other conveyance and assumption instruments or any other ancillary agreement to convey title to any asset or thing of value upon the execution, delivery and filing of such conveyance and assumption instruments or such other ancillary agreements; or (ii) making any other representations or granting any

 

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warranties, express or implied, either in fact or by operation of law, by statute or otherwise;

 

(c)                                   any terms or conditions implied by Applicable Law in any jurisdiction in relation to the Separation and/or the Distribution are excluded to the fullest extent permitted by Applicable Law or, if incapable of exclusion, any right or remedies in relation to them are irrevocably waived;

 

(d)                                  the only right or remedy of any Transaction Party in relation to any provision of this Agreement or any other Transaction Document shall be for breach of this Agreement or the relevant Transaction Document;

 

(e)                                   except for any liability in respect of a breach of this Agreement or any other Transaction Document, no Transaction Party (or any of its Representatives) shall owe any duty of care or have any liability in tort or otherwise to any other Transaction Party (or its respective Representatives) in relation to the Separation and/or the Distribution; and

 

(f)                                    each Transaction Party hereby waives (and shall procure that each of its Affiliates shall waive) any requirement for compliance with the requirements and provisions of any “bulk-sale” or “bulk transfer” Applicable Laws of any jurisdiction that may otherwise be applicable with respect to the Separation and/or the Distribution.

 

34.3                         The remedies in this Agreement shall be in lieu of, and not in addition to, the remedies provided for under Applicable Law. In particular, and without limitation to the foregoing, each Party hereby explicitly waives the right of contract rescission under articles 23 et seq. and 205 CO.

 

34.4                         Each Transaction Party agrees to the terms of this Clause 34 ( Whole Agreement ) on its own behalf and as agent for each of its Representatives.

 

35.             WAIVERS, RIGHTS AND REMEDIES

 

Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement or any of the Transaction Documents shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time. No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

36.             COUNTERPARTS

 

This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

37.             VARIATIONS

 

No amendment of this Agreement (or of any other Transaction Document) shall be valid unless it is in writing and duly executed by or on behalf of all of the parties to it.

 

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38.             INVALIDITY

 

Each of the provisions of this Agreement and the other Transaction Documents is severable. If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

39.             NO THIRD PARTY ENFORCEMENT RIGHTS

 

A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

40.             GOVERNING LAW

 

40.1                         Governing Law . This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

41.             DISPUTE RESOLUTION

 

41.1                         This Clause 41 ( Dispute Resolution ) shall apply to any dispute, controversy or claim arising out of, relating to, or in connection with this Agreement, including, without limitation, any dispute relating to the existence, validity or termination of this Agreement (each, a Dispute ).

 

41.2                         Before entering into any arbitration pursuant to Clauses 41.4 , a Party shall give written notice of a Dispute to the other Party (a Dispute Notice ). The Dispute Notice shall:

 

(a)                                  state that it is a Dispute Notice being submitted pursuant to this Clause 41 ( Dispute Resolution );

 

(b)                                  identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(c)                                   set out any steps taken by that Party or its Affiliates to resolve it.

 

41.3

 

(a)                                  Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the Resolution Period ). The time limit specified in this Clause 41.3 may be extended by the written agreement of the Parties.

 

(b)                                  Notwithstanding the foregoing, either Party may, at any time, seek interim or provisional relief, whether from an emergency arbitrator appointed and acting in accordance with the LCIA Rules, a tribunal constituted under the LCIA Rules and/or

 

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from a national court of competent jurisdiction, in advance of or in aid of the arbitration proceedings contemplated by Clause 41.4.

 

41.4                         If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(a)                                  the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the LCIA Rules );

 

(b)                                  the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(c)                                   the seat of arbitration shall be London;

 

(d)                                  the written and spoken language to be used in the arbitral proceedings shall be English; and

 

(e)                                   the award of the arbitral tribunal shall be final and binding upon the parties and judgment may be entered on an award in any court of competent jurisdiction.

 

41.5                         Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Ancillary Agreement, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with Clause 41.4.

 

41.6                         The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this Clause 41.6 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

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SCHEDULE 1

 

DEFINITIONS AND INTERPRETATION

 

1.                                       Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Accounts Payable means the Alcon Accounts Payable and/or the Novartis Accounts Payable, as applicable;

 

Accounts Receivable means the Alcon Accounts Receivable and/or the Novartis Accounts Receivable, as applicable;

 

Affiliates means, in respect of Novartis, each member of the Novartis Group and, in respect of Alcon, each member of the Alcon Group;

 

Agreed Form  means, in relation to a document, the form of that document which has been initialled on the date of this Agreement for the purpose of identification by or on behalf of both of the Parties (in each case with such amendments as may be agreed in writing by or on behalf of both of the Parties);

 

Agreement means this separation and distribution agreement;

 

Alcon Accounts Payable means all amounts payable at the Separation Date in respect of trade creditors by the relevant Alcon Asset Transferor to the extent Exclusively Related to the Alcon Business (excluding, in any event, any Intercompany Accounts or payables arising in respect of any Intercompany Arrangements, payments in advance, trade bills recoverable, suppliers’ prepayments and accrued revenue);

 

Alcon Accounts Receivable means all amounts receivable at the Separation Date in respect of trade debtors by the relevant Alcon Asset Transferor to the extent Exclusively Related to the Alcon Business (excluding, in any event, any Intercompany Accounts or receivables arising in respect of any Intercompany Arrangements, payments in advance, trade bills recoverable, suppliers’ prepayments and accrued revenue);

 

Alcon Asset Transferees means the members of the Alcon Group set out in Column 3 of Part C ( Alcon Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute an Alcon Asset Transferee (including pursuant to Clause 25.4 ( Additional Asset Transfers );

 

Alcon Asset Transferors means the members of the Novartis Group set out in Column 1 of Part C ( Alcon Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute an Alcon Asset Transferor (including pursuant to Clause 25.4 ( Additional Asset Transfers );

 

Alcon Business means the worldwide ophthalmic surgical, over-the-counter vision care and contact lens care and contact lens businesses conducted at any time prior to the Separation Date by either Party or any of their respective Affiliates, or on or after the Separation Date by any member of the Alcon Group, including the research, Development, Manufacture, or Commercialisation of Alcon Products but excluding the Novartis Products;

 

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Alcon Business Contracts means, in relation to each Alcon Asset Transferor, all the Contracts that are Exclusively Related to the Alcon Business and entered into by or on behalf of, or the benefit of which is held on trust for or has been assigned to, that Alcon Asset Transferor prior to the Separation Date which in any case are outstanding or in respect of which the Alcon Asset Transferor has any rights, liabilities, claims, benefits or obligations as at the Separation Date;

 

Alcon Business Permits means all Permits issued to an Alcon Asset Transferor that are Exclusively Related to the Alcon Business other than Marketing Authorisations;

 

Alcon Carve-out Balance Sheet means the pro forma consolidated balance sheet of Alcon as at 31 December 2018 included in the Registration Statement and the Listing Prospectus;

 

Alcon Group means (a) Alcon; (b) each Person that following completion of the Distribution will be, or will become, a direct or indirect Subsidiary of Alcon; and (c) each other Person that becomes a direct or indirect Subsidiary of Alcon at any time after the Distribution;

 

Alcon Indirect Transferring Entities means each Person listed in Column 1 of Part B ( Alcon Indirect Transferring Entities ) of Exhibit 1 ( Transferors and Transferees );

 

Alcon Intragroup Credit Support Instruments means any Credit Support Instrument provided by a member of the Novartis Group for the benefit of any member of the Alcon Group;

 

Alcon Inventory means, in relation to each Alcon Asset Transferor, all inventories, wherever located, including the raw materials, stocks, work-in-progress, semi-finished and finished Alcon Products, API, packaging and labelling material of the relevant Alcon Asset Transferor, in each case, that are Exclusively Related to the Alcon Business, as of the Separation Date, but excluding any such inventories:

 

(a)                                  that are to be supplied, or that are to be used in the Manufacture of products to be supplied, by the Novartis Group to the Alcon Group pursuant to the Manufacturing and Supply Agreements;

 

(b)                                  any Shared Chemical/API Products (as defined in the Manufacturing and Supply Agreements);

 

(c)                                   that are finished products and necessary for the Novartis Group to provide services under the Transitional Distribution and Services Agreement; or

 

(d)                                  that are to be supplied to a Third Party pursuant to a Contract with a contract manufacturing organisation (other than the Novartis Group) that has not been assigned at the Separation Date to the Alcon Group;

 

Alcon IT Assets means the information technology equipment and assets listed as to be owned by the Alcon Group following the Separation in the Agreed Form IT Assets List;

 

Alcon Liabilities means:

 

(a)                                  all Liabilities included or reflected on the Alcon Carve-out Balance Sheet or any notes or subledgers thereto, it being understood that:

 

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(i)       the Alcon Carve-out Balance Sheet and the notes and subledgers thereto shall be used to determine the types of, and methodologies used to determine, those Liabilities that are included in the definition of Alcon Liabilities pursuant to this paragraph (a); and

 

(ii)      the amounts set forth on the Alcon Carve-out Balance Sheet with respect to any Liabilities shall not be treated as minimum amounts or limitations on the amount of such Liabilities that are included in the definition of Alcon Liabilities pursuant to this paragraph (a);

 

(b)            all other Liabilities that are incurred or accrued by any member of the Alcon Group or the Novartis Group after the date of the Alcon Carve-out Balance Sheet that are of a nature or type that would have resulted in such Liabilities being included as Liabilities on a carve-out combined balance sheet of Alcon or any notes or subledgers thereto as of the date of the Alcon Carve-out Balance Sheet (were such balance sheet, notes or subledgers to be prepared on a basis consistent with the determination of the Liabilities included on the Alcon Carve-out Balance Sheet or any notes or subledgers thereto), it being understood that

 

(i)       the Alcon Carve-out Balance Sheet and the notes and subledgers thereto shall be used to determine the types of, and methodologies used to determine, those Liabilities that are included in the definition of Alcon Liabilities pursuant to this paragraph (b); and

 

(ii)      the amounts set forth on the Alcon Carve-out Balance Sheet with respect to any Liabilities shall not be treated as minimum amounts or limitations on the amount of such Liabilities that are included in the definition of Alcon Liabilities pursuant to this paragraph (b);

 

(c)            all other Liabilities to the extent relating to, arising out of, or resulting from, the Alcon Business regardless of when or where such Liabilities arose or arise, or whether the facts on which they are based occurred prior to, at or after the Separation Date, regardless of where or against whom such Liabilities are asserted or determined (including any such Liabilities arising out of claims made by Novartis’s or Alcon’s respective Affiliates or by Representatives of Novartis or Alcon or their respective Affiliates against either Party or any of its Affiliates) or whether asserted or determined prior to, at or after the Separation Date, and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of any Applicable Law, fraud, misrepresentation or otherwise by either Party or any member of its Group or any of their respective Representatives, including:

 

(i)       all Liabilities to the extent relating to, arising out of, or resulting from, the operation or conduct of the Alcon Business as conducted by any member of the Novartis Group or the Alcon Group at any time prior to, on or after the Separation Date (including any Liability to the extent relating to, arising out of or resulting from any act or failure to act by any Representatives of any applicable member of the Novartis Group or the Alcon Group (whether or not such act or failure to act is or was within such Person’s authority), to the extent such act or failure to act relates to the Alcon Business);

 

(ii)      all Liabilities to the extent relating to, arising out of, or resulting from, the Alcon Transferring Assets (including all Liabilities arising under the Alcon Business Contracts and the Alcon Part of any Shared Contract);

 

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(iii)     all Liabilities for claims made by Third Parties, or the directors, officers, employees, agents of any member of the Alcon Group or the Novartis Group against either Party or any of its Subsidiaries to the extent relating to, arising out of or resulting from the Alcon Business or the Alcon Transferring Assets);

 

(iv)     subject to and in accordance with Clause 11 ( Accounts Payable and Receivable) , the burden of all Alcon Accounts Payable;

 

(v)      any product liability claims or other claims of third parties, including any and all product liabilities, whether such product liabilities are known or unknown, contingent or accrued prior to, at or after the Separation Date, to the extent related to any Alcon Product or any other product Commercialised by the Alcon Group after the Separation Date;

 

(vi)     any Liabilities (including any environmental Liabilities) relating to, arising out of, or resulting from, the Alcon Properties, arising prior to, on, or after the Separation Date;

 

(vii)    without prejudice to the terms of the Manufacturing and Supply Agreements, all Liabilities to the extent relating to, arising out of or resulting from the Manufacture of Alcon Products by any member of the Alcon Group or, prior to the Separation Date, any member of the Novartis Group,

 

it being understood that in determining the extent to which, a particular Liability relates to, arises out of, or results from, the Alcon Business (including the extent to which any Liability should be apportioned to the Alcon Business), the methodologies used to determine the Liabilities included in the Alcon Carve-out Balance Sheet and the notes and subledgers thereto and, if not covered therein, the accounting principles set-out in the Novartis Accounting Manual shall apply;

 

(d)            all other Liabilities that are expressly listed, scheduled or otherwise described by this Agreement or any Ancillary Agreement as Liabilities to be assumed by or allocated to any member of the Alcon Group;

 

(e)            any breach by Alcon or any member of the Alcon Group of this Agreement or any Ancillary Agreement; and

 

(f)             all Liabilities to the extent relating to, arising out of, or resulting from, the Listing Prospectus and/or the Registration Statement, including the preparation and publication thereof and including any and all Liabilities relating to, arising out of or resulting from any untrue statement or alleged untrue statement of a material fact or omission or alleged omission to state a material fact required to be stated therein or necessary to make the statement therein not misleading, with respect to all information contained in the Listing Prospectus and/or the Registration Statement, in each case except for Liabilities referred to in paragraph (d) of the definition of Novartis Liabilities,

 

in each case, excluding any Liabilities in respect of which Novartis agrees to indemnify Alcon (and each member of the Alcon Group) pursuant to Clause 14 ( Asia Investigation );

 

Alcon Part  means the relevant part of a Shared Contract that is Exclusively Related to the Alcon Business;

 

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Alcon Products means:

 

(a)            any contact lens or contact lens care product, including those products listed under part 1 ( Vision Care ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)            any ophthalmic surgical products, including those products listed under part 2 ( Surgical (incl. Diagnostics) ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)            any other products listed under part 3 ( Dry Eye & Ocular Health ), Part 4 ( Viscoelastics ) or Part 5 ( R&D and Clinical Trials ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(d)            any other ophthalmic or vision care product that is, as of the date of this Agreement or at any time prior, lawfully Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates, and any product having substantially the same formula as any of them and that is or has been Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates (in which case, such product shall constitute an Alcon Product in all jurisdictions),

 

in each case other than any product included within paragraphs (a), (b) or (c) of the definition of Novartis Products;

 

Alcon Properties means the real estate, freehold and/or leasehold properties listed as properties to be owned by the Alcon Group following the Separation in the Agreed Form Properties List;

 

Alcon Puurs Site means the land and buildings located at Rijksweg 14 and Lichterveld 3, 2870 Puurs, Belgium, known in the land registry as sections D, number D 1033 A P0000;

 

Alcon Retained Assets has the meaning given in Clause 3.2 ( The Alcon Retained Assets );

 

Alcon Retained Records means the Retained Records that relate to the Alcon Business and will be held by the Novartis Group after the Separation Date, in accordance with the Books and Records Plan;

 

Alcon Share Transferees means the members of the Alcon Group set out in Column 3 of Part A ( Alcon Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute an Alcon Share Transferee;

 

Alcon Share Transferors means the members of the Novartis Group set out in Column 1 of Part A ( Alcon Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute an Alcon Share Transferor;

 

Alcon Switch Rights has the meaning given in Clause 20.1 ( Alcon Switch Rights );

 

Alcon Third Party Credit Support Instruments means any Credit Support Instrument provided by a member of the Novartis Group for the benefit of any Third Party to the extent relating to (i) obligations of any member of the Alcon Group; or (ii) any Alcon Liabilities;

 

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Alcon Transferring Assets has the meaning given in Clause 2.1 ( The Alcon Transferring Assets );

 

Alcon Transferring Books and Records Books and Records that are related to the Alcon Business and that are owned or in the possession of the Novartis Group and which will be transferred to Alcon or another member of the Alcon Group prior to, on or after the Separation Date, as identified in the Books and Records Plan;

 

Alcon Transferring Entity means each Person listed in Column 2 of Part A ( Alcon Transferring Entities ) of Exhibit 1 ( Transferors and Transferees );

 

Alcon Transferring Marketing Authorisations means Marketing Authorisations with respect to the Alcon Products held by members of the Novartis Group, as listed in schedule 2 ( MAs to be Transferred from the Novartis Group to the Alcon Group ) of the MA Transfer Agreement;

 

Ancillary Agreements means:

 

(a)            the Employee Matters Agreement;

 

(b)            the Transitional Services Agreement;

 

(c)            the Tax Matters Agreement;

 

(d)            the Intellectual Property Agreements;

 

(e)            the Manufacturing and Supply Agreements Agreement and the Agreed Form agreements referred to therein;

 

(f)             the Transitional Distribution and Services Agreement and the Promotional Services Agreement;

 

(g)            the Pharmacovigilance Agreement and the Pharmacovigilance Services Agreement;

 

(h)            the Quality Agreements;

 

(i)             the Third Party Claims and Investigations Management Agreement and the Asia Investigation Management Agreement;

 

(j)             the Information Access Agreement; and

 

(k)            the MA Transfer Agreement;

 

Applicable Law means any of the following to the extent the applicable Person is subject thereto: (a) supra-national, federal, national, state, municipal or local statute, law, ordinance, regulation, rule, code, Order or other requirement or rule of law or legal process (including common law); (b) any rule or requirement of any national securities exchange, or (c) any rule or requirement of governmental regulatory authority or agency responsible for the grant of approval, clearance, qualification, licensing or permitting of any aspect of research, Development, Manufacture, or Commercialisation of the Alcon Products or the Novartis Products;

 

Artwork means any paintings, sculptures or other pieces of art;

 

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Asia Investigation means the investigation being conducted by the DOJ and the Commission pursuant to which the following subpoenas or voluntary requests have been issued:

 

(l)             the Grand Jury subpoena dated 8 May 2017 addressed to Alcon Inc, c/o Morrison & Foerster LLP (2017R00136-12);

 

(m)           the Commission subpoena dated 8 May 2017 addressed to Alcon Laboratories Holdings Corp in the Matter of Novartis AG, HO-13265;

 

(n)            the Commission subpoena dated 8 May 2017 addressed to Alcon Laboratories, Inc in the Matter of Novartis AG, HO-13265;

 

(o)            the voluntary request from the Commission dated 8 May 2017 addressed to Novartis AG in the Matter of Novartis AG, HO-13265;

 

(p)            the Grand Jury subpoena dated 21 June 2017 addressed to Alcon Inc, c/o Gibson, Dunn & Crutcher LLP (2017R00136-39); and/or

 

(q)            the voluntary request from the DOJ dated 5 July 2017 addressed to Gibson, Dunn & Crutcher LLP re Novartis International AG/Alcon Inc,

 

but only to the extent to which that investigation relates to certain business practices and/or conduct which occurred between 1 January 2006 and the Separation Date and which occurred in any of Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, Myanmar, Pakistan, the Philippines, Russia, Singapore, Korea, Sri Lanka, Taiwan, Thailand and Vietnam;

 

Asia Investigation Costs means any legal fees, disbursements, costs and expenses incurred by either Party or its Affiliates in the course of the investigation, defense, management or settlement of the Asia Investigation, including, without limitation, court costs, external advisers’ costs and in-house legal costs and management time, but excluding any Monetary Penalty or other damages, awards, settlement sums, penalties or fines;

 

Asia Investigation Management Agreement means the Management Agreement entered into by the Parties in relation to the Asia Investigation on or about the date of this Agreement;

 

Asset Sale Jurisdiction means a jurisdiction in which (i) an Alcon Asset Transferor transfers Alcon Transferring Assets to an Alcon Asset Transferee; or (ii) a Novartis Asset Transferor transfers Novartis Transferring Assets to a Novartis Asset Transferee;

 

Books and Records means books, ledgers, files, databases, documents, reports, plans, records, manuals, company seals, minute books, charter documents, stock or equity record books and other materials (in any form or medium);

 

Books and Records Plan means the Books and Records Plan in the Agreed Form;

 

Brand Licence Agreement means the brand licence agreement entered into between Alcon and Novartis on or about the date of this Agreement;

 

Brazil Continuing Party has the meaning given in Clause 22.3 ( Brazil ROLL Exercise);

 

Brazil Right of Last Look Notice has the meaning given in Clause 22.2 ( Brazil ROLL Notice );

 

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Brazil Seller has the meaning given in Clause 22.1 ( Notice of a potential Brazil Transfer );

 

Brazil Transfer has the meaning given in Clause 22.1 ( Notice of a potential Brazil Transfer );

 

Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

Business Information means, in respect of each of the Novartis Group and Alcon Group:

 

(a)            the information in Books and Records in each of the following categories:

 

(i)       Commercial Information;

 

(ii)      Employee Information;

 

(iii)     Financial Information;

 

(iv)     Manufacturing Information;

 

(v)      Marketing Authorisation Information;

 

(vi)     Medical Information; and

 

(b)            any other information in Books and Records Exclusively Related to the Novartis Business or the Alcon Business,

 

Cash Settlement Plan means the Agreed Form cash settlement plan;

 

Claim means any claim arising under or in relation to this Agreement, including any claim in respect of a breach of any covenant or obligation contained in this Agreement;

 

Claim Notice has the meaning given in Clause 16.2(a);

 

Claimant Party has the meaning given in Clause 16.2(a);

 

CO means the Swiss Code of Obligations (SR 220);

 

Commercial Information means information that relates to the Commercialisation of Alcon Products or Novartis Products, as applicable;

 

Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

 

Commercially Reasonable Efforts to achieve a result means the taking of such steps in the power of the obligated Party which a determined and reasonable person desirous of achieving the result would take, mindful of the chances of achieving the desired result, taking account of all relevant commercial considerations and without any requirement to sacrifice its own commercial interest. Without limitation, the use of Commercially Reasonable Efforts may include making available employees, making payments and/or bringing a legal claim;

 

Commission means the United States Securities and Exchange Commission;

 

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Continuing Intercompany Arrangements means the Intercompany Arrangements listed in Exhibit 4 ( Continuing Intercompany Arrangements ) and any other Intercompany Arrangements which Novartis and Alcon may agree in writing should constitute Continuing Intercompany Arrangements;

 

Contract means any binding contract, agreement, instrument, lease, licence or commitment, together with amendments, modifications and supplements thereto, excluding any contract with any Employee;

 

Contract Transferee’s Parent has the meaning given in Paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commence of Separation ) of Schedule 2 ( Transferring Contracts )

 

Contract Transferor’s Parent has the meaning given in Paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commence of Separation ) of Schedule 2 ( Transferring Contracts )

 

Credit Support Instrument means any guarantee, covenant, indemnity, surety bond, letter of credit or similar assurance or credit support;

 

Defendant Party has the meaning given in Clause 16.2(a);

 

Development means, with respect to any Product, any research, pre-clinical or non-clinical testing, clinical studies, chemistry manufacturing controls (CMC), quality, statistical analysis or report writing, and related development and regulatory activities associated therewith, and Develop and Developed shall be construed accordingly;

 

Dispute has the meaning given in Clause 41 ( Dispute Resolution );

 

Dispute Notice has the meaning given in Clause 41 ( Dispute Resolution );

 

Distribution has the meaning given in Recital J;

 

Distribution Steps Plan means the steps plan prepared in respect of the Distribution and set-out in Exhibit 3 ( Distribution Steps Plan );

 

DOJ has the meaning given in Clause 14 ( Asia Investigation );

 

Employee Benefits means any employee benefits payable to or in respect of any current or former employee of Novartis, Alcon or any of their respective Affiliates, including any post-employment benefits or other long-term employee benefits;

 

Employee Information means information relating to Employees;

 

Employee Matters Agreement means the employee matters agreement entered into between Novartis and Alcon on or about the date of this Agreement;

 

Employees any current or former employee of Novartis, Alcon or any of their respective Affiliates;

 

Exchange Act means the Securities Exchange Act of 1934, as amended;

 

Excluded Books and Records has the meaning given in Clause 17.5 ( Excluded Books and Records );

 

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Exclusively Related to the Alcon Business means exclusively related to, or used or held for use exclusively in connection with, the Alcon Business;

 

Exclusively Related to the Novartis Business means exclusively related to, or used or held for use exclusively in connection with, the Novartis Business;

 

Existing Counsel means:

 

(a)            Gibson, Dunn & Crutcher LLP; and

 

(b)            those attorneys and firms listed in Exhibit 5 ( Existing Counsel ) to represent the individuals identified and any additional counsel retained to replace those attorneys and firms in the event that one or more of those attorneys and firms (i) withdraws, or (ii) ceases to provide services in connection with the Asia Investigation;

 

Financial Information means:

 

(a)            any information (to the extent that such information is held by the other Party) reasonably required to enable receiving Party to prepare and audit the monthly reporting forms of its Group in respect of the period prior to the Separation Date and in respect of the calendar month and the fiscal quarter in which the Separation occurs;

 

(b)            the books, accounts, customer lists and all other records held by a Party to the extent that they:

 

(i)       relate to the period prior to the Separation Date;

 

(ii)      relate to the other Party’s business; and

 

(iii)     are reasonably required for any member of the receiving Party’s Group to fulfil its obligations under Applicable Law;

 

Global Conditions means the conditions set-out in Clause 6.1 ( Global Conditions );

 

Governmental Entity means: (a) any supra-national, national, state, municipal or local government (including any subdivision, court, administrative agency or commission or other authority thereof) or any quasi-governmental or private body exercising any regulatory, importing or other governmental or quasi-governmental authority, including the European Union and any Tax Authority; and (b) any governmental regulatory authority or agency responsible for the grant of approval, clearance, qualification, licensing or permitting of any aspect of research, Development, Manufacture, or Commercialisation of the Alcon Products or the Novartis Products, including the United States Food and Drug Administration and the European Medicines Agency (or their successors);

 

Gross Negligence means any act or failure to act by the relevant Person that: (i) such Person knew may create a risk of material harm; (ii) was intended to cause such harm, or was done in reckless disregard of, or in wanton indifference to, such risk of harm; and (iii) in all the circumstances (having regard to both the probability and seriousness of such harm) was an unreasonable risk for such Person to take;

 

Group means the Alcon Group or the Novartis Group, as applicable;

 

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Indemnifying Party means a Party to this Agreement required to make a payment pursuant to any Indemnity Claim;

 

Indemnitee means a Party to this Agreement to whom a payment is required to be made pursuant to any Indemnity Claim;

 

Indemnity Claim means any Claim under Clause 13.7 ( Novartis Indemnity ), Clause 13.8 ( Alcon Indemnity ), or Clause 14 ( Asia Investigation );

 

Indemnity Payment means a payment required by this Agreement from an Indemnifying Party to an Indemnitee;

 

Information means information, whether or not patentable, copyrightable or protectable as a trade secret, in written, oral, electronic or other tangible or intangible forms, stored in any medium now known or yet to be created, including studies, reports, records, books, contracts, instruments, surveys, discoveries, ideas, concepts, Know-How, techniques, designs, specifications, drawings, blueprints, diagrams, models, prototypes, samples, flow charts, data, computer data, disks, diskettes, tapes, computer programs or other software, marketing plans, customer names, communications by or to attorneys (including attorney-client privileged communications), memos and other materials prepared by attorneys or under their direction (including attorney work product) and other technical, financial, employee or business information or data, documents, correspondence, materials and files;

 

Information Access Agreement means the information access agreement entered into between Novartis and Alcon on or about the date of this Agreement;

 

Innova Line means the Innova equipment line situated at the Novartis Puurs Site;

 

Innova Line Offeree has the meaning given in Clause 21.7 ( Notice of a potential Innova Line Transfer );

 

Innova Line Right of Last Look Notice has the meaning given in Clause 21.8 ( Innova Line ROLL Notice );

 

Innova Line Seller has the meaning given in Clause 21.7 ( Notice of a potential Innova Line Transfer );

 

Innova Line Transfer has the meaning given in Clause 21.7 ( Notice of a potential Innova Line Transfer );

 

Insurance Arrangements has the meaning given in Clause 2.2(o);

 

Insurance Proceeds means, with respect to any insured party, those monies, net of any applicable premium adjustments (including reserves and retrospectively rated premium adjustments) and net of any costs or expenses incurred in the collection thereof, which are: (i) received by an insured from an insurance carrier or its estate; (ii) paid by an insurance carrier or its estate on behalf of the insured; or (iii) received (including by way of setoff) from any Third Party in the nature of insurance, contribution or indemnification in respect of any Liability.

 

Intellectual Property Agreements means the Brand Licence Agreements, Patent and Know-how Licence Agreements, Trademark Co-existence Agreement and the IP Assignment Agreements to be entered into between the Parties on or about the date of this Agreement;

 

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Intellectual Property Rights means:

 

(a)            Patents, utility models and rights in inventions and discoveries, including improvements, designs , invention disclosures);

 

(b)            rights in each of Know-How, confidential Information and trade secrets;

 

(c)            trademarks, service marks, rights in logos and other indicia of the source or origin of goods or services, trade names, rights in each of get-up and trade dress, rights to sue for passing off (including trade mark-related goodwill), rights to sue for unfair competition, and Internet Identifiers;

 

(d)            copyright, moral rights, database rights, rights in designs, and semiconductor topography rights;

 

(e)            any other intellectual property rights; and

 

(f)             all rights or forms of protection, subsisting now or in the future, having equivalent or similar effect to the rights referred to in paragraphs (a)  to (e) above,

 

in each case: (i) anywhere in the world; (ii) whether unregistered or registered (including all applications, rights to apply and rights to claim priority); and (iii) including all divisionals, continuations, continuations-in-part, reissues, extensions, re-examinations, renewals and other pre-grant or post-grant forms thereof;

 

Intercompany Accounts means the Intercompany Non-Trading Accounts and the Intercompany Trading Accounts;

 

Intercompany Arrangements means any Contracts and any other agreements, arrangements, commitments and understandings, whether oral or written, entered into prior to the Separation Date between or among Alcon or any member of the Alcon Group, on the one hand, and Novartis or any member of the Novartis Group, on the other hand;

 

Intercompany Non-Trading Accounts means any amounts owed by a any member of the Novartis Group to any member of the Alcon Group, or by any member of the Alcon Group to any member of the Novartis Group, that are not Intercompany Trading Accounts, including intercompany loans and cash-pooling payables together with accrued interest, if any, on the terms of the applicable debt;

 

Intercompany Trading Accounts means any amounts owed by any member of the Novartis Group to any member of the Alcon Group, or by any member of the Alcon Group to any member of the Novartis Group, that are outstanding or accured in the ordinary course of trading, including amounts due in respect of the supply of raw materials, components and products and services;

 

Internet Identifiers means any internet domain names, internet domain name registration or social media accounts (including the user names and passwords associated therewith);

 

Investigation has the meaning given in the Third Party Claims and Investigations Management Agreement;

 

IP Assignment Agreements means the intellectual property assignment agreement(s) entered into between Alcon and Novartis on or about the date of this Agreement;

 

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IT Assets List means the list of information technology equipment and assets that are to be owned by the Novartis Group, on the one hand, and the Alcon Group, on the other, following the Separation, in the Agreed Form;

 

Know-How means all existing and available technical Information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data;

 

LCIA Rules  has the meaning given in Clause 41 ( Dispute Resolution );

 

Liability or Liabilities means all liabilities, claims, damages (including lost profits), proceedings, demands, Orders, suits, costs, losses and expenses, including reasonable attorney’s fees and expenses, in each case, of every description, whether deriving from contract, common law, statute or otherwise, whether present or future, actual or contingent, direct or indirect, ascertained or unascertained or disputed and whether owed or incurred severally or jointly or as principal or surety;

 

Listing Prospectus means the offering and listing prospectus in the meaning of article 652a of the CO and articles 27 et seqq. of the SIX Listing Rules;

 

Listing Shares has the meaning given in Recital J;;

 

Local Separation Agreement has the meaning given in Clause 4.1 ( Execution of Local Separation Agreements );

 

Manufacture means, as applicable, the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality release, sample retention and stability testing of products, including the active ingredients of such products, and Manufacturing or Manufactured shall be construed accordingly;

 

Manufacturing and Supply Agreement(s)  means the manufacturing and supply agreement or agreements entered into between Alcon and Novartis Pharma AG on or about the date of this Agreement and the related agreements entered into thereunder;

 

Manufacturing Information means information relating to Manufacturing of Alcon Products or Novartis Products, as applicable;

 

Marketing Authorisations means any:

 

(a)            (i) pre- and post- approval marketing authorisations, product licenses, registrations or consents or pricing approvals (including any required manufacturing approval or authorisation) and/or (ii) labelling approval, (in each case, other than manufacturing facility registrations), together with all supplements, amendments and revisions thereto including related to chemistry manufacturing controls of any Governmental Entity to any member of the Novartis Group or Alcon Group (as applicable) relating to the Commercialisation of any Alcon Product or Novartis Product (as applicable);

 

(b)            any pending application to the applicable Governmental Entity for any of the items listed in paragraph (a) above for any Alcon Product or Novartis Product, as applicable (other than applications for manufacturing facility registrations), and all supplements

 

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and amendments filed with respect thereto that have been submitted to, but not yet approved by, the applicable Governmental Entity; and

 

(c)            product notifications not requiring pre-clearance by regulatory authorities and other clearance procedures required to lawfully market the any Alcon Product or Novartis Product (as applicable) in the relevant jurisdictions;

 

Marketing Authorisation Information means existing and available dossiers containing technical information, know-how and data used to obtain and maintain any Marketing Authorisations, including information relating to any Marketing Authorisations for applications (current or planned) to expand the use of any product;

 

MA Transfer Agreement means the agreement relating to the transfer of certain Marketing Authorisations entered into between Alcon and Novartis on or around the date of this Agreement;

 

Medical Information means information relating to clinical and technical matters, including:

 

(a)            Development of Alcon Products or Novartis Products, as applicable; and

 

(a)            therapeutic uses for the approved indications, drug-disease information, and other Alcon Product or Novartis Product, as applicable, characteristics.

 

Monetary Penalty means any monetary payment ordered or imposed by a court and/or agreed with, or ordered or imposed by, any other entity, whether through a judgment, order, deferred prosecution agreement, non-prosecution agreement, declination or otherwise, including, without limitation, fines, penalties, restitution, forfeiture and/or disgorgement;

 

Novartis Accounts Payable means all amounts payable at the Separation Date in respect of trade creditors by the relevant Novartis Asset Transferor to the extent Exclusively Related to the Novartis Business (excluding, in any event, any Intercompany Accounts or payables arising in respect of any Intercompany Arrangements, payments in advance, trade bills recoverable, suppliers’ prepayments and accrued revenue);

 

Novartis Accounts Receivable means all amounts receivable at the Separation Date in respect of trade debtors by the relevant Novartis Asset Transferor to the extent Exclusively Related to the Novartis Business (excluding, in any event, any Intercompany Accounts or receivables arising in respect of any Intercompany Arrangements, payments in advance, trade bills recoverable, suppliers’ prepayments and accrued revenue);

 

Novartis Asset Transferees means the members of the Novartis Group set out in Column 2 of Part E ( Novartis Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute a Novartis Asset Transferee (including pursuant to Clause 25.4 ( Additional Asset Transfers );

 

Novartis Asset Transferors means the members of the Alcon Group set out in Column 1 of Part E ( Novartis Transferring Assets ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute a Novartis Asset Transferor (including pursuant to Clause 25.4 ( Additional Asset Transfers );

 

Novartis Brazil Site means the Novartis Property with site code BRSP/SP01/122;

 

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Novartis Business means all businesses, operations and activities (whether conducted independently or in association with one or more Third Parties through a partnership, joint venture or other mutual enterprise and whether or not such businesses, operations or activities are or have been terminated, divested or discontinued) conducted at any time prior to the Separation Date by either Party or their respective Affiliates, or on or after the Separation Date by any member of the Novartis Group, other than the Alcon Business, including the research, Development, Manufacture including the research, Development, Manufacture, or Commercialisation of, or Commercialisation of Novartis Products;

 

Novartis Business Contracts means, in relation to each Novartis Asset Transferor, all the Contracts that are Exclusively Related to the Novartis Business and entered into by or on behalf of, or the benefit of which is held on trust for or has been assigned to, that Novartis Asset Transferor prior to the Separation Date which in any case are outstanding or in respect of which the Novartis Asset Transferor has any rights, liabilities, claims, benefits or obligations as at the Separation Date;

 

Novartis Business Permits means all Permits issued to a Novartis Asset Transferor that are Exclusively Related to the Novartis Business other than Marketing Authorisations;

 

Novartis Cash Management Arrangements all cash management arrangements pursuant to which Novartis or its Subsidiaries automatically or manually sweep cash from, or automatically or manually transfer cash to, accounts of Alcon or any of its Subsidiaries;

 

Novartis Group means (a) Novartis; (b) each Person that following completion of the Distribution will be, or will become, a direct or indirect Subsidiary of Novartis; and (c) each other Person that becomes a direct or indirect Subsidiary of Novartis at any time after the Distribution;

 

Novartis Intragroup Credit Support Instruments means any Credit Support Instrument provided by a member of the Alcon Group for the benefit of any member of the Novartis Group;

 

Novartis Inventory means, in relation to each Novartis Asset Transferor, all inventories, wherever located, including the raw materials, stocks, work-in-progress, semi-finished and finished Novartis Products, API and packaging and labelling material of the relevant Novartis Asset Transferor, in each case, that are Exclusively Related to the Novartis Business, as of the Separation Date, but excluding any such inventories:

 

(a)            any Shared Chemical/API Products (as defined in the Manufacturing and Supply Agreement);

 

(b)            that are finished products and necessary for the Alcon Group to provide services under the Transitional Distribution and Services Agreement; or

 

(c)            that are to be supplied to a Third Party pursuant to a Contract with a contract manufacturing organisation (other than the Alcon Group) that has not been assigned at the Separation Date to the Novartis Group;

 

Novartis IT Assets means the information technology equipment and assets listed as to be owned by the Novartis Group following the Separation in the Agreed Form IT Assets List;

 

Novartis Liabilities means

 

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(a)            all Liabilities to the extent relating to, arising out of, or resulting from, the Novartis Business, regardless of when or where such Liabilities arose or arise, or whether the facts on which they are based occurred prior to, at or after the Separation Date, regardless of where or against whom such Liabilities are asserted or determined (including any such Liabilities arising out of claims made by Novartis’s or Alcon’s respective Affiliates or by Representatives of Novartis or Alcon or their respective Affiliates against either Party or any of its Affiliates) or whether asserted or determined prior to, at or after the Separation Date, and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of any Applicable Law, fraud, misrepresentation or otherwise by either Party or any member of its Group or any of their respective Representatives, including:

 

(i)       all Liabilities to the extent relating to, arising out of, or resulting from, the operation or conduct of the Novartis Business as conducted by any member of the Novartis Group or the Alcon Group at any time prior to, on or after the Separation Date (including any Liability to the extent relating to, arising out of or resulting from any act or failure to act by any Representatives of any applicable member of the Novartis Group or the Alcon Group (whether or not such act or failure to act is or was within such Person’s authority), to the extent such act or failure to act relates to the Novartis Business);

 

(ii)      all Liabilities to the extent relating to, arising out of, or resulting from, the Novartis Transferring Assets (including all Liabilities arising under the Novartis Business Contracts and any part of a Shared Contract other than the Alcon Part);

 

(iii)     all Liabilities for claims made by Third Parties, or the directors, officers, employees, agents of any member of the Alcon Group or the Novartis Group against either Party or any of its Subsidiaries to the extent relating to, arising out of or resulting from the Novartis Business or the Novartis Transferring Assets);

 

(iv)     subject to and in accordance with Clause 11 ( Accounts Payable and Receivable) , the burden of all Novartis Accounts Payable;

 

(v)      any product liability claims or other claims of third parties, including any and all product liabilities, whether such product liabilities are known or unknown, contingent or accrued prior to, at or after the Separation Date, to the extent related to any Novartis Product or any other product Commercialised by the Novartis Group after the Separation Date;

 

(vi)     any Liabilities (including any environmental Liabilities) relating to, arising out of, or resulting from, the Novartis Properties, arising prior to, on, or after the Separation Date; and

 

(vii)    without prejudice to the terms of the Manufacturing and Supply Agreement, all Liabilities to the extent relating to, arising out of or resulting from the Manufacture of Novartis Products by any member of the Novartis Group or, prior to the Separation Date, any member of the Alcon Group,

 

it being understood that in determining the extent to which, a particular Liability relates to, arises out of, or results from, the Novartis Business (including the extent to which any Liability should be apportioned to the Novartis Business), the methodologies used to determine the Liabilities included in the Alcon Carve-out

 

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Balance Sheet and the notes and subledgers thereto and, if not covered therein, the accounting principles set-out in the Novartis Accounting Manual shall apply;

 

(b)            all other Liabilities that are expressly listed, scheduled or otherwise described by this Agreement or any Ancillary Agreement as Liabilities to be assumed by or allocated to any member of the Novartis Group;

 

(c)            any breach by Novartis or any member of the Novartis Group of this Agreement or any Ancillary Agreement; and

 

(d)            any Liabilities relating to any untrue statement or alleged untrue statement of a material fact made explicitly in Novartis’s name in the Listing Prospectus and/or the Registration Statement, or any omission or alleged omission to state a material fact necessary to make any such statement made explicitly in Novartis’s name not misleading; it being agreed that the information relating to Novartis and the Novartis Group set forth in the Listing Prospectus and/or the Registration Statement that is described in the Novartis Prospectus Statements List shall be the only information that is made explicitly in Novartis’s name for purposes of this paragraph (d), and all other information contained in the Listing Prospectus and/or the Registration Statement shall be deemed to be information supplied by Alcon and made in its name;

 

Novartis Part  means the relevant part of a Shared Contract that is not Exclusively Related to the Alcon Business;

 

Novartis Products

 

(a)            the products listed under part 1 ( Pharmaceuticals ) or Part 6 ( R&D and Clinical Trials ) of the “Novartis” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)            the products listed under the “Emerging Markets Brands” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)            the Sandoz Products; and

 

(d)            any other product that is not an Alcon Product;

 

Novartis Properties means the real estate, freehold and/or leasehold properties listed as properties to be owned by the Novartis Group following the Separation in the Agreed Form Properties List;

 

Novartis Prospectus Statements List means the list of statements in the Registration Statement and/or Listing Prospectus for which Novartis will be responsible, in the Agreed Form;

 

Novartis Puurs Site means the land and buildings located at Rijksweg 14, Lichterstraat 37, 39A, 39B and Lichterveld 7, 2870 Puurs, Belgium, known in the land registry as sections D, numbers 71/W, 66/V, 66/P, 66/R, 71/Y, 71/Z, 82/B, 85/B;

 

Novartis Retained Assets has the meaning given in Clause 2.2 ( The Novartis Retained Assets );

 

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Novartis Retained Records means Retained Records that relate to the Novartis Business and will be held by the Alcon Group after the Separation Date, in accordance with the Books and Records Plan;

 

Novartis Shares means ordinary shares of CHF 0.50 each in the capital of Novartis;

 

Novartis Share Transferees means the members of the Novartis Group set out in Column 3 of Part D ( Novartis Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute a Novartis Share Transferee;

 

Novartis Share Transferors means the members of the Alcon Group set out in Column 1 of Part D ( Novartis Transferring Entities ) of Exhibit 1 ( Transferors and Transferees ) and any other Person that Novartis and Alcon agree in writing shall constitute a Novartis Share Transferor;

 

Novartis Third Party Credit Support Instruments means any Credit Support Instrument provided by a member of the Alcon Group for the benefit of any Third Party to the extent relating to (i) obligations of any member of the Novartis Group; or (ii) any Novartis Liabilities;

 

Novartis Transferring Asset has the meaning given in Clause 3.1 ( The Novartis Transferring Assets );

 

Novartis Transferring Books and Records means Books and Records that are related to the Novartis Business and that are owned or in the possession of the Alcon Group and which will be transferred to Novartis or another member of the Novartis Group prior to, on or after the Separation Date, as identified in the Books and Records Plan;

 

Novartis Transferring Entities means the Persons listed in Column 2 of Part D ( Novartis Transferring Entities ) of Exhibit 1 ( Transferors and Transferees );

 

Novartis Transferring Marketing Authorisations means Marketing Authorisations with respect to the Novartis Products held by members of the Alcon Group, as listed in schedule 1 ( MAs to be Transferred from the Alcon Group to the Novartis Group ) of the MA Transfer Agreement;

 

NYSE means the New York Stock Exchange;

 

Order means any order, decree, writ, injunction, award, judgment or other determination of, or agreement with, any court or any Governmental Entity or any other regulatory or arbitral authority in any jurisdiction;

 

Over-the-counter Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription;

 

Parent Company means any company which holds a majority of the voting rights in another company, or which is a member of another company and has the right to appoint or remove a majority of its board of directors, or which is a member of another company and controls a majority of the voting rights in it under an agreement with the other members, in each case whether directly or indirectly through one or more companies;

 

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Party means Novartis or Alcon and Parties means both of them;

 

Patent and Know-How Licence Agreement means the patent and know-how licence agreement entered into between Alcon and Novartis on or about the date of this Agreement;

 

Patents means utility patents, industrial and utility models, industrial designs, petty patents, design patents, patents of importation, patents of addition, certificates of invention, and other indicia of invention ownership issued or granted by any Governmental Entity; applications for any of the foregoing, including provisional, utility, design, priority, divisional, and continuation (in whole or in part) applications, and all other pre-grant forms of any of the foregoing; and extensions, reissues, re-examinations, renewals, or other post-grant forms of any of the foregoing; and equivalents or counterparts of any of the foregoing;

 

Permits means all permits, licences, certificates, registrations, authorisations or consents issued by a Governmental Entity under any Applicable Law;

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Pharmacovigilance Agreement means agreement relating to pharmacovigilance matters entered into between Alcon and Novartis on or around the date of this Agreement;

 

Pharmacovigilance Services Agreement means the agreement relating to the supply of certain services relating to pharmacovigilance and device vigilance matters entered into between Alcon and Novartis on or around the date of this Agreement;

 

Prescription Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers only via a prescription;

 

Product means an Alcon Product or a Novartis Product;

 

Product List means the list of certain Alcon Products and certain Novartis Products, in the Agreed Form;

 

Properties List means the list of real estate, freehold and/or leasehold properties that are to be owned by the Novartis Group, on the one hand, and the Alcon Group, on the other, following the Separation, in the Agreed Form;

 

Puurs Continuing Party has the meaning given in Clause 21.1 ( Notice of a potential Puurs Transfer);

 

Puurs Right of Last Look Notice has the meaning given in Clause 21.2 ( Puurs ROLL Notice );

 

Puurs Separation Plan means the engineering plan to effect the separation of the Alcon Puurs Site and the Novartis Puurs Site, in the Agreed Form.

 

Puurs Seller has the meaning given in Clause 21.1 ( Notice of a potential Puurs Transfer);

 

Puurs Site means the Alcon Puurs Site or the Novartis Puurs Site, as applicable;

 

Puurs Transfer has the meaning given in Clause 21.1 ( Notice of a potential Puurs Transfer);

 

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Quality Agreements means the quality agreements entered into between Alcon and Novartis on or around the date of this Agreement, as referred to in the Manufacturing and Supply Agreements

 

Registration Statement means the registration statement on Form 20-F (Commission File No. 001-31269) filed by the Alcon with the Commission pursuant to the Exchange Act for the registration of its ordinary shares, as such Registration Statement has been or may be amended and supplemented from time to time, including all documents filed as part thereof or incorporated by reference therein;

 

Relevant Contract Transferee has the meaning given in Paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ) of Schedule 2 ( Transferring Contracts )

 

Relevant Contract Transferor has the meaning given in Paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ) of Schedule 2 ( Transferring Contracts )

 

Relevant Shared Contract Beneficiary has the meaning given in Paragraph 1.8 ( Shared Contracts ) of Schedule 2 ( Transferring Contracts )

 

Relevant Shared Contract Party has the meaning given in Paragraph 1.8 ( Shared Contracts ) of Schedule 2 ( Transferring Contracts )

 

Representatives means, in relation to a specified Person, its respective Affiliates and the directors, officers, employees, agents, advisers, accountants and consultants of that Person and/or of its respective Affiliates;

 

Resolution Period has the meaning given in Clause 41 ( Dispute Resolution );

 

Retained Records means Books and Records which:

 

(a)            cannot transfer or be separated for technical, operational or commercial reasons, or are otherwise agreed by the Parties to be retained in the Books and Records Plan; or

 

(b)            cannot transfer for legal or regulatory reasons or without liability being incurred by the relevant transferor as a result of such transfer,

 

but excluding, in any event, the Excluded Books and Records;

 

Retention Period means, in respect of each category of Retained Records, the time period required under Applicable Law, the duration of which shall be specified in the Books and Records Plan for each category of Retained Records;

 

Run-Off D&O Insurance has the meaning given to it in Clause 18.2 ( Run-off D&O Insurance );

 

Sandoz Products means any products which, as at the date of this Agreement, are researched, Developed, Manufactured, or Commercialised by Sandoz AG or any of its Subsidiaries, or Commercialised as a generic or biosimilar product of the Sandoz division, provided, that if at the date of this Agreement, any product is Commercialised by both (i) Sandoz AG or any of its Subsidiaries; and (ii) a member of the Alcon Group, pursuant to a Marketing Authorisation held solely by the Alcon Group, such product shall constitute an “Alcon Product” when and to the extent Commercialised by a member of the Alcon Group and a “Sandoz Product” (and therefore a “Novartis Product”) when and to the extent Commercialised by Sandoz AG or any of its Subsidiaries;

 

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Securities Act means the Securities Act of 1933, as amended;

 

Separation has the meaning given in Recital D;

 

Separation Balance Sheet has the meaning given in Clause 17.11 ( Separation Date Balance Sheet );

 

Separation Date has the meaning given in Clause 1.2 ( The Separation Date );

 

Separation Steps Plan means the steps plans prepared in respect of the Separation and set-out in Exhibit 2 ( Separation Steps Plan );

 

Shared Contract means any Contract which relates both: to the Alcon Business; and to the Novartis Business or any Novartis Retained Asset, and to which a member of the Novartis Group is a party or in respect of which a member of the Novartis Group has any liability or obligation at the Separation Date, excluding Third Party Supply Agreements (as defined in the Transitional Services Agreement(s));

 

SIX means the SIX Swiss Stock Exchange;

 

SIX Listing Rules  means the Listing Rules of the SIX dated 4 April 2018;

 

Subsidiary and S ubsidiaries means any company in relation to which another company is its Parent Company;

 

Switch Notice has the meaning given in Clause 20.2 ( Switch Process );

 

Switch Process means the process of registering Patanol, Pataday, Patanase and/or Pazeo from Prescription Products to Over-the-counter Products, including the process of obtaining any necessary regulatory approval for such switch;

 

Tax has the meaning given in the Tax Matters Agreement;

 

Tax Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement entered into between Novartis and Alcon on or about the date of this Agreement;

 

Third Party means any Person other than a member of the Alcon Group or the Novartis Group;

 

Third Party Claim has the meaning given in the Third Party Claims and Investigations Management Agreement;

 

Third Party Claims and Investigations Management Agreement means the agreement relating to the management and conduct of Third Party Claims and Investigations entered into between Novartis and Alcon on or about the date of this Agreement;

 

Third Party Consent has the meaning given in Clause 8.2(a)(i);

 

Third Party Proceeds has the meaning given in Clause 15.3 ( Recovery from Third Parties );

 

Third Party Purchaser has the meaning given in Clause 21.1 ( Notice of a potential Puurs Transfer );

 

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Transaction Document means this Agreement, the Ancillary Agreements and the Local Separation Agreements, and any other agreement agreed in writing between Alcon and Novartis to constitute a Transaction Document;

 

Transferring Books and Records means the Alcon Transferring Books and Records and the Novartis Transferring Books and Records;

 

Transferring Business Contracts means, in relation to the transfer of the Alcon Transferring Assets, the Alcon Business Contracts and, in relation to the transfer of the Novartis Transferring Assets, the Novartis Business Contracts;

 

Transferring Entities means the Alcon Transferring Entities and the Novartis Transferring Entities;

 

Transitional Distribution and Services Agreement means the transitional distribution and services agreement to be entered into between Alcon and Novartis on or around the Separation Date;

 

Transitional Services Agreement(s)  means the transitional services agreement or agreements to be entered into between Alcon and Novartis on or around the Separation Date;

 

U.S. Separation means the steps of the Separation, other than the Distribution, identified in connection with the description of the U.S. Intended Tax Treatment, as defined in the Tax Matters Agreement;

 

Waived Books and Records has the meaning given to it in Clause 17.2 ( Retention of original Transferring Books and Records );

 

Working Hours means 9.30am to 5.30pm in the relevant location on a Business Day.

 

2.              Interpretation . In this Agreement, unless the context otherwise requires:

 

(a)            headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

(b)            references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction;

 

(c)            references to sterling or pounds sterling or £ are references to the lawful currency from time to time of England;

 

(d)            references to dollars or $ are references to the lawful currency from time to time of the United States of America; and

 

(e)            any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as without limitation and illustrative and shall not limit the sense of the words preceding those terms.

 

3.              Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including

 

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regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.                                       Schedules . The Schedules and Exhibits to this Agreement comprise schedules and Exhibits to this Agreement and form part of this Agreement.

 

5.                                       Inconsistencies . Where there is any inconsistency between the definitions set out in this Schedule and the definitions set out in any Clause or any other Schedule, then, for the purposes of construing such Clause or Schedule, the definitions set out in such Clause or Schedule shall prevail.

 

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SCHEDULE 2

 

TRANSFERRING CONTRACTS

 

1.1                                Transfers effective prior to the Separation Date : The Parties agree that the provisions of this Schedule 2 ( Transferring Contracts ) shall be interpreted as applying equally to the implementation of the Separation in any jurisdiction prior to the date of this Agreement, with effect from the date on which such implementation is completed, as if references in this Schedule 2 ( Transferring Contracts ) to the Separation Date were references to the date on which such implementation is completed, such that to the extent that any Third Party Consent was required in respect of any Transferring Business Contract in such jurisdiction, the provisions of paragraphs 1.2 ( Efforts to Obtain Third Party Consents ) to 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ) shall be deemed to apply with retrospective effect from the date of the implementation of the Separation in such jurisdiction.

 

1.2                                Efforts to Obtain Third Party Consents . In relation to any Transferring Business Contract that is not transferable without a Third Party Consent, Alcon and Novartis shall, and shall procure that the respective members of their Groups shall, unless otherwise agreed between Alcon and Novartis, use Commercially Reasonable Efforts to obtain such Third Party Consent and cooperate with each other to determine how to address any such outstanding Third Party Consents, subject to paragraph 1.3 ( Fees, Costs and Expenses Relating to Third Party Consents ) and paragraph 1.4 ( Effect of Third Party Consents ).

 

1.3                                Fees, Costs and Expenses Relating to Third Party Consents. Any fees, costs and expenses incurred in connection with obtaining a Third Party Consent shall be borne equally (on a 50/50 basis) by Novartis and Alcon, subject always to the terms of Exhibit 7 ( IT Contract Costs ).

 

1.4                                Effect of Third Party Consents. The Parties agree that the provisions of any document entered into in connection with a Third Party Consent (including by way of novation) shall be without prejudice to the provisions of this Agreement.

 

1.5                                Delayed Transfer of Certain Transferring Business Contracts. If any Transferring Business Contract is required for the provision by the Alcon Group or the Novartis Group, as applicable, of services under the Transitional Distribution and Services Agreement, the Transitional Services Agreement and/or any Manufacturing and Supply Agreements, the transfer of such Transferring Business Contract may be delayed by mutual agreement of Alcon and Novartis until the later of the termination of the Transitional Distribution and Services Agreement, the Transitional Services Agreement and/or the relevant Manufacturing and Supply Agreements or such other date as may be agreed by Novartis and Alcon.

 

1.6                                Third Party Consents Not Obtained Prior to Commencement of Separation.   If any Third Party Consent has not been obtained in relation to any Transferring Business Contract prior to the Separation Date, then the Parties acknowledge and agree that, unless otherwise agreed between Alcon and Novartis, from and after the Separation Date until such Third Party Consent is obtained and the relevant Transferring Business Contract is transferred to the relevant member of the Alcon Group or member of the Novartis Group, as applicable (the Relevant Contract Transferee ):

 

(a)                                  the transfer of such Transferring Business Contract shall not take effect and the relevant member of the Novartis Group (if the Relevant Contract Transferee is a member of the Alcon Group) or member of the Alcon Group (if the Relevant Contract Transferee is a member of the Novartis Group) (as applicable) that is party to the Transferring Business Contract (the Relevant Contract Transferor ) shall remain a

 

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party to such Transferring Business Contract on a fiduciary basis (including performing its obligations under such Transferring Business Contract in its own name but for the account of the Relevant Contract Transferee), and such Relevant Contract Transferor shall in accordance with this paragraph 1.6:

 

(i)       cooperate with the Relevant Contract Transferee, as applicable, to enter into a mutually agreeable arrangement to provide to the Relevant Contract Transferee any claims, rights and other benefits to the extent that they relate to such Transferring Business Contract;

 

(ii)      hold all monies paid to such Relevant Contract Transferor thereunder, or in respect thereof, on or after the Separation Date for the account of the Relevant Contract Transferee (and, for all Tax purposes, any Relevant Contract Transferor receiving such payments shall be treated as receiving such amounts as an agent or nominee for the Relevant Contract Transferee to the extent permitted by Applicable Law); and

 

(iii)     remit such monies to the Relevant Contract Transferee as soon as practicable after receipt, except in each case to the extent that any of the rights comprise, or represent the proceeds from, a Novartis Retained Asset or a Novartis Liability (in respect of a Transferring Business Contract held by a member of the Alcon Group) or an Alcon Retained Asset or an Alcon Liability (in respect of a Transferring Business Contract held by a member of the Novartis Group).

 

(b)                                  to the fullest extent permitted by Applicable Law, the Relevant Contract Transferee shall assume, perform and comply with (as the sub-contractor or agent of the Relevant Contract Transferor) all the obligations of the Relevant Contract Transferor under the relevant Transferring Business Contract (in each case, only to the extent (i) not arising out of, in connection with or relating to a Novartis Retained Asset or a Novartis Liability (in respect of a Transferring Business Contract held by a member of the Alcon Group) or an Alcon Retained Asset or an Alcon Liability (in respect of a Transferring Business Contract held by a member of the Novartis Group), and (ii) not attributable to the Relevant Contract Transferor’s (or its Affiliates’) breach of, or non-performance under any such Transferring Business Contract) and indemnify the Relevant Contract Transferor against all Liabilities actually suffered or incurred as a result of any failure by that Relevant Contract Transferee to perform those obligations in accordance with the terms of this Agreement;

 

(c)                                   the Relevant Contract Transferor shall give reasonable assistance to the Relevant Contract Transferee(at such Relevant Contract Transferee’s request and expense) to enable it to enforce its rights under such Transferring Business Contract;

 

(d)                                  where it is not lawfully able to hold such Transferring Business Contract on a fiduciary basis in accordance with sub-paragraphs (a) to (c) above, the Relevant Contract Transferor and the Relevant Contract Transferee shall cooperate to establish an arrangement reasonably satisfactory to both Persons under which:

 

(i)       the Relevant Contract Transferee shall, as far as legally possible, obtain all of the claims, rights and benefits under such Transferring Business Contract and such Relevant Contract Transferee shall assume and comply with all of the corresponding liabilities and obligations of the Relevant Contract Transferor under such Transferring Business Contract (including by means of any subcontracting, sublicensing or subleasing arrangement); and

 

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(ii)      the Relevant Contract Transferor shall continue to perform and enforce any rights relating to such Transferring Business Contract for the benefit of the Relevant Contract Transferee at such Relevant Contract Transferee’s cost and account, and such Relevant Contract Transferor shall pay or deliver to the Relevant Contract Transferee (as soon as reasonably practicable after receipt) any monies, goods and other benefits which it receives after the Separation Date to the extent that they relate to such Transferring Business Contract (and, for all Tax purposes, any Relevant Contract Transferor receiving such monies, goods and other benefits shall be treated as receiving such items as an agent or nominee for the Relevant Contract Transferee to the extent permitted by Applicable Law), except in each case to the extent that they comprise, or represent the proceeds from, a Novartis Retained Asset or a Novartis Liability (in respect of a Transferring Business Contract held by a member of the Alcon Group) or an Alcon Retained Asset or an Alcon Liability (in respect of a Transferring Business Contract held by a member of the Novartis Group),

 

in each case, the Relevant Contract Transferee’s assumption of any liabilities and obligations shall be limited to the extent (i) not arising out of, in connection with or relating to a Novartis Retained Asset or a Novartis Liability (in respect of a Transferring Business Contract held by a member of the Alcon Group) or an Alcon Retained Asset or an Alcon Liability (in respect of a Transferring Business Contract held by a member of the Novartis Group) and (ii) not attributable to the Relevant Contract Transferor’s or its Affiliates’ breach of, or non-performance under, or with respect to, any such Transferring Business Contract;

 

(e)                                   to the extent that the Relevant Contract Transferee is not lawfully able to perform the obligations under or relating to the relevant Transferring Business Contract from the Separation Date, Novartis or Alcon, as applicable, shall procure that the Relevant Contract Transferor in such Party’s Group (the Contract Transferor’s Parent ) shall (subject to being indemnified by the other Party (the Contract Transferee’s Parent ) for any Liabilities that the Contract Transferor’s Parent or the Relevant Contract Transferor may suffer or incur in connection therewith) do all such things as the Contract Transferee’s Parent may reasonably direct or reasonably require to enable due performance;

 

(f)                                    without prejudice to the provisions of sub-paragraphs (b) or (e) above, the Relevant Contract Transferor shall provide to the Relevant Contract Transferee such Information and assistance as it may reasonably require (including licensing to the Relevant Contract Transferee any relevant Intellectual Property Rights owned by, or licenced to, the Novartis Group or the Alcon Group, as applicable, or assisting with identifying alternative suppliers) with respect to any Transferring Business Contract which is subject to the provisions of this paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ); and

 

(g)                                   the Relevant Contract Transferor holding and maintaining the relevant Transferring Business Contract in accordance with this paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ) shall be deemed to be a service provided under the Transitional Services Agreement and the charging and cost calculation mechanism in the Transitional Services Agreement shall apply.

 

1.7                                Termination of Transferring Business Contracts.   If any Third Party Consent is not obtained or is refused within eighteen (18) months after the Separation Date (or such shorter time period as Novartis and Alcon agree), the Relevant Contract Transferor shall be entitled

 

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to terminate the Transferring Business Contract or Shared Contract (to the extent possible) and both Parties’ (and their respective Affiliates’) obligations under this Agreement in relation to the Transferring Business Contract or Shared Contract shall cease forthwith and references in this Agreement to the Transferring Business Contracts or Shared Contracts shall be construed excluding such Transferring Business Contract or Shared Contract.

 

1.8                                Shared Contracts. With effect from the Separation Date until the termination or expiry of the relevant Shared Contract, in respect of the Alcon Part or Novartis Part (as applicable) of each Shared Contract:

 

(a)                                  subject to sub-paragraphs (b) and (c) below, the provisions of paragraph 1.6 ( Third Party Consents Not Obtained Prior to Commencement of Separation ) of this Schedule 2 ( Transferring Contracts ) shall apply mutatis mutandis as though (i) a Third Party Consent is required in respect of the transfer of the Alcon Part or Novartis Part, as applicable, of such Shared Contract and (ii) such Third Party Consent has not been obtained at the Separation Date;

 

(b)                                  the application provisions of this Schedule 2 ( Transferring Contracts ) to the Shared Contracts referred to in schedule 8 of the Manufacturing and Supply Agreement shall be subject to the terms of schedule 8 of the Manufacturing and Supply Agreement; and

 

(c)                                   if the relevant member of the Alcon Group or member of the Novartis Group (as applicable) wishes to enforce any of its rights under the Alcon Part or Novartis Part (as applicable) (the Relevant Shared Contract Beneficiary ) of any Shared Contract:

 

(i)       it shall give written notice to the relevant member of the Novartis Group (if the Relevant Shared Contract Beneficiary is a member of the Alcon Group) or the relevant member of the Alcon Group (if the Relevant Shared Contract Beneficiary is a member of the Novartis Group) (as applicable) that is party to such Shared Contract (the Relevant Shared Contract Party ) containing reasonably specific details of any claim that it wishes to make to enforce its rights under the Alcon Part or Novartis Part (as applicable) of any Shared Contract, including such Information as is available to it to allow such Relevant Shared Contract Party (as applicable) to assess the merits of such claim and its amount; and

 

(ii)                if:

 

(A)           such Shared Contract primarily relates to the Alcon Business, Alcon (or any member of the Alcon Group) shall, subject to Novartis and each member of the Novartis Group being indemnified by Alcon against all Liabilities suffered or incurred by them to the extent arising out of or resulting from the conduct of any claim having been assumed by Alcon (or any member of the Alcon Group) under this sub-paragraph (A), be entitled (at its election and sole expense) to take such action as it shall deem necessary to negotiate, make, assert, avoid, dispute, deny, defend, resist, appeal, compromise, contest, settle, discharge or otherwise deal with any such claim and to have the conduct of any related proceedings, negotiations or appeals; provided, that Alcon shall ensure that it and each member of the Alcon Group shall:

 

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1.                                       not advance any argument against the counterparty under such Shared Contract or take any step that would reasonably be likely to have an adverse impact on Novartis, any of its Affiliates or the Novartis Business;

 

2.                                       take into account any reasonable requests of Novartis (or any member of the Novartis Group) in respect of such claim; and

 

3.                                       keep Novartis regularly informed in respect of such claim; or

 

(iii)     such Shared Contract primarily relates to the Novartis Business, Novartis (or any member of the Novartis Group of its Affiliates) shall be entitled (at its election and sole expense) to take such action as it shall deem necessary to negotiate, make, assert, avoid, dispute, deny, defend, resist, appeal, compromise, contest, settle, discharge or otherwise deal with any such claim and to have the conduct of any related proceedings, negotiations or appeals; provided, that Novartis shall ensure that it and each member of the Novartis Group shall:

 

(A)                                not advance any argument against the counterparty under such Shared Contract or take any step that would reasonably be likely to have an adverse impact on the Alcon Business;

 

(B)                                take into account any reasonable requests of Alcon (or any member of the Alcon Group) in respect of such claim; and

 

(C)                                keep Alcon regularly informed in respect of such claim.

 

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SCHEDULE 3

 

BRAZIL

 

Part A : Definitions

 

1.1                                Definitions. In this Schedule:

 

Accounting Standards means the Novartis Accounting Manual and, if not covered therein, most recent edition of the International Financial Reporting Standards as published by the International Accounting Standards Board at the time that any amount is to be calculated by reference to these standards;

 

Alcon Brazil means Alcon Brasil Cuidados com a Saúde Ltda.;

 

Audit Team has the meaning given in paragraph 1.2 ( Draft Economic Benefit Statements ) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Brazil Business Instruction has the meaning given in paragraph 1.4(a) of Part D ( Management and Control of the Brazilian Alcon Business ) of this Schedule 3 ( Brazil );

 

Brazil Closing Conditions has the meaning given in paragraph 1.2 ( Brazil Closing Conditions ) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Brazil Delayed Closing Date has the meaning given in paragraph 1.8 ( Brazil Delayed Closing Date ) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Brazil Delayed Closing means completion of the transfer of the Brazilian Alcon Business to Alcon Brazil in accordance with paragraph 1.9 ( Obligations on Brazil Delayed Closing Date ) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Brazil Longstop Date has the meaning given in paragraph 1.6 ( Longstop Date ) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Brazil Representative has the meaning given in paragraph 1.1 ( Brazil Representative ) of Part D ( Management and Control of the Brazilian Alcon Business ) of this Schedule 3 ( Brazil );

 

Brazilian Alcon Business means the Alcon Business as conducted by Novartis Brazil in Brazil, excluding any activities relating to the Manufacture of the Brazilian DEOH Products;

 

Brazilian Alcon Employees means any Alcon Employee (as defined in the Employee Matters Agreement) who is engaged by Novartis Brazil;

 

Brazilian Alcon Liabilities means the Alcon Liabilities of Novartis Brazil;

 

Brazilian Alcon Transferring Assets means the Alcon Transferring Assets owned by Novartis Brazil and:

 

Brazilian DEOH Products means (i) the products listed in Part B ( Brazilian DEOH Products ) of Exhibit 6 ( Brazil Products ); and (ii) any other products Commercialised by Novartis Brazil as part of the Brazilian Alcon Business, and Manufactured by Novartis Brazil in Brazil, prior to Brazil Delayed Closing;

 

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Brazilian L&S Products means (i) the products listed in Part A ( Brazilian L&S Products ) of Exhibit 6 ( Brazil Products ); and (ii) any other products Commercialised by Novartis Brazil as part of the Brazilian Alcon Business, but not Manufactured by Novartis Brazil, prior to Brazil Delayed Closing;

 

Delayed Indemnity Parties has the meaning given in paragraph 1.6 ( Indemnity ) of Part D ( Management and Control of the Brazilian Alcon Business) of this Schedule 3 ( Brazil );

 

DEOH Commercialisation Arrangement has the meaning given in paragraph 1.2(c) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Dispute Notice has the meaning given in paragraph 1.8 ( Dispute Notices ) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Disputed Items has the meaning given in paragraph 1.9 ( Documentation in Support of a Dispute ) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Draft Economic Benefit Statement has the meaning given in paragraph 1.2 ( Draft Economic Benefit Statements ) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Economic Benefit Amount has the meaning given to it in paragraph 1.3 ( Calculation of Economic Benefit Amount ) of Part F ( Form of Economic Benefit Statement ) of this Schedule 3 ( Brazil );

 

Economic Benefit Expert has the meaning given in paragraph 1.11(b) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Economic Benefit Objective has the meaning given in paragraph 1.3 ( Economic Benefit Objective ) of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Economic Benefit Statement has the meaning given in paragraphs 1.11(a) or 1.13(b) as applicable, of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil );

 

Instructing Personnel has the meaning given in paragraph 1.3 ( Instructing Personnel ) of Part D ( Management and Control of the Brazilian Alcon Business) of this Schedule 3 ( Brazil );

 

Novartis Brazil means Novartis Biociȇncias S.A.;

 

Option Agreement means the Agreement For Future Purchase of Alcon Brazil entered into between Novartis Pharma AG, Novartis Holding AG and Alcon Pharmaceuticals Limited on 26 February 2019;

 

Parent Involvement Instruction has the meaning given in paragraph 1.5 ( Parent Involvement Instruction ) of Part D ( Management and Control of the Brazilian Alcon Business ) of this Schedule 3 ( Brazil );

 

Post-Closing Permits has the meaning given in paragraph 1.2(a) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil );

 

Quarterly Accounting Period means a period commencing on 1 January and ending on 31 March, 1 April and 30 June, 1 July and 30 September or 1 October and 31 December, respectively, provided that the first Quarterly Accounting Period shall commence on the Separation Date and shall end on 30 June 2019, in accordance with paragraph 1.1 of Part E ( Economic Benefit Transfer ) of this Schedule 3 ( Brazil ); and

 

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Spin-off means the partial spin-off of Novartis Brazil, with the transfer of the Brazilian Alcon Transferring Assets from Novartis Brazil to Alcon Brazil.

 

Part B : Brazil Delayed Closing

 

1.1                                No Transfer at the Separation Date . The Parties acknowledge that the transfer of the Brazilian Alcon Business and the assumption of the Brazilian Alcon Liabilities cannot occur on the Separation Date and agree that:

 

(a)                                  the transfer of the Brazilian Alcon Business to Alcon Brazil shall be delayed until the Brazil Closing Conditions are satisfied or waived, following which the transfer of the Brazil Alcon Business to Alcon Brazil shall occur in accordance with the provisions of this Schedule 3 ( Brazil );

 

(b)                                  neither Alcon nor any member of the Alcon Group shall assume any Brazilian Alcon Liabilities until Brazil Closing occurs;

 

(c)                                   the provisions of Clauses 13 ( Mutual Release and Indemnification) and 15 (Liabilities and Additional Matters ) shall not apply in respect of the Brazilian Alcon Liabilities until Brazil Closing occurs; and

 

(d)                                  notwithstanding the delayed transfer of the Brazilian Alcon Business, the provisions of Clause 1 ( The Separation ) and the rest of this Agreement shall continue to apply in relation to all Novartis Transferring Assets, Novartis Transferring Entities, Alcon Transferring Assets and Alcon Transferring Entities other than the Brazilian Alcon Business.

 

1.2                                Brazil Closing Conditions . The transfer of the Brazilian Alcon Business to Alcon Brazil and the assumption of the Brazilian Alcon Liabilities by Alcon Brazil shall be conditional on the following conditions (the Brazil Closing Conditions ) being fulfilled or waived in accordance with this Agreement:

 

(a)                                  Alcon Brazil having been validly incorporated under Brazilian Law and having all Permits (other than Marketing Authorisations) reasonably necessary for (i) the Brazilian Alcon Transferring Assets to be transferred to it and (ii) the Brazilian Alcon Business to be conducted by Alcon Brazil substantially in the form it is conducted immediately prior to Brazil Closing, in compliance with Applicable Law, other than (in each case) those Permits that cannot legally be obtained prior to Brazil Closing ( Post-Closing Permits );

 

(b)                                  Alcon Brazil having obtained all Permits (other than Marketing Authorisations) legally necessary under Brazilian Law for Alcon Brazil to import the Brazilian L&S Products into Brazil for Commercialisation by Alcon Brazil in Brazil, other than any Post-Closing Permits;

 

(c)                                   the Parties having agreed an arrangement pursuant to which the Brazilian DEOH Products will be Commercialised in Brazil by Alcon Brazil pending transfer of the Brazilian DEOH Product Marketing Authorisations to Alcon Brazil (the DEOH Commercialisation Arrangement );

 

(d)                                  Alcon Brazil having established an information technology system reasonably sufficient for Alcon Brazil to be practically capable of

 

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(i)       Commercialising the Brazilian L&S Products in Brazil in a manner consistent with that in which the Brazilian L&S Products were Commercialised in Brazil by Novartis Brazil immediately prior to the date of this Agreement;

 

(ii)      Commercialising the Brazilian DEOH Products in accordance with the DEOH Commercialisation Arrangement; and

 

(iii)     acting as the employer of, including managing the payroll and compensation of, the Brazilian Alcon Employees to the minimum standard required by Applicable Law,

 

and the Parties intend for the requirements in sub-paragraph (i) and (ii) above to be satisfied through a new, standalone JD Edwards system operated by the Alcon Group, to which the relevant parts and data of the existing JD Edwards system used by the Novartis Group in respect of the Brazilian Alcon Business will be cloned and relevant data from the Novartis Group’s existing SAP system will be migrated.

 

1.3                                Efforts to Satisfy Brazil Closing Conditions.

 

(a)                                  Each Party shall use its Commercially Reasonable Efforts to procure that each of the Brazil Closing Conditions is fulfilled as soon as practicable after the date of this Agreement.

 

(b)                                  Alcon shall issue such Brazil Business Instructions as are reasonably required in connection with the satisfaction of the Brazil Closing Conditions and shall not issue any Brazil Business Instructions that are inconsistent with the satisfaction of the Brazil Closing Conditions.

 

1.4                                Information Sharing . Each Party shall provide the other Party with any necessary Information reasonably required in connection with the satisfaction of the Brazil Closing Conditions, including in connection with the notices, applications, submissions, reports or other instruments, documents, correspondence or filings required to be made to any Governmental Entity.

 

1.5                                Waiver and Fulfilment of Brazil Closing Conditions . The Parties may, through mutual agreement in writing, waive any Brazil Closing Condition, to the extent permissible under Applicable Law. Each Party shall notify the other promptly upon becoming aware that any Brazil Closing Condition has been fulfilled.

 

1.6                                Longstop Date . If the Brazil Closing Conditions have not been satisfied, or waived in accordance with paragraph 1.5 ( Waiver and Fulfilment of Brazil Closing Conditions ), by 31 December 2022 (the Brazil Longstop Date ), then

 

(a)                                  to the maximum extent permitted under Applicable Law, Novartis (or the relevant member of the Novartis Group, including Novartis Brazil), shall be permitted (and Alcon hereby authorises each of them) to take such steps as Novartis, acting reasonably, considers necessary or desirable to procure the satisfaction of the then outstanding Brazil Closing Conditions, including instructing the Brazilian Alcon Employees to take such steps as Novartis, acting reasonably, considers necessary or desirable to procure the satisfaction of the then outstanding Brazil Closing Conditions; and

 

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(b)                                  Alcon shall provide such assistance and shall provide such services as Novartis may reasonably request in connection any steps taken pursuant to paragraph (a) above or otherwise in connection with the satisfaction of the Brazil Closing Conditions.

 

If the Brazil Conditions have not been satisfied or waived in accordance with paragraph 1.5 ( Waiver and Fulfilment of Brazil Closing Conditions ) within six months of the Brazil Longstop Date, the Parties shall refer the issue to the Separation Committee, which shall determine in good faith, given the facts and circumstances known at the time, the best way to proceed such that the Brazilian Alcon Transferring Assets (or as many of them as possible) can be transferred to Alcon Brazil or such member of the Alcon Group as may be nominated by Alcon as soon as reasonably practicable.

 

1.7                                Costs of Satisfying the Brazil Closing Conditions . Save as provided otherwise in any Transaction Document (including, without limitation, pursuant to Schedule 2 of this Agreement, the terms of the Transitional Services Agreement and the terms of the MA Transfer Agreement):

 

(a)                                  Novartis shall bear all fees, charges and other expenses payable to any legal counsel appointed by any member of the Novartis Group or the Alcon Group to the extent incurred in relation to the transfer of the Brazilian Alcon Transferring Assets to Alcon Brazil, the satisfaction of the Brazil Closing Conditions and/or obtaining the Post-Closing Permits, including all fees, charges and other expenses payable to Freshfields Bruckhaus Deringer LLP and Pinheiro Neto Advogados;

 

(b)                                  subject to paragraph (c) below, Novartis shall bear all other external costs or expenses (other than fees, charges and other expenses payable to any legal counsel) suffered or incurred by any member of the Novartis Group or any member of the Alcon Group in connection with the transfer of the Brazilian Alcon Transferring Assets to Alcon Brazil, the satisfaction of the Brazil Closing Conditions and/or obtaining the Post-Closing Permits including the commercially reasonable costs of cloning the relevant parts and data of the existing JD Edwards system used by the Novartis Group in respect of the Brazilian Alcon Business to a new JD Edwards system operated by the Alcon Group and migrating relevant data from the Novartis Group’s SAP system to such new JD Edwards system operated by the Alcon Group; and

 

(c)                                   Alcon shall bear any external costs or expenses suffered or incurred (other than fees, charges and other expenses payable to any legal counsel) by any member of the Novartis Group or any member of the Alcon Group in connection with:

 

(i)       the transfer of the Brazilian Alcon Transferring Assets to Alcon Brazil, the satisfaction of the Brazil Closing Conditions and/or obtaining the Post-Closing Permits, to the extent such external costs or expenses arise as a result of, or in connection with, a change in the nature (including any change in the manufacturing set-up) of the Brazilian Alcon Business after the Separation Date that arises as a result of or in connection with any Brazil Business Instruction; and/or

 

(ii)      the establishment of an “IRIS” information technology system for Alcon Brazil and moving the Brazillian Alcon Business and relevant data from the JD Edwards system operated by Alcon Brazil referred to in paragraph (b) above to such “IRIS” information technology system.

 

For the avoidance of doubt this paragraph 1.7 ( Costs of Satisfying the Brazil Closing Conditions ) shall not apply in respect of any internal costs of the Novartis Group or the Alcon

 

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Group, respectively, or any costs associated with employing any employees of the Novartis Group or the Alcon Group who may be involved in the satisfaction of the Brazil Closing Conditions (including the Brazilian Alcon Employee Costs).

 

1.8                                Brazil Delayed Closing Date . Brazil Delayed Closing shall occur on the date which is the last Business Day of the month in which all of the Brazil Closing Conditions have been satisfied or waived in accordance with this Agreement, provided that:

 

(a)                                  where the last day of such month is not a Business Day, Brazil Delayed Closing shall instead take place on the first Business Day of the following month; or

 

(b)                                  where less than ten (10) Business Days remain between satisfaction or waiver of the Brazil Closing Conditions and the last Business Day of the month, Brazil Delayed Closing shall take place:

 

(i)       on the last Business Day of the following month;

 

(ii)      where the last day of such month is not a Business Day, the Brazil Delayed Closing shall instead take place on the first Business Day of the month following the month referred to in sub-paragraph (i) above; or

 

(c)                                   on such other date as may be agreed in writing between Alcon and Novartis,

 

such date being the Brazil Delayed Closing Date.

 

1.9                                Obligations on Brazil Delayed Closing Date . Novartis and Alcon shall procure that on the Brazil Delayed Closing Date:

 

(a)                                  Novartis Brazil shall transfer, and Alcon Brazil shall accept, all of such Novartis Brazil’s direct or indirect rights, title and interest in and to each Brazilian Alcon Transferring Asset, through the Spin-off (or as otherwise agreed between the Parties);

 

(b)                                  subject to Clause 13.1 ( Ancillary Agreement Liabilities ), Alcon Brazil shall assume and be responsible for all Brazilian Alcon Liabilities, regardless of when or where such Brazilian Alcon Liabilities arose or arise, or whether the facts on which they are based occurred prior to, at or after the Separation Date (or the Brazil Delayed Closing Date), regardless of where or against whom such Brazilian Alcon Liabilities are asserted or determined (including any such Brazilian Alcon Liabilities arising out of claims made by Novartis’s or Alcon’s respective Affiliates or by Representatives of Novartis or Alcon or their respective Affiliates against either Party or any of its Affiliates) or whether asserted or determined prior to, at or after the Separation Date (or the Brazil Delayed Closing Date), and regardless of whether arising from or alleged to arise from negligence, recklessness, violation of any Applicable Law, fraud, misrepresentation or otherwise by either Party or any member of its Group or any of their respective Representatives;

 

(c)                                   the provisions of  Clauses 13 ( Mutual Release and Indemnification) and 15 (Liabilities and Additional Matters ) shall apply in respect of the Brazilian Alcon Liabilities;

 

(d)                                  the Brazilian Alcon Employees shall transfer to Alcon Brazil in accordance with the terms of the Employee Matters Agreement; and

 

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(e)                                   Alcon Brazil and Novartis Brazil shall enter into the agreement(s) necessary to implement the DEOH Commercialisation Arrangement (the DEOH Agreement(s) ).

 

1.10                         Transfer of Alcon Brazil . Novartis and Alcon shall procure that on the Brazil Delayed Closing Date, or as soon as practicable after the Brazil Delayed Closing Date (and in any event within thirty (30) days of such date, the entire corporate capital of Alcon Brazil, together with any outstanding Intercompany Non-Trading Accounts owed by Alcon Brazil to Novartis Pharma AG and/or Novartis Holding AG, are transferred to Alcon Pharmaceuticals Limited or such member or members of the Alcon Group as Alcon Pharmaceutical Limited may nominate, in accordance with the terms of the Option Agreement (or, if the Option Agreement has terminated in accordance with clause 5 thereof, in accordance with such other terms, agreements or arrangements as Alcon and Novartis may agree in accordance with paragraph 1.10 below)

 

1.11                         Alternative Arrangements to the Option Agreement . The Parties agree and acknowledge that the expiry of the Option Agreement shall be without prejudice to the Parties’ obligation in paragraph 1.10 to procure that the entire corporate capital of Alcon Brazil, together with any outstanding Intercompany Non-Trading Accounts owed by Alcon Brazil to Novartis Pharma AG and/or Novartis Holding AG, are transferred to Alcon Pharmaceuticals Limited or such member or members of the Alcon Group as Alcon Pharmaceutical Limited may nominate, and, if the Spin-off is completed but the Option Agreement has expired in accordance with clause 5 thereof, the Parties’ Brazil Representatives shall negotiate in good faith, and use Commercially Reasonable Efforts to agree (including through escalation to the Separation Committee if necessary), an alternative mechanism (acceptable to both Parties, acting reasonably) through which such transfer can be effected.

 

1.12                         Assistance Following the Brazil Delayed Closing Date . Following the Brazil Delayed Closing Date:

 

(a)                                  the provisions of the MA Transfer Agreement shall apply in respect of any Alcon Transferring Marketing Authorisations that are not transferred to Alcon Brazil on the Brazil Delayed Closing Date;

 

(b)                                  the provisions of the Transitional Services Agreement shall apply in respect of any transitional services identified therein to be provided in respect of Alcon Brazil and/or the Brazilian Alcon Business;

 

(c)                                   Alcon and Novartis shall each use their Commercially Reasonable Efforts to procure that Alcon Brazil obtains the Post-Closing Permits as soon as practicable after the Brazil Delayed Closing Date; and

 

(d)                                  the Parties’ Brazil Representatives shall negotiate in good faith, and use Commercially Reasonable Efforts to agree (including through escalation to the Separation Committee if necessary), whether any additional support reasonably required by Alcon Brazil from the Novartis Group is required in order to complete the transfer of any Brazilian Alcon Transferring Assets to Alcon Brazil that do not transfer to Alcon Brazil on the Brazil Delayed Closing Date and, if so, the terms on which such support may be provided.

 

1.13                         Negotiation of the Brazilian DEOH Commercialisation Arrangement . For the purposes of compliance with paragraph 1.9(e), Novartis and Alcon shall, between the date of this Agreement and the Brazil Delayed Closing Date, negotiate in good faith, and use Commercially Reasonable Efforts to agree (including through escalation to the Separation

 

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Committee if necessary), the DEOH Commercialisation Arrangement and the terms of the DEOH Agreement(s).

 

Part C : Alcon Brazil Manufacturing Facility

 

If, after the Separation Date, Alcon Brazil chooses to establish a manufacturing facility and/or quality control (QC) laboratory in Brazil at the end of the DEOH Commercialisation Arrangement, Novartis shall bear (and shall reimburse the relevant members of the Alcon Group in respect of) half of the capital expenditure incurred by the Alcon Group prior to 31 March 2025 in establishing such manufacturing facility, up to a maximum amount of $10,000,000, provided that Novartis shall only bear such capital expenditure: (i) to the extent the specifications of such facility are no higher than those reasonably necessary; and (ii) in respect of that part of the facility the specifications of which are reasonably necessary, in order for Alcon Brazil to obtain a Brazilian manufacturing licence (or other appropriate licence) in respect of the Brazilian DEOH Products to allow them to sell such products in Brazil at the end of the DEOH Commercialisation Arrangement.  Alcon shall keep Novartis reasonably informed of its intentions to establish a manufacturing facility and/or QC laboratory in Brazil and of the proposed timing of its incurring of any capital expenditure (and seeking reimbursement of half of such capital expenditure) that is the subject of this provision.  When seeking reimbursement of capital expenditure pursuant to this provision, Alcon shall provide reasonable evidence to Novartis of the capital expenditure it has incurred.

 

Part D : Management and Control of the Brazilian Alcon Business

 

1.1                                Brazil Representatives . In order to cooperate in managing the implementation of the provisions set out in this Schedule 3 ( Brazil ), Novartis and Alcon shall notify each other of the identity of a senior member of management (the Brazil Representative ) who shall be the primary point of contact in the event that there is any issue in connection with the operation of the provisions in this Schedule 3 ( Brazil ). The Parties shall notify each other in writing of the contact details for their respective Brazil Representatives from time to time.

 

1.2                                Control of Brazilian Alcon Business . To the maximum extent permissible by Applicable Law and subject to paragraphs 1.3(b) ( Efforts to Satisfy Brazil Closing Conditions ) and 1.6(a) ( Longstop Date ) of Part B ( Brazil Delayed Closing ) and paragraphs 1.12 ( Brazilian Alcon Employees ) and 1.13 ( Policies and Procedures ) of this Part D ( Management and Control of the Brazilian Alcon Business ) of this Schedule 3 ( Brazil ), the Parties intend that, pursuant to this Schedule 3 ( Brazil ), all management and control rights and powers that any member of the Novartis Group has in relation to the Brazilian Alcon Business shall transfer to Alcon with effect from the Separation Date and, accordingly, the Alcon Group shall consolidate the Brazilian Alcon Business into its accounts with effect from the Separation Date.

 

1.3                                Instructing Personnel . As soon as reasonably practicable after the Separation Date, Alcon shall notify Novartis of the names of its personnel permitted to provide Brazil Business Instructions ( Instructing Personnel ) and Novartis Brazil (and each member of the Novartis Group) shall be entitled to rely on and act in accordance with Brazil Business Instructions from Instructing Personnel without further verification. Instructions provided by or on behalf of Alcon Brazil shall not be required to be in writing if they are provided by the Instructing Personnel. Alcon shall be free to change its Instructing Personnel from time to time by providing ten (10) Business Days’ written notice to Novartis’ Brazil Representative.

 

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1.4                                Conduct Pending Delayed Closing . From the Separation Date until the Brazil Delayed Closing Date, Novartis shall procure that Novartis Brazil shall:

 

(a)                                  subject to paragraphs 1.3(b) and 1.6(a) of Part B ( Brazil Delayed Closing ) and paragraphs 1.12 ( Brazilian Alcon Employees ) and 1.13 ( Policies and Procedures ) of this Part D  ( Management and Control of the Brazilian Alcon Business ) and to the maximum extent permitted by Applicable Law, act in accordance with any instructions provided to it by any of the Instructing Personnel in relation to any aspect of the management and operation of the Brazilian Alcon Business or any part of it (a Brazil Business Instruction ), including the making (or otherwise) of expenditure, investments, employee matters (including the hiring or dismissal of any Brazilian Alcon Employee), determining operating or financial policies of the Brazilian Alcon Business, and/or developing the Brazilian Alcon Business into new areas and undertaking activities not previously undertaken in relation to that the Brazilian Alcon Business; and

 

(b)                                  except to the extent otherwise instructed by the Instructing Personnel in accordance with this paragraph 1.4 ( Conduct Pending Delayed Closing ), ensure that the Brazilian Alcon Business is carried on in the ordinary course of business consistent with past practice.

 

1.5                                Parent Involvement Instruction . To the extent that the implementation of any Brazil Business Instruction requires an action or actions of a Person employed by Novartis but who is not a Brazilian Alcon Employee (whether because Applicable Law prevents such Brazil Business Instruction from being given directly to a Brazilian Alcon Employee or for any other reason) (a Parent Involvement Instruction ), Alcon shall also provide the Brazil Business Instruction, in writing to Novartis’s Brazil Representative, specifying (i) that it is the Parent Involvement Instruction; (ii) the actions that are required to be taken by such Person; and (iii) a reasonable time within which such actions are required to be taken.

 

1.6                                Indemnity . Alcon hereby undertakes to Novartis (for itself and on behalf of each other member of such Group, including Novartis Brazil) and their respective directors, officers, employees and agents (excluding any Brazilian Alcon Employees) (the Delayed Indemnity Parties ) that with effect from Separation Date Alcon shall indemnify on demand and hold harmless each of the Delayed Indemnity Parties against and in respect of any and all Liabilities, other than Liabilities that are taken into account in calculating any Economic Benefit Amount, resulting directly or indirectly from the Brazilian Alcon Business and/or from any Brazil Business Instruction to the extent that:

 

(a)                                  such Liabilities are not Novartis Liabilities; and

 

(b)                                  the Delayed Indemnity Parties concerned would not have incurred such Liabilities if the Brazilian Alcon Business had been transferred to Alcon Brazil at the Separation Date,

 

but in any case excluding any Liabilities to the extent they arise as a result of a breach of paragraph 1.8 ( Fraud and Gross Negligence) below.

 

1.7                                No Claims Other Than for Fraud or Gross Negligence . Alcon (and each member of the Alcon Group, including Alcon Brazil) shall not be entitled to make any claim for damages against Novartis (or any member of the Novartis Group, including Novartis Brazil) in respect of a breach of this Part D ( Management and Control of the Brazilian Alcon Business ) otherwise than pursuant to a claim brought under paragraph 1.8 ( Fraud and Gross Negligence) below.

 

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1.8                                Fraud and Gross Negligence . Novartis shall procure that neither it nor any of its Affiliates or their respective directors, officers or employees shall act (or fail to act) fraudulently or with Gross Negligence or in wilful default in connection with the implementation of any Brazil Business Instruction (including any Parent Involvement Instructions), but it shall not be a breach of this paragraph 1.8 ( Fraud and Gross Negligence) (and shall accordingly not be acting fraudulently or with Gross Negligence or in wilful default for the purposes of this paragraph) to carry out any act, or fail to act, if to do so is:

 

(a)                                  required to implement any Brazil Business Instruction;

 

(b)                                  required to comply with Applicable Law;

 

(c)                                   required to implement or comply with the terms of this Agreement or any Ancillary Agreement; or

 

(d)                                  taken in good faith to mitigate any other loss or damage to the Brazilian Alcon Business which the relevant Person believes, acting in good faith, could be material in the context of the Brazilian Alcon Business.

 

1.9                                Cooperation and Assistance . Alcon shall (and shall procure that Alcon Brazil shall) supply such cooperation, support, access and other assistance (including the supply of products, the supply of services and access to Information (but excluding any access to Intellectual Property Rights except as referred to in paragraph 1.10 ( IP Licence ) below) as shall be reasonably necessary to allow Novartis Brazil to operate the Brazilian Alcon Business in accordance with this Schedule 3 ( Brazil ).

 

1.10                         IP Licence . Alcon shall (or shall procure that its relevant Affiliates shall) grant Novartis and each member of its Group, including Novartis Brazil, and Novartis shall (or shall procure that its relevant Affiliates shall) grant Alcon and each member of the Alcon Group,  from the Separation Date until Brazil Delayed Closing, a non-exclusive, fully paid up, royalty free and sub-licensable licence or sub-licence (as applicable) to use, notwithstanding any other provision of this Agreement or any of the Ancillary Agreements, any Intellectual Property Rights owned by, or licensed to (i) Alcon (or any member of the Alcon Group), or (ii) Novartis (or any member of the Novartis Group), respectively, under any Ancillary Agreement or otherwise, for the sole purpose of operating the Brazilian Alcon Business in accordance with the provisions of this Schedule 3 ( Brazil ).

 

1.11                         Funding of Brazilian Alcon Business . Subject to Applicable Law, during the period between the Separation Date and the Brazil Delayed Closing Date, funding for the Brazilian Alcon Business shall continue to be provided by the Novartis Group, save that in the event that the Brazilian Alcon business requires funds (for the purposes of working capital, acquisitions, capital expenditure or otherwise) during such period in excess of $10,000,000 and the Brazilian Alcon Business does not have the required funding in place (including though any ordinary course cash pooling arrangements), then such funds shall promptly be provided by the Alcon Group.

 

1.12                         Brazilian Alcon Employees . The provisions of the Employee Matters Agreement shall apply in respect of the Brazilian Alcon Employees.

 

1.13                         Policies and Procedures . Between the Separation Date and the Brazil Delayed Closing Date:

 

(a)                                  Alcon shall procure that in relation to all matters in respect of which, as at the date of this Agreement, the Brazilian Alcon Business operates under an Alcon divisional

 

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conduct policy (for example, “The Lens” policy applicable to certain professional practice) (an “ Alcon Policy ”), the Brazilian Alcon Business shall continue to follow such Alcon Policy;

 

(b)                                  Alcon shall be free to amend any Alcon Policy, including in respect of the Brazilian Alcon Business, provided that any amended Alcon Policy that applies to the Brazilian Alcon Business shall be no less rigorous, and shall not require or authorise behaviour that is more likely to expose the Parties to legal, regulatory and/or compliance risk, than the Alcon Policy in place at the date of this Agreement;

 

(c)                                   subject to paragraph (d) below, Alcon shall procure that in relation to all matters in respect of which, as at the date of this Agreement, the Brazilian Alcon Business operates under a global Novartis Group policy (for example, the Novartis Group “Code of Conduct”) (a “ Novartis Group Policy ”), the Brazilian Alcon Business shall continue to follow such Novartis Group Policy;

 

(d)                                  Alcon shall procure that where the Brazilian Alcon Business currently operates under a Novartis Group Policy that is independently managed by Alcon (for example, as is the case at the date of this Agreement for the “Conflicts of Interest” and “Anti-Bribery” policies), the Brazilian Alcon Business shall continue to follow such Novartis Group Policy (under Alcon’s management) until such time as the Alcon Group has a substantially similar (and no less rigorous) policy in place, from which time the Brazilian Alcon Business shall follow such new substantially similar (and no less rigorous) Alcon Group policy;

 

(e)                                   Alcon shall monitor, and take steps to procure, the Brazilian Alcon Business’ compliance with the Alcon Policies and any Novartis Group Policy referred to in paragraph (d) above in a manner no less rigorous (and which does not require or authorise behaviour that is more likely to expose the Parties to legal, regulatory and/or compliance risk) than Alcon does so at the date of this Agreement;

 

(f)                                    Novartis shall monitor, and take steps to procure, the Brazilian Alcon Business’ compliance with any Novartis Group Policy other than those referred to in paragraph (d) above in a manner no less rigorous (and which does not require or authorise behaviour that is more likely to expose the Parties to legal, regulatory and/or compliance risk) than Novartis does so at the date of this Agreement; and

 

(g)                                   Alcon shall permit the legal representatives of Novartis Brazil to exercise supervision over, and to monitor, all of Novartis Brazil’s operations, including in respect of the Brazilian Alcon Business, to the extent required for such legal representatives to fulfil the duties imposed upon them by Applicable Law and in a manner consistent with past practice prior to the Separation Date.

 

Part E : Economic Benefit Transfer

 

1.1                                Quarterly Accounting Periods . Each Party shall comply with the provisions of this Part E ( Economic Benefit Transfer ) for each Quarterly Accounting Period between the Separation Date and the Brazil Delayed Closing Date. The first Quarterly Accounting Period for which the provisions of this Part E ( Economic Benefit Transfer ) commences on the Separation Date and shall end on 30 June 2019.

 

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1.2                                Draft Economic Benefit Statements . Within one (1) month following the end of each Quarterly Accounting Period, Alcon shall provide Novartis’ internal audit team (or external auditors) (the Audit Team ) a draft statement setting out the Economic Benefit Amount in respect of the Brazilian Alcon Business for such Quarterly Accounting Period (or, if applicable, such part of the Quarterly Accounting Period as falls prior to the Brazil Delayed Closing Date). Each such statement shall be a Draft Economic Benefit Statement .

 

1.3                                Economic Benefit Objective . It is intended that the Economic Benefit Amount shown in each Economic Benefit Statement is the amount that is necessary to be paid to Alcon by Novartis in order to put the Alcon Group and the Novartis Group in the same economic position as they would have been in, taking into account any arrangements that would have been in place in respect of the Brazilian Alcon Business pursuant to any Ancillary Agreement, had the Brazilian Alcon Business been transferred to a member of the Alcon Group on the Separation Date before taking account, in each case, of any Tax effect for Alcon Brazil or Novartis Brazil in respect of such payment that is not explicitly reflected in the calculation of the Economic Benefit Amount (the Economic Benefit Objective ).

 

1.4                                Currency Conversion . The Economic Benefit Amount shall be calculated in Brazilian Real, but shall be paid pursuant to paragraphs 1.14 ( Positive Economic Benefit Amounts ) or 1.15 ( Negative Economic Benefit Amounts ) below in US Dollars, for which purpose each amount shall be converted into US Dollars at the official Brazil PTAX reference rate (as reported by Bloomberg under “BZFXPTAX Index”) quoted by central bank of Brazil (Banco Central do Brasil) on the last Business Day of the applicable reporting period and the sum of such converted amounts shall be the Economic Benefit Amount. The calculation of the Economic Benefit Amount set out in an Economic Benefit Statement shall only be converted into US Dollars in accordance with this paragraph 1.4 ( Currency Conversion ) after the Economic Benefit Statement has been agreed or determined in accordance with this Part E ( Economic Benefit Transfer ).

 

1.5                                Audit Access . Alcon shall, and shall procure that its Affiliates and the Brazilian Alcon Employees shall, provide Novartis’ Audit Team, without charge, such access to their personnel, books and records, calculations and working papers as such Audit Team may reasonably request in connection with its review of the Draft Economic Benefit Statement.

 

1.6                                Application of MSA Prices to Novartis Brazil . The Parties acknowledge that after the Separation Date and before Brazil Delayed Closing Novartis Brazil’s financial reporting system will not record the Transfer Price of the Brazilian Product Manufactured by Novartis Brazil in accordance with paragraph 1.1(k)(iii) of Part F and, accordingly a manual adjustment will be required to be made to the figures extracted from Novartis Brazil’s financial reporting system for the purposes of preparing the Draft Economic Benefit Statement, to ensure that the Transfer Price of such products for the purposes of calculating the Economic Benefit Amount is the applicable Supply Price (as that term is defined in the Manufacturing and Supply Agreement) for the relevant Brazilian Products that would have been charged under Manufacturing and Supply Agreement had such Brazilian Products been supplied under the terms of the Manufacturing and Supply Agreement.

 

1.7                                No Other Amendments . No amendments shall be made to any Draft Economic Benefit Statement except in accordance with the provisions of paragraphs 1.8 ( Dispute Notices ) to 1.13 ( The Economic Benefit Expert ) below.

 

1.8                                Dispute Notices . Novartis’ Audit Team may dispute a Draft Economic Benefit Statement by notice in writing (in this Schedule 3 ( Brazil ), a Dispute Notice ) delivered to Alcon within three (3) weeks following receipt of the Draft Economic Benefit Statement. Any Dispute Notice shall specify (i) which items of the Draft Economic Benefit Statement are

 

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disputed; (ii) the reasons therefor, making specific reference (where relevant and reasonably possible) to the parts of this Schedule 3 which the Novartis Audit Team asserts have not been complied with in preparing the relevant statement; and (iii) to the extent practicable, any adjustments that the Novartis Audit Team considers should be made to the Draft Economic Benefit Statement. The regime provided for in this paragraph 1.8 shall be in lieu of, not in addition to, any duty to immediately inspect and notify according to the CO.

 

1.9                                Documentation in Support of a Dispute . Any Dispute Notice shall be accompanied by all relevant supporting documentation and working papers on which the Novartis Audit Team wishes to rely, it being acknowledged that the Novartis Audit Team shall provide further documentation to support its claims promptly on reasonable request by Alcon or, where relevant, the Economic Benefit Expert. Only those items or amounts specified in a Dispute Notice shall be treated as being in dispute (the Disputed Items ) and no amendment may be made by any party, or any Economic Benefit Expert, to any items or amounts which are not Disputed Items.

 

1.10                         Failure to Serve a Dispute Notice . If the Novartis Audit Team does not serve a Dispute Notice under and within the time period set out in paragraph 1.8 ( Dispute Notices ), the Draft Economic Benefit Statement shall constitute the Economic Benefit Statement in respect of the Brazilian Alcon Business for the relevant Quarterly Accounting Period to which that Economic Benefit Statement relates.

 

1.11                         Service of a Dispute Notice . If the Novartis Audit Team does serve a Dispute Notice under and within the time period set out in paragraph 1.8 ( Dispute Notices ), the Parties shall use their reasonable endeavours to resolve the Disputed Items as soon as reasonably practicable and either:

 

(a)                                  if the Parties reach agreement on the Disputed Items within twenty (20) Business Days of the service of the relevant Dispute Notice (or such longer period as they may agree in writing), the Draft Economic Benefit Statement shall be amended to reflect such agreement and shall then constitute the Economic Benefit Statement in respect of the relevant Quarterly Accounting Period to which that Economic Benefit Statement relates; or

 

(b)                                  if the Parties do not reach agreement in accordance with paragraph (a) above, either Party may refer the dispute to the statutory auditors of Novartis Brazil or such other independent firm of chartered accountants of international repute as the Parties may agree (the Economic Benefit Expert ), on the basis that the Economic Benefit Expert is to make a decision on the dispute and notify the Parties of its decision within twenty (20) Business Days of receiving the reference or such longer reasonable period as the Economic Benefit Expert may determine.

 

1.12                         Cost Sharing . The Parties shall bear the costs in relation to the preparation and certification of any Draft Economic Benefit Statement and in relation to the review of (and any dispute in relation to) any Draft Economic Benefit Statement, including the fees payable to any Economic Benefit Expert, equally (50 per cent. borne by Novartis and 50 per cent. borne by Alcon).

 

1.13                         The Economic Benefit Expert . In any reference to the Economic Benefit Expert in accordance with paragraph 1.11 ( Service of a Dispute Notice ) above:

 

(a)                                  the Economic Benefit Expert shall act as expert and not as arbitrator and shall be directed to determine any dispute in accordance with the Accounting Standards and

 

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Part F ( Form of Economic Benefit Statement ) of this Schedule 3 ( Brazil ) and (if necessary) having regard to the Economic Benefit Objective;

 

(b)                                  the decision of the Economic Benefit Expert shall, in the absence of fraud or manifest error, be final and binding on the Parties and the Draft Economic Benefit Statement shall be amended as necessary to reflect the decision of the Economic Benefit Expert and, as amended, shall be the Economic Benefit Statement in respect of the relevant Quarterly Accounting Period to which that Economic Benefit Statement relates; and

 

(c)                                   each Party shall provide or procure the provision to the Economic Benefit Expert of all such information as the Economic Benefit Expert shall reasonably require including access to their respective advisers and their respective books, records and personnel.

 

1.14                         Positive Economic Benefit Amounts. If following the agreement or determination of an Economic Benefit Statement in respect of any Quarterly Accounting Period the Economic Benefit Amount is a positive amount, Novartis shall pay an amount equal to the Economic Benefit Amount as set out in the relevant Economic Benefit Statement to Alcon within ten (10) Business Days of the date of the agreement or determination of the relevant Economic Benefit Statement.

 

1.15                         Negative Economic Benefit Amounts. If following the agreement or determination of an Economic Benefit Statement in respect of any Quarterly Accounting Period the Economic Benefit Amount is a negative amount, Alcon shall pay an amount equal to the Economic Benefit Amount  as set out in the relevant Economic Benefit Statement (treating it as a positive amount for these purposes) to Novartis within ten (10) Business Days of the date of the agreement or determination of the relevant Economic Benefit Statement.

 

1.16                         Brazilian Accounts Receivable . Novartis and Alcon agree that:

 

(a)                                  the Brazilian Alcon Transferring Assets (which are required to be transferred to Alcon Brazil pursuant to paragraph 1.9(a) of Part B ( Brazil Delayed Closing ) of this Schedule 3 ( Brazil )) includes any Alcon Accounts Receivable owed to Novartis Brazil;

 

(b)                                  on the Brazil Delayed Closing Date, Alcon shall re-pay to Novartis an amount equal to the aggregate amount of the Alcon Accounts Receivable owed to Alcon Brazil arising after the Separation Date in respect of Net Sales that have been taken into account in the calculation of any Economic Benefit Amount, minus the amount of any Bad Debts deducted from the calculation of the Economic Benefit Amount prior to the Brazil Delayed Closing; and

 

(c)                                   after the Brazil Delayed Closing Date, Alcon Brazil shall have the benefit of, and shall manage the collection of, such Alcon Accounts Receivables.

 

If any Alcon Accounts Receivable cannot be transferred to Alcon Brazil on the Brazil Delayed Closing Date, the provisions of clause 11 of this Agreement shall apply.

 

Part F : Form of Economic Benefit Statement

 

1.1                                Definitions . For the purposes of this Part F ( Form of Economic Benefit Statement ):

 

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(a)                                  Bad Debt has the meaning given in paragraph 1.3(h) of this Part F ( Form of Economic Benefit Statement ) of this Schedule 3 ( Brazil );

 

(b)                                  Brazilian Products means the Brazilian DEOH Products and the Brazilian L&S Products;

 

(c)                                   Brazilian Tax Rate means 34.25%;

 

(d)                                  Customer means any Person that acquires and/or intends to acquire any Brazilian Product (including any members of the Alcon Group or the Novartis Group);

 

(e)                                   Deemed Sales to Novartis means sales that, if the Brazilian Alcon Business had transferred to Alcon Brazil on the Separation Date, would have been made by the Brazilian Alcon Business to Novartis Brazil, which shall be deemed to have been made at the pricing (including margin) that would have applied to such sales had such sales been made pursuant to the Manufacturing and Supply Agreement;

 

(f)                                    Brazilian Alcon Employee Costs means the FTE costs incurred by the Novartis Group in connection with the employment of the Brazilian Alcon Employees, other than to the extent that such costs are incorporated in the Transfer Price in the relevant period;

 

(g)                                   Landed Cost means, in respect of each Brazilian Product, any costs incurred by Novartis Brazil in relation to that Brazilian Product in respect of freight, insurance, duty, import and transportation costs;

 

(h)                                  Net Sales means (x) net sales received from the sale and distribution of Brazilian Products or the provision of services, in each case, by Novartis Brazil to any Customer, plus (y) Deemed Sales to Novartis; plus (z) any other revenue received in respect of the Brazilian Alcon Business, but excluding (for the avoidance of doubt and in either (x), (y) or (z)) any amounts received by Novartis Brazil, any other member of its Group or any sub-contractor in respect of Sales Tax for which any member of its Group is liable to account to any Tax Authority.

 

For these purposes, net sales shall be determined in accordance with the Accounting Standards. The deductions booked by Novartis Brazil to calculate the recorded net sales from gross sales shall include the following:

 

(i)       normal trade, quantity and cash discounts;

 

(ii)      Sales Taxes and other taxes levied from Customers in relation to the sale of Brazilian Products to the extent included in the gross amount invoiced;

 

(iii)     amounts repaid or credited due to defects, rejections, recalls or returns, excluding amounts in respect of Sales Tax included in the amounts so repaid or credited, unless the Novartis Group is unable (having used reasonable diligent commercial endeavours) to recover such amounts in respect of Sales Tax by way of repayment or credit;

 

(iv)     rebates and chargebacks to Customers and Third Parties, excluding amounts in respect of Sales Tax included in such rebates and chargebacks, unless Novartis Brazil is unable (having used reasonable diligent commercial endeavours) to recover such amounts in respect of Sales Tax by way of repayment or credit);

 

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(v)      any amounts recorded in gross sales associated with goods provided to Customers for free, with the exception of samples;

 

(vi)     amounts provided or credited to Customers through coupons, other discount programs and co-pay assistance programs;

 

(vii)    delayed ship order credits, discounts or payments related to the impact of price increases between purchase and shipping dates; and

 

(viii)   fees for service payments to Customers for any non-separate services (including compensation for maintaining agreed inventory levels and providing information) and any associated Sales Tax to the extent Novartis Brazil is unable (having used reasonable diligent commercial endeavours) to recover such amounts in respect of Sales Tax by way of repayment or credit,

 

(ix)     and with respect to the calculation of Net Sales:

 

(A)                                Net Sales shall only include the value charged or invoiced on the first sale to a Customer; and

 

(B)                                if a Brazilian Product is delivered to the Customer before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue recognition criteria under Accounting Standards are met;

 

(i)                                      Sales Tax means any turnover, value-added, sales, use, goods and services or similar Tax (excluding, for the avoidance of doubt, any capital gains or similar Tax);

 

(j)                                     SELIC Rate means the overnight rate of the Brazilian Central Bank ascertained by the Sistema Especial de Liquidação e Custodia (SELIC) (Special System for Clearing and Custody)’

 

(k)                                  Transfer Price means:

 

(i)       in respect of each Brazilian Product supplied to Novartis Brazil by a member of the Alcon Group, the amount paid by Novartis Brazil for such Brazilian Products to the relevant member of the Alcon Group;

 

(ii)      in respect of each Brazilian Product provided to Novartis Brazil by a Third Party supplier, the amount paid by Novartis Brazil for such Brazilian Products to such Third Party;

 

(iii)     in respect of each Brazilian Product Manufactured by Novartis Brazil, the applicable Supply Price (as that term is defined in the Manufacturing and Supply Agreement) for the relevant Brazilian Products that would have been charged under Manufacturing and Supply Agreement, had such Brazilian Products been supplied under the terms of the Manufacturing and Supply Agreement; and

 

(l)                                      Working Hours means 9 a.m. to 5 p.m. on a Business Day at the relevant working location.

 

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1.2                                For the avoidance of doubt, the Parties agree that notwithstanding any other provision of this Agreement, the provisions of this Schedule 3 ( Brazil ) shall govern the treatment and sharing of Brazilian Alcon Employee Costs in lieu of the Employee Matters Agreement.

 

1.3                                Calculation of Economic Benefit Amount . The Economic Benefit Amount of the Brazilian Alcon Business in respect of a given period shall be calculated as:

 

(a)                                  the Net Sales of the Brazilian Alcon Business in that period;

 

(b)                                  minus the Transfer Price (exclusive of Sales Taxes) paid in respect of the Products covered by those Net Sales;

 

(c)                                   minus the Landed Cost (exclusive of Sales Taxes) of the Products covered by those Net Sales;

 

(d)                                  minus any obsolete inventory costs, calculated in accordance with the Novartis Accounting Manual;

 

(e)                                   minus the Brazilian Alcon Employee Costs (exclusive of Sales Taxes);

 

(f)                                    minus any “HR” or “REFS” service charged to the Brazilian Alcon Business in Novartis Brazil’s financial reporting system in accordance with the Novartis Accounting Manual;

 

(g)                                   minus any other costs (exclusive of Sales Taxes) incurred by Novartis Brazil in relation to the Brazilian Alcon Business other than the Brazilian Alcon Employee Costs, Landed Costs and any costs of acquiring Products for sale (including, but not limited to, the Transfer Price);

 

(h)                                  minus any undisputed sum (exclusive of Sales Taxes) payable by any Third Party to Novartis Brazil which has not been paid within one hundred and eighty (180) days of the due date for such payment and which is recorded as a bad debt in accordance with the Novartis Accounting Manual during such period ( Bad Debt );

 

(i)                                      plus any Bad Debt (exclusive of Sales Taxes) deducted pursuant to paragraph (h) above in any prior period to the extent that such Bad Debt is recovered in the relevant period;

 

(j)                                     plus any foreign exchange gains and minus any foreign exchange losses from balance sheet items relating to the Brazilian Alcon Business that are denominated in foreign currency in (i.e., non-Brazilian Real denominated balance sheet items) (for the avoidance of doubt, Novartis will not engage in any currency hedging in relation to such currency risk);

 

(k)                                  minus any financing costs incurred by Novartis Brazil in respect of the Brazilian Alcon Business, in accordance with the Novartis Accounting Manual, including as reflected in accounting line items BS01_490 and BS01-516 (or their equivalents from time to time) in Novartis Brazil’s financial reporting system, together with interest thereon charged at the SELIC Rate;

 

(l)                                      minus the amount of:

 

(i)       any expense of Novartis Brazil or a member of Novartis Brazil’s Sales Tax group in connection with or as a result of the Brazilian Alcon Business which

 

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consists of an amount in respect of Sales Tax in respect of the period for which neither Novartis Brazil nor a member of Novartis Brazil’s Sales Tax group is entitled to credit or repayment; and

 

(ii)      any Sales Tax in respect of the period for which Novartis Brazil or Novartis Brazil’s Sales Tax group is liable to account to any Tax Authority in connection with or as a result of the Brazilian Alcon Business,

 

save, in each case, to the extent otherwise deducted or excluded in the calculation of the Economic Benefit Amount;

 

(m)                              minus a sales and distribution charge of 2.5 per cent. of the amount resulting from the calculation at paragraphs 1.3(a) to 1.3(l) (inclusive) above in that period, up to a maximum of USD 400,000 in any financial year;

 

(n)                                  minus (i) an amount equal to the product of (x) the amount resulting from the calculation at paragraphs 1.3(a) to 1.3(l) (inclusive) above, and (y) the Brazilian Tax Rate; and (ii) an amount equal to any withholding tax actually incurred by Novartis Brazil in respect of the Brazilian Alcon Business in that period; and

 

PROVIDED THAT, if and to the extent that any costs incurred by the Novartis Group are subject to reimbursement under any indemnity or equivalent covenant to pay in this Agreement or in an Ancillary Agreement are included in any Economic Benefit Statement, such costs shall not also be recoverable under such indemnity or covenant to pay.

 

1.4                                Economic Benefit Statements. The Economic Benefit Statement for the Brazilian Alcon Business shall detail the following:

 

(a)                                  Net Sales (which will be reported in accordance with the Novartis Brazil financial reporting system) for the relevant quarter by brand, which shall show:

 

(i)       gross sales;

 

(ii)      returns and allowances;

 

(iii)     on-invoice discounts;

 

(iv)     off-invoice discounts;

 

(v)      any other deduction; and

 

(b)                                  each line item forming part of the calculation of the Economic Benefit Amount in accordance with paragraph 1.3 ( Calculation of Economic Benefit Amount ) above (and including, in respect of costs, the itemisation of those costs as between categories of costs).

 

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SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

/s/ Christian Diehl

 

/s/ Michael Stewart

Signed for and on behalf of

 

Signed for and on behalf of

NOVARTIS AG

 

NOVARTIS AG

by:

 

by:

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

Signed for and on behalf of

 

Signed for and on behalf of

ALCON INC.

 

ALCON INC.

by:

 

by:

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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Exhibit 99.2

 

EXECUTION VERSION

 

TAX MATTERS AGREEMENT, dated as of April 8, 2019 (this “ Agreement ”), between Novartis AG, an Aktiengesellschaft organized under the laws of Switzerland (“ Novartis ”), and Alcon Inc., an Aktiengesellschaft organized under the laws of Switzerland (“ Alcon ” and, together with Novartis, the “ Parties ”).

 

WHEREAS, pursuant to the Separation and Distribution Agreement, dated as of April 8, 2019, by and between Novartis and Alcon (the “ Separation Agreement ”), Novartis and Alcon have effected or agreed to effect the Separation and the Distribution;

 

WHEREAS the Parties intend that the applicable steps of the Transactions qualify for the Intended Tax Treatment; and

 

WHEREAS the Parties desire to provide for and agree upon the allocation of Taxes arising prior to, as a result of and subsequent to the Transactions and to provide for and agree upon certain other matters relating to Taxes;

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained herein, Novartis and Alcon hereby agree as follows:

 

ARTICLE I

 

Definitions

 

For purposes of this Agreement, the following terms have the following meanings.  Capitalized terms used but not defined in this Agreement have the meanings ascribed to them in the Separation Agreement.

 

Agreement ” has the meaning ascribed thereto in the preamble.

 

Alcon ” has the meaning ascribed thereto in the preamble.

 

Alcon Indemnity Event ” means any event designated as an “Alcon Indemnity Event” on any of the Schedules that comprise Schedule A.

 

Alcon Separate Return ” means any Tax Return that (a) includes any member of the Alcon Group and (b) does not include any member of the Novartis Group.

 

Capital Stock ” of a Person means (a)  all classes or series of stock or other equity interests in such Person and (b) all instruments properly treated as stock in such Person for applicable Tax purposes.

 

Code ” means the U.S. Internal Revenue Code of 1986, as amended.

 

Default Interest Rate ” means the prime lending rate as published in The Wall Street Journal minus two percent (2%).

 


 

Delayed Interest ” means any asset or entity to which Schedule 3, Brazil , to the Separation Agreement applies and that is not transferred on or prior to the Effective Time.

 

Determination ” means (a) any final determination of liability in respect of a Tax that, under Applicable Law, is not subject to further appeal, review or modification through proceedings or otherwise (including the expiration of a statute of limitations or period for the filing of claims for refunds, amended Tax Returns or appeals from adverse determinations or a final settlement, compromise or other agreement with the relevant Tax Authority), including a “determination” as defined in Section 1313(a) of the Code or execution of an IRS Form 870AD or other similar form, or (b) the payment of Tax by a Party (or its Affiliate) that is responsible for payment of that Tax under Applicable Law (the “ Responsible Party ”), or the execution of an IRS Form 870 or other similar form, with respect to any item disallowed or adjusted by a Tax Authority, as long as the Responsible Party determines that no action should be taken to recoup that payment or file a claim for refund with respect to that item, and the other Party agrees.

 

Effective Time ” means the completion of the Distribution.

 

Global Restructuring Taxes ” means Taxes (other than Transfer Taxes and Transaction Taxes) arising out of the transactions set forth in Part B ( Rest of World Separation Steps Plan ) of Exhibit 2, Separation Steps Plan , to the Separation Agreement.

 

Global Share Transfer Jurisdiction ” means any jurisdiction (i) corresponding to an “Alcon Share Transferor” or “Novartis Share Transferor” in Exhibit 1, Transferors and Transferees , to the Separation Agreement (including any local, state, provincial or federal jurisdiction), other than the United States or (ii) identified as a “Global Share Transfer Jurisdiction” on any of the Schedules that comprise Schedule A.

 

Indemnity Payment ” means an indemnity payment contemplated by any Transaction Document.

 

Intended Tax Treatment ” means the U.S. Intended Tax Treatment and the Swiss Intended Tax Treatment.

 

IRS ” means the U.S. Internal Revenue Service.

 

Novartis Consolidated Return ” means any Tax Return for any consolidated, combined, unitary, affiliated, aggregate or similar group that includes both (a) any member of the Novartis Group and (b) any member of the Alcon Group.

 

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Novartis Indemnity Event ” means any event designated as a “Novartis Indemnity Event” on any of the Schedules that comprise Schedule A.

 

Novartis Separate Return ” means any Tax Return that (a) includes any member of the Novartis Group and (b) does not include any member of the Alcon Group.

 

Notice Action ” means any action designated as a “Notice Action” and occurring at any time during the period specified for such action, in each case on any of the Schedules that comprise Schedule A.

 

Opinion ” means the written opinion of Cravath, Swaine & Moore LLP that, subject to the accuracy of and compliance with the relevant Representations, the steps of the Restructurings described in Exhibit A-1-A and the Distribution should qualify for their U.S. Intended Tax Treatment.

 

Ordinary Taxes ” means Taxes other than (a) Transaction Taxes, (b) Global Restructuring Taxes and (c) Transfer Taxes.

 

Parties ” has the meaning ascribed thereto in the preamble.

 

Post-Distribution Prohibited Action ” means any action designated as a “Post-Distribution Prohibited Action” and occurring at any time during the period specified for such action, in each case on any of the Schedules that comprise Schedule A.

 

Post-Separation Period means, except as otherwise provided in any of the Schedules that comprise Schedule A, any taxable period (or portion thereof) beginning after the Separation Date.

 

Pre-Separation Period means, except as otherwise provided in any of the Schedules that comprise Schedule A, any taxable period (or portion thereof) ending on or before the Separation Date.

 

Proposed Acquisition Transaction ” has the meaning ascribed thereto on Schedule A-1.

 

Refund Recipient ” has the meaning ascribed thereto in Section 2.08.

 

Regulations ” means the Treasury regulations promulgated under the Code or any successor Treasury regulations.

 

Representations ” means representations made by the Parties and their Affiliates that serve as a basis for the Transaction Rulings and Opinion.

 

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Restricted Action ” means any action designated as a “Restricted Action” and occurring at any time during the period specified for such action, in each case on any of the Schedules that comprise Schedule A.

 

Restructurings ” means the transactions described in Exhibit 2, Separation Steps Plan , to the Separation Agreement.

 

Ruling ” means any ruling (including any supplemental ruling) issued by a Tax Authority concerning the Transactions, whether granted prior to, on or after the date hereof.

 

Satisfactory Guidance ” has the meaning ascribed thereto in Section 4.04(b).

 

Separation Agreement ” has the meaning ascribed thereto in the preamble.

 

Swiss Intended Tax Treatment ” has the meaning ascribed thereto on Schedule A-2.

 

Swiss Tax Rulings ” has the meaning ascribed thereto on Schedule A-2.

 

Tax ” means any and all taxes, imposts, duties, withholdings, assessments, levies, fees, duties or other charges imposed, collected or withheld by a Governmental Entity, in each case in the nature of a tax, whether direct or indirect, and together with any interest, penalties, additional amounts and additions related thereto.

 

Tax Advisor ” means a Tax counsel or accountant of recognized national standing in the relevant jurisdiction.

 

Tax Authority ” means any Governmental Entity charged with the determination, collection or imposition of Taxes.

 

Tax Benefit ” means any Tax refund or other reduction of Taxes paid or currently payable as a result of a credit or offset or the Tax effect of any item of loss, deduction or credit or any other item (including increases in Tax basis).

 

Tax Contest ” means an audit, review, examination or other administrative or judicial proceeding, in each case by any Tax Authority, other than any audit, review, examination or other administrative or judicial proceeding involving a criminal claim, inquiry or investigation.

 

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Tax Return ” means (i) any return, declaration, statement, report, claim, schedule, form or information return filed or required or permitted to be filed with any Tax Authority relating to Taxes, including any supplement, schedule or attachment thereto and any amendment thereof and (ii) any Transfer Pricing Document.

 

Tax Return Preparer ” has the meaning ascribed thereto in Section 3.01.

 

Transaction Filing ” means any filing designated as a “Transaction Filing” on any of the Schedules that comprise Schedule A.

 

Transaction Rulings ” means the U.S. Tax Ruling and the Swiss Tax Rulings.

 

Transaction Tax Contest ” means a Tax Contest with the purpose or effect of determining or redetermining Transaction Taxes.

 

Transaction Taxes ” means all Taxes resulting from the failure of any applicable step of the Transactions to qualify for its Intended Tax Treatment and all reasonable out-of-pocket legal, accounting and other advisory and court fees incurred in connection with liability for such Taxes, in each case, whether imposed on a Party or any of its Affiliates or on a Third Party.

 

Transactions ” means the Restructurings and the Distribution.

 

Transfer Pricing Document ” means any return, declaration, statement, report, claim, schedule, form or information return related to transfer pricing reporting and documentation (whether or not required or permitted to be filed with any Tax Authority), including country-by-country reporting and documentation of the type described in the Base Erosion and Profit Shifting Action 13 adopted by the Organization for Economic Co-operation and Development.

 

Transfer Taxes ” means any sales, use, value-added, stamp, duty, excise, documentary, filing, recording, registration or other transfer Taxes incurred as a result of the Transactions.

 

Unqualified Tax Opinion ” has the meaning ascribed thereto in Section 4.04(c).

 

U.S. Intended Tax Treatment ” has the meaning ascribed thereto on Schedule A-1.

 

U.S. Tax Ruling ” has the meaning ascribed thereto on Schedule A-1.

 

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Wrong Pocket Asset ” means any property, right or asset that is subject to Clause 25 of the Separation Agreement.

 

ARTICLE II

 

Tax Indemnity

 

SECTION 2.01.                                    Indemnity by Alcon.   From and after the Effective Time, Alcon shall be liable for, and shall indemnify and hold harmless Novartis and its Affiliates from, the following, without duplication:

 

(a)                             Transaction Taxes allocated to Alcon under Section 2.03;

 

(b)                             Transfer Taxes allocated to Alcon under Section 2.04;

 

(c)                              Global Restructuring Taxes allocated to Alcon under Section 2.05; and

 

(d)                             Ordinary Taxes allocated to Alcon under Section 2.06.

 

SECTION 2.02.                                    Indemnity by Novartis.   From and after the Effective Time, Novartis shall be liable for, and shall indemnify and hold harmless Alcon and its Affiliates from, the following, without duplication:

 

(a)                             Transaction Taxes allocated to Novartis under Section 2.03;

 

(b)                             Transfer Taxes allocated to Novartis under Section 2.04;

 

(c)                              Global Restructuring Taxes allocated to Novartis under Section 2.05; and

 

(d)                             Ordinary Taxes allocated to Novartis under Section 2.06.

 

SECTION 2.03.                                    Allocation of Transaction Taxes.   (a) Transaction Taxes shall be allocated to Alcon to the extent such Transaction Taxes result from:

 

(i)        the failure of any Representation or any representation herein made by Alcon or any of its Affiliates to be true, correct and complete when made;

 

(ii)     the breach by Alcon or any of its Affiliates of any covenant or agreement contained in any Transaction Document (including those contained in Section 4.03, without regard to Section 4.04), Transaction Ruling or Opinion;

 

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(iii) any Alcon Indemnity Event; or

 

(iv)                                     any other action or failure to act by Alcon or any of its Affiliates after the Effective Time that it knows or reasonably should expect, after consultation with a Tax Advisor, could give rise to Transaction Taxes, except to the extent such action or failure to act is otherwise expressly required or permitted by the Transaction Documents (other than under Section 4.04).

 

(b)                             Transaction Taxes shall be allocated to Novartis to the extent such Transaction Taxes result from:

 

(i)        the failure of any Representation or any representation herein made by Novartis or any of its Affiliates to be true, correct and complete when made, except any Representation that is substantially the same as any Representation made by Alcon or any of its Affiliates;

 

(ii)     the breach by Novartis or any of its Affiliates of any covenant or agreement contained in any Transaction Document, Transaction Ruling or Opinion;

 

(iii) any Novartis Indemnity Event; or

 

(iv)                                     any other action or failure to act by Novartis or any of its Affiliates after the Effective Time that it knows or reasonably should expect, after consultation with a Tax Advisor, could give rise to Transaction Taxes, except to the extent such action or failure to act is otherwise expressly required or permitted by the Transaction Documents.

 

(c)                              Notwithstanding Section 2.03(a) or (b), if a Transaction Tax would otherwise be allocated under both Section 2.03(a) and (b), then such Transaction Tax shall be allocated between the Parties in proportion to the relative degrees of fault of the members of the Alcon Group (and such members’ Affiliates and, if applicable, counterparties) and the members of the Novartis Group (and such members’ Affiliates and, if applicable, counterparties).

 

(d)                             If a Transaction Tax is not otherwise allocated under this Section 2.03, then such Transaction Tax shall be allocated to Novartis.

 

(e)                              Notwithstanding any other provision of this Agreement, if Transaction Taxes are incurred and, as a result of such Transaction Taxes, any member of the Novartis Group or the Alcon Group actually realizes a Tax Benefit, then the Parties shall make appropriate payments to share the Tax Benefit in the same manner as the

 

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Taxes were allocated pursuant to this Agreement (provided that no Tax shall be considered to be allocated to a Party for purposes of computing a payment under this Section 2.03(e) to the extent such other Party owes but has not yet paid any amount in respect of such Tax).

 

SECTION 2.04.                                    Allocation of Transfer Taxes.   Transfer Taxes that are value-added Taxes: (a) of the Alcon Group shall be allocated to Alcon and (b) of the Novartis Group shall be allocated to Novartis.  All Transfer Taxes other than value-added Taxes shall be allocated to Novartis.

 

SECTION 2.05.                                    Allocation of Global Restructuring Taxes.   All Global Restructuring Taxes shall be allocated to Novartis.

 

SECTION 2.06.                                    Allocation of Ordinary Taxes.   (a) Except as otherwise provided in this Section 2.06, Ordinary Taxes shall be allocated as follows.

 

(i)        For any Pre-Separation Period:

 

(A)                                Ordinary Taxes of the Novartis Group and Alcon Group that are attributable to the Alcon Business shall be allocated to Alcon; and

 

(B)                                all other Ordinary Taxes of the Novartis Group and Alcon Group shall be allocated to Novartis.

 

(ii)     For any Post-Separation Period:

 

(A)                                Ordinary Taxes of the Novartis Group shall be allocated to Novartis; and

 

(B)                                Ordinary Taxes of the Alcon Group shall be allocated to Alcon.

 

The determination of whether Ordinary Taxes of the Novartis Group and Alcon Group are attributable to the Alcon Business shall be made according to the methodology set forth in Exhibit 1 hereto.  Novartis and Alcon shall use Commercially Reasonable Efforts to cooperate in determining whether Ordinary Taxes of the Novartis Group and Alcon Group are attributable to the Alcon Business.

 

(b)                             Notwithstanding the foregoing:

 

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(i)        Ordinary Taxes of the Novartis Group and Alcon Group for Post-Separation Periods that are attributable to any Wrong Pocket Asset or Delayed Interest shall be allocated in accordance with Section 2.06(a)(i) until such time that such asset or interest is transferred to its ultimate owner in accordance with the Separation Agreement, and such Taxes shall be determined on a “with and without” basis; and

 

(ii)     Ordinary Taxes arising as a result of any action by Alcon or its Affiliates described in Section 4.08 shall be allocated to Alcon.

 

(c)                              With respect to each Alcon Transferring Entity in a Global Share Transfer Jurisdiction, Novartis shall cause the applicable Alcon Share Transferor to indemnify the applicable Alcon Share Transferee for any Ordinary Taxes allocated to Novartis with respect to such Alcon Transferring Entity under this Section 2.06 that Novartis would be required to indemnify pursuant to Section 2.02 (subject to the limitations in Section 2.07).

 

SECTION 2.07.                                    Limitation on Indemnification of Ordinary Taxes .  Notwithstanding any other provision in this Agreement to the contrary:

 

(a)                             Neither Novartis nor Alcon shall be required to indemnify or hold harmless Alcon and its Affiliates or Novartis and its Affiliates for any Ordinary Taxes pursuant to Section 2.01 or Section 2.02, respectively, in each case for any individual item of Ordinary Taxes that does not exceed $10,000.  For the avoidance of doubt, an individual item of Tax is a single type of Tax imposed by a single Tax Authority with respect to a single Tax assessment.

 

(b)                             The provisions of Section 2.07(a) shall not apply to:  (i) Ordinary Taxes attributable to any Wrong Pocket Asset or Delayed Interest or (ii) Ordinary Taxes which are not yet due and payable (taking into account any extensions) as of the Separation Date.

 

SECTION 2.08.                                    Refunds and Credits.   Subject to and in accordance with Schedule A, if Novartis, Alcon or any of their respective Affiliates receives a refund of a Tax for which the other Party is liable (in whole or in part) under this Agreement (a “ Refund Recipient ”), such Refund Recipient shall pay to the other Party, within 30 days of receipt of such refund, an amount equal to the product of (a) such refund, net of any Taxes and reasonable out-of-pocket expenses incurred in connection with the receipt of such refund, multiplied by (b) the percentage of such Tax for which the other Party is liable under this Agreement (reduced to the extent such other Party owes but has not yet paid any amount in respect of such Tax under this Agreement).  If a Party would be a Refund Recipient but for the fact that it elected to apply a refund to which it would

 

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otherwise have been entitled against a Tax liability arising in a subsequent taxable period, then for purposes of the immediately preceding sentence, such Party shall be treated as a Refund Recipient and the economic benefit of so applying the refund shall be treated as a refund, and such Party shall be treated as receiving such refund on the due date of the Tax Return to which such refund is applied to reduce the subsequent Tax liability.  If a Refund Recipient pays an amount to the other Party in respect of a refund under this Section 2.08 and such refund is subsequently disallowed or reduced by the relevant Taxing Authority, then such other Party shall repay such amount (or the relevant portion thereof, determined in accordance with the principles of this Section 2.08) to the Refund Recipient, net of any Taxes and reasonable out-of-pocket expenses incurred in connection with the receipt and repayment of such amount.

 

ARTICLE III

 

Preparation and Filing of Tax Returns; Payment of Taxes

 

SECTION 3.01.                                    Preparation of Tax Returns.   Except as otherwise provided on any of the Schedules that comprise Schedule A or in Section 3.02, (a) with respect to any taxable period ending on or before December 31, 2018, (i) Alcon shall prepare and timely file, or cause to be prepared and timely filed, any Alcon Separate Return of a type that a member of the Alcon Group has historically been responsible for preparing and (ii) Novartis shall prepare and timely file, or cause to be prepared and timely filed, all Novartis Separate Returns, all Novartis Consolidated Returns and all other Alcon Separate Returns and (b) with respect to any taxable period ending on or after January 1, 2019, (i) Novartis shall prepare and timely file, or cause to be prepared and timely filed, all Novartis Consolidated Returns and all Novartis Separate Returns and (ii) Alcon shall prepare and timely file, or cause to be prepared and timely filed, all Alcon Separate Returns.  The Party required to prepare (or cause to be prepared) any Tax Return under this Section 3.01 or Section 3.02 of this Agreement shall be referred to as the “ Tax Return Preparer ” with respect to such Tax Return.  The Party that is the Tax Return Preparer with respect to a Tax Return shall be responsible for all costs and expenses associated with the preparation and filing of such Tax Return pursuant to this Section 3.01 or Section 3.02, as applicable.

 

Section 3.02.            Preparation of Certain Transfer Pricing Documents.    Notwithstanding anything to the contrary in Section 3.01, (a) Novartis shall prepare and timely file, or cause to be prepared and timely filed, all Transfer Pricing Documents for any transaction relating to the Alcon Business occurring in 2018 and (b) Alcon shall prepare and timely file, or cause to be prepared and timely filed, all Transfer Pricing Documents for any transaction relating to the Alcon Business that:  (i) involves at least one member of the Novartis Group or otherwise affects any Tax Return of any member

 

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of the Novartis Group and (ii) occurs at any time in 2019 prior to the Effective Time.  For the avoidance of doubt, any Transfer Pricing Document prepared by Alcon pursuant to clause (b) of the preceding shall be a Tax Return subject to Sections 3.03(a) – (c) of this Agreement for which Alcon shall be the Tax Return Preparer and Novartis shall be the other Party.

 

SECTION 3.03.                                    Method of Preparing Tax Returns.    To the extent that the Tax Return Preparer is required to prepare a Tax Return that is described in Section 3.01(a)(i) or that directly relates to (i) Taxes or related amounts for which the other Party is responsible under this Agreement, (ii) any Tax Benefit to which such other Party is entitled under this Agreement or (iii) matters affecting a Tax Return that such other Party is required to prepare (or cause to be prepared) under Section 3.01 or Section 3.02:

 

(a)                             the Tax Return Preparer shall prepare (or cause to be prepared) such Tax Return or the relevant portions thereof on a basis consistent with past practice (except as required by Applicable Law or as determined in good faith by the Tax Return Preparer), and the Tax Return Preparer shall notify the other Party of any such portions not prepared on a basis consistent with past practice;

 

(b)                             the Tax Return Preparer shall, upon request, provide the other Party access to such Tax Return or relevant portions thereof, all related workpapers and such additional information as the other Party may reasonably request at least thirty (30) days prior to the due date (including any valid extensions) for filing such Tax Return and shall consider in good faith such other Party’s reasonable comments; and

 

(c)                              the Parties shall attempt in good faith to resolve any issues arising out of the review of such Tax Return.

 

Section 3.04.                                    Information Packages.   Each Party (a) shall provide to the other Party (in the format reasonably determined by the other Party) all information and assistance requested by the other Party as reasonably necessary, consistent with the practices of the Novartis Group and Alcon Group in preparing Tax Returns as of the date hereof, to prepare any Tax Return required to be prepared under Section 3.01 or Section 3.02 on a timely basis and (b) in so providing such information and assistance, shall use any systems and third-party service providers as are consistent with such practices.

 

SECTION 3.05.                                    Payment of Taxes.   In addition to its obligations under Section 3.03, the Tax Return Preparer shall, no later than five (5) Business Days prior to the due date (including any valid extensions) for filing any Tax Return that it is required to prepare or cause to be prepared under Section 3.01, notify the other Party of any amount (including any portion of the total) shown as due on such Tax Return for which such other Party must indemnify the Tax Return Preparer under this Agreement, together

 

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with back-up calculations (including any applicable back-up calculations described on any of the Schedules that comprise Schedule A).  Such other Party shall pay such amount to the Tax Return Preparer no later than the due date (including any valid extensions) for filing such Tax Return.  The Tax Return Preparer shall timely pay (or cause to be timely paid) to the relevant Taxing Authority any Taxes shown as due on any Tax Returns that it is required to prepare or cause to be prepared under Section 3.01, without regard to whether it has received the payment described in the immediately preceding sentence.  The obligation to make payments to the relevant Taxing Authority or failure to give notice under this Section 3.05 shall not affect the Tax Return Preparer’s right, if any, to be indemnified or otherwise receive payments with respect to such Taxes under this Agreement, except to the extent that any such failure to give notice has actually prejudiced the other Party.

 

SECTION 3.06.                                    Amendments.   Each Party shall not (and shall cause its Affiliates not to) amend, withdraw, revoke or otherwise alter any Tax Return if doing so would reasonably be expected to (a) increase Taxes or related amounts for which the other Party is responsible under this Agreement or (b) decrease any Tax Benefit to which such other Party is entitled under this Agreement, in each case without the prior written consent of the other Party (not to be unreasonably withheld, conditioned or delayed).

 

SECTION 3.07.                                    Carrybacks.   With respect to any member of the Alcon Group that was a member of a consolidated, combined, unitary, affiliated, aggregate or similar group that included any member of the Novartis Group in any Pre-Separation Period, Alcon shall, and shall cause its Affiliates to, make any available elections to waive the right to carry back any Tax attributes of such member of the Alcon Group from any Post-Separation Period to any such Pre-Separation Period of such member and shall not make any affirmative election to claim any such carryback.

 

ARTICLE IV

 

Tax Matters Relating to the Transactions

 

SECTION 4.01.                                    Mutual Representations.   As of the date of this Agreement, each Party represents that:

 

(a)                             all Representations made by it or its Affiliates are true, correct and complete; and

 

(b)                             it knows of no fact, and has no plan or intention to take or fail to take any action, if it knows or reasonably should expect, after consultation with a Tax Advisor, that such fact, action or failure to act (i) is inconsistent with the Representations given and other information provided by it or its Affiliates in connection with any

 

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Transaction Ruling or Opinion, (ii) is inconsistent with the qualification of any applicable step of the Transactions for its Intended Tax Treatment or (iii) could adversely affect the issuance, effectiveness or validity of any Transaction Ruling or Opinion.

 

SECTION 4.02.                                    Mutual Covenants.   (a) Each Party shall use its reasonable best efforts to cause the Opinion to be issued, including by executing letters containing reasonable and customary representations that are true, correct and complete on behalf of itself and its Affiliates.

 

(b)                             Except as otherwise expressly required or permitted by the Transaction Documents, after the Effective Time neither Party shall take or fail to take, or cause or permit its respective Affiliates to take or fail to take, any action, if such action or failure to act (i) would be inconsistent with the Representations given and other information provided by it or its Affiliates in connection with any Transaction Ruling or Opinion, (ii) would be inconsistent with the qualification of any applicable step of the Transactions for its Intended Tax Treatment or (iii) could adversely affect the issuance, effectiveness or validity of any Transaction Ruling or Opinion.

 

SECTION 4.03.                                    Restricted Actions.   (a)  Subject to Section 4.04, Alcon shall not (and shall not cause or permit any of its Affiliates to), in any transaction or series of transactions, engage in any Restricted Action.

 

(b)                             If Alcon merges or consolidates with another Person to form a new Person or another Person acquires a majority of the Capital Stock of Alcon, references in this Agreement to Alcon shall also include that new Person or that acquiring Person, as applicable, and references to Capital Stock of Alcon shall also include the Capital Stock of that new Person or that acquiring Person, as applicable.

 

SECTION 4.04.                                    Consent To Take Certain Restricted Actions.   (a) Alcon may (and may cause or permit its Affiliates to) take an action otherwise prohibited under Section 4.03(a) if, prior to taking such action, Novartis provides consent.  Novartis may not withhold its consent if Alcon has provided Novartis with Satisfactory Guidance with respect to such action.  In all other cases, Novartis’s consent shall be at its sole discretion.

 

(b)                             For purposes of this Agreement, “ Satisfactory Guidance ” means either a Ruling or an Unqualified Tax Opinion, at the election of Alcon, in either case satisfactory to Novartis in its sole discretion in both form and substance, including with respect to any underlying assumptions or representations and any legal analysis contained therein, and concluding that the proposed action will not cause any applicable step of the Transactions to fail to qualify for its Intended Tax Treatment.

 

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(c)                              For purposes of this Agreement, “ Unqualified Tax Opinion ” means an unqualified “will” opinion of a Tax Advisor, reasonably acceptable to Novartis, that permits reliance by Novartis.  The Tax Advisor, in issuing its opinion, shall be permitted to rely on the validity and correctness, as of the date given, of any previously issued Opinion, Unqualified Tax Opinions and Rulings, unless such reliance would be unreasonable under the circumstances, and shall assume that the applicable steps of the Transactions would have qualified for the Intended Tax Treatment if the action in question did not occur.

 

SECTION 4.05.                                    Procedures Regarding Opinions and Rulings.

 

(a)                             Satisfactory Guidance.   Subject to Section 4.05(e), if Alcon notifies Novartis that it desires to take a Restricted Action and seeks Satisfactory Guidance for purposes of Section 4.04, Novartis, at the request of Alcon, shall use Commercially Reasonable Efforts to expeditiously obtain, or assist Alcon in obtaining, such Satisfactory Guidance.  Notwithstanding the foregoing, Novartis shall not be required to take any action pursuant to this Section 4.05(a) if, upon request, Alcon fails to certify that all information and representations relating to Alcon or any of its Affiliates in the relevant documents are true, correct and complete or fails to obtain certification from any counterparty to any Proposed Acquisition Transaction or to any other Restricted Action involving a counterparty that all information and representations relating to such counterparty in the relevant documents are true, correct and complete.  Alcon shall reimburse Novartis for all reasonable out-of-pocket costs and expenses incurred by Novartis or any of its Affiliates in obtaining Satisfactory Guidance within twenty (20) days after receiving an invoice from Novartis therefor.

 

(b)                             Other Rulings and Opinions Relating to the Transactions.   Subject to Section 4.05(a), Novartis shall have the right to obtain a Ruling, any other guidance from any Tax Authority or an opinion of Tax counsel or an accounting firm relating to the Transactions at any time in Novartis’s sole discretion.  Alcon, at the request of Novartis, shall use Commercially Reasonable Efforts to expeditiously obtain, or assist Novartis in obtaining, any such Ruling, other guidance or opinion; provided , however , that Alcon shall not be required to make any representation or covenant that it does not reasonably believe is (and will continue to be) true, accurate and consistent with historical facts.  Novartis shall reimburse Alcon for all reasonable out-of-pocket costs and expenses incurred by Alcon or any of its Affiliates in obtaining any such Ruling, other guidance or opinion requested by Novartis within twenty (20) days after receiving an invoice from Alcon therefor.

 

(c)                                   Participation Rights.   If either Party seeks to obtain a Ruling pursuant to Section 4.05(a) or a Ruling (or any other guidance from any Tax Authority

 

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relating to the Transactions) that can reasonably be expected to affect the other Party’s liabilities under this Agreement, then such Party shall (i) keep the other Party informed of all material actions taken or proposed to be taken in that regard, (ii) reasonably in advance of the submission of any ruling request, provide the other Party with a draft thereof, consider the other Party’s comments on such draft and provide the other Party with a final copy thereof and (iii) provide the other Party with notice reasonably in advance of, and (subject to the approval of the applicable Tax Authority) permit the other Party to attend, any formally scheduled meetings with the applicable Tax Authority that relate to such Ruling or such other guidance.

 

(d)                             Pre-Separation Rulings.   Novartis and Alcon shall, and shall cause the applicable members of the Novartis Group and Alcon Group, respectively, to, cooperate on a basis consistent with past practice with respect to any request for a ruling from a Tax Authority or advance agreement or other similar proceeding with a Tax Authority that remains pending at the time of the Distribution and the resolution of which is reasonably expected to affect Taxes, or otherwise require the cooperation, of both Novartis (or any other member of the Novartis Group), on the one hand, and Alcon (or any other member of the Alcon Group), on the other hand.

 

(e)                              Limitations on Seeking Rulings.   Notwithstanding anything herein to the contrary, Alcon shall not seek a ruling from any Tax Authority with respect to a Pre-Separation Period (whether or not relating to the Transactions), and Novartis shall not be required to obtain or assist in obtaining any such ruling, if Novartis determines that there is a reasonable possibility that such action could have an adverse impact on Novartis or any of its Affiliates.

 

SECTION 4.06.                                    Notice Actions.   (a) If Alcon proposes to (i) enter into, (ii) permit to occur or (iii) cause or permit any of its Affiliates to enter into or permit to occur any Notice Action, Alcon shall undertake in good faith to provide Novartis, no later than twenty (20) days following the signing of any written agreement with respect to such Notice Action or obtaining knowledge of the occurrence of any such Notice Action that takes place without written agreement, with a written description of such transaction (including the information required to be provided with respect to such Notice Action as set forth on the relevant Schedule included in Schedule A) and additional information as Novartis may reasonably request; provided , that in no case shall Alcon be required to provide Novartis with any material non-public information.

 

SECTION 4.07.                                    Reporting.   The Parties each (a) shall timely file (or cause to be timely filed) any appropriate information and statements (including any Transaction Filings) to report the applicable steps of the Transactions as qualifying for the Intended Tax Treatment and (b) except to the extent required by a change of

 

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Applicable Law or a Determination, shall not (and shall not cause or permit any of its respective Affiliates to) take any position on any Tax Return, financial statement or other document (or otherwise with a Tax Authority) that is inconsistent with such qualification.  If either Party determines it is required to (x) report any applicable step of the Transactions in a manner other than as qualifying for its Intended Tax Treatment or (y) take any position on any Tax Return, financial statement or other document (or otherwise with a Tax Authority) that is inconsistent with such qualification, such Party shall promptly notify the other Party of its determination, and the Parties shall use Commercially Reasonable Efforts to cooperate to determine the reporting of such step of the Transactions in a manner consistent with Applicable Law.

 

SECTION 4.08.                                    Additional Post-Distribution Prohibited Actions.   Following the Distribution, Alcon shall not, and shall cause its Affiliates not to, (a) take any action on the date of the Distribution that is outside the ordinary course of business of the Alcon Group or (b) without the prior written consent of Novartis, engage in any Post-Distribution Prohibited Action.

 

ARTICLE V

 

Tax Matters Relating to Other Agreement

 

SECTION 5.01.                                    Termination of Tax Sharing Agreements and Tax Groups.   (a) Prior to the Effective Time, the Parties shall terminate all Tax allocation or sharing agreements that are exclusively between one or more members of the Novartis Group, on the one hand, and one or more members of the Alcon Group, on the other hand (other than this Agreement or any other Transaction Document).  Upon termination, all rights and obligations under such agreements shall cease.

 

(b)                             To the extent one or more members of the Alcon Group, on the one hand, and one or more members of the Novartis Group, on the other hand, are members of the same combined, consolidated or unitary Tax group for purposes of filing any Tax Return and such group does not automatically terminate as a result of the Transactions, the Parties shall cooperate to terminate such group effective prior to the Effective Time.

 

SECTION 5.02.                                    Amount of Indemnity Payments.   The amount of any Indemnity Payment shall be (a) reduced to take into account any Tax Benefit actually realized by the indemnitee resulting from the incurrence of the liability in respect of which the Indemnity Payment is made and (b) increased to take into account any Tax cost actually realized by the indemnitee resulting from the receipt of the Indemnity Payment (including any Tax cost arising from such Indemnity Payment having resulted in income or gain to either Party, and any Taxes imposed on additional amounts payable pursuant to this clause).

 

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SECTION 5.03.                                    Tax Treatment of Indemnity Payments.   The Parties shall cooperate in a commercially reasonable manner to determine the treatment of Indemnity Payments for all relevant Tax purposes as and when they are made.

 

SECTION 5.04.                                    Treatment of Wrong Pocket Assets and Delayed Interests.   To the extent permitted by Applicable Law and except as otherwise provided on any of the Schedules that comprise Schedule A, the Parties agree to treat, and to cause their respective Affiliates to treat, for all Tax purposes, (a) any Wrong Pocket Asset and Delayed Interest as having been transferred to its ultimate owner (or, if applicable for any Wrong Pocket Asset, as having remained with its ultimate owner) in accordance with the Separation Agreement as of the Effective Time and (b) any payments, goods and other benefits received by the transferor in respect of such Wrong Pocket Asset or Delayed Interest prior to its transfer to its ultimate owner in accordance with the Separation Agreement as having been received by such transferor as an agent or nominee for such ultimate owner.

 

ARTICLE VI

 

Procedural Matters

 

SECTION 6.01.                                    Tax Contests.   (a) Novartis or Alcon, as applicable, shall, within thirty (30) days of becoming aware of any Tax Contest (including a Transaction Tax Contest) that could reasonably be expected to cause the other Party to have an indemnification obligation (or refund entitlement) under this Agreement, notify such other Party of such Tax Contest and thereafter promptly forward or make available to such other Party copies of notices and communications relating to the relevant portions of such Tax Contest (the Party so required to notify such other Party, the “ Notifying Party ”).  Notwithstanding the preceding sentence, if the applicable Tax Authority requests a response, or other action is required, with respect to such Tax Contest within thirty (30) days of the Notifying Party becoming aware of such Tax Contest, the Notifying Party shall notify the other Party of such Tax Contest as soon as possible following the Notifying Party becoming aware of such Tax Contest.  A failure by a Party to give notice as provided in this Section 6.01(a) (or to promptly forward any such notices or communications) shall not relieve the other Party’s indemnification obligations under this Agreement, except to the extent that such other Party shall have been actually prejudiced by such failure.

 

(b)                             With respect to any Tax Contest Novartis and Alcon are aware of as of the date of this Agreement, which Tax Contests are identified on Exhibit 2 hereto, Novartis shall have the right to control the conduct and settlement of such Tax Contest.  With respect to any other Tax Contest other than a Transaction Tax Contest, (i) Novartis

 

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shall have the exclusive right to control the conduct and settlement of any Tax Contest of (A) any member of the Novartis Group and (B) to the extent such Tax Contest relates to a Novartis Consolidated Return, any member of the Alcon Group, and (ii) Alcon shall have the exclusive right to control the conduct and settlement of any other Tax Contest of any member of the Alcon Group.  Notwithstanding the foregoing, if the conduct or settlement of any portion or aspect of any such Tax Contest could reasonably be expected to cause the other Party to have an indemnification obligation (or refund entitlement) under this Agreement, then (i) such other Party shall have the right to share joint control over the conduct and settlement of such portion or aspect and (ii) whether or not such other Party exercises that right, Novartis or Alcon, as applicable, shall not accept or enter into any settlement without the prior written consent of such other Party (not to be unreasonably withheld, conditioned or delayed).

 

(c)                              Novartis and Alcon shall have the right to control jointly the conduct and settlement of any Transaction Tax Contest.  Notwithstanding the foregoing, Novartis shall be entitled to control exclusively the conduct and settlement of any Transaction Tax Contest if Novartis notifies Alcon that (notwithstanding the rights and obligations of the Parties under this Agreement) Novartis agrees to pay (and indemnify Alcon against) any Transaction Taxes resulting from such Transaction Tax Contest.

 

(d)                             In any case where the Parties control jointly the conduct and settlement of any Tax Contest (or portion or aspect thereof):  (i) neither Party shall accept or enter into any settlement of such Tax Contest (or the relevant portion or aspect thereof) without the prior written consent of the other Party (not to be unreasonably withheld, conditioned or delayed), (ii) both Parties shall have a right to review and consent to (not to be unreasonably withheld, conditioned or delayed) any correspondence or filings to be submitted to any Tax Authority with respect to such Tax Contest (or the relevant portion or aspect thereof), (iii) both Parties shall have the right to attend any formally scheduled meetings with any Tax Authority or hearings or proceedings before any judicial authority, in each case with respect to such Tax Contest (or the relevant portion or aspect thereof) and (iv) in the event the Tax Contest relates to a Tax Return for which Novartis is the Tax Return Preparer, Alcon shall not consult or otherwise retain any Tax counsel, accountant or other advisor in connection with such Tax Contest unless such Person is a Tax Advisor reasonably acceptable to Novartis.

 

(e)                              All reasonable costs, expenses and fees (including legal, accounting and other advisory and court fees) incurred after the Distribution in the course of conducting any Tax Contest, shall be borne by the Parties in the same manner as the Taxes that are the subject of such Tax Contest are allocated between the Parties pursuant to this Agreement.

 

18


 

SECTION 6.02.                                    Cooperation.   Novartis and Alcon shall, and shall cause their respective Affiliates to, cooperate fully with all reasonable requests from the other Party in connection with matters covered by this Agreement, including the preparation and filing of Tax Returns, the calculation of Taxes, the determination of the proper financial accounting treatment of Tax items and the conduct and settlement of Tax Contests.  Such cooperation shall include (a) the execution of any document that may be necessary or reasonably helpful in connection with the preparation and filing of Tax Returns, the conduct and settlement of Tax Contests or obtaining any Satisfactory Guidance in accordance with this Agreement and (b) compliance with Clause 17 of the Separation Agreement ( provided , however , that Books and Records relating to Taxes shall be retained by the relevant Group until the expiration of the relevant statute of limitations (including extensions)).

 

SECTION 6.03.                                    Indemnification Claims and Payments.   (a) A Party shall be entitled to make a claim for indemnification with respect to Taxes under this Agreement when such Party determines that it or one of its Affiliates is entitled to such payment and is able to calculate with reasonable accuracy the amount of such payment.  Except as otherwise provided in Section 3.05, such Party shall provide to the other Party notice of such claim within sixty (60) Business Days after the first date on which it so becomes entitled to make such claim.  Such notice shall include a description of such claim and a detailed calculation of the amount claimed.  Such notified Party shall make the claimed payment to the notifying Party within sixty (60) days after receiving such notice, unless such notified Party reasonably disputes its liability for, or the amount of, such payment.

 

(b)                             Notwithstanding Section 6.03(a), with respect to any claim for payment with respect to Taxes that are the subject of a Tax Contest, the Party seeking indemnification (the “ Indemnified Party ”) shall not be entitled to make a claim for payment until there has been a Determination with respect to such Taxes, provided , however , that if the Indemnified Party is able to pay a reasonable estimate or agreed amount of such Taxes or other commercially reasonable amount (such amount, the “ Deposit Amount ”) to the applicable Tax Authority and the payment of such Deposit Amount would suspend or avoid the imposition or accrual of interest or penalties with respect to such Taxes, unless both Parties agree otherwise, the other Party (the “ Indemnifying Party ”) shall pay the Deposit Amount to the Indemnified Party promptly after the Indemnified Party is able to determine the Deposit Amount with reasonable accuracy, and, upon receipt of payment from the Indemnifying Party, the Indemnified Party shall promptly remit the Deposit Amount to the applicable Tax Authority.

 

(c)                              A failure by a Party to give notice as provided in Section 6.03(a) shall not relieve the other Party’s indemnification or other payment obligations under this

 

19


 

Agreement, if any, except to the extent that such other Party shall have been actually prejudiced by such failure.  Nothing in this Section 6.03 shall prejudice a Party’s right to receive payments pursuant to Section 3.05.

 

(d)                             The Parties shall cooperate in good faith to determine the manner in which any payments required to be made under this Agreement shall be made, including by providing for any such payments to be made directly between the Parties’ respective subsidiaries.

 

ARTICLE VII

 

Miscellaneous

 

SECTION 7.01.                                    Incorporation.   Clauses 15.6 ( No Double Recovery and No Double Counting ), 15.7 ( Specific Performance ), 26 ( Further Assurances ), 32 ( Notices ), 35 (W aivers, Rights and Remedies ), 36 ( Counterparts ), 37 ( Variations ), 38 ( Invalidity ), 39 ( No Third Party Enforcement Rights ) and 40 ( Governing Law ) and of the Separation Agreement are hereby incorporated by reference into this Agreement, mutatis mutandis .

 

SECTION 7.02.                                    Dispute Resolution .  The Parties shall use Commercially Reasonable Efforts to cooperate to resolve any dispute, controversy or claim arising out of, relating to or in connection with this Agreement.  If the Parties are unable to resolve such dispute, controversy or claim after complying with the preceding sentence, such dispute, controversy or claim shall be a “Dispute” within the meaning of the Separation Agreement and shall be subject to the provisions of Clause 41 ( Dispute Resolution ) of the Separation Agreement for resolution of Disputes.

 

SECTION 7.03.                                    Termination.   This Agreement will be automatically terminated if, at any time before the Distribution, the Separation Agreement is terminated.  In the event of the termination of this Agreement pursuant to this Section 7.03, this Agreement, except for the provisions of this Section 7.03, will become void and have no effect, without any liability on the part of any Party or its directors, officers or stockholders.

 

SECTION 7.04.                                    Confidentiality.   Each Party hereby acknowledges that confidential Information of such Party or its Affiliates may be exposed to employees and agents of the other Party or its Affiliates as a result of the activities contemplated by this Agreement.  Each Party agrees, on behalf of itself and its Affiliates, that such Party’s obligations with respect to Information of the other Party or its Affiliates shall be governed by Clause 28 ( Confidentiality ) of the Separation Agreement.

 

20


 

SECTION 7.05.                                    Assignability.   Neither this Agreement nor any of the rights, interests or obligations under this Agreement shall be assigned, in whole or in part, by operation of Applicable Law or otherwise by either Party without the prior written consent of the other Party.  Any purported assignment without such consent shall be void.  Subject to the preceding sentences, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the Parties and their respective successors and assigns.  Notwithstanding the foregoing, either Party may assign this Agreement without consent in connection with (a) a merger transaction in which such Party is not the surviving entity and the surviving entity acquires or assumes all or substantially all of such Party’s assets, (b) the sale of all or substantially all of such Party’s assets or (c) the acquisition of all of the Capital Stock of such Party; provided , however , that the assignee expressly assumes in writing all of the obligations of the assigning Party under this Agreement, and the assigning Party provides written notice and evidence of such assignment and assumption to the non-assigning Party.

 

SECTION 7.06.                                    Entire Agreement.   This Agreement and the Schedules hereto contain the entire agreement between the Parties with respect to the subject matter hereof and supersede all previous agreements, negotiations, discussions, writings, understandings, commitments and conversations with respect to such subject matter, and there are no agreements or understandings between the Parties with respect to the subject matter hereof other than those set forth or referred to herein or therein.

 

SECTION 7.07.                                    Separation Agreement; Schedule A.   In the event of any inconsistency between this Agreement and the Separation Agreement or any other Transaction Document, the provisions of this Agreement will control.  In the event of any inconsistency between this Agreement (other than Schedule A) and Schedule A, the provisions of Schedule A will control.  For the avoidance of doubt, no provision of any Transaction Document (other than this Agreement), including the Third Party Claims and Investigations Management Agreement, shall apply to the conduct of Tax Contests, which shall be governed exclusively by the provisions of this Agreement.

 

SECTION 7.08.                                    Headings.   The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 

SECTION 7.09.                                    Survival of Covenants.   Except as expressly set forth in this Agreement, the provisions in this Agreement shall survive the consummation of the Transactions and shall remain in full force and effect for the full period of all applicable statutes of limitations (giving effect to any waiver, mitigation or extensions thereof) plus ninety (90) days.

 

21


 

SECTION 7.10.                                    Late Payments.   Any amount owed by one Party to another Party under this Agreement that is not paid when due will bear interest at the Default Interest Rate from the due date of the payment to the date paid.

 

SECTION 7.11.                                    Interpretation.   Words in the singular shall be held to include the plural and vice versa and words of one gender shall be held to include the other gender as the context requires.  The terms “hereof”, “herein”, “herewith”, “this Agreement” and words of similar import, unless otherwise stated, shall be construed to refer to this Agreement as a whole (including all of the schedules hereto) and not to any particular provision of this Agreement.  Any capitalized terms used in any schedule to this Agreement but not otherwise defined therein shall have the meaning ascribed thereto in this Agreement.  Article, Section or Schedule references are to the articles, sections and schedules of or to this Agreement unless otherwise specified.  Any definition of or reference to any agreement, instrument or other document herein (including any reference herein to this Agreement) shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified from time to time (subject to any restrictions on such amendments, supplements or modifications set forth herein).  The word “including” and words of similar import when used in this Agreement shall mean “including, without limitation,” unless the context otherwise requires or unless otherwise specified.  The word “or” shall not be exclusive.  References to “written” or “in writing” include in electronic form.  Any reference to any provisions of the Code or Regulations or to other Applicable Laws shall be deemed to include any amendments or successor provisions thereto as appropriate.  References to dollars or $ are references to the lawful currency from time to time of the United States of America.  Any reference herein to a “Section” number shall include a reference to the corresponding Section numbers in the Schedules that comprise Schedule A.  NOTWITHSTANDING THE FOREGOING, THE PURPOSE OF ARTICLE IV IS TO ENSURE THAT THE APPLICABLE STEPS OF THE TRANSACTIONS QUALIFY FOR THE INTENDED TAX TREATMENT AND, ACCORDINGLY, THE PARTIES AGREE THAT THE LANGUAGE THEREOF SHALL BE INTERPRETED IN A MANNER THAT SERVES THIS PURPOSE TO THE GREATEST EXTENT POSSIBLE.

 

[ Signature Page Follows ]

 

22


 

SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Peter Schreiner

 

/s/ Gabriela Schwarz

 

 

 

Name:

Peter Schreiner

 

Name:

Gabriela Schwarz

 

 

 

 

 

Title:

Head of Tax

 

Title:

Head of M&A Tax

 

 

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

23


 

SCHEDULE A

 


 

SCHEDULE A-1

 

United States

 


 

SCHEDULE A-1

 

ARTICLE I

 

Definitions

 

For purposes of this Schedule A-1, the following terms have the following meanings.

 

10% Acquisition Transaction ” means any transaction or series of transactions that would be a Proposed Acquisition Transaction if the percentage specified in the definition of Proposed Acquisition Transaction were 10% instead of 20%.

 

Active Trade or Business ” means the active conduct (determined in accordance with Section 355(b) of the Code) of the trade or business of U.S. Alcon described in the Representations for purposes of satisfying the requirements of Section 355(b) of the Code.

 

Notice Action ” has the meaning ascribed thereto in Section A-1-4.06.

 

Post-Separation Period ” means, notwithstanding the definition of Post-Separation Period in the Agreement, any taxable period (or portion thereof) beginning after the date identified on Exhibit A-1-B hereto.

 

Pre-Separation Period ” means, notwithstanding the definition of Pre-Separation Period in the Agreement, any taxable period (or portion thereof) ending on or before the date identified on Exhibit A-1-B hereto.

 

Proposed Acquisition Transaction ” has the meaning ascribed thereto in Section A-1-4.03(b).

 

United States ” or “ U.S. ” means the United States of America.

 

U.S. Intended Tax Treatment ” means the qualification of the steps of the Transactions identified in Exhibit A-1-A hereto for the corresponding treatment set forth therein.

 

U.S. Alcon ” means the corporation identified as such on Exhibit A-1-D hereto.

 

U.S. Ordinary Taxes ” means Ordinary Taxes imposed, collected or withheld by or on behalf of the United States or any political subdivision thereof (whether state or local), including through any agency, authority, instrumentality, regulatory body, court or other entity exercising power on behalf thereof or through the implementation of any agreement or treaty entered into with the United States.

 

U.S. Tax Ruling ” means the private letter ruling issued to Novartis by the IRS in connection with the Transactions, as described in Exhibit A-1-D hereto.

 


 

ARTICLE II

 

*              *              *

 

SECTION A-1-2.03.            Allocation of Transaction Taxes.

 

(a)           Each of the following items shall constitute an “Alcon Indemnity Event”:

 

(i)                                            The application of Section 355(a)(1)(B), 355(e) or 355(f) of the Code to any of the Transactions as a result of any direct, indirect or deemed acquisition after the Distribution of Capital Stock or assets of Alcon or any of its Affiliates; and

 

(ii)                                         any action by Alcon or any of its Affiliates described in (1) Section A-1-4.03 without regard to Section 4.04.

 

(b)           Each of the following items shall constitute a “Novartis Indemnity Event”:

 

(i)                                            The application of Section 355(a)(1)(B), 355(e) or 355(f) of the Code to any of the Transactions as a result of any direct, indirect or deemed acquisition after the Distribution of Capital Stock or assets of Novartis or any of its Affiliates.

 

*              *              *

 

SECTION A-1-2.06.            Allocation of Ordinary Taxes.   (a) Ordinary Taxes that are U.S. Ordinary Taxes shall be allocated between the Pre-Separation Period and Post-Separation Period as provided in Section 2.06 of the Agreement except that Pre-Separation Period and Post-Separation Period shall have the meaning ascribed to each, respectively, in this Schedule A-1.

 

(b)           The determination of which U.S. Ordinary Taxes for the Pre-Separation Period are attributable to the Alcon Business shall be made in accordance with the methodology described in Exhibit A-1-B.

 


 

*              *              *

 

ARTICLE III

 

*              *              *

 

ARTICLE IV

 

*              *              *

 

SECTION A-1-4.03.            Restricted Actions.   (a) During the period beginning on the date of the Distribution and ending on the first day after the two-year anniversary of the Distribution, the following are Restricted Actions:

 

(i)              liquidating or partially liquidating, whether by merger, consolidation, conversion or otherwise;

 

(ii)             entering into, causing or permitting any Proposed Acquisition Transaction;

 

(iii)            redeeming or otherwise repurchasing (directly or indirectly) any Capital Stock of Alcon, except to the extent such redemptions or repurchases meet the following requirements:  (A) there is a bona fide, non-Tax business purpose for the repurchases of such Capital Stock, (B) such Capital Stock is widely held, (C) the repurchases of such Capital Stock will be made on the open market and (D) the aggregate amount of repurchases of such Capital Stock will be less than 20% of the total value of the outstanding Capital Stock of Alcon (determined on the date of the Distribution);

 

(iv)            selling, transferring or disposing of 40% or more of the consolidated gross assets that Alcon and its Subsidiaries held immediately before the Distribution;

 

(v)             causing or permitting U.S. Alcon to cease to be a member of Alcon’s “separate affiliated group” within the meaning of Section 355(b)(3)(B) of the Code; and

 

(vi)            causing or permitting U.S. Alcon to cease to engage in the Active Trade or Business.

 

(b)           (i) For purposes of this Schedule A-1, “ Proposed Acquisition Transaction ” means any transaction or series of transactions (or any agreement, understanding or arrangement to enter into a transaction or series of transactions) as determined for purposes of Section 355(e) of the Code, in connection with which one or more Persons would (directly or indirectly) acquire, or have the right to acquire (including pursuant to an option, warrant or other conversion right), from any other Person or Persons, Capital Stock of Alcon or U.S. Alcon that, when combined with any other acquisitions of Capital Stock of Alcon or U.S. Alcon, respectively, that occur on or

 


 

after the Distribution (but excluding any transaction described in clause (ii)), comprises 20% or more of the value or the total combined voting power of all interests that are treated as outstanding equity in Alcon or U.S. Alcon, respectively, for U.S. federal income Tax purposes immediately after such transaction or, in the case of a series of transactions, immediately after any transaction in such series.  For this purpose, any recapitalization, repurchase or redemption of the Capital Stock of, and any amendment to the certificate of incorporation (or other organizational documents) of, Alcon or U.S. Alcon shall be treated as an indirect acquisition of the Capital Stock of Alcon or U.S. Alcon, respectively, by any shareholder to the extent such shareholder’s percentage interest in interests that are treated as outstanding equity in Alcon or U.S. Alcon, respectively, for U.S. federal income Tax purposes increases by vote or value.

 

(ii)             Notwithstanding the foregoing, a Proposed Acquisition Transaction shall not include (A) the adoption by Alcon of a shareholder rights plan that meets the requirements of IRS Revenue Ruling 90-11, 1990-1 C.B. 10, (B) transfers of Capital Stock of Alcon that satisfy Safe Harbor VII (relating to acquisitions of stock listed on an established market) of Section 1.355-7(d) of the Regulations or (C) issuances of Capital Stock of Alcon that satisfy Safe Harbor VIII (relating to acquisitions in connection with a Person’s performance of services) or Safe Harbor IX (relating to acquisitions by a retirement plan of an employer) of Section 1.355-7(d) of the Regulations; provided , however , that such transaction or series of transactions shall constitute a Proposed Acquisition Transaction if meaningful factual diligence is necessary to establish that Section A-1-4.03(b)(ii)(A), (B) or (C) applies.

 

(c)           The provisions of this Section A-1-4.03, including the definition of “Proposed Acquisition Transaction”, are intended to monitor compliance with Section 355 of the Code and shall be interpreted accordingly.  Any clarification of, or change in, Section 355 of the Code or the Regulations thereunder shall be incorporated into this Section A-1-4.03 and its interpretation; provided , that no such clarification or change shall have the effect of permitting any action otherwise prohibited under this Section A-1-4.03.

 

*              *              *

 

SECTION A-1-4.06.            Notice Actions.   During the period beginning on the date of the Distribution and ending on the first day after the 30-month period following the Distribution, any 10% Acquisition Transaction is a Notice Action, and the information required to be provided with respect to any such 10% Acquisition Transaction includes (a) the type and amount of Capital Stock to be acquired or issued and (b) an explanation as to why such transaction does not result in the application of Section 355(a)(1)(B), 355(e) or 355(f) of the Code to the Transactions.

 

SECTION A-1-4.07.            Reporting.   The following are Transaction Filings: any appropriate information and statements required by Section 6045B of the Code and Sections 1.355-5 and 1.368-3 of the Regulations.

 


 

SECTION A-1-4.08.            Additional Post-Distribution Prohibited Actions.   With respect to each Identified Novartis Tax Position identified in Exhibit A-1-C, taking any action or failing to take any action, in each case, described in Exhibit A-1-C or otherwise taking any action or failing to take any action or filing any Tax Return (including with respect to any Post-Separation Period) in a manner inconsistent with or that otherwise would be reasonably expected to adversely affect such Identified Novartis Tax Position shall be a Post-Distribution Prohibited Action.

 

ARTICLE V

 

*              *              *

 

ARTICLE VI

 

*              *              *

 

ARTICLE VII

 

*              *              *

 


 

SCHEDULE A-2

 

Switzerland

 


 

SCHEDULE A-2

 

ARTICLE I

 

Definitions

 

For purposes of this Schedule A-2, the following terms have the following meanings. Capitalized terms used but not defined in this Schedule have the meanings ascribed to them in the Separation Agreement or the Tax Matters Agreement.

 

APL Split ” means the transfer of the ophthalmic business by way of equity contribution to NOAG and subsequent distribution of NOAG to Novartis.

 

Basel-Stadt Tax Ruling ” means the tax ruling Novartis has obtained with the cantonal tax administration of Basel-Stadt in connection with the Transaction as described in Exhibit A-2-A hereto.

 

Fribourg Tax Confirmation ” means the confirmation Novartis has obtained from the finance department of the Fribourg government in connection with the Transaction as described in Exhibit A-2-A hereto.

 

Fribourg Tax Ruling ” means the tax ruling Novartis has obtained with the cantonal tax administration of Fribourg in connection with the Transaction as described in Exhibit A-2-A hereto.

 

NOAG ” means Novartis Ophthalmics AG, a Swiss company limited by shares with legal seat at c/o Alcon Pharmaceuticals Limited, Rue Louis-d’Affry 6, 1701 Fribourg, canton of Fribourg.

 

NOAG Asset Transfer and Contribution Agreement ” means the Asset Transfer and Contribution Agreement between Alcon Pharmaceuticals Ltd. and NOAG dated 1 October 2018 concerning the transfer of the ophthalmic business.

 

Novartis Contribution Agreement ” means the Contribution Agreement between Novartis and Alcon dated 14 November 2018 concerning the transfer of the Alcon Transferring Entities, some shares in Alcon and other assets by way of equity contribution to Alcon.

 

SFTA ” means the Swiss Federal Tax Administration.

 

SFTA Tax Ruling ” means the tax ruling Novartis has obtained with the SFTA in connection with the Transaction as described in Exhibit A-2-A hereto.

 

Swiss Intended Tax Treatment ” means the qualification of the steps of the Transaction set forth below in Exhibit A-2-B hereto.

 

Swiss Stamp Duty ” means the tax imposed based on the Swiss Federal Act on Stamp Duties of 27 June 1973 (Bundesgesetz über die Stempelabgaben) as

 


 

amended from time to time together with the related ordinances, regulations and guidelines.

 

Swiss Tax Rulings ” means the Basel-Stadt Tax Ruling, the Fribourg Tax Ruling and the SFTA Tax Ruling.

 

Swiss Withholding Tax ” means the tax imposed based on the Swiss Federal Act on Withholding Tax of 13 October 1965 (Bundesgesetz über die Verrechnungssteuer) as amended from time to time together with the related ordinances, regulations and guidelines.

 

Switzerland ”, “ Swiss ” or “ CH ” means the territory of the Swiss Confederation as defined by its laws in accordance with international law.

 

VAT ” means Swiss value added tax.

 

VATA ” means the Swiss Federal Act of 12 June 2009 on VAT.

 

ARTICLE II

 

*              *              *

 

SECTION A-2-2.03.            Allocation of Transaction Taxes.

 

Any action described in Section A-2-4.03 shall constitute an “Alcon Indemnity Event”.

 

*              *              *

 

SECTION A-2-2.04.            Allocation of Transfer Taxes.

 

(a)           In accordance with the NOAG Asset Transfer and Contribution Agreement Alcon Pharmaceuticals Ltd. and NOAG will initiate and pursue in respect of the transfer of assets the mandatory notification procedure (“Meldeverfahren”) as foreseen in article 38 VATA. At closing, Alcon Pharmaceuticals Ltd. is registered in the UID register under the number CHE-116.268.023 MWST and NOAG under the number CHE-158.079.611 MWST. To that respect and in accordance with the NOAG Asset Transfer and Contribution Agreement, Alcon Pharmaceuticals Ltd. and NOAG will cooperate with each other and, within the applicable legal deadlines, notify the SFTA of the transfer of assets, and undertake in a timely manner all steps required by Swiss law in connection with such notification procedure (including the timely filing of the signed form 764). Alcon Pharmaceuticals Ltd. shall provide all information and documentation to NOAG which is necessary to evidence the previous input VAT deductions and use of goods or services received within 20 days after Closing. By application of the notification procedure, no specific indication of any VAT being due (e.g. “incl. VAT”, etc.) shall be made, except for the notion that the notification procedure applies. Should, however, VAT be chargeable on the transfer of assets or any part thereof, it shall be fully payable by NOAG. In such event, Alcon Pharmaceuticals Ltd. shall promptly notify NOAG after

 


 

being so advised by the SFTA and, if requested, deliver an invoice for purposes of VAT; and NOAG shall pay to Alcon Pharmaceuticals Ltd. the amount of the VAT (together with any interest or penalties relating thereto) due.

 

(b)           In accordance with the Novartis Contribution Agreement the Parties will initiate and pursue in respect of the transfer of assets the mandatory notification procedure (“Meldeverfahren”) as foreseen in article 38 VATA. At closing Novartis is registered in the UID register under the number CHE-116.268.023 MWST and Alcon is registered under the number CHE-116.268.023 MWST. To that respect and in accordance with the Novartis Contribution Agreement, the Parties will cooperate with each other and, within the applicable legal deadlines, notify the SFTA of the transfer of assets, and undertake in a timely manner all steps required by Swiss law in connection with such notification procedure. This includes, but is not limited to, the timely filing of the signed form 764. Novartis shall provide all information and documentation to Alcon which is necessary to evidence the previous input VAT deductions and use of goods or services received within 20 days after Closing. By application of the notification procedure, no specific indication of any VAT being due (e.g. “incl. VAT”, etc.) shall be made, except for the notion that the notification procedure applies. Should, however, VAT be chargeable on the transfer of assets or any part thereof, it shall be fully payable by Alcon. In such event, Novartis shall promptly notify Alcon after being so advised by the SFTA and, if requested, deliver an invoice for purposes of VAT; and Alcon shall pay to Novartis the amount of the VAT (together with any interest or penalties relating thereto) due.

 

*              *              *

 

SECTION A-2-2.05.            Allocation of Ordinary Taxes.

 

In accordance with the NOAG Asset Transfer and Contribution Agreement all Ordinary Taxes imposed, collected or withheld by or on behalf of Alcon Pharmaceuticals Ltd. shall be allocated to Alcon Pharmaceuticals Ltd. except for Taxes which are allocated to either of Novartis or NOAG according to the Fribourg Tax Confirmation or except for Taxes which arise in connection with an Alcon Pharmaceuticals Ltd. Tax Contest where an adjustment is made related to the Ophtha business as defined in the NOAG Asset Transfer and Contribution Agreement.

 

*              *              *

 

ARTICLE III

 

*              *              *

 

ARTICLE IV

 

*              *              *

 


 

SECTION A-2-4.03.            Restricted Actions.

 

(a)           The following Restricted Actions apply for Alcon:

 

(i)              Alcon failing to comply or causing or permitting any of its Affiliates to fail to comply with the facts and conditions stated in the Swiss Tax Rulings relating to Alcon and any of its Affiliates, including Alcon Pharmaceuticals Ltd. In particular, during the period beginning on the Separation Date and ending on the second anniversary date of the Separation, Alcon failing to continue the holding activity at its legal seat in the canton of Fribourg comprising the management of participations, the monitoring of performance and financial results, the controlling, and the exercise of shareholder rights in connection with its participations with at least three full-time employees having their work place in Switzerland and board meeting that are physically held predominately (more than 50%) in Switzerland.

 

(ii)             During the period beginning on the Separation Date and ending on 31 December 2022, Alcon Pharmaceuticals Ltd. or Alcon failing to comply with the facts and conditions of the Fribourg Tax Confirmation, including the obligation of Alcon to have an annual meeting with the finance department of the canton of Fribourg to assess the situation of the presence of the group and its future prospects canton of Fribourg and the obligation of Alcon Pharmaceuticals Ltd. to maintain a minimum of 262 FTEs during this period.

 

*              *              *

 


Exhibit 99.3

 

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 


 

EMPLOYEE MATTERS AGREEMENT

 


 


 

CONTENTS

 

Clause

 

Page

 

 

 

1.

ALCON EMPLOYEES

3

2.

EMPLOYMENT LIABILITIES

7

3.

LONG-TERM ASSIGNEES

9

4.

CASH BONUS

9

5.

PROTECTION OF TERMS AND CONDITIONS

10

6.

COMPENSATION REVIEW

12

7.

SHARE-BASED INCENTIVE SCHEMES

12

8.

CERTAIN US EMPLOYEE BENEFIT MATTERS

17

9.

BOOKS AND RECORDS

18

10.

RESTRICTIVE COVENANTS

18

11.

STAND-ALONE EB ARRANGEMENTS

20

12.

RETAINED NOVARTIS EB ARRANGEMENTS

20

13.

TRANSITIONAL PERIODS AND TRANSITIONAL SERVICES

22

14.

ALLOCATION OF EMPLOYEE BENEFIT LIABILITIES

23

15.

PLAN-SPECIFIC EXCEPTIONS

23

16.

DEFINED CONTRIBUTION BENEFITS

27

17.

GENERAL

28

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

29

SCHEDULE 2 CERTAIN EMPLOYEE BENEFIT ARRANGEMENTS

33

SCHEDULE 3 DELAYED EMPLOYEE TRANSFERS

34

 

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EMPLOYEE MATTERS AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

1.                                       NOVARTIS AG , a corporation ( Aktiengesellschaft ) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number ( UID ) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland. ( Novartis )

 

2.                                       ALCON INC. , a corporation ( Aktiengesellschaft ) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number ( UID ) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland ( Alcon Inc. )

 

(together the parties )

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

Whereas:

 

A.                           Novartis, acting through its Subsidiaries, currently conducts, among other businesses, the Alcon Business. At the date of this Agreement, Alcon Inc. is a direct, wholly owned Subsidiary of Novartis.

 

B.                           The Novartis shareholders have approved the separation of the Alcon Business from the Novartis Business into Alcon Inc. and have entered into a Separation and Distribution Agreement on or around the date of this Agreement.

 

C.                           Clause 10.1(a) of the Separation and Distribution Agreement provides that, among other things, the parties will enter into this Employee Matters Agreement which sets out the terms and conditions on which the Separation and the Distribution are to be implemented in relation to employees and employee benefits.

 

IT IS AGREED:

 

PART A: EMPLOYEES

 

1.       ALCON EMPLOYEES

 

1.1                                Identification

 

(a)                                  The parties acknowledge and agree that Current Alcon Employees are:

 

(i)     those employees of the Novartis Group or the Alcon Group who work wholly or substantially in the Alcon Business as at the Separation Date, including any employee who is identified as a Long-Term Assignee. For these purposes ‘wholly or substantially’ means that such employees spend 70 per cent. or more of their time working in the Alcon Business; and

 

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(ii)    any other employees of the Novartis Group or the Alcon Group that the parties have agreed in writing shall be Current Alcon Employees.

 

(b)                                  The parties acknowledge and agree that Former Alcon Employees are:

 

(i)     former employees of the Novartis Group or the Alcon Group who no longer work for either the Novartis Group or the Alcon Group as at the Separation Date and who worked wholly or substantially in the Alcon Business as of the date immediately prior to the termination of their employment, including any employee who was identified as a Long-Term Assignee. For these purposes ‘wholly or substantially’ means that such employees spent 70 per cent. or more of their time working in the Alcon Business; and

 

(ii)    any other former employees of the Novartis Group or the Alcon Group that the parties have agreed in writing shall be Former Alcon Employees.

 

(c)                                   The Former Alcon Employees and the Current Alcon Employees shall together be referred to as the Alcon Employees .

 

(d)                                  Alcon Employees shall exclude in each case:

 

(i)     any employees of the Novartis Group that the parties have agreed in writing shall not be either Current Alcon Employees or Former Alcon Employees; and

 

(ii)    any employees who meet the criteria set out at clauses 1.1(a)(i) or 1.1(b)(i) above temporarily as a result of a rotation, short term assignment, commuter arrangement and/or business trip, unless otherwise agreed in writing between the parties due to business criticality.

 

(e)                                   The parties acknowledge and agree that:

 

(i)     Current Novartis Employees are those employees who, as at the Separation Date, work in the Novartis Group or the Alcon Group and who, as of immediately prior to the Separation Date, are not Alcon Employees; and

 

(ii)    Former Novartis Employees are those former employees of the Novartis Group or the Alcon Group who no longer work for the Novartis Group as at the Separation Date and, as of the date immediately prior to the termination of their employment, were not Alcon Employees.

 

(f)                                    The Former Novartis Employees and the Current Novartis Employees shall together be referred as the Novartis Employees .

 

(g)                                   The parties acknowledge that:

 

(i)     Exhibit 1 of this Agreement sets out a preliminary list of Current Alcon Employees (updated as at 31 January 2019). Novartis shall provide a final version of this list to Alcon as soon as practicable following the Separation Date;

 

(ii)    Exhibit 2 of this Agreement preliminarily sets out the number of Current Alcon Employees in: (i) each member of the Alcon Group and (ii) each

 

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jurisdiction in which Current Alcon Employees work (updated as at 31 January 2019); and

 

(iii)   Exhibit 3 of this Agreement sets out a preliminary list of the individuals referred to in clause 1.1(d) above (updated as at 31 January 2019).

 

1.2                                Legal entity carve-outs

 

(a)                                  If any Current Novartis Employee is found or alleged to have been employed by Alcon Inc. or a member of its Group as from the Separation Date it is agreed that:

 

(i)     in consultation with Alcon Inc., Novartis or the relevant member of its Group may within ten Business Days of being so requested by Alcon Inc. (as long as the request is made no later than three months after the Separation Date), make to that person an offer in writing to employ him or her, such offer to be subject to, and to take effect upon, the termination referred to below; and

 

(ii)    the offer to be made will preserve the person’s period of continuous employment and will be made on terms that are substantially comparable to the terms and conditions of employment applicable to such person immediately prior to the Separation Date (including salary and benefits, but excluding any equity plans, share-based incentive schemes or other long-term incentive plans).

 

(b)                                  As from the date on which Novartis or the relevant member of its Group makes a written offer of employment, in accordance with clause 1.2(a)(i) above, and provided that the relevant member of the Alcon Group takes such steps as are legally possible to terminate the employment of the person concerned as soon as reasonably practicable following the date of the written offer of employment referred to at clause 1.2(a)(i) above (either by giving notice or transferring the person by agreement to be concluded between the relevant member of the Alcon Group, the person concerned and the relevant member of the Novartis Group), Novartis shall be responsible for and shall indemnify and keep indemnified Alcon Inc. (for itself and as trustee for any relevant member of its Group) against all Liabilities from time to time made, suffered or incurred by Alcon Inc. (or any other member of its Group) as a result of:

 

(i)     the actual or alleged transfer of such Current Novartis Employee to a member of the Alcon Group and (regardless of whether there has been such a transfer) any employment Liabilities relating to such person;

 

(ii)    employing such Current Novartis Employee on and from the Separation Date until such termination (up to the time reasonably expected to have achieved such termination in accordance with the terms of any applicable contract of employment and Applicable Law but subject to a maximum period of six months unless prevented by the terms of any applicable contract of employment or Applicable Law); and

 

(iii)   such termination.

 

(c)                                   Novartis and Alcon Inc. agree to co-operate in good faith to minimise the Liabilities which are subject to the indemnity referred to in clause 1.2(b) above.

 

(d)                                  If any Current Alcon Employee is found or alleged to have been employed by Novartis or a member of its Group as from the Separation Date it is agreed that:

 

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(i)     in consultation with Novartis, Alcon Inc. or the relevant member of its Group may within ten Business Days of being so requested by Novartis (as long as the request is made no later than three months after the Separation Date), make to that person an offer in writing to employ him or her, such offer to be subject to, and to take effect upon, the termination referred to below; and

 

(ii)    the offer to be made will preserve the person’s period of continuous employment and will be made on terms that are substantially comparable to the terms and conditions of employment applicable to such person immediately prior to the Separation Date (including salary and benefits, but excluding any equity plans, share-based incentive schemes or other long-term incentive plans).

 

(e)                                   As from the date on which Alcon Inc. or the relevant member of its Group makes a written offer of employment in accordance with clause 1.2(d)(i) above, and provided that the relevant member of the Novartis Group takes such steps as are legally possible to terminate the employment of the person concerned as soon as reasonably practicable following the date of the written offer of employment referred to at clause 1.2(d)(i) above (either by giving notice or transferring the person by agreement to be concluded between the relevant member of the Novartis Group, the person concerned and the relevant member of the Alcon Group), Alcon Inc. shall be responsible for and shall indemnify and keep indemnified Novartis (for itself and as trustee for any relevant member of its Group) against all Liabilities from time to time made, suffered or incurred by Novartis (or any other member of its Group) as a result of:

 

(i)     any employment Liabilities relating to such person;

 

(ii)    employing such person on and from the Separation Date until such termination (up to the time reasonably expected to have achieved such termination in accordance with the terms of any applicable contract of employment and Applicable Law but subject to a maximum period of six months unless prevented by the terms of any applicable contract of employment or Applicable Law); and

 

(iii)   such termination.

 

(f)                                    Novartis and Alcon Inc. agree to co-operate in good faith to minimise the Liabilities which are subject to the indemnity referred to in clause 1.2(e) above.

 

(g)                                   The parties shall cooperate to, so far as possible, make arrangements for the services of any:

 

(i)     Current Alcon Employee to whom this clause 1.2 applies to be made available on an interim basis to the Alcon Group (including but not limited by way of secondment) until such time as his or her employment is transferred to the Alcon Group or terminated in accordance with this clause 1.2; and

 

(ii)    Current Novartis Employee to whom this clause 1.2 applies to be made available on an interim basis to the Novartis Group (including but not limited by way of secondment) until such time as his or her employment is transferred to the Novartis Group or terminated in accordance with this clause 1.2.

 

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(h)                                  Any Current Alcon Employee or Current Novartis Employee to whom this clause 1.2 applies and who is not offered employment by the Alcon Group or the Novartis Group, respectively, in accordance with this clause 1.2, or who rejects such offer, shall no longer by considered a Current Alcon Employee or a Current Novartis Employee for purposes of this Agreement.

 

2.       EMPLOYMENT LIABILITIES

 

2.1                                This clause 2 sets out the general principles for allocating employment and service-related Liabilities between the parties. In the event of a conflict between the provisions of this clause 2 (other than clause 2.3 below) and any other clause in this Agreement, the provisions of the other clause shall prevail.

 

2.2                                All employment and service-related Liabilities (including wages, salaries, employer’s Liabilities in respect of associated Taxes and other periodic outgoings) in respect of:

 

(a)                                  Alcon Employees, whether arising before, on or after the Transfer Date, shall be borne or discharged by Alcon Inc. or a relevant member of its Group; and

 

(b)                                  Novartis Employees, whether arising before, on or after the Transfer Date, shall be borne or discharged by Novartis or a relevant member of its Group.

 

2.3                                Except as provided under clause 1.2(e) above or clause 2.4(v) below, notwithstanding any other provision in this Agreement to the contrary, all severance costs and Liabilities in respect of employees who meet the criteria set out at clause 1.1(a)(i) or clause 1.1(b)(i) above, and, in each case, are or were employees of the Novartis Group, but who do not in fact transfer to Alcon Inc. (or a relevant member of its Group) on or prior to the Separation Date (e.g., because they have refused to transfer), shall be borne or discharged by Novartis or a relevant member of its Group.

 

2.4                                Alcon Inc. shall (for itself and for each member of its Group) indemnify and keep indemnified Novartis (for itself and as trustee for each other member of its Group) against all Liabilities (ignoring any amount in respect of Long-Term Employee Benefits, as to which see Part B) in respect of:

 

(i)     the employment of any of the Alcon Employees (including, without limitation, any changes to terms and conditions of employment by Alcon Inc. or any other member of its Group);

 

(ii)    any termination of the employment of any Alcon Employee following the Transfer Date including, but not limited to, all claims relating to severance, termination pay, pay in lieu of notice of termination and similar obligations;

 

(iii)   any failure by Alcon Inc. or any other member of its Group to provide information and reasonable assistance to Novartis to enable Novartis or any member of its Group to comply with any obligation to inform or consult with employee representatives in connection with the matters contemplated by this Agreement;

 

(iv)   any breach by Alcon Inc. or any member of its Group of clause 5 below; and

 

(v)    any act or omission by Alcon Inc. or any member of its Group in relation to any Alcon Employee before the date such employee was intended to transfer as a result

 

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of which that Alcon Employee treats his employment as having been terminated prior to such date,

 

in each case whether such Liabilities arise or relate to a period before, on, or after the Separation Date.

 

2.5                                Novartis shall (for itself and for each member of its Group) indemnify and keep indemnified Alcon Inc. (for itself and as trustee for each other member of its Group) against all Liabilities (ignoring any amount in respect of Long-Term Employee Benefits, as to which see Part B) in respect of:

 

(i)     the employment of any of the Novartis Employees (including, without limitation, any changes to terms and conditions of employment by Novartis or any other member of its Group);

 

(ii)    any termination of the employment of any Novartis Employee including, but not limited to, all claims relating to severance, termination pay, pay in lieu of notice of termination and similar obligations;

 

(iii)   any failure by Novartis or any other member of its Group to provide information and reasonable assistance to Alcon Inc. to enable Alcon Inc. or any member of its Group to comply with any obligation to inform or consult with employee representatives in connection with the matters contemplated by this Agreement;

 

(iv)   any act or omission by Novartis or any member of its Group in relation to any Novartis Employee before the date such employee was intended to transfer as a result of which that Novartis Employee treats his employment as having been terminated prior to such date; and

 

(v)    any benefits claims made by Alcon Employees under welfare benefit plans retained by the Novartis Group,

 

in each case whether such Liabilities arise or relate to a period before, on, or after the Transfer Date.

 

2.6                                Notwithstanding the provisions of clauses 2.2 to 2.5 above, all Liabilities in respect of legal claims made by Transferred Alcon Employees which:

 

(a)                                  relate to the alleged wrongful acts of Alcon Inc. or any member of its Group in respect of the period after the Transfer Date, shall be borne or discharged by Alcon Inc. or a relevant member of its Group;

 

(b)                                  relate to the alleged wrongful acts of Novartis or any member of its Group in respect of the period prior to the Transfer Date, shall be borne and discharged by Novartis or a relevant member of its Group; and

 

(c)                                   are attributable to the alleged wrongful acts of both Alcon Inc. (or any member of its Group) and Novartis (or any member of its Group), shall be allocated fairly as between the parties, save that where liabilities for the alleged wrongful acts can be apportioned by reference to a clear proportion of fault, then such proportion shall be used to determine the apportionment of such liabilities.

 

2.7                                Notwithstanding the provisions of clauses 2.2 to 2.5 above, all Liabilities in respect of legal claims made by Transferred Novartis Employees which:

 

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(a)                                  relate to the alleged wrongful acts of Novartis or any member of its Group in respect of the period after the Transfer Date, shall be borne or discharged by Novartis or a relevant member of its Group;

 

(b)                                  relate to the alleged wrongful acts of Alcon Inc. or any member of its Group in respect of the period prior to the Transfer Date, shall be borne and discharged by Alcon Inc. or a relevant member of its Group; and

 

(c)                                   are attributable to the alleged wrongful acts of both Alcon Inc. (or any member of its Group) and Novartis (or any member of its Group), shall be allocated fairly as between the parties, save that where liabilities for the alleged wrongful acts can be apportioned by reference to a clear proportion of fault, then such proportion- shall be used to determine the apportionment of such liabilities.

 

2.8                                The terms of the Claims Management Agreement shall apply to the management of any Third Party Claims and/or Investigations arising out of, or relating to, the matters set out in this Agreement. For the purposes of this clause 2.8, the terms ‘Third Party Claims’ and ‘Investigations’ shall be defined by reference to the Claims Management Agreement.

 

3.       LONG-TERM ASSIGNEES

 

3.1                                Notwithstanding the provisions of clause 2 above, unless otherwise agreed between the parties (such agreement not to be unreasonably withheld or delayed), Liabilities for services provided to or in respect of Alcon Employees and Novartis Employees who are Long-Term Assignees (including but not limited to in respect of Tax equalisation, costs for Tax advice, and Crown relocation services costs) shall, in each case, be borne by the legal entity which is invoiced by the Third Party, save that this clause 3.1 shall not apply to any invoice issued in error provided that, within 28 days of receipt of such invoice, the receiving party notifies the relevant Third Party of the error and the relevant Third Party rectifies the error such that the invoice is issued to the intended recipient.

 

3.2                                Alcon Inc. will use its Best Endeavours to ensure that, as from the Separation Date, it (or the relevant member of its Group) enters into a services agreement directly with the Third Party and is invoiced directly by such Third Party in respect of the Liabilities (referred to at clause 3.1 above) for:

 

(a)                                  services provided to or in respect of Alcon Employees who are Long-Term Assignees on and/or following the Separation Date; and

 

(b)                                  services provided to or in respect of Transferred Alcon Employees who were Long-Term Assignees prior to the Separation Date.

 

3.3                                The parties shall, and shall procure that the relevant members of each of their Groups shall, cooperate in respect of any immigration or regulatory matters arising in respect of any Long-Term Assignees, who were immediately prior to the Separation Date and who continue to be immediately following the Separation Date, on an international assignment from the Alcon Group to the Novartis Group or from the Novartis Group to the Alcon Group.

 

4.       CASH BONUS

 

4.1                                To the extent legally possible and administratively practicable, Current Alcon Employees will, as from the Separation Date, continue to be eligible to participate in the cash bonus plans applicable to the Alcon Group immediately prior to the Separation Date.

 

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4.2                                If required, Alcon Inc. shall establish and administer new cash bonus plans (the Alcon Bonus Plans ).

 

4.3                                Alcon Inc. shall, or shall procure that a member of its Group shall, pay out cash bonuses to eligible Alcon Employees in respect of the bonus year in which the Separation Date occurs (the Separation Year ) on or around the normal bonus pay date and in accordance with the principles and/or bonus rules set in respect of the Separation Year, SAVE THAT:

 

(a)                                  Alcon Inc. may make such reasonable adjustments to performance targets and metrics as may be necessary to take account of the Separation to ensure that participants are not materially prejudiced or advantaged as a result of the Separation; and

 

(b)                                  the amount of any such bonus paid to a Transferred Alcon Employee shall be adjusted to take account of any pro-rated cash bonus which may have been paid to that Transferred Alcon Employee in respect of the Separation Year as a result of his or her transfer from the Novartis Group to the Alcon Group in preparation for the Separation.

 

5.       PROTECTION OF TERMS AND CONDITIONS

 

5.1                                The provisions of this clause 5 shall apply to Current Alcon Employees for so long as such employees continue in the same roles with any member of the Alcon Group save that no member of the Alcon Group shall seek to demote any Current Alcon Employee to avoid the application of this clause 5. For the avoidance of doubt, nothing in this clause 5 shall otherwise prevent a member of the Alcon Group from terminating the employment of any Current Alcon Employee or assigning any Current Alcon Employee to a different role, location or position in accordance with applicable policies of the Alcon Group.

 

5.2                                In respect of the period ending 1 January 2021, Alcon Inc. shall procure that:

 

(a)                                  each Current Alcon Employee will continue to receive at least the same basic salary as such Current Alcon Employee received immediately prior to the Separation Date;

 

(b)                                  each Current Alcon Employee will continue to receive employee benefits (including Long-Term Employee Benefits but excluding any equity plans, share-based incentive schemes or other long-term incentive plans) which Alcon reasonably considers to be substantially comparable, taken as a whole, to the employee benefits (including Long-Term Employee Benefits but excluding any equity plans, share-based incentive schemes or other long-term incentive plans) of such Current Alcon Employee immediately prior to the Separation Date; and

 

(c)                                   no Current Alcon Employee will suffer a change to his or her overall employment terms (whether contractual or otherwise) including, without limitation, any employment terms related to length of service (but excluding any equity plans, share-based incentive schemes or other long-term incentive plans) which, when taken as a whole viewed in the round (including to the extent relevant alongside any other changes being made at the same time to that Current Alcon Employee’s employment terms), would in Alcon Inc.’s reasonable opinion acting in good faith be regarded as materially detrimental.

 

5.3                                If the employment of any Current Alcon Employee is terminated by reason of redundancy within 24 months following the Separation Date, Alcon Inc. shall procure that benefits shall be provided to such Current Alcon Employee which are no less favourable than

 

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those provided under such redundancy and severance policies and benefits (whether contractual or otherwise and giving due credit to the Current Alcon Employee for any additional service or earnings from the Separation Date onwards) (but excluding Long-Term Employee Benefits) as were applicable in respect of that particular Current Alcon Employee immediately prior to the Separation Date.

 

5.4                                To the extent legally possible and administratively practicable, Current Alcon Employees will, as from the Separation Date, continue to be eligible to participate in the employee benefit plans applicable to the Alcon Group immediately prior to the Separation Date.

 

5.5                                If required, Alcon Inc. shall establish and administer new employee benefit plans (the Alcon Benefit Plans ).

 

5.6                                The terms and conditions of the Alcon Benefit Plans (including Employee Benefit Arrangements but excluding any equity plans, share-based incentive schemes or other long-term incentive plans) shall be substantially comparable, taken as a whole, to the terms and conditions of the employee benefit plans (including Employee Benefit Arrangements but excluding any equity plans, share-based incentive schemes or other long-term incentive plans) which the relevant employees participated in immediately prior to the Separation Date.

 

5.7                                Without limiting the foregoing, with respect to each Alcon Employee (excluding Former Alcon Employees), Alcon Inc. shall, or shall cause the relevant member of its Group to:

 

(a)                                  solely with respect to Transferred Alcon Employees, and with effect from the Transfer Date, to the extent not assumed prior to the date of this Agreement, assume responsibility for all ‘paid time off’ benefits, including vacation pay, sick pay, banked leave, flexitime and other payments for time off of normal work hours accrued by such Transferred Alcon Employee (excluding Former Alcon Employees), including in respect of the period prior to the Transfer Date; and

 

(b)                                  with effect from the date on which such Alcon Employee becomes eligible to participate in any welfare plan maintained by Alcon Inc. or any other member of its Group:

 

(i)     to the extent not already waived prior to the date of this Agreement, waive all limitations as to pre-existing conditions, exclusions, evidence of insurability provisions, waiting periods with respect to such participation and coverage requirements or similar provisions under the Alcon Benefit Plans that are welfare plans (as defined in section 3(1) of ERISA or any equivalent Applicable Law) applicable to such employees to the extent such conditions, exclusions and waiting periods or other provisions were satisfied or did not apply to such employees under welfare plans maintained by the Novartis Group immediately prior to such date; and

 

(ii)    to the extent not already provided as at the date of this Agreement, provide such Alcon Employee (excluding Former Alcon Employees) with credit for any co-payments and deductibles paid prior to such date in satisfying any analogous deductible or out-of-pocket requirements to the extent applicable under any such plan in the year in which such date occurs, to the extent credited under the welfare plans maintained by the Novartis Group immediately prior to such date. Under fully insured arrangements, Alcon Inc. shall, and shall procure that the other members of its Group shall, use its Best

 

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Endeavours to negotiate that the relevant insurer applies transitional credit for co-payments and deductibles already paid during such year. To the extent that the insurer does not agree to provide such credit, and any Alcon Employee brings a claim in connection with consequent loss arising from such decision, Alcon Inc. shall, and shall procure that the other members of its Group shall, provide reasonable compensation to such Alcon Employee in satisfaction of any such claim.

 

5.8                                For the avoidance of doubt, the provisions of this clause 5 are without prejudice to the operation of any Applicable Law in relation to the terms and conditions of employment of the relevant employees.

 

6.       COMPENSATION REVIEW

 

In respect of any Transferred Alcon Employee or Transferred Novartis Employee, the parties shall cooperate in relation to the first annual compensation and performance review process following the Separation Date to ensure such review processes are carried out, so far as practicable, in accordance with usual business practice and that service with the Novartis Group or the Alcon Group (respectively) is taken into consideration where relevant.

 

7.       SHARE-BASED INCENTIVE SCHEMES

 

The Separation — Distribution

 

7.1                                The parties agree that it is not intended that any participant holding an outstanding award under one or more Novartis share-based incentive plans as at the Separation Date shall be materially disadvantaged as regards such awards as a result of the Distribution in connection with the Separation and its impact on the Novartis share price.  The provisions of this clause 7.1 should be interpreted in light of this general principle. Accordingly:

 

(a)                                  the parties acknowledge that any participants (whether Novartis Employees or Alcon Employees) holding awards under a Novartis share-based incentive scheme in the form of restricted shares ( Restricted Shares ) as at the record date for the Distribution shall participate in the Distribution alongside all other Novartis Shareholders and accordingly do not need to be compensated or otherwise ‘kept whole’. The Distribution shall be based on the full number of Restricted Shares granted under the relevant award prior to calculating the participant’s allotment on a pro-rata basis. Participants holding Restricted Shares, who paid Tax at grant in Switzerland, may elect to transfer all (but not a portion) of the blocking restrictions applicable to the Restricted Shares under the relevant award to the shares received pursuant to the Distribution;

 

(b)                                  as soon as practicable following the Separation Date (and, in any event, by the later of 60 days from the Separation Date and 60 days from the first date after the Separation Date when the granting of share-based awards is not prevented by dealing restrictions, subject in both cases to the relevant plan rules and any Applicable Law), Novartis (or a member of its Group) shall grant (at its own cost) each Novartis Employee who holds a restricted stock unit ( RSU ) immediately prior to the Separation Date a share-based award over shares in the capital of Novartis equal to the number of RSUs held by such Novartis Employee immediately prior to the Distribution multiplied by the Novartis Keep Whole Ratio (each a RSU Keep Whole Award );

 

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(c)                                   such RSU Keep Whole Awards will be granted under the applicable Novartis equity plan but will vest according to a vesting schedule substantially similar to the vesting schedule that would have otherwise applied to the related RSU if the Separation had not occurred;

 

(d)                                  as soon as practicable following the Separation Date (and, in any event, by the later of 60 days from the Separation Date and 60 days from the first date after the Separation Date when the granting of share-based awards is not prevented by dealing restrictions, subject in both cases to the relevant plan rules and any Applicable Law), Novartis (or a member of its Group) shall grant (at its own cost) each Novartis Employee who holds an outstanding performance share award ( PSU ) immediately prior to the Separation Date a share-based award over shares in the capital of Novartis equal to the number of PSUs held by such Novartis Employee immediately prior to the Distribution multiplied by the Novartis Keep Whole Ratio (each a PSU Keep Whole Award );

 

(e)                                   such PSU Keep Whole Awards will be granted under the applicable Novartis PSU plan but will vest according to a vesting schedule and, where applicable, pursuant to performance criteria substantially similar to the vesting schedule and, where applicable, performance criteria that would have otherwise applied to the related PSU if the Separation had not occurred. For the avoidance of doubt, the PSU Keep Whole Awards will not carry any entitlement to receive dividend equivalents;

 

(f)                                    notwithstanding any other provision of this clause 7, Novartis undertakes to use its Best Endeavours to adjust the performance conditions applicable to all outstanding PSUs in such manner as it may consider necessary to take account of the Separation;

 

(g)                                   as soon as practicable and legally possible following the Separation Date (and, in any event, by the later of 60 days from the Separation Date and 60 days from the first date after the Separation Date when the granting of share-based awards is not prevented by dealing restrictions, subject in both cases to the relevant plan rules and any Applicable Law), Alcon Inc. (or a member of its Group) shall grant (at its own cost) each Alcon Employee who holds a Novartis Award described in clauses 7.1(b) or 7.1(d) above (other than Option Awards) immediately prior to the Separation Date a share-based award over shares in the capital of Alcon equal to the number of relevant awards held by such Alcon Employee immediately prior to the Distribution multiplied by the Alcon Keep Whole Ratio (each an Alcon Keep Whole Award );

 

(h)                                  such Alcon Keep Whole Awards shall be granted pursuant to the rules of whichever share-based incentive plan operated by the Alcon Group at the time of grant with terms that Alcon Inc. considers are most closely aligned to the terms of the share-based incentive plan operated by the Novartis Group pursuant to which the related Novartis Award had been granted but will vest according to a vesting schedule and, where applicable, pursuant to performance criteria and subject to non-compete restrictions that are substantially similar to the vesting schedule and, where applicable, performance criteria and non-compete restrictions that would have otherwise applied to the related Novartis Award if the Separation had not occurred; and

 

(i)                                      participants who hold vested awards under a Novartis share-based incentive scheme, which were granted in the form of options and held by participants (whether Novartis Employees or Alcon Employees) as at the Separation Date (the Option Awards ), will upon exercising such Option Awards receive one Novartis share and the cash equivalent of one-fifth of an Alcon share for every option exercised.

 

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Outstanding share-based awards under Novartis Group plans — Alcon Employees

 

7.2                                Novartis undertakes to use its Best Endeavours to ensure that share-based awards held by Alcon Employees pursuant to a share-based incentive scheme operated by Novartis or another member of its Group ( Novartis Awards ), shall be treated in a manner consistent with the “involuntary termination” treatment in the relevant share-based incentive scheme, to the extent possible under the relevant plan rules and any Applicable Law and save as otherwise specified in individual award agreements. Except as provided in clause 7.1(a) above, participants holding Novartis Awards will not participate in the Distribution in respect of such Novartis Awards.

 

7.3                                For the avoidance of doubt Novartis (or a relevant member of its Group) shall not take any action pursuant to this clause 7 which would require shareholder approval or which could trigger any significant legal, Tax (including the loss of any Tax-favourable treatment) or operational issues for the relevant participant, Alcon Inc., Novartis or any member of their Groups.

 

7.4                                For the purposes of clause 7.2 above, the “involuntary termination” treatment of Novartis Awards held by Alcon Employees shall be that:

 

(a)                                  PSUs, excluding Alcon Keep Whole Awards, will vest on the applicable normal vesting date subject to time pro-rating (such pro-rating to be based on the full number of months worked between the commencement of the performance period and the Separation Date as a proportion of the original vesting period) and the application of performance conditions and forfeiture restrictions in accordance with the relevant Novartis plan rules;

 

(b)                                  all mandatory deferred share bonus plan awards will vest in full on the applicable normal vesting date;

 

(c)                                   all awards under the UK Employee Share Ownership Plan or the Incentive Conversion Plan (whether Tax-advantaged or otherwise) will vest in full on the applicable normal vesting date;

 

(d)                                  all awards under the Ireland Share Participation Scheme will continue to be held by the relevant trustee until the third anniversary of the applicable date of grant; and

 

(e)                                   all other outstanding Novartis awards, excluding Alcon Keep Whole Awards, will vest or be forfeited (including as a result of time pro-ration) in accordance with the relevant Novartis award agreements or plan rules

 

provided that, to the extent applicable, any awards vesting pursuant to this clause 7.4 shall not be paid until the earliest time permitted under section 409A of the Code in order to avoid the imposition of any additional Taxes or penalties under section 409A of the Code.

 

To the extent that such treatment of Novartis Awards results in the delivery of Novartis shares to Alcon Employees on or after the date of the Distribution, Novartis shall, consistent with prior practise, issue an invoice for the delivery of such shares to the relevant Alcon Group employing entity and such entity shall (and Alcon shall procure that each such employing entity shall) reimburse Novartis for the delivery of such Novartis shares.  It is hereby acknowledged and agreed that Alcon shall satisfy the obligations of all relevant Alcon Group employing entities under this clause 7.4 by making the payments to Novartis described in Exhibit 4.

 

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7.5                                For the avoidance of doubt, Alcon Keep Whole Awards will not be subject to accelerated vesting or pro-rata forfeiture pursuant to clause 7.4 above.

 

7.6                                Novartis (or a relevant member of its Group) will (using Novartis payroll systems) administer the payment of income Tax, social security obligations and equity reporting obligations in respect of all Novartis Awards which vest at the Separation Date (save where such obligations are required to be fulfilled by a different entity in accordance with Applicable Law).

 

7.7                                Alcon Inc. (or a relevant member of its Group) will (using Alcon Group payroll systems) administer the payment of income Tax, social security obligations and equity reporting obligations in respect of all Alcon Keep Whole Awards with a vesting date following the Separation Date (save where such obligations are required to be fulfilled by a different entity in accordance with Applicable Law), provided that Alcon Inc. (or a relevant member of its Group) shall operate a ‘sell to cover’ or ‘net settlement’ arrangement (as applicable in accordance with Novartis’s past practice and the rules of the relevant plan).

 

7.8                                This clause 7.8 shall only apply where Novartis is unable to administer the payment of income Tax, social security obligations and/or equity reporting obligations in respect of Novartis Awards, Option Awards, PSU Keep Whole Awards and/or RSU Keep Whole Awards.

 

(a)                                  Alcon Inc. (or a relevant member of its Group) will (using Alcon Group payroll systems) administer the payment of income Tax, social security obligations and equity reporting obligations in respect of Novartis Awards, Option Awards, PSU Keep Whole Awards and RSU Keep Whole Awards (as necessary) with a vesting date following the Separation Date (save where such obligations are required to be fulfilled by a different entity in accordance with Applicable Law), provided that Novartis (or a relevant member of its Group) shall operate a ‘sell to cover’ or ‘net settlement’ arrangement (as applicable in accordance with Novartis’s past practice and the rules of the relevant plan), and will provide the resulting funds to Alcon Inc. (or relevant member of its Group) to enable the Alcon Group to comply with its obligations in this regard.

 

(b)                                  To the extent permitted under the relevant Novartis plan rules and any Applicable Law, Novartis undertakes to sell such number of the shares underlying the Novartis Awards, the PSU Keep Whole Awards, the Option Awards and the RSU Keep Whole Awards as may be necessary for the sale proceeds to satisfy any applicable Tax withholdings and to pay such amounts to Alcon Inc. in sufficient time for Alcon Inc. or the applicable member of its Group to pay such Tax to the relevant Tax Authority within any applicable timescale, provided always that Alcon Inc. provides Novartis with any information that Novartis may reasonably request in this respect in a timely manner.

 

7.9                                Novartis agrees to indemnify Alcon Inc. (or a relevant member of its Group) for any Liabilities borne by the Alcon Group in connection with the Novartis Awards (except for the obligation to reimburse Novartis for the delivery of Novartis shares described in clause 7.4 above), the Option Awards, the PSU Keep Whole Awards and the RSU Keep Whole Awards, including any Tax. Alcon Inc. shall, and shall procure that the other members of its Group shall, use its Best Endeavours to ensure that the relevant member of the Alcon Group seeks any applicable Tax relief in respect of the Novartis Awards, the Option Awards, the PSU Keep Whole Awards and the RSU Keep Whole Awards and indemnifies Novartis in respect of any such Tax relief obtained, provided always that Novartis provides Alcon Inc. with any information that it may reasonably request in this respect in a timely manner.

 

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7.10                         This clause 7.10 shall only apply to Transferred Alcon Employees whose Novartis Awards lapse or are forfeited (or will lapse or be forfeited) either in whole or in part as a result of the Separation, including as a result of time pro-ration.  As soon as practicable following the Separation Date (and, in any event, by the later of 60 days from the Separation Date and 60 days from the first date after the Separation Date when the granting of share-based awards is not prevented by dealing restrictions, subject in both cases to the relevant plan rules and any Applicable Law), Alcon Inc. (or a member of its Group) shall grant (at its own cost) each relevant Transferred Alcon Employee a share-based award over shares in the capital of Alcon substantially equal in value to the value of the portion of their Novartis Awards which lapsed or was forfeited (or will lapse or be forfeited) as a result of the Separation.  For the purposes of this calculation the value of each lapsed or forfeited Novartis Award shall be equal to the Novartis Closing Share Price and the value of each replacement Alcon award shall be equal to the Day-1 Alcon Share Price (and any replacement PSUs shall have conditions that are based on target performance levels, and subject to non-compete restrictions, that are determined by Alcon), where relevant, disregarding any loss (or expected loss) of Tax-favourable treatment (each a Compensation Award ).

 

7.11                         Such Compensation Awards shall be granted pursuant to the rules of whichever share-based incentive plan operated by the Alcon Group at the time of grant with terms that Alcon Inc. considers are most closely aligned to the terms of the share-based incentive plan operated by the Novartis Group pursuant to which the related Novartis Award had been granted but will (i) vest according to a vesting schedule and, where applicable, pursuant to performance criteria and non-compete restrictions that are substantially similar to the vesting schedule and, where applicable, performance criteria and non-compete restrictions that would have otherwise applied to the related Novartis Award if the Separation had not occurred; and (ii) be subject to a blocking restriction equal to the blocking restriction (if any) remaining applicable to the relevant Novartis Award at the Separation Date (subject in each case to any variations for Tax-advantaged awards that the parties consider to be necessary or desirable).

 

CET Members

 

7.12                         This clause 7.12 shall apply if any member of the Novartis Group corporate executive team (or similar body) is an Alcon Employee (each a CET Member ).  The treatment of share-based awards held by CET Members shall be determined by the remuneration committee of the board of directors of Novartis (acting reasonably and in good faith and following informal consultation with Alcon Inc. and taking into account the provisions of this clause 7), subject to the rules of any relevant share-based incentive scheme and any Applicable Law.

 

Future share-based incentives

 

7.13                         Alcon Inc. confirms that it shall establish and operate its own share-based incentive schemes for the benefit of some or all of the Alcon Employees and that, on the Separation Date an Alcon Employee who, immediately prior to the Separation Date, is eligible to participate in one or more Novartis share-based incentive scheme(s) shall be eligible to participate in such Alcon share-based incentive scheme(s) as are operated for Alcon Employees at the same level as that Alcon Employee participated in the applicable Novartis share-based incentive scheme(s) immediately prior to the Separation Date.  Alcon Inc. confirms that it will recognise such Alcon Employees’ lengths of service with Novartis prior to the Separation Date for the purposes of determining their eligibility for retirement under the Alcon share-based incentive scheme(s). For the avoidance of doubt, this clause 7.13 shall not require Alcon Inc. or any member of its Group to establish, operate or maintain share-based incentives schemes of any particular type or form.

 

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8.                    CERTAIN US EMPLOYEE BENEFIT MATTERS

 

Flexible Spending Arrangements

 

8.1                                To the extent not already established or sponsored before the date of this Agreement, no later than the end of the last relevant Service Term, Alcon Inc. shall establish or sponsor, or shall procure that a member of its Group establishes or sponsors, one or more flexible benefit plans under a cafeteria plan qualifying under Section 125 of the Code for the benefit of US Alcon Employees providing for medical and dependent care flexible spending accounts (the Alcon FSAs ).

 

8.2                                Alcon Inc. shall, or shall procure that a member of its Group shall, cause the Alcon FSAs to accept, effective as of the end of the last relevant Service Term, a spin-off of the flexible spending arrangements of each US Alcon Employee who has any such arrangements under a flexible benefit plan under a cafeteria plan qualifying under Section 125 of the Code of a member of the Novartis Group (the Novartis FSAs ) from the Novartis FSAs, and to honour and continue, to the extent still applicable, the elections made by such US Alcon Employees with respect to the Novartis FSAs for such plan year.  From and after the end of the last relevant Service Term, the Alcon Group shall be solely responsible for all flexible spending arrangement claims by all individuals whose flexible spending arrangements transfer pursuant to this clause 8.2.

 

Workers’ Compensation

 

8.3                                Effective as of the Separation Date, the US Alcon Employees who are employees of the Alcon Group shall be covered under a workers’ compensation insurance policy of the Alcon Group (the Alcon Workers Compensation Policy ).  In the case of any workers’ compensation claim of any US Alcon Employee in respect of his or her employment with the Alcon Group, such claim shall be reported under the Alcon Workers Compensation Policy or another workers’ compensation insurance policy of the Alcon Group if the event, injury, illness or condition giving right to such workers’ compensation claim with respect to such US Alcon Employee occurs on or after the Separation Date.

 

8.4                                Alcon Inc. agrees to indemnify Novartis (or the relevant member of its Group) for any Liabilities borne by the Novartis Group in connection with any workers’ compensation claims with respect to US Alcon Employees, to the extent that such claim is the responsibility of the Alcon Group pursuant to clause 8.3 above, or the failure of Alcon Inc. to meet its obligations pursuant to such clauses.

 

Health and Welfare Benefit Claims

 

8.5                                To the extent not already established or sponsored before the date of this Agreement, no later than the earlier of (x) the end of the last relevant Service Term or (y) the end of the plan year following the plan year in which the Separation occurs, Alcon Inc. shall establish or sponsor, or shall procure that a member of its Group establishes or sponsors, health and welfare benefit plans or arrangements including those that provide medical, dental, retiree welfare, death or disability benefits to US Alcon Employees (the date each such plan is established, an Alcon H&W Plan Date ).  Such health and welfare benefit plans or arrangements shall be designed such that they provide benefits that are substantially comparable to those provided under the Novartis health and welfare benefit plans or arrangements in which the US Alcon Employees participate as of the Separation Date (the Novartis US H&W Plans ), in compliance with clause 5.2(b). With respect to each such health and welfare benefit plan or arrangement, Alcon Inc. shall establish third part administrator

 

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and insurance arrangements reasonably necessary to administer such plan or arrangement and provide benefits thereunder.

 

8.6                                The US Alcon Employees shall continue to participate in each Novartis US H&W Plan following the Separation Date until the Alcon H&W Plan Date corresponding to the Alcon Benefit Plan intended to replace such Novartis US H&W Plan in accordance with clause 8.5 above, and upon such date, the US Alcon Employees will commence participation in such Alcon Benefit Plan.  This clause 8.6 shall also apply to continuation health coverage pursuant to COBRA, such that if any US Alcon Employee (and/or his or her eligible dependents) are receiving such coverage under a Novartis US H&W Plan as of the applicable Alcon H&W Plan Date, he or she (and/or his or her eligible dependents) shall instead, consistent with Applicable Law, receive such coverage under the corresponding Alcon Benefit Plan as of such date.

 

8.7                                In accordance with the Transitional Services Agreement, Alcon Inc. shall, or shall procure that a member of its Group, pays to Novartis or the applicable member of its Group in a timely manner all premiums related to the coverage of the US Alcon Employees (and/or their eligible dependents) under each health and welfare benefit plan or arrangement of the Novartis Group for the period beginning on the Separation Date and ending on the applicable Alcon H&W Plan Date.

 

8.8                                Alcon Inc. agrees to indemnify Novartis (or the relevant member of its Group) for any Liabilities borne by the Novartis Group in connection with any health and welfare coverage with respect to US Alcon Employees, to the extent such coverage is the responsibility of the Alcon Group pursuant to clause 8.6 or clause 8.7 above, or the failure of Alcon Inc. to meet its obligations pursuant to such clause.

 

9.                    BOOKS AND RECORDS

 

For the avoidance of doubt, the provisions of clause 18 of the Separation and Distribution Agreement shall apply in respect of the Alcon Transferring Books and Records and the Novartis Transferring Books and Records in respect of the Alcon Employees and Novartis Employees respectively.

 

10.             RESTRICTIVE COVENANTS

 

Non-solicitation

 

10.1                         Novartis will not, and undertakes to procure that each member of the Novartis Group will not, for a period of two years immediately following the Separation Date, directly or indirectly:

 

(a)                                  solicit or induce any Restricted Alcon Employee to become employed or engaged whether as employee, consultant or otherwise by any member of the Novartis Group; or

 

(b)                                  knowingly induce or encourage any Restricted Alcon Employee to no longer be employed or engaged by the Alcon Group.

 

10.2                         The restrictions in clause 10.1 above may be relaxed, or additional exceptions permitted by advance written approval of the Head of HR of the Alcon Group, and shall in any event not apply to the solicitation, inducement or encouragement (as applicable) by Novartis of any person:

 

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(a)                                  who is employed or engaged in response to a general solicitation to the public or general advertising, including in periodicals, newspapers, trade publications and the Internet, not directly targeted at Restricted Alcon Employees; or

 

(b)                                  who is employed or engaged through an employment agency, provided that no member of the Novartis Group encourages or advises such agency to approach any Restricted Alcon Employee; or

 

(c)                                   who has not been employed by the Alcon Group for a period of six months or longer as at the date of solicitation, inducement or encouragement (as applicable); or

 

(d)                                  whose employment or engagement with the Alcon Group has been terminated by the employing entity within the Alcon Group; or

 

(e)                                   who is under formal notice of termination from the relevant Alcon Group employing entity.

 

Non-employment

 

10.3                         Novartis will not, and undertakes to procure that each member of the Novartis Group will not, for a period of two years immediately following the Separation Date employ or engage any Restricted Alcon Employee whether as employee, consultant or otherwise.

 

10.4                         The restrictions in clause 10.3 above may be relaxed, or additional exceptions allowed by written approval of the Head of HR of the Alcon Group, and shall in any event not apply to the employment or engagement (as applicable) of any person:

 

(a)                                  who has not been employed by the Alcon Group for a period of six months or longer as at the date of employment or engagement (as applicable); or

 

(b)                                  whose employment or engagement with the Alcon Group has been terminated by the employing entity within the Alcon Group; or

 

(c)                                   who is under formal notice of termination from the relevant Alcon Group employing entity.

 

Reasonableness of Restrictions

 

10.5                         The parties acknowledge that each undertaking contained in this clause 10:

 

(a)                                  is given to Alcon Inc. and each member of the Alcon Group;

 

(b)                                  shall be construed as a separate undertaking and if one or more of the undertakings is held to be against the public interest or unlawful or in any way an unreasonable restraint of trade, the remaining undertakings shall continue to bind Novartis; and

 

(c)                                   is an entirely independent restriction and is no greater than is reasonably necessary to protect the interests of the Alcon Group. If any such restriction shall be held void or unenforceable but would be valid if deleted in part or reduced in its application, then that restriction shall apply with such modifications as may be necessary to make it valid and effective.

 

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PART B: LONG-TERM EMPLOYEE BENEFITS

 

11.             STAND-ALONE EB ARRANGEMENTS

 

11.1                         Subject to the exceptions provided for in clause 15 below, to the extent not already completed before the date of this Agreement, Novartis and Alcon Inc. shall, subject to Applicable Law, each take any action necessary and use their Best Endeavours to obtain any third party consents necessary, in order to ensure that Alcon Inc., or the relevant member of its Group, assumes sponsorship of and responsibility for all of the Past Service Benefits in respect of all of the active (including any “active frozen” members), deferred and retiree members under or in connection with each Stand-Alone EB Arrangement (including, without limitation, the plans and arrangements set forth on Schedule 2, Part A) with effect from the Separation Date.

 

11.2                         With respect to each Stand-Alone EB Arrangement that is Funded, on or prior to the end of the last relevant Service Term, Alcon Inc. shall, subject to Applicable Law, take any action necessary for Alcon Inc., or the relevant member of its Group, to establish such trusts or other funding vehicles as are required to be maintained with respect thereto (each, a Stand-Alone Trust ”).  Novartis shall cooperate with Alcon Inc. as is necessary for Alcon Inc. to carry out its obligations pursuant to this clause 11.2.

 

11.3                         As soon as practicable following the establishment of each Stand-Alone Trust, Novartis, or the relevant member of its Group, shall direct that the assets allocated to the Past Service Benefits relating to the applicable Stand-Alone EB Arrangement shall be transferred to such Stand-Alone Trust.  Such transfer shall be implemented in a manner consistent with clauses 12.6 through 12.11, mutatis mutandis .

 

12.             RETAINED NOVARTIS EB ARRANGEMENTS

 

12.1                         Except where a specific Retained Novartis EB Arrangement is referred to, clauses 12.2 to 12.13 below shall apply in relation to each Retained Novartis EB Arrangement (including, without limitation, the plans and arrangements set forth on Schedule 2, Part B).

 

12.2                         To the extent not already established or sponsored before the date of this Agreement, Alcon Inc. shall establish or sponsor, or procure that a member of its Group establishes or sponsors, such Alcon EB Arrangements (including related trusts or other funding vehicles) as are required pursuant to this clause 12 to accept a transfer of Past Service Benefits, and of any underlying plan assets in accordance with clauses 12.6 through 12.11, in respect of the Transferring Members with effect on and from the Separation Date.

 

12.3                         Subject to the exceptions provided for in clause 15 below, Novartis and Alcon Inc. shall each use their Best Endeavours to ensure that, to the extent not already completed before the date of this Agreement, with effect from the Separation Date:

 

(a)                                  the Past Service Benefits for or in respect of any Transferring Member shall be transferred to an appropriate Alcon EB Arrangement; and

 

(b)                                  Novartis shall determine whether the Past Service Benefits for or in respect of any such Transferring Member are to be transferred by consent or on a without consent “bulk transfer” basis and Novartis and Alcon Inc. shall use their Best Endeavours to ensure that the transfer can be effected in accordance with Applicable Law on the basis chosen by Novartis.

 

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12.4                         Notwithstanding anything in this Agreement to the contrary, the Alcon EB Arrangements (including related trusts or other funding vehicles) required to accept a transfer of Past Service Benefits in accordance with this clause 12 from each of the Pension Plan for Salaried Employees of Novartis Corporation (the Novartis Pension Plan ) and the Alcon Retirement Plan (together with the Novartis Pension Plan, the US Pension Plans ) shall be established no later than the end of the last relevant Service Term and the transfer of Past Service Benefits in respect of the US Pension Plans shall occur on the date the applicable Alcon EB Arrangement is established (each such date, a US Pension Plan Date ).

 

12.5                         In the event that Novartis or a member of its Group makes a contribution to a US Pension Plan (or its related trust or other funding vehicle) following the Separation Date but prior to the date the asset transfer contemplated by this Agreement with respect to such US Pension Plan occurs, Alcon Inc. shall, or shall procure that a member of its Group shall, at Novartis’ election, either (a) make a contribution to such US Pension Plan (or its related trust or other funding vehicle) in respect of the US Alcon Employees who have accrued Past Service Benefits under such US Pension Plan, with such contribution to be calculated by the applicable Plan Actuary, or (b) reimburse Novartis or the applicable member of its Group for a portion of such contribution that relates to the US Alcon Employees who have accrued Past Service Benefits under such US Pension Plan, as calculated by the Plan Actuary.

 

12.6                         Subject to clause 12.8 and to the exceptions provided for in clause 15 below, and to the extent not already transferred before the date of this Agreement, Novartis shall determine whether and to what extent any underlying plan assets in respect of any transferred Past Service Benefits of the Transferring Members (the amount of such assets in respect of each such transfer being the Relevant Transfer Amount in respect of such transfer) shall be transferred from the Retained Novartis EB Arrangement to the receiving Alcon EB Arrangement on or following the Separation Date.

 

12.7                         Subject to clause 12.8, to the extent not already valued prior to the date of this Agreement, the value of Past Service Benefits for the purposes of calculating each Relevant Transfer Amount shall be the actuarial value of such Past Service Benefits at the later of (a) the Separation Date and (b) the date the relevant receiving Alcon EB Arrangement is established (the Transfer Amount Valuation Date ), as calculated by the Plan Actuary in accordance with the applicable local statutory funding basis, regardless of whether such Past Service Benefits are fully funded on that basis at the relevant time.

 

12.8                         If Applicable Law requires that a particular amount of assets be transferred in respect of the transferred Past Service Benefits, such amount shall be the Relevant Transfer Amount in respect of those Past Service Benefits, and shall accordingly be transferred from the Retained Novartis EB Arrangement to the receiving Alcon EB Arrangement on or following the Separation Date in accordance with this Agreement.

 

12.9                         To the extent not already paid prior to the date of this Agreement, Novartis and the Alcon Group shall use their Best Endeavours to procure that each Relevant Transfer Amount is paid in accordance with this clause 12 in cash and/or such form of assets held in the Retained Novartis EB Arrangement as is selected by the Plan Actuary, acting reasonably, as a representative selection of the asset portfolio held by the relevant Retained Novartis EB Arrangement.  Novartis and the Alcon Group shall use their Best Endeavours to agree the due date for each payment of the Relevant Transfer Amount.

 

12.10                  In the event that a Relevant Transfer Amount is not transferred on the Transfer Amount Valuation Date, then, to the extent permitted by Applicable Law, Novartis shall be permitted to equitably adjust such Relevant Transfer Amount in order to reflect any applicable changes (including the payment of benefits and the contribution of assets)

 

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occurring during the period beginning on the Transfer Amount Valuation Date and ending on the date such Relevant Transfer Amount is transferred, as well as expenses incurred by Novartis and the members of its Group during such period, so that neither party is advantaged nor disadvantaged by such transfer occurring after the Transfer Amount Valuation Date.

 

12.11                  No transfer of assets shall be made under clause 12.9 above in respect of the Past Service Benefits of any Transferring Member to the extent that:

 

(a)                                  Applicable Law does not permit such transfer; or

 

(b)                                  the Alcon Group or relevant Alcon EB Arrangement does not assume responsibility for such Past Service Benefits (despite the Alcon Group having used its Best Endeavours to procure that the relevant Alcon EB Arrangement does so).

 

12.12                  Subject to Applicable Law and to clause 12.13, Alcon Inc. shall provide (or shall procure that a member of its Group provides) Long-Term Employee Benefits for and in respect of each Transferring Member in respect of service before the Transfer Amount Valuation Date which in the opinion of the relevant actuary as at the Transfer Amount Valuation Date are substantially equivalent in value to the Long-Term Employee Benefits which would have been provided under the relevant Retained Novartis EB Arrangement for and in respect of such Transferring Member if he or she had remained a member of such Retained Novartis EB Arrangement following the Transfer Amount Valuation Date, provided that the “relevant actuary” for these purposes shall be:

 

(a)                                  in the case of a Retained Novartis EB Arrangement which is Funded, the Plan Actuary; or

 

(b)                                  in the case of a Retained Novartis EB Arrangement which is Unfunded, the Novartis Actuary.

 

12.13                  In relation to any Retained Novartis EB Arrangement which is Funded, Alcon Inc.’s obligation to provide (or procure that a member of its Group provides) Long-Term Employee Benefits under clause 12.12 above shall be subject to the receipt of the Relevant Transfer Amount in respect of such Retained Novartis EB Arrangement by the appropriate Alcon EB Arrangement.

 

13.             TRANSITIONAL PERIODS AND TRANSITIONAL SERVICES

 

13.1                         To the extent not already completed before the date of this Agreement, if so requested by Alcon Inc. and agreed by Novartis in respect of any Transferring Member who is at the Separation Date a member of a Retained Novartis EB Arrangement, Novartis shall use its Best Endeavours to ensure that such Transferring Member shall be permitted to continue as a member of the relevant Retained Novartis EB Arrangement for a transitional period following the Separation Date (each such Transferring Member being a Transitional Member and such period being the Transitional Period for such Transitional Member), on such terms as Novartis and Alcon Inc. may agree, in order to allow Alcon Inc. to make suitable alternative arrangements.  To the extent not already agreed before the date of this Agreement, Alcon Inc. and Novartis shall use their Best Endeavours to agree the terms of participation during any Transitional Period as soon as reasonably practicable following the date of this Agreement.

 

13.2                         Where a Transitional Period is agreed in respect of any Transitional Member, all references in clauses 12, 15 and 16 to the “Separation Date” shall be treated as references to the end of the Transitional Period applicable to such Transitional Member.

 

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13.3                         Where Novartis agrees to provide (or to procure that a member of its Group provides) employee benefits administration services to any member of the Alcon Group for a transitional period following the Separation Date in respect of any Employee Benefit Arrangement, unless otherwise agreed in writing between the parties, Alcon Inc. shall not (and shall procure that no member of its Group shall) make any amendments to the rules or discretionary practices governing such Employee Benefit Arrangement during the transitional period applicable to such Employee Benefit Arrangement.

 

13.4                         Without limiting the generality of this clause 13, the US Alcon Employees who, immediately prior to the Separation Date, were accruing benefits under a US Pension Plan, shall continue to accrue benefits under such plan during the period beginning on the Separation Date and ending on the applicable US Pension Plan Date for so long as they remain employed by Alcon Inc. or a member of its Group ( Post-Separation Date Benefit Accruals ) and any such Post-Separation Date Benefit Accruals shall be deemed Past Service Benefits for purposes of this Agreement, and shall transfer to the applicable Alcon EB Arrangement in accordance with clause 12.4 above. Until the date that Past Service Benefits and assets related to each US Pension Plan are transferred to the applicable Alcon EB Arrangement and its related trust or other funding vehicle, the Novartis Pension Plan shall recognize the applicable Post-Separation Date Benefit Accruals.

 

14.             ALLOCATION OF EMPLOYEE BENEFIT LIABILITIES

 

14.1                         Alcon Inc. shall with effect on and from the Separation Date or the applicable US Pension Plan Date, as applicable, indemnify Novartis and each member of its Group against any Employee Benefit Liabilities which arise:

 

(a)                                  under or in connection with any Stand-Alone EB Arrangement (except to the extent that Novartis or a member of its Group expressly assumes responsibility for such Employee Benefit Liabilities pursuant to clause 15 below); or

 

(b)                                  under or in connection with any Retained Novartis EB Arrangement to the extent that such Employee Benefit Liabilities relate to any Transferring Member.

 

14.2                         For the avoidance of doubt, where Alcon Inc. has an obligation to indemnify Novartis under clause 14.1, that obligation shall apply:

 

(a)                                  in respect of active, deferred and pensioner members of the relevant Employee Benefit Arrangement; and

 

(b)                                  in respect of service before, on and after the Separation Date.

 

15.             PLAN-SPECIFIC EXCEPTIONS

 

15.1                         The following exceptions shall apply to the provisions of clauses 11 to 14 above.

 

Switzerland — Pension Fund 1

 

15.2                         In relation to the “Pension Fund 1” of the Novartis Group established in Switzerland,  Novartis shall, or shall procure that the relevant member of its Group shall, retain responsibility for all Liabilities (and underlying plan assets) in respect of Past Service Benefits to or in respect of any person who is a pensioner member as at the Separation Date under the Novartis Group’s “Pension Fund 1” in Switzerland.

 

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Switzerland — Alcon Umbrella Plan ( URP )

 

15.3                         In relation to the URP, it is hereby agreed that: (i) the Liabilities (including in respect of Past Service Benefits) of the Inactive Alcon Members, who accrued benefits in the URP, will transfer to Alcon Inc. with effect on and from the Separation Date; (ii) Alcon Inc. will be liable for all payments to such Inactive Alcon Members arising in respect of their participation in the URP; and (iii) Alcon Inc. will pay out the benefits for any such member satisfying the eligibility criteria. For the avoidance of doubt, Novartis shall not be liable for any payments due to such Inactive Alcon Members arising in respect of their participation in the URP.

 

United Kingdom — Novartis UK Pension Scheme

 

15.4                         The parties acknowledge and agree that the Alcon UK Pension Scheme shall be treated as a Stand Alone EB Arrangement for the purposes of clause 11 of Part B ( Long Term Employee Benefits ) of this Agreement such that Alcon Inc., or the relevant member of its Group, shall assume sponsorship of and responsibility for all of the Past Service Benefits in respect of all the active (frozen), deferred and retiree members under or in connection with the Alcon UK Pension Scheme with effect from the Separation Date.

 

15.5                         In relation to the Novartis UK Pension Scheme:

 

(a)                                  Novartis shall, or shall procure that the relevant member of its Group shall, retain responsibility for all Liabilities (and underlying plan assets) in respect of Past Service Benefits to or in respect of the active (frozen), deferred and retiree members of the Novartis UK Pension Scheme in respect of service with any member of the Alcon Group before the Separation Date. For the avoidance of doubt, Novartis shall, or shall procure that the relevant member of its Group shall, retain responsibility for the Past Service Benefits to or in respect of the former Cibavision associates who are members of the Novartis UK Pension Scheme as at the Separation Date; and

 

(b)                                  Novartis undertakes to Alcon Inc. to pay, or procure payment, on demand to Alcon Inc. a sum equal to each and any Liability and expense incurred, sustained or paid by Alcon Inc. or any member of the Alcon Group (including any costs and expenses sustained or paid as a result of defending or settling a claim) after the Separation Date arising pursuant to section 75 of the UK Pensions Act 1995, as amended, and the regulations made thereunder, in respect of Alcon Eye Care UK Limited’s, or any other member of the Alcon Group’s, cessation of participation in the Novartis UK Pension Scheme.

 

Belgium and the Netherlands — Alcon Belgium Pension Fund

 

15.6                         In relation to the Alcon Belgium Pension Fund (as defined in Schedule 1), Past Service Benefits (and underlying plan assets) for in respect of the following shall be transferred to Alcon Inc. or a member of its Group pursuant to clause 12 with effect from the Separation Date:

 

(a)                                  all Alcon Employees whose employment transfers from Alcon-Couvreur to Alcon Laboratories Belgium BVBA on or prior to the Separation Date;

 

(b)                                  all active, deferred and pensioner members as at the Separation Date of the ring-fenced section of the Alcon Belgium Pension Fund which relates to employees and former employees of Alcon NV; and

 

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(c)                                   all active, deferred and pensioner members as at the Separation Date of the ring-fenced section of the Alcon Belgium Pension Fund which relates to employees and former employees of Alcon B.V.

 

15.7                         With effect from the Separation Date, Novartis shall (or shall procure that the relevant member of its Group shall) retain responsibility for Liabilities (and underlying plan assets) in respect of all Past Service Benefits under the Alcon Belgium Pension Fund other than those Past Service Benefits referred to in clause 15.6.

 

Japan — Defined Benefit Corporate Pension Plan

 

15.8                         In relation to the Defined Benefit Corporate Pension Plan of the Novartis Group established in Japan (the DBCPP ), Novartis shall (or shall procure that the relevant member of its Group shall) retain responsibility for all Liabilities (and underlying plan assets) in respect of Past Service Benefits of Inactive Alcon Members (if applicable) to or in respect of any person who is not an active member of the DBCPP as at the Separation Date.

 

United States of America — ESCP, ESCP II, ASERP, GRP, Rabbi Trust, VEBA Trust and the Deferred Compensation Plans

 

15.9                         In relation to the Executive Salary Continuation Plan of the Novartis Group (the ESCP ), the Executive Salary Continuation Plan II of the Novartis Group (the ESCP II ), the Alcon Supplemental Executive Retirement Plan of the Alcon Group (the ASERP ) and the Alcon Executive Retirement Plans Grantor Trust of the Alcon Group (the Rabbi Trust ), to the extent not already assumed before the date of this Agreement, Novartis shall, or shall procure that the relevant member of its Group shall, assume sponsorship of the ESCP, the ESCP II, the ASERP and the Rabbi Trust and all assets and Liabilities (including in respect of Past Service Benefits) arising out of or relating to the ESCP, the ESCP II, the ASERP and the Rabbi Trust. For the avoidance of doubt, Novartis shall not assume any Liabilities in respect of the future salary increases of the US Alcon Employees.

 

15.10                  In relation to the Alcon Global Retirement Policy ( GRP ), it is hereby agreed that all Liabilities under the GRP shall be retained by Alcon Inc. or a member of its Group. Alcon Inc. will provide a lump-sum pay-out in respect of Novartis Employees with an accrued GRP benefit who have at least 7 years of combined service with the Alcon Group and the Novartis Group at the Separation Date, excluding those Novartis Employees who have already received a payment of their accrued benefit and Novartis Employees whose principal place of employment is in Argentina (in which case, separate rules based on local regulations will apply). For the avoidance of doubt, Novartis shall not be liable for any payments due to Alcon Employees or Novartis Employees, arising in respect of their participation in the GRP. Novartis and the members of its Group shall use their commercially reasonable efforts to serve as paying agents on behalf of Alcon Inc. and the members of its Group in connection with the payments to be made to Novartis Employees in respect of the GRP in accordance with the foregoing.

 

15.11                  Consistent with clause 8.8 above, in relation to the Novartis Corporation Post Employment Welfare Benefits Plan (the Novartis Retiree Welfare Plan ), all Liabilities (including in respect of Past Service Benefits) with respect to US Alcon Employees will transfer to a retiree welfare benefit plan established or sponsored by a member of the Alcon Group as of the applicable Alcon H&W Plan Date and all assets with respect to US Alcon Employees held in a trust or other funding mechanism established in accordance with Section 401(h) of the Code to cover expenses incurred under the Novartis Retiree Welfare Plan will transfer to a trust or other funding mechanism established by Alcon Inc. or a member of its Group in accordance with Section 401(h) of the Code as of the applicable Alcon H&W Plan

 

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Date.  Beginning on the Separation Date and ending on the applicable Alcon H&W Plan Date, with respect to the Novartis Retiree Welfare Plan, Alcon Inc. shall, or shall procure that the relevant member of its Group shall reimburse Novartis or the applicable member of its Group for any claims incurred by US Alcon Employees under the Novartis Retiree Welfare Plan to the extent that such claims are paid in respect of such period.

 

15.12                  In the event a US Alcon Employee ceases participation in a deferred compensation plan established or sponsored by the Novartis Group, other than by means of a termination of employment, and has irrevocable deferral elections in effect at the time such participation ceases, then, Alcon Inc. shall establish or sponsor, or procure that a member of its Group establishes or sponsors, a deferred compensation plan, which shall honour and continue such irrevocable deferral elections.  In the event a US Alcon Employee continues participating in a deferred compensation plan established or sponsored by the Novartis Group from and after the Separation Date, Novartis and Alcon Inc. shall cooperate to ensure, to the extent practicable, that such employee’s irrevocable deferral elections shall, to the extent necessary to avoid any additional taxation or penalty under Section 409A of the Code, continue to be honoured for so long as such participation continues.

 

15.13                  In the event that any Novartis Award held by a US Alcon Employee that is subject to an irrevocable deferred compensation election vests following the Separation Date, Novartis or its designee shall pay to Alcon Inc. or the applicable member of its Group in a timely manner an amount in cash equal to the aggregate fair market value of the Novartis Shares, net of applicable taxes, underlying such Novartis Award (after taking into account the achievement of any applicable performance criteria), measured as of the applicable vesting date, provided that such payment shall be conditioned on Novartis’ receipt of written notice that such US Alcon Employee’s applicable deferred compensation plan account has been appropriately credited in respect of such vested Novartis Award.

 

Spain — Alcon Spanish Pension Plan

 

15.14                  In relation to the defined benefit pension plan sponsored by Alcon Cusi S.A. (the Alcon Spanish Plan ), Past Service Benefits (and underlying plan assets) in respect of active members of the Spanish Plan whose employment transfers to Alcon Healthcare, SAU on or prior to the Separation Date shall be transferred to Alcon Inc. or a member of its Group pursuant to clause 12 with effect from the Separation Date.

 

15.15                  With effect from the Separation Date, Novartis shall (or shall procure that the relevant member of its Group shall) retain responsibility for Liabilities (and underlying plan assets) in respect of all Past Service Benefits under the Alcon Spanish Plan other than those referred to in clause 15.14.

 

Mexico — Alcon Mexico Pension Plan

 

15.16                  In relation to the defined benefit pension plan in Mexico (the Alcon Mexican Plan), Past Service Benefits (and underlying plan assets) in respect of active members of the Mexican Plan whose employment transfers to Alcon Laboratorios S.A. de C.V. on or prior to the Separation Date shall be transferred to Alcon Inc. or a member of its Group pursuant to clause 12 with effect from the Separation Date.

 

15.17                  With effect from the Separation Date, Novartis shall (or shall procure that the relevant member of its Group shall) retain responsibility for Liabilities (and underlying plan assets) in respect of all Past Service Benefits under the Alcon Mexican Plan other than those referred to in clause 15.16.

 

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16.             DEFINED CONTRIBUTION BENEFITS

 

16.1                         Novartis and Alcon Inc. agree that where any Alcon Employee or any employee of an Alcon Transferring Entity has accrued defined contribution benefits prior to the Separation Date in a Retained Novartis EB Arrangement:

 

(a)                                  Novartis shall, or shall procure that the relevant member of its Group shall, use reasonable efforts to procure the vesting of those benefits (if they would otherwise lapse as a result of the Separation); and

 

(b)                                  subject to clauses 16.2 to 16.4 below and clause 15.9 above, Novartis and Alcon Inc. shall cooperate in good faith to procure a transfer of the account balances of such person from that Retained Novartis EB Arrangement to an Alcon EB Arrangement.

 

United States of America — Defined Contribution Plan

 

16.2                         To the extent not already established or sponsored before the date of this Agreement, no later than 1 January 2020, Alcon Inc. shall establish or sponsor, or procure that a member of its Group establishes or sponsors a defined contribution plan that includes a qualified cash or deferred arrangement (within the meaning of section 401(k) of the Code) (the Alcon 401(k) Plan ) providing benefits to US Alcon Employees participating in any qualified cash or deferred arrangement (within the meaning of section 401(k) of the Code) sponsored by any member of the Novartis Group (collectively, the Novartis 401(k) Plans ).

 

16.3                         As soon as practicable following the establishment of the Alcon 401(k) Plan, Novartis shall, or shall procure that the relevant member of its Group shall cause to be transferred from the Novartis 401(k) Plans to the Alcon 401(k) Plan the assets and Liabilities relating to the account balances of the US Alcon Employees (whether vested or unvested) in accordance with the applicable requirements of all Applicable Laws, including the Code.  From and after the time that such transfer is complete, the relevant member of the Alcon Group shall administer the accounts of US Alcon Employees in the Alcon 401(k) Plan in accordance with all Applicable Laws, including the Code.  Except as otherwise provided for in this clause 16.3, such transfer of assets shall consist of cash, cash equivalents or participant loan receivables equal to all the accrued benefit Liabilities relating to all account balances referred to in the first sentence of this clause 16.3, including such Liabilities for the beneficiaries of the US Alcon Employees and including such accrued benefit Liabilities arising under any applicable qualified domestic relations order.  The relevant member of the Alcon Group shall direct the trustee of the Alcon 401(k) Plan to accept such transfers of assets and Liabilities from the Novartis 401(k) Plans.  No later than 30 days prior to the date of the transfer of assets and Liabilities pursuant to this clause 16.3, Novartis shall, to the extent necessary and with the cooperation of Alcon Inc. as necessary, file Internal Revenue Service Form 5310-A regarding such transfer of assets and Liabilities from the Novartis 401(k) Plans to the Alcon 401(k) Plan, as described in this clause 16.3.  Following the foregoing transfer, the Alcon Group and/or the Alcon 401(k) Plan shall assume all Liabilities of the Novartis Group under the Novartis 401(k) Plans with respect to all participants in the Novartis 401(k) Plans whose balances were transferred to the Alcon 401(k) Plan and their beneficiaries pursuant to such transfer, and the Novartis Group and the Novartis 401(k) Plans shall have no Liabilities to provide such participants and their beneficiaries with benefits under the Novartis 401(k) Plan following such transfer.  With respect to company contributions to the Novartis 401(k) Plans in respect of US Alcon Employees, the entity employing a US Alcon Employee at the time such contributions are incurred shall be responsible for such contributions in respect of such individual.  Novartis and Alcon Inc. shall use reasonable efforts to minimize the duration of any “blackout period” imposed in connection with each transfer of account balances from the Novartis 401(k) Plan to the Alcon 401(k) Plan.  Alcon Inc. will cooperate

 

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with Novartis in effecting a transition of all outstanding loans of US Alcon Employees under the Novartis 401(k) Plan in a manner designed to prevent a deemed distribution.

 

16.4                         To the extent not already established or sponsored before the date of this Agreement, on or prior to 1 January 2020, Alcon Inc. shall establish or sponsor, or procure that a member of its Group establishes or sponsors a defined contribution plan that includes a qualified cash or deferred arrangement (within the meaning of section 401(k) of the Code) that is intended to be qualified pursuant to the Puerto Rico Internal Revenue Code of 2011, as amended (the PR Code , and such qualified cash or deferred arrangement, the Alcon PR Savings Plan ) providing benefits to US Alcon Employees participating in the qualified cash or deferred arrangement (within the meaning of section 401(k) of the Code) that is intended to be qualified pursuant to the PR Code and sponsored by any member of the Novartis Group (such qualified cash or deferred arrangement, the Novartis PR Savings Plan ).  As soon as practicable after the establishment of the Alcon PR Savings Plan, Novartis shall, or shall procure that the relevant member of its Group shall cause to be transferred from the Novartis PR Savings Plan to the Alcon PR Savings Plan the assets and Liabilities relating to the account balances of the US Alcon Employees (whether vested or unvested) in accordance with the applicable requirements of all Applicable Laws, including the PR Code.  Such transfer of assets from the Novartis PR Savings Plan to the Alcon PR Savings Plan shall be implemented in a manner consistent with requirements applicable to the transfer of assets from the Novartis 401(k) Plan to the Alcon 401(k) Plan and described in clause 16.3 above.  Following the foregoing transfer, the Alcon Group and/or the Alcon PR Savings Plan shall assume all Liabilities of the Novartis Group under the Novartis PR Savings Plan with respect to all participants in the Novartis PR Savings Plan whose balances were transferred to the Alcon PR Savings Plan and their beneficiaries pursuant to such transfer, and the Novartis Group and the Novartis PR Savings Plan shall have no Liabilities to provide such participants and their beneficiaries with benefits under the Novartis PR Savings Plan following such transfer.  With respect to company contributions to the Novartis PR Savings Plan in respect of Alcon Employees, the entity employing an Alcon Employee at the time such contributions are incurred shall be responsible for such contributions in respect of such individual.

 

16.5                         Alcon Inc. agrees to indemnify Novartis (or the relevant member of its Group) for any Liabilities borne by the Novartis Group in connection with the transfer of account balances described in clauses 16.3 and 16.4 above.

 

17.             GENERAL

 

17.1                         The provisions of clauses 27 ( Further Assurances ) to 42 ( Dispute Resolution ) (inclusive) in the Separation and Distribution Agreement shall apply to this Agreement as if references in those clauses to the “Agreement” were references to this Employee Matters Agreement.

 

17.2                         This Agreement shall apply to the extent the actions and steps contemplated therein have not already been completed by the parties prior to the Separation Date. For the avoidance of doubt, no actions or steps should be required to be undertaken again if they have already successfully been completed. In such cases, the relevant provisions of this Agreement shall have the effect of memorialising the parties’ steps and actions prior to the Separation Date.

 

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SCHEDULE 1

 

DEFINITIONS AND INTERPRETATION

 

1.                                       Definitions . In this Agreement, all capitalised terms used but not defined shall have the meanings given to them in the Separation and Distribution Agreement unless otherwise required by the context.

 

2.                                       The following words and expressions shall have the following meanings:

 

Agreement or Employee Matters Agreement means this employee matters agreement;

 

Alcon Belgium Pension Fund means the defined benefit pension plan of the Alcon Group established in Belgium, in which certain Alcon Employees employed in the Netherlands also participate;

 

Alcon EB Arrangement means any Employee Benefit Arrangement established or sponsored by Alcon Inc. or any member of its Group;

 

Alcon Keep Whole Ratio means an amount equal to the Per Share Dividend Value divided by the Day-1 Alcon Share Price;

 

Best Endeavours to achieve a result means the taking of all steps in the obligated Party’s power which are capable of producing the desired result and which a prudent, determined and reasonable obligee, acting in his own interests and desiring to achieve that result, would take, so long as the result is legally obtainable. The use of “Best Endeavours” may require the obligated Party to incur significant expenditure or loss and to sacrifice its own commercial interest but not to the point of ruin or bankruptcy. A requirement to use “Best Endeavours” in this Agreement is intended to impose a higher standard than a requirement to use “Commercially Reasonable Efforts”;

 

COBRA means the US Consolidated Omnibus Budget Reconciliation Act of 1985, as amended, and any applicable similar state or local laws;

 

Code means the US Internal Revenue Code of 1986, as amended;

 

Commercially Reasonable Efforts to achieve a result means the taking of such steps in the power of the obligated Party which a determined and reasonable person desirous of achieving the result would take, mindful of the chances of achieving the desired result, taking account of all relevant commercial considerations and without any requirement to sacrifice its own commercial interest. Without limitation, the use of Commercially Reasonable Efforts may include making available employees, making payments and/or bringing a legal claim;

 

Day-1 Alcon Share Price means the Day-1 Alcon Valuation divided by the number of Alcon shares to be distributed to holders of Novartis shares on the date of the Distribution;

 

Day-1 Alcon Valuation means the value of Alcon (in CHF) as at the date immediately prior to the date of the Distribution, as determined by Novartis;

 

Employee Benefit Arrangement means any plan, scheme, arrangement or agreement under which any Long-Term Employee Benefits are provided;

 

Employee Benefit Liabilities means any Liabilities and/or obligations in respect of any Employee Benefit Arrangement;

 

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ERISA means the Employee Retirement Income Security Act of 1974, as amended;

 

Employees means any current or former employee of Novartis, Alcon Inc. or any of their respective Affiliates;

 

Funded in relation to any Retained Novartis EB Arrangement or Stand-Alone EB Arrangement, as applicable, means that assets are accumulated under or in respect of that arrangement before the corresponding benefits start being paid.  For the purposes of this definition, assets shall mean assets which are separate from those of the employer and shall exclude any accounting or internal balance sheet provision;

 

Inactive Alcon Member means:

 

(a)                                  former employees of the Novartis Group who previously worked wholly or substantially in the Alcon Business, whether or not immediately prior to the Separation Date, including any employee who identified as a Long-Term Assignee. For these purposes, ‘wholly or substantially’ means that such employees spent 70 per cent. or more of their time working in the Alcon Business; and

 

(b)                                  any other former employees of the Novartis Group that the parties have agreed in writing shall be Inactive Alcon Members;

 

Long-Term Assignee means an employee who is on a cross divisional long-term international assignment or project, for a period of one to five years, to a business other than that which he or she is engaged by his or her ‘home’ employer to work in and shall exclude any Short-Term Assignee;

 

Long-Term Employee Benefits means any employee benefits which constitute “post-employment benefits” or “other long-term benefits” under IAS 19;

 

Novartis Actuary means an actuary or firm of actuaries nominated by Novartis for the purposes of this Agreement;

 

Novartis Closing Share Price means the reported closing price for Novartis shares (in CHF) on the SIX Swiss Exchange as at the end of trading on that exchange on the last trading day before the date of the Distribution;

 

Novartis Keep Whole Ratio means an amount equal to the Per Share Dividend Value divided by the Revised Novartis Share Price;

 

Past Service Benefits means all Long-Term Employee Benefits which are actually, prospectively or contingently payable under an Employee Benefit Arrangement to or in respect of any person in respect of service with any member of the Novartis Group or the Alcon Group before the Separation Date;

 

Per Share Dividend Value means an amount equal to the Day-1 Alcon Share Price divided by five (5);

 

Plan Actuary means, in respect of any Stand-Alone EB Arrangement or Retained Novartis EB Arrangement, the actuary or firm of actuaries appointed to provide actuarial advice in respect of such Stand-Alone EB Arrangement or Retained Novartis EB Arrangement;

 

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Restricted Alcon Employee means Current Alcon Employees, including but not limited to Transferred Alcon Employees (but excluding Former Alcon Employees), in GJFA 4 and above;

 

Retained Novartis EB Arrangement means an Employee Benefit Arrangement of the Novartis Group under which, as at the Separation Date, Long-Term Employee Benefits are provided both:

 

(a)                                  to Alcon Employees; and

 

(b)                                  to employees or former employees of any member of the Novartis Group other than Alcon Employees;

 

Revised Novartis Share Price means an amount equal to the Novartis Closing Share Price minus the Per Share Dividend Value;

 

Separation and Distribution Agreement means the separation and distribution agreement entered into between the parties on or around the date of this Agreement;

 

Service Term has the meaning given in the Transitional Services Agreement;

 

Short-Term Assignee means an employee who is on a cross-divisional international short-term assignment or project, for a period of four to twelve months, to a business other than which he or she is engaged by his/her ‘home’ employer to work in;

 

Stand-Alone EB Arrangement means each Employee Benefit Arrangement which is maintained or sponsored by an Alcon Transferring Entity as at the Separation Date;

 

Tax has the meaning given in the Tax Matters Agreement;

 

Transfer Date means the date on which the applicable Alcon Employee’s employment was transferred (by any means) from the Novartis Group to the Alcon Group prior to and in contemplation of the Separation;

 

Transferred Employee means a Transferred Alcon Employee and/or a Transferred Novartis Employees as applicable;

 

Transferred Alcon Employee means a Current Alcon Employee or Former Alcon Employee whose employment was transferred (by any means) from the Novartis Group to the Alcon Group prior to the date of this Agreement in contemplation of the Separation;

 

Transferred Novartis Employee means a Current Novartis Employee or Former Novartis Employee whose employment was transferred (by any means) from the Alcon Group to the Novartis Group prior to the date of this Agreement in contemplation of the Separation;

 

Transferring Member means any person who:

 

(a)                                  is an Alcon Employee; and

 

(b)                                  has accrued Past Service Benefits under a Retained Novartis EB Arrangement other than Past Service Benefits for which responsibility is to be assumed or retained by Novartis or a member of the Novartis Group pursuant to clause 15 above;

 

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Unfunded means in relation to any Employee Benefit Arrangement which is a defined benefit plan (as defined in IAS 19), an arrangement which is not funded;

 

US Alcon Employee means an Alcon Employee whose principal place of employment is in the United States of America;

 

US Inactive Alcon Member means an Inactive Alcon Member whose principal place of employment is in the United States of America; and

 

US Transferred Alcon Employee means a Transferred Alcon Employee whose principal place of employment is in the United States of America.

 

3.                                       Interpretation . In this Agreement, unless the context otherwise requires:

 

(a)                                  references to a Person include any individual, firm, body corporate (wherever incorporated), government, state or agency of a state or any joint venture, association, partnership, works council or employee representative body (whether or not having separate legal personality);

 

(b)                                  headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

(c)                                   references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction;

 

(d)                                  references to sterling or pounds sterling or £ are references to the lawful currency from time to time of England;

 

(e)                                   references to dollars or $ are references to the lawful currency from time to time of the United States of America; and

 

(f)                                    any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

 

4.                                       Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the Liability of Novartis or Alcon Inc. (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

5.                                       Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

6.                                       Inconsistencies . Where there is any inconsistency between the definitions set out in this Schedule and the definitions set out in any Clause or any other Schedule, then, for the purposes of construing such Clause or Schedule, the definitions set out in such Clause or Schedule shall prevail.

 

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SCHEDULE 2

 

CERTAIN EMPLOYEE BENEFIT ARRANGEMENTS

 

Part A:  Stand-Alone EB Arrangements

 

1.                                       Alcon Laboratories, Inc. Deferred Compensation Plan

 

2.                                       Alcon Laboratories, Inc. Restoration Plan

 

3.                                       Alcon Laboratories, Inc. Grandfathered Supplemental Executive Plan

 

4.                                       Alcon Excess 401(k) Plan

 

5.                                       Alcon Deferred Compensation Plan

 

6.                                       Alcon Laboratories, Inc. Global Retirement Policy

 

7.                                       Alcon Pharmaceuticals, Ltd. International Umbrella Retirement Plan

 

Part B:  Retained Novartis EB Arrangements

 

1.                                       Pension Plan for Salaried Employees of Novartis Corporation

 

2.                                       Novartis Corporation Investment Savings Plan

 

3.                                       Alcon Retirement Plan

 

4.                                       Novartis Corporation Retirement Savings Plan for Puerto Rico Employees

 

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SCHEDULE 3

 

DELAYED EMPLOYEE TRANSFERS

 

Part A: Definitions

 

1.               Definitions. In this Schedule:

 

Delayed Transfer Alcon Employee means a Current Alcon Employee whose employment was due to transfer from the Novartis Group to the Alcon Group prior to the date of this Agreement in contemplation of the Separation but whose employment did not in fact transfer due to applicable local law restrictions;

 

Delayed Transfer Novartis Employee means a Current Novartis Employee whose employment was due to transfer from the Alcon Group to the Novartis Group prior to the date of this Agreement in contemplation of the Separation but whose employment did not in fact transfer due to applicable local law restrictions;

 

Delayed Transfer Employee means a Delayed Transfer Alcon Employee and/or a Delayed Transfer Novartis Employee; and

 

Delayed Transfer Date means the earliest date on which the applicable Delayed Transfer Employee’s employment may legally transfer (by any means) from the Novartis Group to the Alcon Group (or vice versa) in connection with the Separation.

 

Part B: Delayed Transfer Employees

 

2.               In respect of the Delayed Transfer Employees, the provisions of this Agreement shall apply such that:

 

(a)                                  references to a Transferred Novartis Employee shall be read as references to a Delayed Transfer Novartis Employee;

 

(b)                                  references to a Transferred Alcon Employee shall be read as references to a Delayed Transfer Alcon Employee;

 

(c)                                   references to a Transferred Employee shall be read as references to a Delayed Transfer Employee; and

 

(d)                                  references to the Separation Date shall be read as references to the Delayed Transfer Date.

 

3.               For the avoidance of doubt, the terms and conditions of employment, applicable to each Delayed Transfer Employee immediately prior to the date of this Agreement, shall continue to apply during the period between the date of this Agreement and the Delayed Transfer Date.

 

Part C: Brazilian Alcon Employees

 

4.               In respect of any Brazilian Alcon Employee, the provisions of this Agreement shall apply such that, subject to the exception set out in paragraph 5 of this Schedule 3 below:

 

(a)                                  references to an Alcon Employee shall be read as references to a Brazilian Alcon Employee; and

 

34


 

(b)                                  references to the Separation Date shall be read as references to the Brazil Delayed Closing Date.

 

5.               In respect of the Brazilian Alcon Employees, clause 7.1(g) of this Agreement shall be deleted and replaced in its entirety by the following provision:

 

“Any Brazilian Alcon Employee who holds any Novartis Award described in clauses 7.1(b) or 7.1(d) above (other than Option Awards) immediately prior to the Brazil Delayed Closing Date will:

 

(i)              be treated as a “good leaver” under the applicable Novartis plan rules on the Brazil Delayed Closing Date; and

 

(ii)           in respect of any Novartis shares that have been forfeited as a result of such employee being a “good leaver”, be granted a share-based award over shares in the capital of Alcon as soon as practicable and legally possible following the Brazil Delayed Closing Date (and, in any event, by the later of (i) 60 days from the Brazil Delayed Closing Date; and (ii) 60 days from the first date after the Brazil Delayed Closing Date when the granting of share-based awards is not prevented by applicable dealing restrictions, subject in both cases to the relevant plan rules and any Applicable Law) (the Alcon Keep Whole Award ). The value of the Alcon Keep Whole Award will be calculated as follows:

 

a.               the value of the forfeited shares under the relevant Novartis Award will be determined by reference to the fair market value closing price of Novartis shares as at the Brazil Delayed Closing Date; and

 

b.               the number of Alcon shares to be granted under the relevant Alcon Keep Whole Award will be determined by reference to the fair market value closing price of Alcon shares as at the Separation Date.”

 

6.               For the avoidance of doubt, the terms and conditions of employment, applicable to the Brazilian Alcon Employees immediately prior to the date of this Agreement, shall continue to apply during the period between the date of this Agreement and the Brazil Delayed Closing Date.

 

Part D: Interim arrangements

 

7.               The parties shall cooperate to, so far as reasonably possible, make arrangements for the services of any:

 

(a)                        Delayed Transfer Alcon Employee to be made available on an interim basis to the Alcon Group (including but not limited by way of secondment) until the Delayed Transfer Date unless such person is terminated prior to such date;

 

(b)                        Delayed Transfer Novartis Employee to be made available on an interim basis to the Novartis Group (including but not limited by way of secondment) until the Delayed Transfer Date unless such person is terminated prior to such date; and

 

35


 

(c)                         Brazilian Alcon Employee to be made available on an interim basis to the Alcon Group (including but not limited by way of secondment) until the Brazil Delayed Closing Date unless such person is terminated prior to such date.

 

36


 

SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

  ALCON INC

 

 

 

 

 

 

 

 

/s/ Merrick McCracken

 

/s/ Tom Hudnall

 

 

 

Name:

Merrick McCracken

 

Name:

Tom Hudnall

 

 

 

Title:

SVP, Global H.R.

 

Title:

Authorized Signatory

 

37


Exhibit 99.4

 

Execution Copy

 

DATED 8 APRIL 2019

 

NOVARTIS PHARMA AG

 

and

 

ALCON INC.

 


 

MANUFACTURING AND SUPPLY AGREEMENT
relating to the separation of the Alcon
surgical and vision care business Puurs/Barcelona/Brazil

 


 


 

MANUFACTURING AND SUPPLY AGREEMENT

 

 

 

Page

 

 

 

1.

DEFINITIONS AND INTERPRETATION

1

 

 

 

2.

MANUFACTURE AND SUPPLY

21

 

 

 

3.

FORECASTS AND ORDERS — PUSH/PULL

25

 

 

 

4.

CAPACITY BASELINE AND GATING PLAN

29

 

 

 

5.

TOLL MANUFACTURE

33

 

 

 

6.

PRODUCTS MANUFACTURED USING MATERIALS PURCHASED FROM PURCHASER

35

 

 

 

7.

SHARED CONTRACTS

35

 

 

 

8.

SHARED CHEMICAL/API PRODUCT/SHARED PACKAGING MATERIAL

36

 

 

 

9.

DELIVERY OF PRODUCT

36

 

 

 

10.

PRICE AND PRICE ADJUSTMENTS

40

 

 

 

11.

INVOICE, PAYMENT AND CURRENCY CONVERSION

44

 

 

 

12.

ELECTRONIC SYSTEMS

45

 

 

 

13.

QUALITY CONTROL

46

 

 

 

14.

KEY PERFORMANCE INDICATORS

46

 

 

 

15.

RELATIONSHIP MANAGEMENT

48

 

 

 

16.

DISPUTE ESCALATION

49

 

 

 

17.

ACCEPTANCE OF PRODUCT

50

 

 

 

18.

REGULATORY MATTERS

52

 

 

 

19.

DOCUMENTATION AND REPORTS

53

 

 

 

20.

PRODUCT SPECIFICATIONS

54

 

 

 

21.

NEW PRODUCT SKUS

54

 

 

 

22.

CAPITAL EXPENDITURE AND COSTS OF DEVELOPMENT WORK

56

 

i


 

23.

DEVELOPMENT WORK

57

 

 

 

24.

CONTINUOUS IMPROVEMENT PROGRAMME

58

 

 

 

25.

WRITE OFF COSTS

58

 

 

 

26.

ARTWORK AND SHARED MOULDS

59

 

 

 

27.

SERIALISATION, AGGREGATION AND OTHER ANTI-FALSIFICATION REGULATIONS

60

 

 

 

28.

PHARMACOVIGILANCE

60

 

 

 

29.

PRODUCT ACTION

61

 

 

 

30.

SUPPLIERS OF MATERIALS AND SHARED PACKAGING MATERIALS

61

 

 

 

31.

CONFIDENTIALITY

62

 

 

 

32.

FORCE MAJEURE

64

 

 

 

33.

AUDIT AND INSPECTION RIGHTS

65

 

 

 

34.

ETHICAL STANDARDS AND HUMAN RIGHTS

67

 

 

 

35.

SAFETY HAZARDS

68

 

 

 

36.

WARRANTIES

69

 

 

 

37.

INDEMNITY AND LIABILITY

69

 

 

 

38.

INSURANCE

71

 

 

 

39.

INTELLECTUAL PROPERTY

71

 

 

 

40.

DURATION AND TERMINATION

74

 

 

 

41.

CONSEQUENCES OF TERMINATION

77

 

 

 

42.

TECHNICAL TRANSFER

78

 

 

 

43.

BRIDGING STOCK

83

 

 

 

44.

RISK MANAGEMENT

84

 

 

 

45.

NOTICE

84

 

 

 

46.

SURVIVAL OF RIGHTS AND OBLIGATIONS

86

 

ii


 

47.

ASSIGNMENT

86

 

 

 

48.

WHOLE AGREEMENT

86

 

 

 

49.

THIRD PARTY RIGHTS

87

 

 

 

50.

GOVERNING LAW AND ARBITRATION

87

 

 

 

51.

VARIATION OR WAIVER

89

 

 

 

52.

COSTS

89

 

 

 

53.

INTEREST

89

 

 

 

54.

PAYMENTS

89

 

 

 

55.

INVALIDITY

90

 

 

 

56.

COUNTERPARTS

90

 

 

 

57.

RELATIONSHIP OF THE PARTIES

90

 

 

 

58.

FURTHER ASSURANCE

90

 

iii


 

THIS MANUFACTURING AND SUPPLY AGREEMENT   is made the 8th day of April 2019 (the “Effective Date” )

 

BETWEEN:

 

(1)                                 NOVARTIS PHARMA AG, a corporation (Aktiengesellschaft) incorporated in Switzerland whose registered office is at Lichtstrasse 35, 4056 Basel, Switzerland (the “ Supplier ”);

 

AND

 

(2)                                 ALCON INC., a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (the “ Purchaser ”),

 

(each a “Party” and together the “Parties” ).

 

WHEREAS:

 

(A)                               By the Separation Agreement (as defined below) the Alcon surgical and vision care business will be transferred from its existing ownership structure under the ultimate control of Novartis AG to be held on a standalone basis under the Purchaser on the terms and conditions set out in the Separation Agreement.

 

(B)                               In the Separation Agreement, the parties to the Separation Agreement have agreed to enter into this Agreement (or procure the Parties hereto enter into this Agreement) for the Manufacture of Products by the Supplier and the supply of those Products to the Purchaser.

 

(C)                               The Brazil Delayed Business referenced in Exhibit 5 is to be transferred to the Purchaser or its Affiliate pursuant to the Separation Agreement, but has not been so transferred as at the Effective Date. Upon (but not before) the transfer to the Purchaser or its Affiliate of the Brazil Delayed Business, the Delayed Site Transferring Products shall become Products for the purposes of this Agreement and shall be Manufactured and supplied under this Agreement by the Supplier.

 

(D)                               The Purchaser wishes to have Manufactured and to purchase, and the Supplier wishes to Manufacture or have Manufactured and supply, the Products subject to the terms and conditions of this Agreement.

 

NOW IT IS AGREED as follows:

 

1.                                      DEFINITIONS AND INTERPRETATION

 

1.1                               In this Agreement:

 

“Additional HSE Requirements” means the Purchaser’s requirements for the Supplier with respect to environmental, health and safety matters associated with the

 

1


 

Manufacture of Products under this Agreement, as set out in Part A, Exhibit 10 ( Standards and Policies ). For the avoidance of doubt, Additional HSE Requirements do not include the Purchaser’s internal HSE policies and procedures.

 

“Affected Products” has the meaning given to it in clause 4.9.

 

“Affected Site” has the meaning given to it in clause 4.8.

 

Affiliate means with respect to any person, any such person that controls, is controlled by or is under common control with such person, and “Affiliates” shall be interpreted accordingly. For purposes of this definition, “control” means the power to direct the management and policies of a person (directly or indirectly), whether through ownership of voting securities, by contract or otherwise (and the terms “controlled by” and “under common control” shall be interpreted accordingly).

 

“Agreement” means this agreement and the Exhibits and Annexures attached thereto.

 

“Alcon Group” means Alcon, Inc. and its Affiliates from time to time.

 

“Allocation” has the meaning given to it in clause 4.9.

 

Anti Falsification Regulations means the serialisation and other traceability requirements under the EU Falsified Medicines Directive 2011/62/EU (EUFMD) (and delegated legislation including Regulation (EU) 2016/161) and the Drug Supply Chain Security Act and any successor legislation or materially equivalent legislation enacted or adopted as of the date hereof in any Territory.

 

“API” means, on a Product-by-Product basis, the active pharmaceutical ingredient or drug substance, as applicable, for such Product (or constituting such Product, in the case of Shared Chemical/API Products).

 

“API Supplier” means, with respect to a Product, the supplier of any API used in the Manufacture of such Product as at the Effective Date and any additional supplier of such API subsequently approved by the Purchaser.

 

“Applicable Law” means, to the extent applicable to the Parties or their activities under this Agreement, any supra-national, European Union, federal, national, state, municipal or local statute, law, ordinance, regulation, rule, code, order (whether executive, legislative, judicial or otherwise), judgment, injunction, notice, decree, or other requirement or rule of law or legal process (including common law), or any other order of, or agreement issued, promulgated or entered into by, any Governmental Entity, any applicable Codes of Conduct, or any rule or requirement of any national securities exchange, including cGMP, each as may be amended from time to time.

 

“Artwork” means, with respect to a Product and an applicable Territory, the artwork (including the electronic files from which printed components are generated, including technical specifications, graphic files, technical drawings and reproduction files and materials), labelling and packaging for such Product in such Territory, and references to “ Artwork ” shall include a reference to each component of such artwork.

 

2


 

Batch Constrained Products has the meaning set out in clause 3.4(E).

 

“Batch Record” means a document that records the details required by cGMP and the Quality Agreement about the Manufacture of a batch of a Product, in the form prescribed by the Quality Agreement.

 

“Base Price” has the meaning set out in clause 10.2.

 

Brazil Delayed Business has the meaning given to that term in the Separation Agreement.

 

“Bridging Stock” has the meaning set out in clause 43 ( Bridging Stock ).

 

“Bulk Product” means:

 

(A)                               each of the SKUs listed in Part B of Exhibit 1 (Products);

 

(B)                               any applicable New Product SKU introduced under this Agreement as a Bulk Product; and

 

(C)                               with effect from the applicable Delayed Site Transferring Product Commencement Date, any relevant Delayed Site Transferring Product, which is to be supplied as a Bulk Product,

 

in each case, requiring further primary and/or secondary packaging or other manufacture prior to being commercialised, and “Bulk Products” shall be construed accordingly.

 

“Business Continuity Plan” shall mean a plan clearly defining and documenting a set of measures designed to (i) allow a quick response to a disruptive event so that the business process is restored to a minimum required operational level; (ii) recover the business process in a defined time frame and/or (iii) address dual sourcing requirements for specific Products (as agreed by the Parties), such plan shall cover in particular all key personnel, resources, services and actions which are required to manage the business continuity management process.

 

“Business Day” means a day which is not a Saturday, a Sunday or a public holiday in the canton of Basel-Stadt (Switzerland), Fort Worth, Texas (USA), or a jurisdiction in which a relevant obligation under this Agreement is to be performed, but excluding any day in the period 24 December to 1 January (inclusive).

 

“Business Review Meetings” has the meaning given to it in clause 15.3.

 

“Calendar Year” means any period of twelve (12) months commencing on 1 January.

 

“Capital Expenditure” means a capital expenditure made in respect of the Manufacture of Products under this Agreement.

 

3


 

“Certificate of Analysis” means a certificate signed by a qualified person pursuant to the Quality Agreement confirming that the batch of Products to which it relates meet the applicable Specifications.

 

“Certificate of Compliance” means a certificate signed by a qualified person pursuant to the Quality Agreement confirming that the batch of Products to which it relates has been manufactured in accordance with the relevant Marketing Authorization and cGMP.

 

“Chemicals” means, on a Product-by-Product basis, all non API ingredients used in the applicable formulation for such Product.

 

“Commencement Date” means the Effective Date except in respect of:

 

(A)                               a New Product SKU, for which it means the applicable NPS Commencement Date; and

 

(B)                               a Delayed Site Transferring Product, for which it means the applicable Delayed Site Transferring Product Commencement Date.

 

“Commercially Reasonable Efforts” means, with respect to the efforts (including financial spend) to be expended by a Party to achieve any objective, all reasonable, diligent commercial efforts to accomplish such objective that a person with operations of a similar scale and standing in the pharmaceutical industry would normally use when conducting an on-going business for its own benefit to accomplish a similar objective under similar circumstances.

 

“Confidential Information” means, subject to clause 31.5, all information (including all oral and visual information, and all information recorded in writing or electronically, or in any other medium or by any other method) directly or indirectly disclosed to or obtained by one Party or its Affiliates from the other Party or its Affiliates, or a Third Party acting on that Party’s behalf that either (i) the disclosing party designates as being confidential or (ii) which, under the circumstances surrounding disclosure, ought reasonably to be treated as confidential, including the following information:

 

(A)                               any information relating to the business of either Party including, any ideas; business methods; finance; prices, business, financial, sales, marketing, development or manpower plans or forecasts; customer lists or details; computer systems and software; products or services; know-how or other trade secrets; processes; marketing opportunities; other matters connected with the Products or services Manufactured, marketed, provided or obtained by either Party; information concerning either Party’s relationships with actual or potential clients, customers or suppliers and the needs and requirements of either Party and of such persons; information relating to the packaging and admission of Products, including packaging methods, testing methods and results, and storage and transportation details;

 

(B)                               any information ascertainable by the inspection or analysis of samples;

 

(C)                               any information disclosed pursuant to the Quality Agreement; and

 

4


 

(D)                               any other information which the disclosing Party has reasonably advised the non-disclosing Party in writing would, if disclosed in breach of the confidentiality obligation being imposed under this Agreement, be liable to cause material harm to the Party whose information is disclosed.

 

“Contract Year” means a period of twelve (12) months commencing on the Effective Date or any anniversary thereof ( provided that the last Contract Year for each Product shall end on the date of expiry or termination of this Agreement in respect of that Product).

 

Contract Execution Manager ” has the meaning given to it in clause 15.2.

 

Control ” means, in relation to a person, the ability of another person to ensure that the activities and business of the first mentioned person are conducted in accordance with the wishes of that other person (whether by exercise of contractual rights, ownership of shares or otherwise), and a person shall be deemed to have “Control” of a body corporate if that person has the contractual right to procure that the activities and business of that body corporate are conducted in accordance with that person’s wishes or if that person possesses the majority of the issued share capital or the voting rights in that body corporate or the right to receive the majority of the income of that body corporate on any distribution by it of all of its income or the majority of its assets on a winding up;

 

“Conversion Cost” means, in respect of a Product, the Total Product Cost of that Product less, to the extent included therein, the Materials Costs (excluding production consumables) representing third party and intercompany landed costs and excluding testing costs and material handling costs.

 

“current Good Manufacturing Practice” or “cGMP” means all applicable standards relating to current good manufacturing practice for fine chemicals, intermediates, active pharmaceutical ingredients, bulk products and/or finished pharmaceutical/medical device products (as appropriate) required by:

 

(A)                               the provisions of Commission Directive 2003/94/EC together with the guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use contained in Volume 4 “Guidelines for good manufacturing practices for medicinal products for human and veterinary use” of “The Rules Governing Medicinal Products in the European Union” (as the same may be amended from time to time);

 

(B)                               the then-current standards, practices and procedures required, promulgated or endorsed by the FDA as defined in the provisions of 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R. Parts 210-211 and 600-680; and

 

(C)                               the equivalent Applicable Law in any relevant country,

 

in each case, as applicable to the relevant Manufacturing Site or the Product or both.

 

“Customer Relationship Manager” has the meaning given to it in clause 15.1.

 

5


 

“Data Pack” means, in respect of a Product, a data pack containing such of the technical information listed in Exhibit 12 ( Data Pack Requirements ) that is in the possession of the Supplier’s Group, that is not in the possession of the Purchaser’s Group, and that is required to accomplish the technical transfer of such Product.

 

“Default Delivery Terms” means FCA Delivery Terms.

 

“Defaulting Party” has the meaning given in clause 40.9.

 

“Defective” means, with respect to a Product, that such Product did not, at the time of Delivery, meet the representations, warranties or covenants set out in this Agreement with respect to Products Manufactured and supplied to the Purchaser under this Agreement, including as set out in clause 2.3, or the quality requirements set out in the Quality Agreement (but excluding, for clarity, any such failure to meet such representations, warranties, covenants, or requirements as a result of any action or omission of the Purchaser or its Affiliates), and “Defect” shall be construed accordingly.

 

“Delayed Closing Date” has the meaning given in Exhibit 7 of the Separation Agreement.

 

“Delayed Product Initial Term” has the meaning given in clause 40.4.

 

“Delayed Site” means the Manufacturing Site at Professor Vicente Roo Ave, 90, Brooklin Paulista, BR-04636-000, Sao Paulo SP, Brazil.

 

“Delayed Site Transferring Product” means a product identified as such in Exhibit 5 ( Delayed Site ).

 

“Delayed Site Transferring Product Commencement Date” means, in respect of a Delayed Site Transferring Product, the Delayed Closing Date.

 

“Delivery Failure” has the meaning given in clause 9.3(A).

 

“Delivery Terms” means, in respect of each Product, the Default Delivery Terms or such other delivery terms as are set out with respect to such Product in Exhibit 1 ( Products ) or as the Parties may otherwise agree from time to time, and “Deliver” , “Delivery” and “Delivered” shall be construed accordingly as applicable.

 

“Development Work” means, in respect of a Product, any analysis, testing, reformulation, redesign or other research and development activity (including the preparation of reports in relation to those activities), but excluding any such activities that:

 

(A)                               are required for the Manufacture or supply of that Product as at the Effective Date;

 

(B)                               are required to be undertaken in relation to that Product by the Quality Agreement;

 

6


 

 

 

(C)                               are agreed by the Parties pursuant to clauses 23 ( Development Work ) and 24 ( Continuous Improvement Programme ); or

 

(D)                               comprise a change of Artwork in accordance with clause 26 ( Artwork and Shared Moulds ).

 

Dispute ” has the meaning given in clause 50.3.

 

Dispute Notice ” has the meaning given in clause 50.4.

 

“Droptainer Products” means those Products set out in Part A of Exhibit 1 ( Products ).

 

“Effective Date” has the meaning given on the first page of this Agreement.

 

“Executive Officers” means, for the Supplier the Head of Novartis Technical Operations and Senior Vice President, Global Manufacturing and Technical Operations of the Purchaser, or their respective designees.

 

“Export Documentation” means, in respect of each Product, shipping documentation evidencing the export of such Product from the territory in which the relevant Manufacturing Site is located.

 

“FCA Delivery Terms” means FCA ( Insert Manufacturing Site ) (Incoterms 2010), as the case may be.

 

“FDA” means the United States Food and Drug Administration, or any successor agency thereto.

 

“Finished Product” means:

 

(A)                               each of the SKUs listed in Part A of Exhibit 1 ( Products );

 

(B)                               any applicable New Product SKU introduced under this Agreement as a Finished Product; and

 

(C)                               with effect from the applicable Delayed Site Transferring Product Commencement Date, any relevant Delayed Site Transferring Product, which is to be supplied as a Finished Product,

 

and “ Finished Products ” shall be construed accordingly.

 

“Firm Order” means a Pull Firm Order or a Push Firm Order (as applicable).

 

“Firm Zone” means a Pull Firm Zone or a Push Firm Zone (as applicable).

 

First Approval ” has the meaning set out in clause 42.3;

 

“Forecast Schedule” has the meaning given in clause 3.1(D).

 

7


 

“Force Majeure” means, any cause or circumstance preventing, hindering or delaying either Party performing all or part of its obligations under this Agreement which arises from or is attributable to acts, events, omissions or accidents beyond the reasonable control of the Party so prevented, including any of the following:

 

(A)                               war, threat of or preparation for war, armed conflict;

 

(B)                               terrorist attack, civil war, civil commotion or riots;

 

(C)                               epidemic or pandemic;

 

(D)                               any law or governmental order, rule, regulation or direction, or any action taken by a Governmental Entity, including but not limited to imposing an embargo, export or import restriction, quota or other restriction or prohibition, in each case, of general application or generally affecting the industries in which the Parties participate;

 

(E)                                any flood, earthquake, hurricane or other natural disaster, weather-related conditions, explosions or fires; and

 

(F)                                 to the extent beyond the reasonable control of the relevant Party (or, as applicable, the Permitted Subcontractor), any labour dispute, including strikes, industrial action or lockouts.

 

For the purposes of this definition of Force Majeure neither increasing costs (unless in excess of market norms due to acts, events, omissions or accidents beyond the reasonable control of the Party affected) nor a lack of funds will be interpreted as putting the event beyond the reasonable control of the Party affected.

 

“Gating Plan” has the meaning given to it in clause 4.1.

 

“Gating Volumes” means in relation to a Product Technology for each Calendar Year of the relevant Product Term for that Product, the aggregate volume of that Product Technology to be Manufactured by (or for) Supplier’s Group during that Calendar Year as set out in the Gating Plan for that Calendar Year or as otherwise agreed by the Manufacturing and Supply Team in accordance with clause 4.1.

 

“Gating Year” means a Calendar Year in the Gating Plan (provided that the last Gating Year for each Product shall end on the date of expiry or termination of this Agreement in respect of that Product).

 

“Global PV Agreement” means the pharmacovigilance agreement in relation to (among other things) the Products entered into between the Supplier (and/or its Affiliate), the Purchaser (and/or its Affiliate) on the Effective Date.

 

“Governmental Entity” means any supra-national, European Union, federal, national, state, county, local, municipal or other governmental, regulatory or administrative authority, agency, commission or other instrumentality, any court, tribunal or arbitral body with competent jurisdiction, or any national securities exchange or automated quotation service including, any governmental regulatory authority or agency

 

8


 

responsible for the grant approval, clearance, qualification, licensing or permitting of any aspect of the research, development, Manufacture, marketing, distribution or sale of the Products including (as applicable) the FDA, the European Medicines Agency, or any successor agency thereto.

 

“Group” means the Supplier’s Group and/or the Purchaser’s Group (as the context requires).

 

“IFRS” means the edition of the International Financial Reporting Standards as published by the International Accounting Standards Board that is effective at the time that any cost to be calculated by reference to these standards hereunder is recognized.

 

“Improvement” means any new or improved process, technique, method, formula, invention or know-how that arises out of a continuous improvement programme agreed by the Parties pursuant to clause 24 ( Continuous Improvement Programme ) or any Development Work or Artwork, in each case devised, made or reduced to practice either by the Supplier or the Purchaser during the Term.

 

“Independent Expert” means a laboratory or expert mutually agreed upon by the Parties or, if no such agreement can be reached within twenty (20) Business Days of either Party proposing the referral of a dispute under clause 17 ( Acceptance of Product ) or Exhibit 7 ( Toll Manufacture Provisions ) for the determination by (or recommendation in respect of, as applicable) an independent expert, a laboratory or expert appointed by the President of the International Chamber of Commerce or his nominee upon the application of either Party.

 

Inflation Adjustment ” has the meaning given to it in clause 10.4(A).

 

Inflation Reconciliation ” has the meaning given to it in clause 10.7(B).

 

“Information Access Agreement” means the information access agreement to be entered into between Novartis AG and Alcon Inc. on or about the date of this Agreement.

 

“Initial Term” has the meaning given to it in clause 40.3.

 

“Insolvency Event” means, in relation to a person:

 

(A)                               it is, or is deemed for the purpose of any Applicable Law to be, insolvent or unable to pay its debts as they fall due;

 

(B)                               it admits an inability to pay debts as they fall due;

 

(C)                               it suspends making payments on any of its debts or announces an intention to do so;

 

(D)                               by reason of actual or anticipated financial difficulties, it begins negotiations with any creditor for the rescheduling of any of its indebtedness outside the ordinary course of business;

 

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(E)                                it is in breach of any covenant or other term of a loan or financial facility and a counterparty under such loan or financial facility accelerates, or calls for repayment of, any outstanding indebtedness as a result of such breach;

 

(F)                                 the fair value of its assets is less than its liabilities (taking into account contingent and prospective liabilities and disregarding inter-company loans between Affiliates); or

 

(G)                               a moratorium is declared in respect of any indebtedness; or

 

(H)                              any event occurs, or proceeding is taken, with respect to the person in any jurisdiction in which it has assets and to which it is subject, that has an effect equivalent to any of the events mentioned in (A) to (G) above.

 

“Insolvency Proceeding” means, in relation to a person:

 

(A)                               any step is taken with a view to entering into a moratorium or a composition or similar arrangement with its creditors;

 

(B)                               a meeting of its shareholders or directors is convened for the purpose of considering any resolution for, to bring an application for, or to file documents with a court or any registrar for, its winding-up, judicial management or dissolution or any such resolution is passed;

 

(C)                               any person brings an application for, or files documents with a court or any registrar for, its winding-up, judicial management or dissolution or such order is made; or

 

(D)                               a liquidator, judicial manager, administrator or similar officer is appointed in respect of any of its assets.

 

“Intellectual Property Rights” means all: (i) patents; (ii) know-how and trade secrets; (iii) trademarks; (iv) internet domain names; (v) copyrights; (vi) rights in designs; (vii) database rights; and (viii) all rights or forms of protection, anywhere in the world, having equivalent or similar effect to the rights referred to in paragraphs (i) to (vii) above, in each case whether registered or unregistered and including applications for registration of any such thing.

 

“Invoice Currency” means (i) U.S Dollar (USD); or (ii) in circumstances where the U.S Dollar (USD) is not the applicable operating currency of the Supplier or Nominated Supplier (as the case may be), the applicable operating currency of the Supplier or Nominated Supplier (as the case may be) that issues the invoice, as determined by the Supplier or Nominated Supplier and indicated in an applicable invoice.

 

ISRM Security Standards ” means the ISRM security standards of Novartis as may be updated from time to time.

 

“Joint Improvement IP” means any Intellectual Property Rights allocated to the joint ownership of the Parties (or their respective Affiliates) in accordance with clause 39.4(C)(iii).

 

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“Key Performance Indicators” or “KPIs” means the key performance indicators set out in Exhibit 4 ( Key Performance Indicators ) or otherwise agreed by the Parties from time to time in accordance with clause 14 ( Key Performance Indicators ).

 

“KPI1 (ASP)” has the meaning set out in Exhibit 4, Part A ( Key Performance Indicators ).

 

“KPI2 (SDP)” has the meaning set out in Exhibit 4, Part A ( Key Performance Indicators ).

 

“Latent Defect” means any Defect that is not readily determinable upon a reasonable inspection of the Product, based on visual inspection or other agreed inspection method (without the obligation to open the packaging) and review of the Certificate of Analysis, Certificate of Compliance and/or Batch Record (if applicable).

 

“Lead Time” means, in respect of each Product, the minimum number of days between when a Firm Order must be placed to when it can be shipped, as set out against such Product in Exhibit 1 ( Products ) or, as applicable, agreed pursuant to clause 21 ( New Product SKUs ) or agreed following implementation of the Lead Time reduction contemplated in clause 3.4(D).

 

“LIBOR” means the London interbank offered rate, being the interest rate offered in the London inter-bank market for three month US dollar deposits or any equivalent interest rate agreed by the Parties in good time prior to LIBOR ceasing to exist, if LIBOR ceases to exist.

 

“Long Term Transfer Plan” has the meaning set out in clause 42.1.

 

“Manufacture” means the planning, purchasing of materials for, manufacturing, producing, processing, compounding, holding and storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality assurance and release, sample retention and quality testing of Product.

 

“Manufacturer’s Batch Certificate” means a certificate attesting that a Product batch has a Certificate of Analysis and a Certificate of Compliance.

 

“Manufacturing and Supply Team” has the meaning given to it in clause 15.2

 

“Manufacturing Licences” means any certificates, permits, licences and approvals issued by any relevant Governmental Entity in connection with Manufacture by or on behalf of the Supplier at the Manufacturing Sites.

 

“Manufacturing Sites” means facilities of the Supplier and/or its Affiliates or Permitted Subcontractors:

 

(A)                               at which the Products listed against such facilities in Exhibit 1 ( Products ) are Manufactured as at the Effective Date, as further summarised in Exhibit 2 ( Manufacturing Sites );

 

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(B)                               in relation to which the Supplier has, as at the Effective Date, entered into a binding agreement for the Manufacture of Products, as set out in Exhibit 2 ( Manufacturing Sites ); and

 

(C)                               such other manufacturing facilities as the Parties may agree from time to time in writing in accordance with clause 2.7 or clause 2.8.

 

For each of the facilities (including the Delayed Site) included under (A) and (B) above, Exhibit 2 ( Manufacturing Sites ) shall set out the identity of the Supplier entity or Permitted Subcontractor which owns and operates such facility.

 

“Margin” has the meaning set out in Exhibit 16, Part C.

 

“Marketing Authorisations” means, in respect of a Product, such marketing authorisation, approval, licence, registration or other authorisations issued by a Governmental Entity from time to time in connection with the placing of that Product on the market in the relevant Territory (or, as applicable, a finished product manufactured using that Product), and Marketing Authorisation” shall be construed accordingly.

 

“Marketing Authorisation Holder” means, in respect of a Marketing Authorisation, the holder of such Marketing Authorisation from time to time.

 

“Materials” means, as applicable and to the extent used in the Manufacture of the Products, any materials, compounds or components including, without limitation: (a) raw ingredients, (b) intermediates, (c) excipients, (d) processing aids, (e) Chemicals, (f) with respect to Bulk Products and Finished Products, API, and (g) with respect to Bulk Products (as applicable) and Finished Products, packaging and labelling materials and components (including printed and non-printed components) thereof.

 

Materials Adjustment ” has the meaning given to it in clause 10.4(B).

 

“Materials Cost” means the costs of Manufacture that relate to the Materials including the purchase prices, inbound freight, customs and insurance charges and non-deductible tax charges.

 

“Minimum Order Quantity” or “MOQ” means, in respect of each Product, the volume of that Product set out in Exhibit 1 ( Products ) or, as applicable, agreed pursuant to clause 21 ( New Product SKUs ).

 

“Minimum Remaining Shelf Life” has the meaning given to it in clause 3.4(B).

 

“Minimum Target Volume” has the meaning given to it in clause 4.2.

 

New Product Launches ” has the meaning given in clause 21.

 

“New Product SKU” means:

 

(A)                               a new SKU for an existing Product that does not require the performance of Development Work, packaging or transportation testing, or generation of new stability data (such as, by way of example, a line extension of an existing

 

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Product requiring only changes to pack sizes and/or labelling or other Artwork to allow for sales in different markets);

 

(B)                               a SKU comprising a Bulk Product that is already Manufactured by the Supplier or the Permitted Subcontractor in the course of Manufacturing an existing Finished Product for the Purchaser; or

 

(C)                               a SKU comprising a Shared Chemical/API Product or a Shared Packaging Material that is already Manufactured under the terms of a Shared Contract in the course of Manufacturing an existing Finished Product or Bulk Product for the Purchaser, and ,

 

in each case the existing Product, Finished Product or Bulk Product in (A) to (C) shall be referred to as the “ Original Product ”).

 

“Nominated Supplier” means any member of the Supplier’s Group to whom the Supplier sub-contracts the Manufacture or supply of Products to the Purchaser (including invoicing).

 

“Non-Defaulting Party” has the meaning given to it in clause 40.9.

 

“Notice” has the meaning given to it in clause 45.1.

 

Novartis Control Manual ” means the Novartis control manual as set out in Appendix 1 to Exhibit 16 ( Supply Price Adjustment and Catalogue ).

 

Novartis Delayed Interest ” means the Novartis Transferring Assets in Brazil as defined in Exhibit 7 of the Separation Agreement.

 

“Novartis’s Group” means Novartis AG and its Affiliates from time to time.

 

“NPS Commencement Date” means, in respect of a New Product SKU, the first date that such New Product SKU is added to this Agreement pursuant to clause 21.5.

 

“Ointments Products” means those Products identified as an ointment product set out in Part A of Exhibit 1 ( Products ).

 

“Payment” has the meaning given to it in clause 1.2(O).

 

“Permitted Subcontractor” means a Third Party to whom the Supplier directly or indirectly sub-contracts in whole or in part the Manufacture of one or more Products and that is approved or deemed approved by the Purchaser in accordance with clause 2.6 of this Agreement and listed under Annex E of the Quality Agreement.

 

“Product” means, as applicable, a Finished Product, a Bulk Product, a Shared Chemical/API Product or a Shared Packaging Material (including in each case, if applicable and with effect from the relevant Commencement Date, any Delayed Site Transferring Product or New Product SKU) in each case designated as a Pull Product or a Push Product in Exhibit 1 ( Products ) and in each case, Manufactured and supplied under this Agreement, and “ Products ” shall be construed accordingly.

 

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“Product Action” means a recall or withdrawal with respect to any Product supplied under this Agreement, whether such recall or withdrawal pertains to Products held by end customers, held by the Supplier or the Purchaser in storage, or at any other point in the supply chain.

 

Product Technology ” means the following categories of Finished Product (as indicated for each Finished Product in Exhibit 1 to this Agreement):

 

(A)                               Viscoelastic Product;

 

(B)                               Droptainer Product; and

 

(C)                               Ointment Products.

 

each a Product Technology and together the “ Product Technologies ”.

 

“Product Term” has the meaning given to it in clause 40.6.

 

“Pull Firm Order” has the meaning given in clause 3.2(C).

 

“Pull Firm Zone” means in respect of each Pull Product the first four (4) months of each Forecast Schedule for each such Pull Product indicated on Exhibit 1 ( Products ) or such other period as may be agreed between the Parties on a Product-by-Product basis.

 

“Pull Products” means any Product Manufactured under this Agreement that is not a Push Product .

 

“Purchaser” has the meaning given to it in the preamble.

 

“Purchaser’s Group” means the Alcon Group.

 

“Purchaser Improvement IP” means any Intellectual Property Rights subsisting in an Improvement, ownership of which is allocated to the Purchaser or its Affiliates in accordance with clause 39.4(C)(ii), and excluding, for the avoidance of doubt, any Joint Improvement IP.

 

“Purchaser Material” means in respect of a Product or other Material purchased by or on behalf of the Supplier from a member of the Purchaser’s Group or a Shared Contract CMO for use in the Manufacture of a Product to be supplied to the Purchaser (or its Affiliate) under this Agreement as listed in Exhibit 8 ( Purchaser Materials ) and “ Purchaser Materials ” shall be construed accordingly.

 

“Purchaser System” has the meaning given to it in Exhibit 17.

 

“Push Basis” has the meaning given to it in Exhibit 17.

 

“Push Firm Order” has the meaning given to it in Exhibit 17.

 

“Push Products” has the meaning given to it in Exhibit 17.

 

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“Quality Agreement” means, in respect of a Product, the quality assurance agreement relating to the Manufacture and supply of Products in substantially the form attached to this Agreement at Exhibit 3 ( Quality Agreement ) entered into between the Purchaser or its Affiliate and the Supplier or its Affiliate on the Effective Date (together with, in respect of each Product, a Product-specific annex setting out specific details in relation to that Product), each as may be amended by the Parties from time to time during the Term.

 

“Quality Management System” means the Supplier’s Group’s system of quality management controls designed to ensure regulatory compliance and to assure product safety, quality and efficacy in the Supplier’s Group’s operations with regard to the manufacture and supply of investigational materials or products for sale or distribution;

 

“Quality Standards” means, in respect of each Product, the more stringent of either:

 

(A)                               the Supplier’s Group’s quality standards in respect of the Manufacture of the Products and the traceability of API used in the Products, in each case as at the Effective Date; or

 

(B)                               the quality standards in respect of the Products and the traceability of API used in the Products, in each case as prescribed from time to time during the Term by Applicable Law, including cGMP and applicable industry codes,

 

provided that the same shall always be in compliance with Applicable Law, including cGMP.

 

“S&OP Meetings” has the meaning given to it in clause 15.1.

 

“Sales Tax” means any sales, goods, services, turnover, value-added, or similar Tax and any Tax charged on the import or export of any goods or services.

 

“Sanctions and Export Controls” means any Applicable Law that prohibits or places restrictions on the supply of certain products, materials, equipment, technology, software, know-how and/or information to certain markets and/or that prohibits or places restrictions on other dealings (including financial transactions) with certain territories or with particular persons or organisations within certain territories.

 

“Separation” has the meaning set out in the Separation Agreement.

 

“Separation Agreement” means the Separation Agreement entered into by and between Novartis AG and Alcon Inc., dated on or about the date of this Agreement.

 

“Shared Chemical/API Product” means:

 

(A)                               each of the SKUs listed in Part C of Exhibit 1 (Products);

 

(B)                               any applicable New Product SKU introduced under this Agreement as a Shared Chemical/API Product in accordance with clause 21 (New Product SKUs); and

 

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(C)                               with effect from the applicable Delayed Site Transferring Product Commencement Date, any relevant Delayed Site Transferring Product, which is to be supplied as a Shared Chemical/API Product,

 

in each case, comprising an API or Chemical for use in the manufacture of pharmaceutical products (as applicable) by or for the Purchaser or its Affiliates, and “Shared Chemical/API Products” shall be construed accordingly.

 

“Shared Contract” means any contract that has not been Separated, is in effect as at the Effective Date and provides for  the supply of the Shared Chemical/API Products, Shared Packaging Materials and/or Purchaser Materials listed in Exhibit 1 ( Products ) or Exhibit 8 ( Purchaser Materials ).

 

“Shared Packaging Material” means packaging and labelling materials and components (including printed and non-printed components) supplied for use in the manufacture of Product and/or any equivalent Purchaser Materials in each case as listed in Exhibit 1 ( Products ) or Exhibit 8 ( Purchaser Materials ).

 

“Site Volume Reconciliation” has the meaning given to it in clause 10.7.

 

“SKU” means stock-keeping unit.

 

“Specifications” means, in respect of a Product, or a Material used in the Manufacture of that Product:

 

(A)                               the specifications for that Product or Material (as applicable) registered or approved in the relevant Marketing Authorisation; or

 

(B)                               if there is no Marketing Authorisation in respect of the Product (because such Product can, in accordance with Applicable Law be put on the market without a Marketing Authorisation) or if the Marketing Authorisation in respect of that Product does not contain any specifications for that Product or Material (as applicable), the specifications for that Product or Material as set out in the relevant Annex to the Quality Agreement (as amended from time to time in accordance with the Quality Agreement).

 

“Specific Technical Transfer” has the meaning given to it in clause 42.5.

 

“Supplier” has the meaning given to it in the preamble.

 

Supplier Code ” means the Novartis Supplier Code as set out in Exhibit 10 ( Standards and Policies ).

 

“Supplier Improvement IP” means any Intellectual Property Rights subsisting in an Improvement, ownership of which is allocated to the Supplier or its Affiliates in accordance with clause 39.4(C)(i), and excluding, for the avoidance of doubt, any Joint Improvement IP.

 

“Supplier’s Group” means the Novartis Group.

 

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“Supplier System IP” means any and all Intellectual Property Rights subsisting in the Supplier’s System that is owned by or licensed to the Supplier’s Group.

 

“Supply Price” means, in respect of each Product, the supply price determined in accordance with clause 10 ( Price and Price Adjustments ).

 

“Target Gating Volume” has the meaning set out in clause 4.1(A).

 

“Tax” means all taxes, levies, duties, imposts, charges and withholdings of any nature whatsoever together with all penalties, charges and interest relating to any of them or to any failure to file any return required for the purposes of any of them.

 

“Technical Transfer Milestones” has the meaning set out in clause 42.12 .

 

“Technical Transfer Team” means the representatives of each Party nominated as being responsible for the oversight and implementation of the Long Term Transfer Plan.

 

“Term” has the meaning set out in clause 40.1.

 

“Territory” means:

 

(A)         in respect of each Finished Product, the country (or countries) in which that Finished Product is placed on the market (and where, if applicable, there is a granted Marketing Authorisation for such Product from time to time) and as set out in Part A of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties);

 

(B)          in respect of each Bulk Product or Shared Packaging Material, the country (or countries) in which products Manufactured using such Bulk Product or Shared Packaging Material are placed on the market (and where, if applicable, there is a granted Marketing Authorisation for such product from time to time) and as set out in Part B of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties); and

 

(C)          in respect of each Shared Chemical/API Product, the country (or countries) in which products Manufactured using such Shared Chemical/API Product are placed on the market (and where, if applicable, there is a granted Marketing Authorisation for such product from time to time) and as set out in Part C of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties).

 

“Third Party” means from any company other than the Purchaser and its Affiliates and the Supplier and its Affiliates.

 

“Toll Manufacturing Basis” has the meaning set out in clause 5.1.

 

“Toll Material” has, in respect of a Tolled Product, the meaning set out in Exhibit 7 ( Toll Manufacture Provisions ).

 

“Tolled Product” has the meaning set out in Exhibit 7 ( Toll Manufacture Provisions ).

 

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“Total Product Cost” means, in respect of a Product, the fully-absorbed cost of Manufacture as calculated in a manner consistent with IFRS and the Total Product Costing methodology employed by the Supplier and its Affiliates for other products, including (without limitation) the costs of Materials, direct labour, ordinary course quality assurance costs, equipment maintenance costs, and other costs variable with production, plus an allocation of the Manufacturing Site’s fixed overhead consistent with the Supplier’s Total Product Cost calculated in accordance with the Novartis Control Manual, but excluding any profit made by the Supplier or any of its Affiliates through the application of transfer pricing. For the avoidance of doubt, the Total Product Cost of each Product for 2019 is reflected in Exhibit 1 ( Products ) as such Product’s Base Price.

 

“Transaction Documents” means this Agreement, the Separation Agreement, the Transitional Distribution Services Agreement (India), the Transitional Distribution Services Agreement (Legacy Ciba), the Global Transitional Services Agreement, the Quality Agreement, the Global Pharmacovigilence Agreement, the Pharmacovigilence Services Agreement, the MA Transfer Agreement, the Puurs Asset Transfer Agreement and Notarial Deed, the  Puurs Testing Services Agreement, the Puurs Site Service Agreement, the Brand Licence Agreement, the IP Assignment Agreement, Information Access Agreement, Tax Matters Agreement and any document or instrument entered into or delivered pursuant hereto or thereto.

 

“Transitional Services Agreements” means the Global Transitional Services Agreement and the Puurs Testing Services Agreement dated on or around the Effective Date between a member of the Supplier’s Group (as the provider of services) and a member of the Purchaser’s Group (as the recipient of services).

 

“Trigger Date” means the date with effect from which the relevant Product (or proposed New Product SKU) shall be Manufactured on a toll (zero cost, consignment) manufacturing basis.

 

“Viscoelastics Products” means those Products set out in Part A1 of Exhibit 1 ( Products ).

 

“Viscoelastics Requirements” has the meaning set out in clause 4.3.

 

Volume Based Adjustment ” has the meaning set out in clause 10.4(C).

 

“Working Hours” means, in relation to a notice served or audit performed under this Agreement, 09:00 to 17:00 in the place of receipt of such notice or place of such audit on a Business Day.

 

1.2          In this Agreement, unless specified otherwise:

 

(A)          references to clauses, paragraphs, Exhibits and Annexes are to clauses and paragraphs of, and Exhibits and Annexes to, this Agreement;

 

(B)          headings to clauses, Exhibits, Annexes and paragraphs are for convenience only and do not affect the interpretation of this Agreement;

 

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(C)          the Exhibits and Annexes form part of this Agreement and shall have the same force and effect as if expressly set out in the body of this Agreement, and any reference to this Agreement shall include the Exhibits and Annexes;

 

(D)          a reference to any statute, regulation or statutory provision shall be construed as a reference to the same as in effect at the applicable time, including as it may have been, or may from time to time be, consolidated, amended, modified, extended or re-enacted and any successor or materially equivalent legislation enacted or adopted;

 

(E)             references to a “company” shall be construed so as to include any firm, company, corporation, legal entity or body corporate;

 

(F)             references to a “person” shall be construed so as to include any individual, company, government, state or agency of a state, local or municipal authority or government body or any joint venture, association or partnership (whether or not having separate legal personality);

 

(G)          use of any gender includes the other genders;

 

(H)          references to the singular shall include the plural and vice-versa;

 

(I)              references to writing shall include any modes of reproducing words in a legible and non-transitory form, and accordingly shall exclude e-mail and other transitory modes;

 

(J)           any reference to a “day” (including within the phrase “Business Day” ) shall mean a period of 24 hours running from midnight to midnight;

 

(K)            references to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than England, be treated as including what most nearly approximates in that jurisdiction to the English legal term;

 

(L)          the word “registered” , when used in connection with Materials or with any process, is to be construed as a reference to the fact that details of such Materials or process have been (and/or are required to be) registered with any applicable Governmental Entity (whether in a Marketing Authorisation or otherwise);

 

(M)         (i)           the rule known as the ejusdem generis rule shall not apply and accordingly general words introduced by the word “other” shall not be given a restrictive meaning by reason of the fact that they are preceded by words indicating a particular class of acts, matters or things;

 

(i)              the use of the phrase “ not unreasonably withheld ” and similar constructions shall be deemed to mean “not to be unreasonably withheld, conditioned or delayed”;

 

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(ii)          the use of the words “includes” or “including” shall be deemed to say also “without limitation” ; and

 

(iii)         general words shall not be given a restrictive meaning by reason of the fact that they are followed by particular examples intended to be embraced by the general words;

 

(N)          each Party may satisfy its obligations under this Agreement either directly or indirectly through one or more members of its Group (including, in the case of the Supplier, through a Nominated Supplier), whether or not expressly stated, provided that each Party shall remain the principal obligor for the performance of its obligations hereunder;

 

(O)          any indemnity or covenant to pay (the “Payment Obligation” ) being given on an “after-Tax basis” or expressed to be “calculated on an after-Tax basis” means that the amount payable pursuant to such Payment Obligation (the “Payment” ) shall be calculated in such a manner as will ensure that, after taking into account:

 

(i)              any Tax required to be deducted or withheld from the Payment;

 

(ii)             the amount and timing of any additional Tax which becomes payable by the recipient of the Payment (or a member of the Supplier’s Group or the Purchaser’s Group, as the case may be) as a result of the Payments being subject to Tax in the hands of that person; and

 

(iii)            the amount and timing of any Tax benefit which is obtained by the recipient of the Payment (or a member of the Supplier’s Group or the Purchaser’s Group, as the case may be) to the extent that such Tax benefit is attributable to the matter giving rise to the Payment Obligation or to the receipt of the Payment,

 

which amount and timing is to be determined by the auditors of the recipient at the shared expense of both Parties and is to be certified as such to the Party making the Payment, the recipient of the Payment is in the same position as that in which it would have been if the matter giving rise to the Payment Obligation had not occurred;

 

(P)             unless specified to the contrary, references to “indemnify” and “indemnifying” any person against any circumstance include indemnifying and holding that person harmless on an after-Tax basis and:

 

(i)              the provisions of clause 37 ( Indemnity and Liability ) shall apply to such indemnification;

 

(ii)             references to the Supplier indemnifying each member of the Purchaser’s Group shall constitute undertakings by the Supplier to Purchaser for itself and on behalf of each other member of the Purchaser’s Group; and

 

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(iii)            references to the Purchaser indemnifying each member of the Supplier’s Group shall constitute undertakings by the Purchaser to the Supplier for itself and on behalf of each other member of the Purchaser’s Group;

 

(Q)          unless specified to the contrary, any amount to be paid or provided under any clause of this Agreement for any supply made under or in connection with this Agreement is exclusive of Sales Tax; and

 

(R)          references to “ costs ” and “ expenses ” incurred by a person shall include any Sales Tax or amount in respect thereof comprised in such costs or expenses, other than Sales Tax or amounts in respect thereof for which that person or, if relevant, any other member of its Group for the relevant Sales Tax purposes is entitled to credit or repayment.

 

2.           MANUFACTURE AND SUPPLY

 

2.1          On and subject to the provisions of this Agreement, the Supplier shall Manufacture and supply, or have Manufactured and supplied, to the Purchaser, and the Purchaser shall purchase, or procure the purchase by an Affiliate of the Purchaser of, the Products for which a Firm Order is placed until the end of the applicable Product Term and:

 

(A)          in accordance with clause 3 ( Forecasts and Orders — Push/Pull ) in respect of Pull Products; and

 

(B)          in accordance with ( Forecasts and Orders — Push/Pull ) and Exhibit 17 ( Push Products ) in respect of Push Products.

 

2.2             The Purchaser may commence purchasing each Product under this Agreement from the applicable Commencement Date, unless otherwise agreed in writing by the Parties.

 

2.3             The Supplier shall (or, subject to clause 2.6, shall procure that a Permitted Subcontractor or Nominated Supplier will) Manufacture the Products at the Manufacturing Sites in accordance with:

 

(A)          the applicable Specifications on the Effective Date (unless changed in accordance with clause 20 ( Product Specifications ));

 

(B)          current Good Manufacturing Practice and responsible procurement guidelines;

 

(C)          the applicable Manufacturing Licences;

 

(D)           the applicable Marketing Authorisations (in the case of Shared Chemical/API Products, to the extent relevant);

 

(E)          the Quality Agreement and the applicable Quality Standards;

 

(F)          Pull Firm Orders and Push Firm Orders;

 

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(G)          Applicable Law in the country of Manufacture relevant to the Manufacture of the Product; and

 

(H)          Applicable Law in the Territory where the Product (or in the case of Shared Chemical/API Products or Shared Packaging Materials, any product incorporating such Products or Materials) is to be sold in relation to the Manufacture of such Product.

 

2.4          During the Term, the Supplier shall (or, subject to clause 2.6 shall procure that a Permitted Subcontractor or Nominated Supplier will) obtain (where not held already) and maintain all necessary Manufacturing Licences from the relevant Governmental Entity as are required for the Manufacture of the Products at the Manufacturing Sites.

 

2.5          The Parties hereby acknowledge that the Supplier may, on prior written notice to the Purchaser, nominate any of its Affiliates to act as its Nominated Supplier under this Agreement to Manufacture and supply Products to, and receive payment from, the Purchaser (or its Affiliate), provided that :

 

(A)          the Supplier shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such supply; and

 

(B)          such entity shall cease to be a Nominated Supplier if it ceases to be an Affiliate of the Supplier and the Supplier shall be required to either perform the obligations of such former Affiliate or procure its replacement by another Affiliate prior to it ceasing to be an Affiliate.

 

The Supplier may change the Nominated Supplier from time to time by notice in writing to the Purchaser (provided always that such Nominated Supplier is an Affiliate of the Supplier) subject to the terms set forth in clause 40 ( Technical Transfer ).  References in this Agreement to the Supplier shall be deemed to include any appointed Nominated Suppliers.

 

2.6          The Supplier may not sub-contract the Manufacture of Products (or any part thereof) to a Third Party without the prior written consent of the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed), provided that each Third Party arrangement set out in Annex E of the Quality Agreement shall be deemed to have been given the prior written consent of the Purchaser and the Third Party listed shall be a Permitted Subcontractor.  Any Third Party sub-contractor engaged by the Supplier with the prior written consent of the Purchaser in accordance with this clause 2.6 shall be deemed to be a Permitted Subcontractor. The Supplier will ensure that all Permitted Subcontractors and all Nominated Suppliers act in compliance with the terms and conditions of this Agreement, including but not limited to, complying with all Applicable Laws, and shall ensure that the Permitted Subcontractors and Nominated Suppliers are subject to confidentiality obligations that are no less restrictive than those found at clause 31 ( Confidentiality ) and, to the extent practicable, grant the Purchaser audit and inspection rights substantially equivalent to those set out in clause 33 ( Audit and Inspection Rights ).  The engagement of Permitted Subcontractors and

 

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Nominated Suppliers shall not relieve the Supplier from any of its liabilities or obligations under this Agreement and the Supplier shall remain liable as primary obligor to the Purchaser for the acts or omissions of all Permitted Subcontractors and Nominated Suppliers as if they were the acts or omissions of the Supplier.

 

2.7          The Supplier may not:

 

(A)          change a Permitted Subcontractor;

 

(B)          make any material amendments to contracts with Permitted Subcontractors relating to the Manufacture or supply of Products (including any amendment that would adversely affect the Purchaser or require an amendment to a Marketing Authorisation or permit held by the Purchaser) except where such changes are required by a Governmental Entity (and in such case, only upon reasonable advance notice to the Purchaser); or

 

(C)          in respect of a Product, change (or permit a Nominated Supplier or Permitted Subcontractor to change) the API Supplier or the supplier of any registered Materials,

 

in each case without the prior written consent of the Purchaser (such consent not to be unreasonably withheld or delayed) and in accordance with any applicable change control provisions set out in the Quality Agreement.

 

2.8             The Supplier may not change or permit the change of any Manufacturing Site other than as provided for in the Long Term Transfer Plan without the prior written consent of the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed), provided that any change of any Manufacturing Site (other than any provided for in the Long Term Transfer Plan) shall:

 

(A)            be subject to any applicable change control provisions set out in the Quality Agreement; and

 

(B)          comply with Applicable Law.

 

2.9          In the event that Applicable Law or a Governmental Entity or local customs office requires that the Parties (or their Affiliates) enter into a local agreement in relation to the Manufacture or supply of a particular Product by the Supplier (or its Nominated Supplier) to the Purchaser (or its designated Affiliate), the Parties shall negotiate in good faith and enter into such local agreements on a Product-by-Product and country-by-country basis to give effect to the transactions contemplated by this Agreement in relation to such Product in such country, provided that :

 

(A)          the Parties shall only enter into such local agreements where required by Applicable Law or a Governmental Entity or local customs office to do so;

 

(B)          each such local agreement shall be limited in scope to those matters for which it is necessary for the Parties (or their Affiliates) to contract locally;

 

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(C)          subject to clause 2.9(B), each local agreement shall be consistent with the terms of this Agreement and not have an disproportionate adverse effect on either Party;

 

(D)          the Parties shall procure that, in respect of any Product, such local agreement is terminated in the event that this Agreement expires or is terminated in relation to such Product; and

 

(E)          subject to clause 2.9(A) and any requirements of Applicable Law, in the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of such a local agreement, the provisions of this Agreement shall prevail.

 

Without prejudice to the rights and obligations of the Parties under clause 10 ( Price and Price Adjustments ), to the extent there is an inconsistency between the provisions of this Agreement and the provisions of any local agreement, either Party may refer the matter to the Manufacturing and Supply Team which may agree a mechanism to address any such inconsistency.

 

2.10           The Supplier shall not be obliged to Manufacture and/or supply, and the Purchaser shall not be obliged to purchase, any Product if such Manufacture, supply or purchase would cause that Party to be in breach of Sanctions and Export Controls (including but not limited to debarred individuals and ITAR). U.S. export control and economic sanctions laws and the export control and economic sanctions laws of other countries, including but not limited to EU Member States, Singapore, and Switzerland, may govern the export, sale, and/or use of Products. The Purchaser shall be responsible for obtaining any required government authorisations under the relevant Sanctions and Export Controls.  Each Party to this Agreement agrees to comply fully with all relevant Sanctions and Export Controls to assure that no Product or any portion thereof is exported, sold, or otherwise transferred directly or indirectly, in violation of Applicable Law.

 

Manufacture and Supply from Delayed Site

 

2.11           Until the transfer of the Brazil Delayed Business to the Supplier’s Group:

 

(A)          the Supplier shall not commence Manufacture and supply under this Agreement of any Product for which the Delayed Site is the Manufacturing Site; and

 

(B)          each Delayed Site Transferring Product for which the Delayed Site is the Manufacturing Site shall be deemed not to be included in this Agreement until the Delayed Site Transferring Product Commencement Date.

 

2.12           In respect of each Delayed Site Transferring Product:

 

(A)          with effect from the Delayed Site Transferring Product Commencement Date, the Supplier shall commence Manufacture and supply under this Agreement of each Delayed Site Transferring Product for which the Delayed Site is the Manufacturing Site;

 

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(B)           Delayed Site Transferring Products which:

 

(i)              were ordered by the Purchaser’s Group in the ordinary course of business prior to the Delayed Site Transferring Product Commencement Date; and

 

(ii)          are scheduled to be delivered on or after the Delayed Site Transferring Product Commencement Date,

 

(as recorded in the Supplier’s Systems in the ordinary course of business on the Delayed Site Transferring Product Commencement Date) shall be deemed to have been ordered by the Purchaser under this Agreement pursuant to Firm Orders and shall be Delivered (and invoiced) in accordance with this Agreement.

 

2.13           Where not already provided in Exhibit 1 ( Products ), prior to the Delayed Site Transferring Product Commencement Date, the Parties shall agree, on a basis consistent with the terms of this Agreement, upon the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Manufacture of the relevant Delayed Site Transferring Product.

 

3.           FORECASTS AND ORDERS — PUSH/PULL

 

3.1             Forecasting and ordering of Product(s) under this Agreement shall be conducted:

 

(A)          on a pull Manufacturing basis in respect of Pull Products as set out in clauses 3.2 and 3.4;

 

(B)          on a push Manufacturing basis in respect of Push Products as set out in clauses 3.3 and 3.4 and Exhibit 17 ( Push Products ); or

 

(C)          on a Toll Manufacturing Basis in respect of Push Products or Pull Products that are Tolled Products as set out in clause 5 ( Toll Manufacture ) and Exhibit 7 ( Toll Manufacturing Provisions ), and

 

(D)          in respect of both Pull Products and Push Products, on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for both Pull Products and for Push Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “ Forecast Schedule ”).

 

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3.2           Pull Products

 

(A)          Manufacturing and supply of Pull Products under this Agreement shall be pursuant to the Forecast Schedules (in each case as they relate to Pull Products) and to the Pull Firm Orders submitted by the Purchaser, as further described in this clause 3.2.

 

(B)          The initial Forecast Schedule is attached to this Agreement at Exhibit 14 ( Initial Pull Product Forecast Schedule ) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Pull Products and Push Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date (for both Push Products and Pull Products).

 

(C)          Provided that the volumes of Pull Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Pull Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Pull Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Pull Firm Order” ). Each Pull Firm Order shall be for not less than the Minimum Order Quantity of Pull Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity.  If the volumes specified in the Pull Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Pull Firm Order confirmation process set out at 3.2(E).

 

(D)          The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing.  No oral communications shall comprise a commitment to supply.  Each Pull Firm Order shall specify the volumes of Pull Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 ( Products ).

 

(E)          The Supplier shall respond to each Pull Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):

 

(i)              within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Pull Firm Order; and

 

(ii)             within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Pull Product required.

 

In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Pull Firm Order. Unless otherwise agreed by

 

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the Parties, the Supplier shall be obliged to acknowledge Pull Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments.  The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Pull Firm Order, the Purchaser shall respond to any proposed amendments to the Pull Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments.  If the Purchaser:

 

(iii)           accepts such amendments, the Pull Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or

 

(iv)           rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection.

 

The Parties agree that if the Parties cannot agree an amendment to the Pull Firm Order pursuant to this clause 3.2(E) that the Pull Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clause 16 ( Dispute Escalation ), in which case such matter shall be determined in accordance with clause 16 ( Dispute Escalation ).

 

(F)            The Purchaser, either electronically or by such other means determined by the Manufacturing and Supply Team, shall deliver to the Supplier purchase orders corresponding to the Pull Product volumes shown in the Pull Firm Orders to such location as reasonably requested by the Supplier in writing. The purchase order shall be in such form as is mutually agreed by the Manufacturing and Supply Team and shall specify the Pull Product(s) and country(ies) to which it relates; have assigned to it a number which shall be used by the Parties in all correspondence relating thereto and shall be submitted in accordance with the Lead Times set out in Exhibit 1 ( Products ) and the applicable Firm Zone for the Pull Product(s) shown in each Pull Firm Order so that the Supplier may process the Pull Firm Orders.

 

(G)           The Supplier will supply Pull Product in accordance with Pull Firm Orders that comply with this clause 3.2 and the applicable Gating Plan and for which the Supplier receives purchase orders in accordance with clause 3.2(F), unless such requirements are changed in accordance with clause 3.2(H) or clause 3.2(I).

 

(H)           Without prejudice to the Parties’ obligations with respect to the Firm Zone of any Forecast Schedule, if discussion of the relevant requirements of a Pull Firm Order is requested by the Supplier, then the relevant planning personnel from both Parties will discuss in good faith, provided that the Supplier shall have no obligation to agree any production schedule or Delivery timetable which would exceed the applicable Gating Volumes for the relevant Product as set out in the Gating Plan for that Gating Year.

 

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(I)             The Purchaser and the Supplier shall each establish a single point of ordering and forecasting in respect of Pull Products for the purposes of carrying out its obligations under this clause 3.2, subject to any agreed delegation of supply and/or invoicing and/or payment to Nominated Suppliers or other Affiliates of a Party in accordance with this Agreement.

 

3.3                               Push Products

 

(A)           Manufacturing and supply of Push Products under this Agreement shall be pursuant to the requirements for the forecasting and ordering of Push Products, as further described in Exhibit 17 ( Push Products ) and clause 3.1(D).

 

(B)           The Parties acknowledge that whilst they are contemplating supplying certain Products at the Barcelona and Puurs Manufacturing Sites on a Push Basis they acknowledge that this form of forecasting and ordering is dependent on the availability of the Purchaser System which is only expected to support the supply of Push Products on a Push Basis for a limited duration. If the Parties are unable to establish an alternative IT system to successfully manage the supply of Push Products on a Push Basis in good time before such the Purchaser System ceases to be available to both Parties to support such forecasting and ordering on a Push Basis then the affected Manufacturing Sites will have to agree a transition to forecasting and ordering on a pull order basis for all Push Products. For the avoidance of doubt supply of Push Product on a Push Basis is conditional on the Purchaser Systems being available to successfully support the forecast and order process set out in Exhibit 17.

 

3.4                               Products (both Pull Products and Push Products)

 

(A)           Bridging Stock shall not be treated on a different basis to any standard order of Product in the Forecast Schedules provided pursuant to this clause 3 ( Forecasts and Orders — Push/Pull ). The Parties acknowledge that through long term S&OP planning, arrangements will be made to manage and record long term planning of Bridging Stock.

 

(B)           Subject to clause 3.4(C) the Supplier shall ensure that on the day of Delivery in accordance with the Delivery Terms and clause 9 ( Delivery of Product ), and unless (i) agreed otherwise between the Parties on a Product-by-Product basis or (ii) a different percentage of registered shelf life is set forth on Exhibit 1 ( Products ) for the applicable Product, each Product shall have remaining at least seventy-five per cent. (75%) of their registered shelf life (with respect to each Product, the “ Minimum Remaining Shelf Life ”).

 

(C)           Other than in relation to an agreed list of exceptional circumstances there shall be no requirement for the Supplier to maintain a specific level of safety stock of Products or Materials. Where any exceptional agreement is reached for the maintenance of any safety stock for Materials, the Purchaser requesting the provision of such safety stock will: (A) at the discretion of the Supplier, bear the carrying cost (calculated at 7% financial interest plus actual warehousing costs if any) associated with such safety stock, and (B) bear the associated risk for such safety stock in each case due to (i) the expiry or termination of this

 

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Agreement in respect of any relevant Product; (ii) a change in the Forecast Schedule in respect of such Product; or (iii) a change in any Product requirements to the extent that any Materials comprising the safety stock do not comply with the applicable Specifications and Quality Standards or meet the other requirements of this Agreement, provided that the Supplier shall use reasonable endeavours to mitigate such risk (for example, and without limitation, by applying a First in First Out inventory management system).

 

(D)           The Parties acknowledge that the Lead Time of one hundred and twenty (120) calendar days applicable to Products in Exhibit 1 ( Products ) on the Effective Date should be improved over time and the Supplier has resolved to use its Commercially Reasonable Efforts to reduce the Lead Time for all Product Technologies supplied under this Agreement to one hundred (100) calendar days within two (2) years from the Effective Date.

 

(E)            In relation to any Products that are (i) the subject of an ongoing technical transfer pursuant to this Agreement and (ii) have been identified in Exhibit 1 ( Products ) as Products where a full batch of such Product must be ordered (“ Batch Constrained Products ”), if during the implementation of the relevant technical transfer the Purchaser orders Batch Constrained Product at a quantity below the batch size set out against such Batch Constrained Product in Exhibit 1 ( Products ) or the requirements for a particular Manufacturing run of such Product does not consume a full batch, then the Parties shall discuss in good faith how to mitigate the potential wastage of unused Materials used in the proposed Manufacture of such Batch Constrained Product. If the Supplier agrees to proceed with the Manufacture of any Batch Constrained Product it shall be on the basis that the Supplier shall be entitled to charge the Purchaser for the cost (without applying any mark-up) of the unused Materials that cannot be recovered.

 

(F)            The provisions of this clause 3 ( Forecasts and Orders — Push/Pull ) are subject to the provisions of clause 4 ( Capacity Baseline and Gating Plan ) in the event that an Allocation is required to be made.

 

4.                                      CAPACITY BASELINE AND GATING PLAN

 

4.1                                Within the third Quarter of each Calendar Year following the Effective Date during the Term, the Parties shall meet (the “ Gating Meeting ”) to agree on a gating plan specifying the Manufacturing capacity for each Product Technology to be allocated to the Purchaser by the Supplier at each Manufacturing Site for each month within the next Calendar Year (each a “ Gating Year ”) based on:

 

(A)           a baseline indication of the Purchaser’s Group’s volume requirements (calculated on the basis of Products to be Delivered as opposed to Products ordered) as supplied in advance by the Purchaser to the Gating Meeting (the “ Target Gating Volume ”);

 

(B)           current available capacity at the relevant Manufacturing Sites supplied by the Supplier in advance to the Gating Meeting, taking due account of any actual or anticipated constraints on the capacity at any such Manufacturing Site for the

 

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Manufacture of relevant Products (including with reference to the applicable then-current Forecast Schedule and the Supplier’s other actual or anticipated operations at such Manufacturing Site) and taking account of any agreed New Product SKU volumes;

 

(C)           the then current Viscoelastics Requirements; and

 

(D)           planned transfers of Product under the Long Term Transfer Plan and any Specific Technology Transfers,

 

in each case for each of the Product Technologies at the relevant Manufacturing Sites for the relevant Gating Year under consideration (each a “ Gating Plan ”). The Gating Plan shall be approved by the Manufacturing and Supply Team. The initial Gating Plan for all Product Technologies and containing, inter alia, the Viscoelastic Requirements, is set out in Exhibit 6 ( Initial Gating Plan ) to this Agreement.

 

For the avoidance of doubt Gating Plans shall not include volumes of any Shared Chemical/API Product or Shared Packaging Material supplied under this Agreement. Further, even though the Viscoelastic Requirements are set on an annual basis for a five (5) year period, the Parties shall seek to agree the applicable monthly allocation of such Gating Volumes of the Viscoelastic Requirements for the applicable Gating Year at the relevant Gating Meeting.

 

4.2                                The Purchaser (or one of its Affiliates) shall place orders for Products for up to 90% of the Gating Volume for each Product Technology in the Gating Plan for the relevant Gating Year (“ Minimum Target Volume ”) on a take or pay basis, meaning that the Purchaser shall be obligated to pay the full Conversion Cost for all such Product up to the Minimum Target Volume for the relevant Product Technology irrespective of whether an order is placed for such Product, provided that the foregoing shall not apply:

 

(A)           if the Parties agree in writing in advance to mitigate the order shortfall by substituting or increasing an alternative volume of Product (whether from another Product Technology or a New Product SKU);

 

(B)           in circumstances where the Supplier, through no fault of the Purchaser, is unable to or otherwise does not supply the Products within the Product Technology up to the Minimum Target Volume; or

 

(C)           where the Supplier Delivers Products for that Product Technology that are Defective, or if such Product becomes Defective after Delivery to the Purchaser or its Affiliate, and in either case, the Supplier is unable to or otherwise does not supply replacement non-Defective Product in accordance with this Agreement.

 

If the Purchaser gives at least three (3) months’ advance notice in writing that it is not likely to meet the Minimum Target Volume for a Product Technology in a Gating Year the Parties agree to discuss any reasonable mitigation proposals in good faith (including the extent of any write-off of Materials) in the next S&OP

 

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Meeting and, if the Parties do not agree, the issue may be escalated in accordance with clause 4.5.

 

4.3                                The Parties shall agree a fixed Gating Volume for each of the eight (8) Gating Years after the Effective Date (2019 to 2026) for the Viscoelastic Products (the “ Viscoelastic Requirements ”) as part of the initial Gating Plan. At the expiry of the second anniversary of the Effective Date, the Parties shall meet through the Manufacturing and Supply Team to discuss in good faith whether there is any need to adjust the Gating Volumes in the Viscoelastic Requirements for each of the 2024 to 2026 Gating Years (taking due account of the status of the movement of Products under the Long Term Transfer Plan).  Any adjustment to such Gating Volumes for each of the 2024 to 2026 Gating Years shall be agreed in writing by the Parties.

 

4.4                                In addition and subject to the Viscoelastic Requirements, the Purchaser may request that the Gating Volumes for all other Product Technologies in any subsequent Gating Year’s Gating Plan at least match the capacity of a Product Technology available at a particular Manufacturing Site in the current Gating Year’s Gating Plan and the Parties shall consider such request in good faith, save that the Parties shall take account of actual usage of the previous year’s allocated capacity; agreed constraints on or commitments in relation to capacity; any Product divestments planned and mutually agreed upon by the Parties and the movement of Products in the Long Term Transfer Plan.

 

4.5                                If the Parties do not agree the Gating Plan by 30 September in the preceding Calendar Year to the Gating Year of the relevant Gating Plan or any matters relating to the Long Term Transfer Plan the matter shall be referred to the Manufacturing and Supply Team for resolution who shall respectively endeavour in good faith to resolve the matter presented to them as expeditiously as possible and shall take account of the factors set out in clauses 4.1, 4.7 and 4.8 to 4.10 . If any dispute related to the Gating Plan or Long Term Transfer Plan cannot be resolved within the Manufacturing and Supply Team within thirty (30) days after such request for referral, then the Manufacturing and Supply Team shall refer such dispute to the Executive Officers of each Party for resolution. If a referral is made to the Executive Officers, they shall meet by telephone or in person promptly to discuss the matter submitted and to determine a resolution in accordance with clause 16 ( Dispute Escalation ).

 

4.6                                Save as is provided in clause 4.3, once agreed in writing by the Parties by the Manufacturing and Supply Team, a Gating Plan for a Gating Year shall become binding on the Parties and Firm Orders shall be placed in accordance with the applicable Gating Volumes set out in such Gating Plan, except that Purchaser shall be entitled to place Purchase Orders deviating from the Gating Volumes of Product (aggregated on a Product Technology basis) agreed in the Gating Plan for that Gating Year by no more than an aggregate + / - 10% for the balance of the Gating Year provided however, that volumes agreed in any Firm Order already placed may not be varied.

 

4.7                                If in any Gating Year the Purchaser requests a volume increase in respect of a Product Technology of a Product by more than 10% above the Gating Volumes

 

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agreed for the Product Technology in the Gating Plan for the applicable period, the Supplier shall use Commercially Reasonable Efforts to ensure it has  sufficient Manufacturing capacity at the applicable Manufacturing Site to satisfy the Purchaser’s requested increase in volumes of such Product Technology, subject always to the overall capacity constraints of the relevant Manufacturing Site(s) and the considerations set out in clauses 4.8 to 4.10 below. For the avoidance of doubt, the Supplier shall have no obligation to supply Product in excess of 110% of the Gating Volumes of relevant Product set out in the Gating Plan for the relevant period in the relevant Gating Year if unable to do so despite having used Commercially Reasonable Efforts to supply up to 110% of the Gating Volumes referred to above.

 

4.8                                The Supplier shall ensure that it has sufficient capacity over the applicable Product Term to meet the demand which will be agreed for a Product in the Gating Plan. If the Supplier, a Nominated Supplier or a Permitted Subcontractor is unable to Manufacture the quantities of Products forecasted or ordered by the Purchaser in accordance with this Agreement as a result of:

 

(A)           shortages of Materials that are used both in the Manufacture of Products and in the manufacture of products for the Supplier’s Group or its Third Party customers; or

 

(B)           constraints on the capacity at:

 

(i)             the Manufacturing Site; or

 

(ii)            any manufacturing site operated by the Supplier’s Group at which any Materials are manufactured,

 

(the “Affected Site” ), in each case including as a result of any repair or remediation being required in respect of the Affected Site or any equipment at the Affected Site that is used in the Manufacture of Products or Materials (as applicable),

 

then, without prejudice to the capacity threshold in the Gating Plan and clause 32 ( Force Majeure ), clauses 4.9 and 4.10 shall apply.

 

4.9                                In the circumstances contemplated by clause 4.8, the Supplier shall (or shall procure that the Nominated Supplier or Permitted Subcontractor shall) refer the decision as to how to allocate the available Materials, or available capacity at the Affected Site to the Manufacturing and Supply Team who shall make such allocation, between:

 

(A)           the Products;

 

(B)           products manufactured by the Supplier’s Group for commercialisation by the Supplier’s Group that rely on the same Materials or Affected Site; and

 

(C)           products manufactured by the Supplier’s Group for commercialisation by its Third Party customers that rely on the same Materials or Affected Site,

 

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(collectively, the “ Affected Products ”) in a fair and reasonable manner as if all Affected Products were to be commercialised by and for the sole benefit of the Supplier’s Group, taking account of all relevant factors, including the indications of each Affected Product, the risk and likely duration of any stock out of each Affected Product, the availability in the relevant jurisdiction of alternatives to each Affected Product and whether or not each Affected Product is medically critical (the “ Allocation ”).

 

4.10                         In the circumstances contemplated by clause 4.8:

 

(A)           the Purchaser shall, on request, provide the Manufacturing and Supply Team and the Supplier, Nominated Supplier or Permitted Subcontractor with such information as the Supplier, Nominated Supplier or Permitted Subcontractor may reasonably require in order to determine the Allocation in accordance with clause 4.9;

 

(B)           notwithstanding anything to the contrary in clause 3 ( Forecasts and Orders —Push/Pull/Toll ), each Firm Order shall be deemed to be revised (as to quantities of Products and/or Delivery dates, as applicable) to the extent necessary to accord with the Allocation as determined by the Manufacturing and Supply Team (and the Purchaser shall be deemed to agree with such revision) and the provisions of clause 25 ( Write Off Costs ) shall not apply to such change in volume; and

 

(C)           for the purposes of clause 9 ( Delivery of Product ), the due date for Delivery in respect of any Firm Order shall reflect any revision to such Firm Order  made pursuant to this clause 4.10.

 

4.11                         The Purchaser shall ensure that the quantities of Product shown in the Forecast Schedule do not, at the time such quantities first appear in the Firm Zone, exceed, on an annual basis, the available capacity at the relevant Manufacturing Site as mutually agreed in the Gating Plan and that Purchaser shall order and acquire ninety per cent (90%) of the Gating Volumes in any Gating Plan.

 

5.                                      TOLL MANUFACTURE

 

5.1                                The Parties agree that:

 

(A)           as at the Effective Date the Viscoelastics Products shall be Tolled Products Manufactured on a toll (zero cost, consignment) manufacturing basis (“ Toll Manufacturing Basis ”) and that the Purchaser proposes to supply the API, syringes, and security/safety device as Materials for the Viscoelastics Products (the “ VE Toll Materials ”) to the Supplier on a Toll Manufacturing Basis; and

 

(B)           at any time during the Term, the Purchaser may propose that a Product (including a New Product SKU introduced, or proposed to be introduced, pursuant to clause 21 ( New Product SKUs )) shall be Manufactured on a Toll Manufacturing Basis) and any such proposal must identify the Materials that the Purchaser proposes to supply to the Supplier on a Toll Manufacturing Basis.

 

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5.2                                The Supplier shall consider each proposal made pursuant to clause 5.1(B) in good faith and shall not unreasonably refuse to Manufacture (or have Manufactured) the proposed Product(s) on a Toll Manufacturing Basis. The Parties agree that a refusal to Manufacture on a Toll Manufacturing Basis due to lack of site-readiness shall be deemed to be unreasonable; provided, that the Supplier may condition its acceptance of any proposal to Manufacture on a Toll Manufacturing Basis on the Supplier being given a reasonable amount of time, which shall be no less than three (3) months in length, to prepare any applicable Manufacturing Site for Manufacturing on a Toll Manufacturing Basis and the Purchaser shall cooperate with and provide such information as is reasonably necessary for such preparations.

 

5.3                                If the Parties agree that a Product shall be Manufactured on a Toll Manufacturing Basis it shall be Manufactured in accordance with this clause 5 ( Toll Manufacture ) and the terms set out in Part 1 of Exhibit 7 ( Toll Manufacture Provisions ) and further the Parties shall (each acting reasonably and in good faith) agree and execute a Tolled Product Exhibit in the form attached to this Agreement in Part C of Exhibit 7 ( Form of Tolled Product Exhibit ) (a form of which is  annexed to this Agreement at Part B of Exhibit 7 ( Form of Tolled Product Exhibit ) for the Viscoelastics Products). Each Tolled Product Exhibit shall specify (among other things):

 

(A)           the Trigger Date with effect from which the relevant Product (or proposed New Product SKU) shall be Manufactured on a Toll Manufacturing Basis;

 

(B)           if applicable (in accordance with paragraph 4 of Part 1 of Exhibit 7 (Toll Manufacture Provisions)), the Existing Materials Cost (as defined in Exhibit 7) at which the Purchaser shall purchase from the Supplier any stock-on-hand of the Materials that will, with effect from the Trigger Date, be supplied by the Purchaser on a Toll Manufacturing Basis, which Existing Materials Cost shall be calculated in accordance with paragraph 4.1 of Exhibit 7 (Toll Manufacture Provisions); and

 

(C)           the Supply Price (and the applicable Invoice Currency) at which the Supplier shall supply the relevant Tolled Product to the Purchaser when Manufacturing using Materials supplied on a Toll Manufacturing Basis, which Supply Price shall be calculated in accordance with clause 10.1, save that in calculating the Total Product Cost of any Tolled Product Manufactured on a Toll Manufacturing Basis, the Actual Cost (as defined in Exhibit 7)  paid (or payable) by the Purchaser or its Affiliates for Toll Materials shall be disregarded in calculating the Total Product Cost of that Tolled Product.

 

5.4                                With effect from the Effective Date in relation to the Viscoelastic Products and the Trigger Date for all other Products to be manufactured on a Toll Manufacturing Basis, the provisions of Exhibit 7 ( Toll Manufacture Provisions ) shall apply in respect of the Manufacture of the relevant Product.  Any product agreed to be supplied as a Tolled Product shall continue to be supplied on a Toll Manufacturing Basis unless mutually agreed by the Parties.

 

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5.5                                In respect of the Viscoelastic Product, the Parties acknowledge that as at the Effective Date the Supplier and Purchaser for the purposes of such Manufacture rely on interim systems, procedures and processes to manage such Manufacture on a Toll Manufacturing Basis (or with an equivalent capability in relation to the management of Manufacturing on a Toll Manufacture Basis) (the “ Interim Toll Manufacture Systems ”). The Parties agree that the Supplier shall be entitled to continue to Manufacture (or have Manufactured) that Product on a Toll Manufacturing Basis under this Agreement using those Interim Toll Manufacture Systems until the Parties have the capability to enable the Manufacture of the relevant Product(s) using new systems, procedures and processes that would enable the Manufacture of such Product(s) to continue to be undertaken on a Toll Manufacturing Basis taking account of the IT systems changes being implemented by both Parties after the Effective Date and both Parties shall use their Commercially Reasonable Efforts to implement and operate such new systems, processes and procedures as the Supplier may reasonably require (taking account of any updates to relevant IT systems) as soon as reasonably practicable in respect of any Viscoelastic Products following a request from the Supplier.

 

6.                                      PRODUCTS MANUFACTURED USING MATERIALS PURCHASED FROM PURCHASER

 

6.1                                If, in respect of a Product, a member of the Purchaser’s Group is at any time during the Term:

 

(A)           the supplier to the Supplier (or its Permitted Subcontractor) of any Materials used in the Manufacture of that Product; and

 

(B)           the Supplier (or its Permitted Subcontractor) purchases and takes title to such Materials from the Purchaser or its Affiliate,

 

the provisions of Exhibit 8 ( Purchaser Materials ) shall apply in respect of the Manufacture of the relevant Product. Products which contain Purchaser Materials shall be identified as such on Exhibit 1 ( Products ).

 

6.2                               For the avoidance of doubt, neither this clause 6 ( Products Manufactured using Materials Purchased from Purchaser ) nor Exhibit 8 ( Purchaser Materials ) shall apply in respect of any Product for which the Purchaser’s Group supplies Materials on a Toll Manufacturing Basis.

 

7.                                      SHARED CONTRACTS

 

7.1                                The Parties have agreed the following to achieve a Separation of the relevant part of each Shared Contract after Separation in accordance with 7.1(A) and 7.1(B) below. Until satisfactory Separation of a Shared Contract the Supplier and the Purchaser shall respectively use their Commercially Reasonable Efforts to maintain relationships under the Shared Contracts and continue to operate the Shared Contracts, including without limitation fulfilling all their respective obligations under such Shared Contracts in the same manner as applied for the twelve months prior to the Separation in accordance with the terms of the

 

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Separation Agreement (where it is acknowledged that the obligation to transfer or separate the Shared Contracts has been delayed).

 

(A)           Where the Purchaser requires the Supplier to continue to procure a Chemical/API or Shared Packaging Material which is subject to a Shared Contract under the terms of a Shared Contract for incorporation in a Product being supplied under this Agreement then such Shared Chemical/API will be deemed to comprise a “Purchaser Material” under this Agreement and the terms of clause 6 and Exhibit 8 ( Purchaser Materials ) shall apply.

 

(B)           Where the Purchaser requires the Supplier to continue to procure a Chemical/API or Shared Packaging Material which is subject to a Shared Contract under the terms of a Shared Contract for incorporation in a product of the Purchaser that will not be Manufactured under this Agreement, then such Chemical/API will be deemed to comprise a “Shared Chemical/API Product” or a Shared Material under this Agreement and the terms of clause 8 shall apply.

 

8.                                      SHARED CHEMICAL/API PRODUCT/SHARED PACKAGING MATERIAL

 

Where the Purchaser requires the Supplier to continue to procure a Chemical or API or any packaging Materials under the terms of a Shared Contract for incorporation into a product of the Purchaser that will not be Manufactured under this Agreement, but requires the Supplier to provide testing or other quality related services in relation to that Shared Chemical/API Product or Shared Packaging Material, then all other terms and conditions of this Agreement apply in respect of that Shared Chemical/API Product or Shared Packaging Material as if it were a Product, save that the Supplier shall not be obliged to incur any greater cost or expense than would apply to the supply of the applicable Shared Chemical/API Product or Shared Packaging Material under the relevant part of the Shared Contract and the terms of Schedule 2 of the Separation Agreement shall apply to any Liabilities incurred under or in respect of, and any rights arising in relation to, the relevant part of such Shared Contract.

 

9.                                      DELIVERY OF PRODUCT

 

9.1                                Under the terms of this Agreement Delivery of Product by the Supplier shall commence on or following the applicable Commencement Date and all provisions of this clause 9 ( Delivery of Product ) (including references to the Product Term) apply from the applicable Commencement Date.

 

9.2                               Delivery Terms

 

The Supplier (or the Nominated Supplier) shall Deliver or procure the Delivery of the Product specified in the Firm Order for that month on the date confirmed for Delivery by the Supplier in the Firm Order, within - eight (8) or +zero (0) days, in accordance with the Delivery Terms, provided that:

 

(A)           such Firm Order meets the requirements set forth in clause 3 ( Forecasts and Orders — Push/Pull ) and Exhibit 17 (Push Products), including the applicable Lead Time requirements as set out in Exhibit 1 ( Products ) for the Products covered by such Firm Order;

 

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(B)                               the quantity of Products Delivered by the Supplier (or the Nominated Supplier) may vary by ± ten per cent. (10%) from the quantities specified by the Purchaser in the relevant Firm Order. For the avoidance of doubt, such variance shall not constitute a breach of this Agreement by the Supplier and, without prejudice to clause 17 ( Acceptance of Product ), the Purchaser (or its relevant Affiliate) shall not be entitled to reject any Delivery on the basis of such variance;

 

(C)                               the Supplier (or the Nominated Supplier) shall notify and confirm with the Purchaser of the actual Delivery date and quantities in accordance with clause 3.2(E) and notify any subsequent anticipated delay in Delivery or change in the actual Delivery date as promptly as practicable.

 

9.3                               Delivery Failure

 

(A)                               Where the quantity of Products Delivered is less than that required by the relevant Firm Order, the Parties shall enter into good faith discussions regarding replacements of such under-Delivered Products (where requested by the Purchaser), and, unless otherwise agreed by the Purchaser, in the event of any such Product shortfall greater than ten per cent. (10%) of a Firm Order or the Products are not delivered on the Delivery date (“ Delivery Failure ”), the Supplier shall use Commercially Reasonable Efforts to Deliver any such Product shortfall as soon as reasonably practicable after the original Delivery date in accordance with such Delivery schedule as may be mutually agreed between the Parties and in any event within ten (10) Business Days of the date specified for Delivery of the relevant Product.

 

(B)                               In the event of a Delivery Failure following the expiration of the period referred to in clause 9.3(A), for any Firm Order (or portion thereof) which cannot be Delivered, the Purchaser shall be entitled to either:

 

(a)                                 cancel such Firm Order (or the relevant portions thereof) without penalty to Purchaser; or

 

(b)                                 purchase replacement Product from a Third Party, and the Supplier shall be obliged to reimburse the Purchaser the difference between the recorded price paid for such replacement Product and the Supply Price that Purchaser would have paid to Supplier for the equivalent quantities of Product;

 

(C)                               In the event of a Delivery Failure following the expiration of the period referred to in clause 9.3(A), additionally or alternatively to the remedies in 9.3(B) above, the Purchaser shall be entitled to recover from Supplier any costs, expenses, fees, loss and liability (including legally binding commitments to pay out of pocket damages to end customers or third party suppliers) actually incurred by the Purchaser as a direct result of such Delivery Failure (subject always to the variance referred to at clause 9.3(B) above and any variation agreed by the Parties); and

 

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(D)                               Any delay in Delivery to the extent due to any reason listed below shall not be regarded as Delivery Failure:

 

(a)                                 Force Majeure;

 

(b)                                 Purchaser’s change of a Firm Order/Push Firm Order or any gross negligence on the part of the Purchaser; or

 

(c)                                  as specifically provided in respect of Purchaser Materials as set out in Exhibit 8 ( Purchased Materials ).

 

9.4                               The Supplier shall provide or procure the provision to the Purchaser (or its relevant Affiliate) with each Delivery the corresponding Manufacturer’s Batch Certificate (or Certificate of Analysis plus Certificate of Compliance) and any other agreed Delivery documentation (which shall include any documentation required by Applicable Law and, where applicable, the relevant Batch Record).  In respect of Shared Chemical/API Product, and where required by Applicable Law with respect to the Manufacture of Products using such Shared Chemical/API Product, Delivery documentation shall include written confirmation from the relevant Governmental Entity that the Manufacturing Site complies with standards of cGMP at least equivalent to those required for the Manufacture of APIs in the European Union.

 

9.5                               Risk in and title to the Products (other than Tolled Products) shall remain with the Supplier until Delivered in accordance with the Delivery Terms at which point it will pass to the Purchaser (or its relevant Affiliate).  Risk in and title to the Tolled Products shall pass in accordance with paragraph 5.4 of Exhibit 7 ( Toll Manufacture Provisions ).

 

9.6                               The Purchaser (or its relevant Affiliate as applicable) shall collect the Products Delivered from the agreed Delivery site within five (5) Business Days of the Delivery date set out by the Purchaser in the relevant Firm Order, or within five (7) Business Days of the Delivery date set out in the notice delivered by the Supplier (or the Nominated Supplier) pursuant to this clause 9.1, if different.

 

9.7                               If, pursuant to clause 9.1, the Supplier in any three (3) consecutive month period during the Term delivers quantities of Product that are, in aggregate, in excess of those specified in the relevant Firm Orders (disregarding the ± ten per cent. (10%) variance referred to in clause 9.2(B)), the Purchaser may, at its election and if such aggregate excess is at least equal to the applicable Minimum Order Quantity, delete a quantity equal to that aggregate excess from any pending Firm Order.  For the purposes of clause 3 ( Forecasts and Order — Push/Pull ), the Supplier shall be deemed to have agreed to any change to a Firm Order, or additional Firm Order, that the Purchaser may require pursuant to this clause 9.7.

 

9.8                               Without prejudice to the provisions of clauses 9.2 to 9.7 and subject to clause 9.9, in respect of Products to be exported from the country in which the applicable Manufacturing Site is located:

 

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(A)                               Unless the Parties agree otherwise or agree on alternate Delivery Terms for that Product, the Parties acknowledge and agree that in accordance with the FCA Delivery Terms (where applicable):

 

(i)             the Supplier (or the Nominated Supplier) shall be the exporter of record in respect of Products Delivered under this Agreement;

 

(ii)            the Purchaser (or its relevant Affiliate) shall be the importer of record and shall be responsible for all import formalities and responsible for arranging the transport or shipment of such Products from the territory in which they are Manufactured; and

 

(iii)           from time to time, in order to demonstrate to competent Governmental Entities that the Products have been exported from the territory of Manufacture and that the Supplier has charged the appropriate rate of applicable Sales Tax in respect of such Products, the Supplier may reasonably require original Export Documentation or a copy otherwise acceptable to the applicable Governmental Entity in relation to some or all of the Products Delivered under this Agreement.

 

(B)                               The Purchaser shall:

 

(i)             retain or cause the retention of originals or electronic copies of all Export Documentation in respect of Products Delivered under this Agreement; and

 

(ii)            except as requested by the Supplier pursuant to clause 9.8(A)(iii), require its Third Party logistics service provider to retain originals or electronic copies of all such Export Documentation,

 

in each case until the end of the seventh (7th) Calendar Year following the Calendar Year in which Delivery occurs.

 

(C)                               In the event that the Supplier requires Export Documentation in respect of any Products Delivered under this Agreement, the Supplier shall notify the Purchaser accordingly with reference to the invoice numbers to which the required Export Documentation relates and the Purchaser shall:

 

(i)             provide or procure the provision of electronic copies of such Export Documentation to the Supplier as promptly as reasonably practicable, and in any event within ten (10) Business Days of receipt of notice from the Supplier pursuant to this clause 9.8(C); and

 

(ii)            if so requested by the Supplier, use its Commercially Reasonable Efforts to provide or procure the provision of the following to the Supplier:

 

(a)                                 printed copies (certified to be true copies of the originals) of such Export Documentation as promptly as reasonably

 

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practicable and in any event within two (2) weeks of notice from the Supplier pursuant to this clause 9.8(C); and/or

 

(b)                                 originals of such Export Documentation as promptly as reasonably practicable.

 

9.9                               Clause 9.8 shall not apply if the Parties have agreed that Delivery of Products to be exported shall not occur on the basis of the FCA Delivery Terms, in which case the agreed Delivery Terms shall apply.

 

10.                               PRICE AND PRICE ADJUSTMENTS

 

10.1                        The initial Supply Price for Products for the 2019 Calendar Year shall be set out in Exhibit 1 ( Products ) of this Agreement (calculated as Base Price plus applicable Margin as set out in Exhibit 16, Part C). The Supply Price of each Product for any subsequent Calendar Year shall equal the Base Price for such Calendar Year (as adjusted in accordance with clause 10.4, if applicable) plus the applicable Margin.

 

10.2                        The “ Base Price ” for each Product shall be determined as follows:

 

(A)                               the Base Price for each Product for 2019 as set out in Exhibit 1 ( Products ) in local currency (being the actual price of a relevant Product for 2018 (comprising Total Product Cost and agreed variances from the 2018); and

 

(B)                               in each subsequent Calendar Year the Base Price for each Product shall be equal to the Base Price for that Product in the preceding Calendar Year, as adjusted in accordance with clause 10.4, if applicable.

 

10.3                        The “ Margin ” for each Product shall be determined in accordance with Exhibit 16, Part C.

 

10.4                        Within thirty (30) Business Days of receipt of the Gating Plan for the next Gating Year (as agreed in accordance with clause 4), the Supplier shall notify the Purchaser of the Base Price, the Margin and the Supply Price for each Product for the following Calendar Year during the applicable Term (each such notice, a “ Pricing Notice ”), such Pricing Notice shall include the inflation indices applied under clause 10.4(A) for each country. The Base Price for each Product for the following Calendar Year will be calculated as follows:

 

(A)                               Inflation Adjustments : the part of the then-existing Base Price corresponding to the Conversion Cost, overhead rate and the Supply Price Catalogue shall be adjusted by an amount equal to such part of the then-existing Base Price multiplied by the percentage increase or decrease in the most recently available prior twelve (12) months of the relevant index specified in Exhibit 18 ( Inflation Rate Source ) for the country in which such Manufacture takes place (“ Inflation Adjustment ”), provided, that if the relevant body does not report an index for the relevant country for the relevant period, the source of the relevant index shall be as mutually agreed by the Parties through the Manufacturing and Supply Team. Provided that the Inflation Adjustment will only be made for the country in which such Manufacture takes place if the percentage increase or

 

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decrease represented by the Inflation Adjustment exceeds 3% and then only to the extent of the incremental inflation amount above 3%. An illustrative example of the Inflation Adjustment is set out in Part A of Exhibit 16.

 

(B)                               Material Price Adjustments : the part of the then-existing Base Price corresponding to the Materials Cost shall be adjusted on an aggregate basis to reflect the full amount (and not just the amount above the threshold) of variations in the price of the Material components for the relevant Product Technology if the following thresholds are met by Manufacturing Site and by Product Technology for both the budget for the following Calendar Year and the end of year reconciliation, such thresholds being:

 

(i)                                     Chemicals / APIs +/- $150k

 

(ii)                                  All other Materials +/- 5%

 

(each a “ Materials Adjustment ”).  For purposes of this clause 10.4(B) , the variation in the price of the Material components shall be measured based on the average price paid by the Supplier for all volumes of such Material component at such Manufacturing Site.

 

(C)                               Volume Based Price Adjustments : a volume based price adjustment shall be applied to the Base Price as follows:

 

(i)                                     if the Target Gating Volume agreed in the Gating Plan for the next Gating Year for the aggregate of each Product Technology at each Manufacturing Site) deviates by more than +/- 5% compared to the 2018 baseline Gating Volume, the Supply Price per unit shall: (1) where volumes are less than the baseline Gating Volume, be increased; or (2) where volumes are greater than the baseline Gating Volume, decreased, by a percentage of the Conversion Costs (as set out in Exhibit 1 ( Products )) equivalent to the percentage of such entire Gating Volume deviation;

 

(ii)                                  the end of year Site Volume Reconciliation mechanism set out in clause 10.7 will be applied if at the end of Gating Year the actual Gating Volume of each Product Technology at each Manufacturing Site deviates from the Target Gating Volume (the “ Volume Based Adjustment ”).

 

Provided that

 

(iii)                               the Volume Based Adjustment shall not apply to the extent that the Gating Volume deviates downwards due to the Supplier’s inability to supply the relevant Product (including in the event of Force Majeure);

 

(iv)                              Product transfers included in the Long Term Transfer Plan in that Gating Year shall not be considered when calculating the Volume Based Price Adjustments to the Supply Price;

 

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(v)                                 in the case of termination by the Supplier pursuant to clause 40 (other than in the case where the Purchaser is in material breach) and a technical transfer plan applies, the mechanism above shall apply (i.e. the Volume Based Adjustment shall not apply to increase the Supply Price on the remaining Products). Similarly, if volume decreases as a result of Supplier request (e.g., early termination of Viscoelastics Products due to the decommissioning of the Inova Line), the Volume Based Adjustment shall not apply to increase the Supply Price on the remaining Products; and

 

(vi)                              in the case of any termination by the Purchaser pursuant to clause 40 (other than where the Supplier is in material breach), the volume adjustment pricing mechanism described in this clause 10.4(C) applies.

 

(D)                               the Base Price for the following Calendar Year shall be the sum of such adjusted parts of the Base Price calculated pursuant to clause 10.4(A) to 10.4(C). As shown in the illustrative example attached as an Appendix to Exhibit 16 ( Supply Price Adjustment and Catalogue ).

 

10.5                        The Supply Price catalogue indicating what should be included in the calculation of the Supply Price and what should form an additional service to be invoiced separately is set out in Exhibit 16 ( Supply Price Adjustment and Catalogue ).

 

10.6                        The Parties agree to review the Base Price and the application of the Supply Price mechanism referred to above at the end of the Initial Term. If no agreement is reached as to the basis for any such change, the current mechanism shall continue to apply.

 

10.7                        At the end of each Calendar Year, the Supplier shall calculate:

 

(A)                               in respect of each Product Technology:

 

A x CC

 

where:

 

(i)                                     A is the amount by which the actual volume of the relevant Product Technology is either greater than one hundred and five per cent. (105%) of the target Gating Volume (a positive value) or less than ninety-five per cent. (95%) of the target Gating Volume (a negative value); and

 

(ii)                                  CC is the applicable Conversion Cost of the relevant Product Technology,

 

and the results of these calculations shall be aggregated for each Manufacturing Site to determine the “Site Volume Reconciliation” .

 

(B)                               in respect of each Product Technology the Parties shall undertake a reconciliation of the amount determined through the Inflation Adjustment for that Product Technology against the actual percentage increase or decrease in the

 

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relevant index specified in Exhibit 18  ( Inflation Rate Source ) for the country in which such Manufacture takes place in the previous twelve (12 months) provided, that if the relevant body does not report an index for the relevant country for the relevant period, the source of the relevant index shall be as mutually agreed by the Parties through the Manufacturing and Supply Team in the original Inflation Adjustment (the “ Inflation Reconciliation ”).

 

(C)                               If the aggregate of the Inflation Reconciliation and the Site Volume Reconciliation is:

 

(i)                                     a positive sum, the Supplier shall issue a credit note to the Purchaser in respect of such sum and shall, at the Purchaser’s option, either:

 

(a)                                 apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliate; or

 

(b)                                 pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing; or

 

(ii)                                  a negative sum, the Supplier shall issue a debit note to the Purchaser in respect of such sum and the Purchaser shall pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing,

 

provided that (i) the debit/credit offset set out in this clause 10.7 may only be applied in the original currency of the Supply Price and as between the original parties to the supply relationship and not other members of their respective Groups and (ii) prior to the issuance of any credit note or debit note pursuant to this clause 10.7, the Manufacturing and Supply Team shall convene a meeting to review and discuss the Inflation Reconciliation and the Site Volume Reconciliation.

 

10.8                        The Purchaser shall respond to any Pricing Notice delivered by the Supplier to the Purchaser pursuant to Exhibit 16, Part C within thirty (30) days of receipt of the notice (or by such other date as agreed between the Parties) and such response will either acknowledge the Base Prices of the Products for the following Calendar Year or may, in good faith, propose such amendments as may be reasonably requested in accordance with this Agreement.  Unless otherwise agreed by the Parties, the Purchaser shall be obliged to acknowledge the Base Prices, without proposed amendments, which comply with the requirements of this clause 10 ( Supply Price ).  In the event that the Purchaser fails to respond to the Supplier’s Pricing Notice within thirty (30) days, the Purchaser shall be deemed to have acknowledged the Base Prices for the following Calendar Year.  The Supplier shall respond to any such proposed amendments to the Base Prices within five (5) Business Days confirming whether it accepts or rejects such proposed amendments.  In the event of any disagreement between the Parties regarding any adjustment to a Base Price, the matter shall be considered by the

 

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Manufacturing and Supply Team, in accordance with clause 15 ( Relationship Management ). During the pendency of any good faith dispute regarding an adjustment to a Base Price, the then current Base Price shall apply for all Firm Orders placed in accordance with this Agreement, and following the resolution of such good faith dispute the Supplier shall issue a credit or debit note (as applicable) to the Purchaser to reflect the difference between the Supply Price actually paid during such good faith dispute and the Supply Price that should have been paid had the Base Price from the start of the relevant Contract Year corresponded to the Base Price applicable as a result of such resolution of such good faith dispute.

 

10.9                        The Supply Price and any amounts payable or reimbursed pursuant to a Site Volume Reconciliation shall be exclusive of any Sales Tax or amounts in respect thereof that may be applicable to any payment, transaction or activity contemplated under this Agreement, which the Purchaser shall pay in addition to the Supply Price under presentation by the Supplier or its Nominated Supplier of a valid Sales Tax invoice (where applicable).

 

10.10                 Delivery shall be in accordance with the Default Delivery Terms unless otherwise agreed between the Parties.  Where, irrespective of the relevant Delivery Terms agreed in respect of a Product, the Supplier pays for any expenses, costs and charges in respect of freight, customs clearance (other than the costs of clearance for export under the FCA Delivery Terms) and/or insurance that are not included in the Supply Price, then the Purchaser shall reimburse the Supplier for such expenses, costs and charges.

 

11.                               INVOICE, PAYMENT AND CURRENCY CONVERSION

 

11.1                        From the applicable Commencement Date, the Supplier (or the Nominated Supplier) shall invoice the Purchaser, or any Affiliate of the Purchaser that the Purchaser designates to receive invoices by reasonable advance written notice to Supplier (or the Nominated Supplier), for Products Manufactured and supplied under the terms of this Agreement upon or following Delivery of such Products at the Supply Price in effect at the time the applicable Firm Order was placed.  Each invoice shall be in a form mutually agreed by the Parties, and shall include such information as is reasonably requested by the Purchaser, provided that each invoice issued pursuant to this clause 11.1 shall specify:

 

(A)                               the Purchaser’s (or its Affiliate’s) purchase order number;

 

(B)                               the Supply Price in respect of the Product Delivered denominated in the Invoice Currency;

 

(C)                               the quantity of the Product actually Delivered and SKU reference;

 

(D)                               the amount of Sales Tax due in respect of the Product Delivered; and

 

(E)                                any other amounts reimbursable to the Supplier or its Nominated Supplier pursuant to this Agreement.

 

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11.2                        Any amounts reimbursable to the Supplier or its Nominated Supplier pursuant to this Agreement other than the Supply Price for Product Delivered and any associated Sales Tax may be invoiced and paid separately from any invoice relating to the Supply Price for Product Delivered and any associated Sales Tax.

 

11.3                        The Purchaser shall pay to the Supplier the Supply Price for the Products Delivered following the applicable Commencement Date pursuant to Firm Orders within sixty (60) days of receipt of invoice from the Supplier or its nominated Affiliate (the “ Payment Terms ”).

 

11.4                        The Purchaser shall pay or procure the payment of the invoices issued by the Supplier (or the Nominated Supplier) to the Supplier in the Invoice Currency for that Product within sixty (60) days of receipt of invoice from the Supplier or the Nominated Affiliate (as applicable) by electronic transfer to the account nominated by the Supplier or the Nominated Supplier in the invoice.

 

11.5                        If the Purchaser does not pay or procure the payment of any invoice when due, the Purchaser shall pay (or procure the payment of) to the Supplier (or the Nominated Supplier) interest on any outstanding undisputed amount at the rate set out in clause 53 ( Interest ).

 

11.6                        In the event that:

 

(A)                               either Party is required to pay any sum (other than the Supply Price) to reimburse the other Party for any costs or expenses incurred by that other Party; and

 

(B)                               those costs or expenses are incurred by that other Party in a currency other than the applicable Invoice Currency,

 

the amount to be paid by the first Party by way of reimbursement shall be calculated by the invoicing Party by calculating the United States Dollars (USD) or Invoice Currency (as applicable) equivalent using such invoicing Party’s then-current standard exchange rate methodology as applied in its external reporting.

 

12.                               ELECTRONIC SYSTEMS

 

12.1                        Subject to the Transitional Services Agreement and the Information Access Agreement, each Party shall take reasonable care to ensure that:

 

(A)                               nothing done by it or its Affiliates’ employees shall contaminate, corrupt, impair or adversely affect any of the other Group’s computers, computer software and computer data and, without prejudice to the generality of the foregoing, shall take due care to ensure that no invasive programs, “computer viruses” or “logic bombs” shall be introduced to any of the other Group’s computers, computer software or data; and

 

(B)                               it operates reasonably up to date commercially available anti-virus software, including regularly updating the virus signature files of such software, and an electronic firewall and such other technical safeguards as good IT practice

 

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requires in relation to network or IT infrastructure (in each case, to the extent that such network or infrastructure may connect to the other Group’s information technology) and in accordance with ISRM Security Standards.

 

13.                               QUALITY CONTROL

 

13.1                        The Supplier and the Purchaser shall enter into the Quality Agreement which shall govern matters relating to quality assurance, quality control and quality management systems with respect to the Manufacture of Products as more particularly set out therein.

 

13.2                        The Supplier or any Permitted Subcontractor will perform such quality assurance tests on Products as may be provided for in the Quality Agreement.

 

13.3                        The Supplier shall, or shall procure that any Permitted Subcontractor shall, maintain all records as necessary and appropriate to demonstrate compliance with cGMP and the Quality Standards.

 

13.4                        In the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of the Quality Agreement in respect of quality assurance, quality management and compliance with cGMP, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

14.                               KEY PERFORMANCE INDICATORS

 

14.1                        Subject to clause 14.2, the Parties have agreed for all Products a set of (i) operational Key Performance Indicators and (ii) quality Key Performance Indicators, as set out in Part A and Part B of Exhibit 4 ( Key Performance Indicators ) respectively.

 

14.2                        The Parties acknowledge that in respect of KPI 1 (SDP) and KPI 2 (ASP) set out in Part A of Exhibit 4 ( Key Performance Indicators ) specific KPI targets for the Supplier shall not be implemented prior to 01 January 2020 and thereafter shall only be implemented following the establishment, by mutual agreement of the Parties, of:

 

(A)                               a baseline for KPI performance for KPI 1 (SDP) and KPI 2 (ASP) in the 2019 Contract Year; and

 

(B)                               specific KPI targets for KPI 1 (SDP) and KPI 2 (ASP) for the 2020 and 2021 Contract Years.

 

Either Party may escalate a failure to agree such KPI targets prior to 01 December 2019 through the dispute escalation and resolution process set out in clause 16 ( Dispute Escalation ).

 

14.3                        The Supplier shall use Commercially Reasonable Efforts to achieve:

 

(A)                               the Key Performance Indicators set out in Exhibit 4 ( Key Performance Indicators ) Part A and B (except for KPI 1 (SDP) and KPI 2 (ASP)), with the

 

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specific targets therefor (including any variations for specific Products or Manufacturing Sites);

 

(B)                               subject to agreement of the specific targets for KPI 1 (SDP) and KPI 2 (ASP) in accordance with clause 14.2,  KPI 1 (SDP) and KPI 2 (ASP) from the date of agreement of the specific targets for those Key Performance Indicators; and

 

(C)                               thereafter during the Term, the Key Performance Indicators as mutually agreed between the Parties through the Manufacturing and Supply Team.

 

14.4                        Without prejudice to clause 14.1, the Parties shall monitor the Supplier’s performance against the Key Performance Indicators at the S&OP Meetings in good faith with a view to improving such performance.

 

14.5                        Without limiting the Supplier’s obligation under clause 14.3 to use Commercially Reasonable Efforts, the Parties agree and acknowledge that any failure of the Supplier to meet the Key Performance Indicators shall not in and of itself amount to a breach of this Agreement, save that in respect of  KPI 1 (SDP) and KPI 2 (ASP) the bonus/malus incentive system set out in clause 14.6 and  Exhibit 4, Part C ( Key Performance Indictors ) shall be implemented during the annual budgeting process, once each Calendar Year.

 

14.6                        Subject to agreement of the specific targets for KPI 1 (SDP) and KPI 2 (ASP) in accordance with clause 14.2, the Parties shall calculate the percentage point variance against the agreed specific KPI targets allocated to each of KPI 1 (SDP) and KPI 2 in accordance with Exhibit 4, Part C  ( Key Performance Indictors ) and the following adjustment mechanism shall be applied in relation to the aggregate Supply Price for the relevant Calendar Year as part of the annual budgeting process:

 

(A)                               underachievement of the specific annual KPI targets for KPI 1 (SDP) and KPI 2 (ASP) shall lead to a Supply Price reduction by way of a credit note being issued to the Purchaser by the Supplier for an amount calculated in accordance with Exhibit 4, Part C ( Key Performance Indictors ) and the Supplier shall, at the Purchaser’s option, either:

 

(i)                                     apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliates; or

 

(ii)                                  pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing; or

 

(B)                               overachievement of the specific annual KPI targets for KPI 1 (SDP) and KPI 2 (ASP) shall lead to a Supply Price increase by way of a bonus payment payable by the Purchaser to the Supplier for an amount calculated in accordance with Exhibit 4, Part C  ( Key Performance Indictors ) in addition to the over total annual of Supply Price paid for that Calendar Year and the Supplier shall issue a debit note to the Purchaser in respect of such sum and the Purchaser shall

 

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pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing,

 

provided that (i) the debit/credit offset set out in this clause 14.6(B) may only be applied in the Invoice Currency and (ii) prior to the issuance of any credit note or debit note pursuant to this clause 14.6(B) the Manufacturing and Supply Team shall convene a meeting to review and discuss the adjustments contemplated in this clause 14.6.

 

(C)                               Any amounts payable or reimbursed pursuant to this clause 14.6 shall be exclusive of any Sales Tax or amounts in respect thereof that may be applicable to any payment, transaction or activity contemplated under this Agreement, which the Purchaser shall pay in addition to the Supply Price under presentation by the Supplier or its Nominated Supplier of a valid Sales Tax invoice (where applicable).

 

14.7                        Consequences of underachievement of KPIs.   If the Supplier fails to meet its KPI commitments under clause 14.3, then the Purchaser may request that the Supplier prepare a remediation plan. Upon request from the Purchaser, the Supplier shall, no later than forty (40) Business Days following the request, present a draft remediation plan to the Purchaser to discuss at the S&OP review meetings held in accordance with clause 15 ( Relationship Management ). Following the Purchaser’s approval of that plan, the Supplier shall implement that approved remediation plan, including any specific corrective actions that the Purchaser has requested as part of its approval. If the Supplier does not: (i) prepare a remediation plan within forty (40) Business Days following request; or (ii) diligently perform the actions required in the agreed remediation plan in all material respects, then the Purchaser may escalate the non-delivery or non-performance of the remediation plan (as applicable) to the Manufacturing and Supply Team.

 

15.                               RELATIONSHIP MANAGEMENT

 

15.1                        In relation to the Manufacturing Sites, the Parties shall each appoint a Customer Relationship Manager (each a “Customer Relationship Manager” ). The Customer Relationship Managers shall meet once a month for the purposes of sales and operations planning, including but not limited to reviewing and coordinating the forecasting and ordering and supply related activities of each of the Parties, review and discussion of available capacity at the relevant Manufacturing Site, any ongoing technical transfer activities, any ongoing issues (if any) with respect to the performance of this Agreement at that Manufacturing Site, forthcoming proposals for New Product SKUs affecting that Manufacturing Site and performance by the Supplier against Key Performance Indicators in relation to that Manufacturing Site (the “ S&OP Meetings ”).  Other representatives of the Parties (such as technical or quality personnel) shall attend S&OP Meetings at the invitation of either Customer Relationship Manager.

 

15.2                        The Parties shall, as soon as reasonably practical after the Effective Date, establish a manufacturing and supply team (the “ Manufacturing and Supply Team ”), led by a Contract Execution Manager nominated by each of the Parties

 

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(each a “ Contract Execution Manager ”), which shall remain in place from the Effective Date for the duration of this Agreement, for the purposes set out in clause 15.3. The Contract Execution Managers shall have overall oversight of and responsibility for implementation of this Agreement.

 

15.3                        The Manufacturing and Supply Team shall meet from time to time as frequently as is necessary, including as reasonably requested by either Party and shall meet in respect of Manufacture and supply of Products, and all other issues relating to the implementation of this Agreement, at least three (3) times in the first Contract Year and thereafter at least once in each subsequent Contract Year to review and discuss business relationship matters and other matters relating to the implementation of this Agreement (the “ Business Review Meetings ”).

 

15.4                        At the first Business Review Meeting, the Manufacturing and Supply Team shall establish its own terms of reference and those of its sub-teams (if any), including any thresholds for decision-making escalation, and each Party shall appoint regular representatives to attend meetings of the Manufacturing and Supply Team, including the Business Review Meetings.

 

15.5                        Neither the Manufacturing and Supply Team nor any sub-team or committee thereof shall have the authority to:

 

(A)                               amend or modify the terms of this Agreement or any other Transaction Document;

 

(B)                               expand the scope of its or their authority;

 

(C)                               waive any right that either Party may have pursuant to this Agreement or any other Transaction Document; or

 

(D)                               determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or any other Transaction Document.

 

15.6                        The teams and committees established under this clause 15 ( Relationship Management ) shall escalate any matters they are not able to resolve in accordance with the provisions of clause 16 ( Dispute Escalation ).

 

16.                               DISPUTE ESCALATION

 

16.1                        Any dispute or difference that is not the subject of resolution by reference to an Independent Expert under the terms of this Agreement, but which arises between the Parties under this Agreement and cannot be resolved by discussion shall be referred to the Customer Relationship Managers for determination (including upon receipt of a Dispute Notice pursuant to clauses 50.3 to 50.8). If the Customer Relationship Managers are unable to resolve the matter within ten (10) Business Days of its referral thereto, the matter shall be referred to the Contract Execution Managers for resolution.  If the Contract Execution Managers are unable to resolve the matter within twenty (20) Business Days of its referral thereto, the matter shall be referred to the Manufacturing and Supply Team for resolution. If the matter is not resolved by the Manufacturing and Supply Team

 

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within twenty (20) Business Days of its referral thereto, the matter shall be referred to the Executive Officers. If the matter is not resolved by the Executive Officers within twenty (20) Business Days of its referral thereto, the dispute escalation and resolution process under this clause 16 ( Dispute Escalation ) will be deemed to have been exhausted in respect of such matter and, notwithstanding that the time limits for resolution of disputes specified in this clause 16 may be extended by the written agreement of the Parties, each Party shall be free to pursue its rights under clauses 50.3 to 50.8 of this Agreement or Applicable Law in respect of such dispute without further reference to this dispute escalation and resolution process.

 

16.2                        Notwithstanding anything to the contrary herein, any matter referred to the Customer Relationship Managers, Contract Execution Managers, or the Manufacturing and Supply Team (as applicable, the “ Reviewing Body ”) for resolution pursuant to this clause 16 ( Dispute Escalation ) may, upon the determination of the Reviewing Body, be escalated to the next Reviewing Body prior to the expiration of the applicable review period if the Reviewing Body determines that it would be in the best interest of either Party to do so based on the significance of the matter and/or the potential harm caused by delaying such an escalation. The length of any reduced review period for such escalations shall be jointly agreed between the Parties (and ad hoc meetings to discuss such escalation shall be arranged by the relevant Reviewing Body) and conducted in accordance with such pre-defined terms of reference as agreed at the initial Business Review Meeting.

 

17.                               ACCEPTANCE OF PRODUCT

 

17.1                        The Purchaser or its relevant Affiliate shall not be entitled to reject any Delivery of Product except in accordance with this clause 17 ( Acceptance of Product ) or as set out in the Quality Agreement.  For the avoidance of doubt, if the Purchaser or its relevant Affiliate fails to check the Product or notify the Supplier (or the Nominated Supplier) within the agreed timeframes set out in clause 17.3 and the Quality Agreement, the Purchaser shall be deemed to have accepted the relevant Delivery of Product.  Without limiting the foregoing, the Supplier shall inform the Purchaser as soon as reasonably practicable and in any event within forty-eight (48) hours if a Delivery is delayed or stopped for any reason.  In such event, the Parties shall work together to agree on a plan (each acting reasonably and in good faith) to ensure the Delivery takes place as soon as possible thereafter and the Supplier shall implement such plan.

 

17.2                        Subject only to clauses 36 ( Warranties ) and 37 ( Indemnity and Liability ) and any termination rights under clause 40 ( Duration and Termination ), the remedies prescribed under this clause 17 ( Acceptance of Product ) shall be the sole and exclusive remedies of the Purchaser or its relevant Affiliate in relation to the quantity of Product Delivered under this Agreement and/or non-compliant, damaged or Defective Product Delivered.

 

17.3                        The Purchaser or its Affiliate shall visually inspect (but not be required to open the packaging of) the Product Delivered for variances and Defects and shall notify the

 

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Supplier (or, if directed by the Supplier, the Nominated Supplier and/or Permitted Subcontractor) in writing:

 

(A)                               within thirty (30) days of Delivery if there is an apparent Defect in the Product (in which case the Purchaser or its relevant Affiliate shall submit a sample of the allegedly Defective Product with such notice);

 

(B)                               within thirty (30) days of Delivery if there is any shortfall below or excess above the Delivery tolerance agreed in clause 9.1;

 

(C)                               within thirty (30) days of Delivery if there are any other Defects or non-compliance, whether or not this includes any quality or actual Defect; or

 

(D)                               during the relevant Product’s Minimum Remaining Shelf Life within thirty (30) days of discovery of a Defect if there is a Latent Defect.

 

17.4                        Complaints in connection with the Product will be handled in accordance with this Agreement and the Quality Agreement.

 

17.5                        If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor of a Product which is (or is alleged to be) damaged or Defective (including any Latent Defects) under clause 17.3 or under the Quality Agreement, the Purchaser or its Affiliate shall store, at Supplier’s expense, the Product concerned in quarantine in accordance with the Supplier’s, the Nominated Supplier’s or the Permitted Subcontractor’s reasonable instructions and give the Supplier, the Nominated Supplier and/or the Permitted Subcontractor reasonable opportunity to inspect and analyse the Product concerned.  On the Supplier’s request, the Purchaser shall return the Product concerned to the Supplier (or, if so directed by the Supplier, the Nominated Supplier or Permitted Subcontractor), at Supplier’s expense, but the Purchaser and/or its Affiliate shall be entitled to retain a sample for testing.  For the avoidance of doubt, any Product Actions resulting from any notifications made by the Purchaser or its Affiliate to the Supplier, the Nominated Supplier and/or the Permitted Subcontractor pursuant to this clause 17 ( Acceptance of Product ) shall be dealt with in accordance with clause 29 ( Product Action ).

 

17.6                        If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor under clause 17.3 or under the Quality Agreement, the Parties shall promptly endeavour to agree whether or not the Product in question is damaged or Defective, or if there was a shortfall or excess of Product on Delivery or a delay in Delivery of Product.  If no agreement is reached within twenty (20) days of the Purchaser’s (or its Affiliate’s) notice under clause 17.3 or under the Quality Agreement the matter shall be determined by an Independent Expert and the decision of the Independent Expert shall be final and binding on the Parties.  The Independent Expert’s fees shall be borne by the Party against whom the Independent Expert’s decision is given.

 

17.7                        To the extent that the Supplier agrees or the Independent Expert finds in favour of the Purchaser, then the Supplier shall either:

 

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(A)                               use its Commercially Reasonable Efforts to replace or procure the replacement of the Product(s) referable to the Delivery in question on a timeframe to be agreed between the Parties on a Product-by-Product basis, each acting reasonably and in good faith; or

 

(B)                               at the Purchaser’s election (acting reasonably), or where it is not reasonably practicable for the Supplier to replace or procure the replacement of the Product(s) referable to the Delivery in question within a timeframe acceptable to the Purchaser (and meet any reasonable associated transportation costs), refund the Purchaser for the Supply Price of such Delivery (if already paid); and

 

(C)                               in either case, the Purchaser shall be entitled to recover costs in accordance with clause 9.3(C),

 

and the Supplier shall, at its option, either promptly collect at its own expense any damaged or Defective Product from the Purchaser or its Affiliate or reimburse the Purchaser’s Group for any reasonable costs incurred in its disposal of such Product or in shipping such Product to the Supplier.  For the avoidance of doubt, the Purchaser shall have no obligation to pay the Supplier for any Product agreed or found to be damaged or Defective in accordance with this clause 17 ( Acceptance of Product ) unless such damaged or Defective Product is replaced free of charge pursuant to clause 17.7(A) and the Supplier shall reimburse the Purchaser for any amounts already paid for such Product where such Product is to be refunded and not replaced.

 

17.8                        If the Parties agree, or the Independent Expert finds, that a Delivery of Product complied with the Specification at the time of Delivery and was Manufactured in accordance with cGMP and the Quality Standards, or that there was no shortfall in the volumes Delivered, the Purchaser shall pay for such Delivery in accordance with this Agreement.

 

17.9                        The Parties agree that this clause 17 shall not place a requirement on the Supplier to rework or reprocess rejected Defective Products unless such activity has been expressly approved and authorised in writing by the Purchaser in accordance with the Quality Agreement.

 

18.                               REGULATORY MATTERS

 

18.1                        Each Party shall ensure that it, or shall procure that where relevant, its Affiliate, at its or their own cost, obtains and maintains throughout the Term all Governmental Entity certificates, permits, licences or approvals that it (or the relevant Affiliate) respectively requires for the purposes of this Agreement and for the performance of its obligations (or the obligations of its Affiliates) under this Agreement.

 

18.2                        Without prejudice to clause 18.1, the Supplier shall, or shall procure that the Nominated Supplier or Permitted Subcontractor shall, at its own cost, (A) obtain and maintain throughout the Term any Manufacturing Licences required in connection with the Manufacture of the Products, and (B) subject to Applicable Laws, provide to the Purchaser promptly upon reasonable request thereof copies of any documentation relating to such Manufacturing Licenses that are required

 

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for the Purchaser (or its Affiliate) to obtain or maintain its Governmental Entity certificates, permits, wholesale distribution licences, licences and approvals, including all Marketing Authorisations, referred to in clause 18.3, or to respond to any official requests or CMC-related questions from any Governmental Entity.

 

18.3                        Without prejudice to clause 18.1, the Purchaser shall (or shall procure that its Affiliates shall), at its own cost, obtain and maintain all Governmental Entity certificates, permits, wholesale distribution licences, licences and approvals, including all Marketing Authorisations, necessary for the Purchaser’s Group to export from the Delivery site, import to the destination Territory, distribute, sell and otherwise commercialise each Product (or, as applicable, Finished Products manufactured using Products) in the relevant Territory and is responsible for any interaction with the relevant Governmental Entity regarding such certificates, permits, licences and approvals.

 

18.4                        The Supplier shall notify the Purchaser as soon as reasonably practicable of any Governmental Entity inspection of Manufacturing Sites in respect of a matter relating to the Manufacture of the Products or of any other regulatory action taken or intended to be taken by a Governmental Entity in relation to the Manufacture of the Products in accordance with the Quality Agreement.

 

19.                               DOCUMENTATION AND REPORTS

 

19.1                        The Parties shall comply with the terms of the Information Access Agreement.

 

19.2                        The Supplier shall, or shall procure that any Nominated Supplier or Permitted Subcontractor (as applicable) shall:

 

(A)                               maintain complete and maintain the documentation relating to the Manufacture of each batch of the Products in accordance with cGMP (including, without limitation, Batch Records, analysis and data supporting each Certificate of Analysis and Certificate of Compliance) and in accordance with the Quality Agreement and shall retain such documentation for the periods set out in the Quality Agreement;

 

(B)                               supply to the Purchaser upon reasonable request copies of the documentation referred to in clause 19.2(A);

 

(C)                               keep complete and systematic records of any other documentation generated pursuant to this Agreement; such records to include any operational documentation relating to Manufacture of the Product, any financial records and procedures (including records for compliance with Applicable Laws), distribution and disposition records and all such other documentation relating to the Products and Manufacturing activities under this Agreement;

 

(D)                               preserve all records referred to in clause 19.2(C) in accordance with the relevant retention periods specified in the Quality Agreement (where applicable) and shall preserve any records not identified in such Quality Agreement for the greater of: (i) five years and (ii) such other period agreed in writing by the Parties; provided that , in the event a legal matter arises requiring preservation

 

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of certain records, the Supplier shall suspend destruction of such records as requested by the Purchaser or any Governmental Entity; and

 

(E)                                permit the Purchaser, its Affiliates and their respective representatives access upon reasonable request during Working Hours to all records retained pursuant to this clause 19 ( Documentation and Reports ).

 

19.3                        For the avoidance of doubt, nothing in clause 19.2(E) shall entitle the Purchaser, its Affiliates or their respective representatives to access financial records, which may be accessed only in accordance with clause 33 ( Audit and Inspection Rights ).

 

19.4                        In the event of any conflict or inconsistency between the provisions of this clause 19 ( Documentation and Reports ) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

20.                               PRODUCT SPECIFICATIONS

 

20.1                        None of the Supplier, a Nominated Supplier or any Permitted Subcontractor may undertake any change with respect to the Manufacture of the Products and/or the Specifications unless the change is first agreed between the Parties or is required by a Governmental Entity in accordance with the change control procedure set out in clause 16 of the Quality Agreement.

 

20.2                        Any change with respect to the Manufacture of the Product and/or the Specifications pursuant to clause 20.1 shall be implemented in accordance with the Quality Agreement.

 

20.3                        If a Governmental Entity requires any change to be made with respect to the Manufacture of the Product and/or the Specifications, the Parties shall, each acting reasonably and in good faith, use all reasonable endeavours to agree an action plan in relation to the implementation of such change within fifteen (15) Business Days of receipt of notice from the Governmental Entity of the required change.

 

20.4                        In the event of any conflict or inconsistency between the provisions of this clause 20 ( Product Specifications ) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

21.                               NEW PRODUCT SKUS

 

21.1                        The Purchaser may, from time to time and in accordance with this clause 21 ( New Product SKUs ), request that the Supplier Manufacture (or have Manufactured) and supply (or have supplied) New Product SKUs under this Agreement.  Any such request shall be accompanied by reasonable details of:

 

(A)                               the characteristics of the New Product SKU (including whether it would, if Manufactured and supplied pursuant to this Agreement, be a Product or a

 

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Shared Chemical/API Product and, if applicable, dose form, strength and number of doses);

 

(B)                               the anticipated market(s) to supply; and

 

(C)                               a non-binding volume plan for a period equal to the required duration of a Forecast Schedule for a Product or a Shared Chemical/API Product (as applicable) or, if shorter, until the scheduled expiration of the Term.

 

21.2                        The Purchaser must notify any request for a New Product SKU to the Supplier reasonably in advance of the first intended Delivery of such New Product SKU.

 

21.3                        Subject to clauses 21.3(A) and 21.3(B), upon receipt of a request pursuant to clause 21.1, the Supplier will consider such request in good faith and will conduct an impact assessment as soon as reasonably practicable, but in no event more than one (1) month other than in exceptional circumstances following Purchaser’s notice delivered under clause 21.1. Following such impact assessment, the Supplier and the Purchaser, acting through the S&OP Meetings, shall review and, if appropriate depending on the outcome of the impact assessment and subject to any amendments that may be agreed between the Parties, agree upon the proposal for the New Product SKU, on a basis consistent with the terms of this Agreement (including the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Manufacture of such New Product SKU and a budget for the estimated costs to be incurred in connection with such New Product SKU), provided that :

 

(A)                               no member of the Supplier’s Group shall be obliged to incur any Capital Expenditure in connection with the introduction of a New Product SKU (and any Capital Expenditure so incurred shall be at the cost and expense of the Purchaser);

 

(B)                               without prejudice to clause 23 ( Development Work ), any incremental costs incurred by any member of the Supplier’s Group associated with such New Product SKU shall be paid by the Purchaser, provided that (i) such costs are approved in advance in writing by the Purchaser; (ii) all such costs are reasonable and, insofar as they consist of amounts payable to any Third Party, are supported by invoices and (iii) no such costs shall be factored into the calculation of Total Product Cost of the New Product SKU.

 

21.4                        The Purchaser will provide a first non-binding forecast schedule in respect of each New Product SKU introduced in accordance with this clause 21 ( New Product SKUs ) not less than six (6) months prior to the first intended Delivery of such New Product SKU (or, if longer, a period equal to the Firm Zone for the New Product SKU).  Such forecast schedule shall be included in the rolling Forecast Schedule provided under clause 3 ( Forecasts and Orders — Push/Pull ).

 

21.5                        Any New Product SKU that is introduced in accordance with this clause 21 ( New Product SKUs ) shall be subject to the terms of this Agreement and shall, with

 

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effect from the date on which the Parties record in writing their agreement to add such New Product SKU to this Agreement, be deemed to be a Product.

 

21.6                        Following the introduction of a New Product SKU in accordance with this clause 21 ( New Product SKUs ), the Supply Price of that New Product SKU shall be adjusted in accordance with clause 10 ( Price and Price Adjustment ); provided, that the initial Supply Price for such New Product SKU shall be reviewed and mutually agreed by the Parties.

 

21.7                        In addition to clause 21.1, the parties have pre-agreed that certain in-flight projects as listed in Exhibit 5 ( New Product SKU — In-Flight Products ) (the “ New Product Launches ”) shall, subject to proposals for the in-flight projects being agreed by the Parties on a basis consistent with the terms of this Agreement (including the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Manufacture of such New Product SKU and a budget for the estimated costs to be incurred in connection with such New Product SKU) and the terms of this clause 21, be Manufactured under the terms of this Agreement.. Where the context permits, references in this Agreement to New Product SKUs shall be deemed to include the New Product Launches.

 

22.                               CAPITAL EXPENDITURE AND COSTS OF DEVELOPMENT WORK

 

22.1                        In the course of the S&OP Meetings and/or Business Review Meetings, the Parties shall discuss in good faith and seek to reasonably determine whether, over the course of the Forecast Schedule and the remaining Term, Capital Expenditure or cost for Development Work at any Manufacturing Site is or is likely to be required to meet anticipated demand and/or to mitigate any capacity constraints that have been identified under clause 3 ( Forecasts and Orders- Pull/Push ), clause 4 ( Capacity Baseline and Gating Plan ), and/or clause 15 ( Relationship Management ) over the following twenty-four (24) months or for any other reason. Provided that it is understood by the Parties that standard recapitalisation activity in respect of any Manufacturing line is already captured as part of Total Product Costs of the relevant Products on that Manufacturing line and no further adjustment is required for the Total Product Costs.

 

22.2                        Exhibit 13 ( Agreed Capital Expenditure ) sets out the agreed Capital Expenditure as at the Commencement Date and allocates responsibilities between the Parties for these known costs that are exceptions to the Total Product Cost.

 

22.3                        Where the Parties agree following good faith discussions that Capital Expenditure or cost for Development Work at Manufacturing Sites (in addition to the Agreed Capital Expenditure) is required in respect of the Manufacture of the Products  such Capital Expenditure and cost for Development Work shall to the extent that it relates to requirements arising or related to the period after the Commencement Date be at the Purchaser’s cost and expense, unless any such Capital Expenditure or cost for Development Work:

 

(A)                               is requested by an applicable Governmental Entity relating to an applicable Manufacturing process in respect of regulatory compliance, in which case the

 

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Purchaser shall bear no cost of such Capital Expenditures or cost for Development Work;

 

(B)           is related to investments for the establishment, maintenance or improvement of cGMP compliance relating to an applicable Manufacturing process, in which case the Purchaser shall bear no cost of such Capital Expenditures or cost for Development Work;

 

(C)           is triggered by a change in Materials or Manufacturing process requested by Supplier, in which case the Purchaser shall bear no Capital Expenditures or cost for Development Work; or

 

(D)           does not relate exclusively to the Products and does not fall within clause  22.3(A) or clause 22.3(C) above, in which case the Supplier and the Purchaser shall each bear a proportionate part of the cost of such Capital Expenditures  and costs for Development Work, taking into account the benefit through the Capital Expenditures and Development Work to the Product(s) compared to other products Manufactured or anticipated for Manufacture at that Manufacturing Site, provided that the costs and responsibility for such Capital Expenditures or costs shall be agreed in advance by the Parties.

 

For the avoidance of doubt, the costs and expenses to be borne by the Purchaser for Development Work shall, to the extent incurred by a member of the Supplier’s Group, be invoiced to the Purchaser by the Supplier apart from Total Product Costs.

 

22.4                         Notwithstanding anything else contained herein to the contrary, Purchaser shall not be responsible for costs incurred in connection with any remediation plan(s) required by a Governmental Entity or otherwise relating to legal compliance matters occurring prior to the Commencement Date.

 

22.5                         In the event that the Purchaser does not agree to meet the cost of any Development Work that is to be met by the Purchaser, then the Supplier shall not be under any obligation to undertake Development Work and shall have no obligation to Manufacture Product for the Purchaser where the failure to undertake Development Work would result in the Supplier being in breach of Applicable Law.

 

23.                               DEVELOPMENT WORK

 

23.1                         The Purchaser acknowledges that, with effect from the Effective Date, the Supplier will not be required to perform or procure the performance of any Development Work in respect of the Manufacture of any Product (including variations to Marketing Authorisations required as a result of such work), with the exception that the Supplier shall be obliged to perform any Development Work that is:

 

(A)           requested by an applicable Governmental Entity relating to an applicable Manufacturing process in respect of regulatory compliance;

 

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(B)           required by Applicable Law;

 

(C)           necessary in order to transfer a Marketing Authorisation or as contemplated by the Separation Agreement or the Transitional Distribution Services Agreement;

 

(D)           agreed between the Parties pursuant to clause 23.2;

 

(E)            necessary in connection with a technical transfer of the Manufacture of a Product or contemplated in the Long Term Transfer Plan.

 

23.2                         The Parties shall identify and agree on any Development Work that is required by Applicable Law in order to complete a Marketing Authorisation transfer or a Marketing Authorisation re-registration or a technical transfer of the Manufacture of a Product, including in accordance with the Long Term Transfer Plan or pursuant to the Separation Agreement, including with respect to the costs to be borne by each Party, and shall agree on timing for the performance of such Development Work.

 

23.3                         Save as provided in clause 22, any Development Work pursuant to this clause 23 ( Development Work ), and any associated Sales Tax, shall be at the Purchaser’s cost and expense, provided that (i) all such costs are reasonable and, insofar as they consist of amounts payable to any Third Party, are supported by invoices.

 

23.4                         Without prejudice to the generality of clause 23.3 but subject to the provisions of the Separation Agreement, in the event that any variation is required to be made to a Marketing Authorisation as a result of or in connection with any Development Work undertaken pursuant to this clause 23 ( Development Work ), the Purchaser shall bear the costs of such variation.

 

24.                               CONTINUOUS IMPROVEMENT PROGRAMME

 

24.1                         The Parties shall meet regularly, but no less than annually, to discuss potential areas of cost reduction applicable to the Manufacture of Products under this Agreement, including any reduction in Material Costs (for example, and without limitation, through the maximisation of usage of a bulk syringe line at the Puurs Manufacturing Site for Viscoelastic Products) and any potential Improvements.  The Parties shall agree on potential areas of cost reduction in writing and each Party may from time to time suggest Improvements to the other.  All cost reductions achieved by an Improvement agreed by the Parties shall be shared equally between the Supplier and the Purchaser.  The Parties shall determine (acting reasonably) whether a portion of the benefit of any Improvement accruing to the Purchaser shall be applied by way of a reduction in the Supply Price.

 

25.                               WRITE OFF COSTS

 

25.1                         The Purchaser shall reimburse the Supplier’s Group for any write-off costs (calculated in accordance with IFRS and the Novartis Control Manual) that the Supplier’s Group incurs for applicable Materials, API, work-in-progress, or Products to the extent caused by:

 

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(A)           any material failure on the part of the Purchaser to purchase the volumes of a Product shown in the Pull Firm Zone of any Forecast Schedule or the Push Firm Zone of any Forecast Schedule; or

 

(B)           any changes to the Manufacture of a Product requested by the Purchaser (including any changes to the Specifications or Artwork in respect of a Product),

 

in each case, such reimbursement to be made only to the extent that:

 

(i)             Materials have been reasonably purchased or ordered (a) in light of the volumes indicated in the Firm Zone of any Forecast Schedule or (b) as safety stock pursuant to clause 3.4(C); and/or

 

(ii)            work-in-progress or Products have been undertaken or Manufactured by or for the Supplier’s Group in light of the volumes indicated in the Firm Zone of any Forecast Schedule.

 

25.2                         Any write-off costs (calculated in accordance with IFRS) that the Supplier’s Group incurs for applicable Materials, API, work-in-progress, or Products held beyond reasonable levels in the context of binding Purchase Orders placed by the Purchaser (and not varied) should be for the account of the Supplier and not the Purchaser.

 

26.                               ARTWORK AND SHARED MOULDS

 

26.1                         The Supplier shall (or shall procure that the Nominated Supplier or Permitted Subcontractor shall) Manufacture the Products incorporating the Artwork used by the Supplier’s Group as at the Effective Date, subject to any subsequent changes made in accordance with Applicable Laws, the Separation Agreement and this clause 26 ( Artwork and Shared Moulds ).

 

26.2                         The Purchaser shall bear the costs of changing the Artwork as required by a Governmental Entity or Applicable Law, or which is otherwise requested by the Purchaser or any of its Affiliates.  If a change in Artwork leads to write off costs for stocks of old Artwork which can no longer be used for the purposes of Manufacturing the Products, such write off costs shall be dealt with under clause 25 ( Write Off Costs ).

 

26.3                         Save as provided in clauses 26.2 and 26.4, the Parties shall mutually agree on provisions regarding responsibility for undertaking any work related to any Artwork changes, including through the addition of any New Product SKU.

 

26.4                         The arrangements made by the Parties for the sharing of certain key moulds and tools by the relevant Manufacturing Sites are as further described in Exhibit 9 ( Shared Moulds ).

 

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27.                               SERIALISATION, AGGREGATION AND OTHER ANTI-FALSIFICATION REGULATIONS

 

27.1                         The Parties will agree responsibility for the application of Anti Falsification Regulations to the Products on a market-by-market basis, provided that serialisation of the Products or other measures implemented pursuant to Anti Falsification Regulations shall be subject to and in accordance with any applicable provisions of the Quality Agreement.

 

27.2                         Any changes to serialisation or other measures implemented pursuant to Anti Falsification Regulations will be carried out in accordance with applicable change control procedures set out in the Quality Agreement.

 

27.3                         Each Party shall bear their own costs in respect of any changes to serialisation or other measures implemented pursuant to Anti Falsification Regulations required, in accordance with Applicable Law, by either Party or any of their respective Affiliates, subject to any Capital Expenditure costs which shall be allocated in accordance with clause 22 (Capital Expenditure and Costs of Development Work) save that it is agreed that:

 

(A)           equipment costs, IT infrastructure costs and connectivity costs at the Supplier Manufacturing Site (in particular when the Supplier is using a Third Party interface provider)  arising in connection with the serialisation of Products or compliance with Anti Falsification Regulations, should be borne by the Supplier;

 

(B)           connectivity cost at the Purchaser (in particular when the Purchaser is using a Third Party interface provider) arising in connection with the serialisation of Products or compliance with Anti Falsification Regulations should be borne by the Purchaser;

 

(C)           costs of the Market Authorisation Holder arising in connection with the Anti Falsification Regulations (assuming the Purchaser is the Market Authorisation Holder) should be borne by the Purchaser.

 

27.4                         Serialisation of the Products or other measures implemented pursuant to Anti Falsification Regulations will be carried out in a manner consistent with the Purchaser’s Group’s systems and in accordance with such other technical requirements as may be agreed between the Parties.

 

28.                               PHARMACOVIGILANCE

 

On or prior to the Effective Date, the Parties shall enter (or shall procure that one of their respective duly authorised Affiliates enters) into the PV Agreement.  The PV Agreement will govern all pharmacovigilance obligations arising as a result of entry into and implementation of this Agreement as more particularly set out therein.  Each Party separately and independently undertakes that, if one of its Affiliates enters into the PV Agreement, that Party shall comply with its Affiliate’s obligations under the PV Agreement as if it were a party thereto.

 

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29.                               PRODUCT ACTION

 

29.1                         If a Governmental Entity requires a Product Action, or the Marketing Authorisation Holder deems it necessary under Applicable Law or customary industry practice to initiate a Product Action (whether as a result of a Party’s request or otherwise), each Party shall provide such assistance as the Marketing Authorisation Holder reasonably requests to facilitate such Product Action and, where applicable, in accordance with the PV Agreement.  The Marketing Authorisation Holder shall have final decision making authority with respect to Product Actions and related matters, including communications with Governmental Entities and the public.

 

29.2                         Where a Product Action is necessitated by a failure by the Supplier or its Affiliate to comply with its responsibilities under this Agreement, the Supplier shall at the sole discretion of the Purchaser, either:

 

(A)           replace the Product recalled; or

 

(B)           refund the Purchaser for the recalled Product; and

 

within sixty (60) days of receipt of an invoice for the same, reimburse the Purchaser for all documented and reasonable costs incurred by the Purchaser or its Affiliates in carrying out the Product Action.

 

29.3                         Each Party shall promptly provide to the other Party any information obtained by it suggesting that a Product Action is or may be necessary.  Further, the Parties shall cooperate in obtaining any additional information that may bear upon whether to initiate a Product Action and in carrying out the Product Action, including by providing or procuring the provision of any information reasonably requested by the other Party.

 

30.                               SUPPLIERS OF MATERIALS AND SHARED PACKAGING MATERIALS

 

30.1                         The Supplier shall, or shall procure that the Nominated Supplier or Permitted Subcontractor shall, be responsible for obtaining and maintaining all Materials necessary for the Manufacture of Products in accordance with this Agreement and Applicable Law, and shall be responsible for ensuring the quality of Materials provided by its suppliers, in each case, in compliance with cGMP and the Quality Standards.

 

30.2                         The Supplier agrees to use its Commercially Reasonable Efforts to source the Materials at a price and on terms and conditions (if any) that are at least as favourable, when taken as a whole, as the terms and conditions of agreements which the Supplier has entered in respect of the supply of materials for its own products or for another customer of the Supplier’s products in the past 12 months.  The assessment of terms will only apply in relation to the supply of materials for products that are the same in all material respects to the Materials including, but not limited to:

 

(A)           the same or broadly equivalent specification;

 

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(B)           of equal or better quality;

 

(C)           for substantially the same volume;

 

(D)           to be supplied over the same or broadly equivalent term; and

 

(E)            delivery of the products to the same geographical area.

 

Without limiting the foregoing, the Supplier will use Commercially Reasonable Efforts to source the Materials at reasonably competitive pricing, terms, and conditions.

 

30.3                         The arrangements for contracts and arrangements relating to the supply of Materials which, as at the Commencement Date, are sourced for both Parties from a single Shared Chemical/API Product Supplier or Shared Packaging Materials Supplier are as further described in clauses 7 to 8 (inclusive) and Exhibit 8 ( Purchaser Materials ).

 

31.                               CONFIDENTIALITY

 

31.1                         No announcement, communication or circular concerning the existence or the subject matter of this Agreement shall be made or issued by or on behalf of any member of the Supplier’s Group or the Purchaser’s Group without the prior written approval of the Supplier and the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed)   that contains any information, statement, fact or opinion that is not either (i) in the public domain prior to the date of this Agreement through no fault of any member of the Novartis Group or the Alcon Group, as applicable, or any of its respective directors, officers, employees, agents, accountants, counsel and other advisors and representatives; or (ii) disclosed in the Listing Prospectus, the Registration Statement or any document publicly filed in connection therewith.

 

31.2                         Subject to clause 31.4, each of the Parties shall treat as confidential and not disclose or use any Confidential Information received or obtained as a result of entering into this Agreement which relates to:

 

(A)           the existence and provisions of this Agreement or the other Transaction Documents; or

 

(B)           the negotiations relating to this Agreement or the other Transaction Documents.

 

31.3                         Subject to clause 31.4, each of the Parties shall treat as confidential and not disclose any Confidential Information of the other Party, and neither Party will use the other Party’s Confidential Information for any purpose other than to perform its obligations arising out of or in connection with this Agreement.  Each Party will ensure that its Affiliates and their respective officers, employees and Permitted Subcontractors comply with the obligations of confidentiality set out in this clause 31 ( Confidentiality ).

 

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31.4                         This clause 31 ( Confidentiality ) shall not prohibit disclosure or use of any information by a Party if and to the extent:

 

(A)           the disclosure or use is required by Applicable Law, any Governmental Entity or any stock exchange on which the shares of such Party (or its holding company) are listed;

 

(B)           the disclosure or use is required to vest the full benefit of this Agreement in such Party;

 

(C)           the disclosure or use is required for the purpose of any arbitral or judicial proceedings arising out of this Agreement;

 

(D)           the disclosure is made to a Tax authority in connection with the Tax affairs of such Party;

 

(E)            the disclosure is made to a ratings agency on a confidential basis in connection with the affairs of such Party;

 

(F)            the disclosure is made to professional advisers of such Party on a need to know basis and on terms that are no less restrictive than the provisions of this clause 31 ( Confidentiality );

 

(G)           the information was lawfully in the possession of such Party or its Affiliates without any obligation of confidentiality prior to such information being received from the other Party hereunder, as evidenced by written records and taking due account of the impact of the Separation on the ownership of such information with a view to preserving any rights of confidentiality that should survive such a Separation;

 

(H)           the other Party has given prior written approval to the disclosure or use; or

 

(I)             such disclosure or use is permitted under clauses 24 ( Continuous Improvement Programme ), 39 ( Intellectual Proper ty) or 42 ( Technical Transfer ) or any Transaction Document,

 

provided that prior to disclosure or use of any information pursuant to clause 31.4(A), (B) or (C), the Party concerned shall, where not prohibited by Applicable Law, promptly notify the other Party of such requirement with a view to providing the other Party with the opportunity to contest such disclosure or use or otherwise to agree the timing and content of such disclosure or use.

 

31.5                         Notwithstanding anything herein to the contrary, Confidential Information shall not include any information in the possession of either Party that:

 

(A)           is lawfully received by such Party or its Affiliates from a third party, without any obligation of confidentiality;

 

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(B)           is publicly available (other than by breach of this Agreement, the Separation Agreement, or any other agreement between or among the Parties or their Affiliates); or

 

(C)           is independently developed by such Party, as evidenced by contemporaneous documentation.

 

31.6                         On termination or expiration of this Agreement and subject to the provisions of clause 42 ( Technical Transfer ), each Party shall (i) return to the disclosing Party all Confidential Information furnished by the disclosing Party to the locations reasonably designated by the disclosing Party and (ii) at the disclosing Party’s sole discretion return, destroy or erase (in each case to the extent reasonably practicable) any copies of the disclosing Party’s confidential information and summaries thereof (whether tangible or intangible and whether or not created or provided by the disclosing Party) in the possession of the receiving Party or any member of the receiving Party’s Group thereof or any of their respective employees, consultants, agents, representatives, contractors or sub-contractors, except: (i) where such Confidential Information is required to be retained by either Party in compliance with Applicable Laws and (ii) that each Party shall be entitled to retain one copy of such Confidential Information, in addition to any archival copies on backup media created automatically in the ordinary course of business, for archival purposes only.

 

32.                               FORCE MAJEURE

 

32.1                         If any Force Majeure event occurs in relation to a Party, a Nominated Supplier or a Permitted Subcontractor which affects or may affect the performance of any of a Party’s obligations under this Agreement, that Party shall promptly notify the other Party as to the nature and extent of the circumstances in question.

 

32.2                         Neither Party shall deemed to be in breach of this Agreement, or shall be otherwise liable to the other Party, by reason only of any delay in performance, or the non-performance of any of its obligations, to the extent that the delay or non-performance is due to any Force Majeure event of which it has duly notified the other Party, and the time for performance of that obligation shall be extended accordingly.

 

32.3                         If the performance by either Party of any of its obligations under this Agreement is prevented or delayed by a Force Majeure event for a continuous period in excess of thirty (30) days, the Parties (or their Affiliates) shall enter into good faith discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable in the circumstances.

 

32.4                         If the performance by either Party of any of its material obligations under this Agreement is prevented or delayed by Force Majeure for sixty (60) days or more, either consecutively or cumulatively in any one Contract Year, then the other Party may terminate this Agreement, in whole or in part with respect to the applicable Product(s), immediately upon written notice.

 

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33.                               AUDIT AND INSPECTION RIGHTS

 

33.1                         Subject to clause 33.5, the Purchaser or its authorised representative shall be entitled, not more than once every two (2) Contract Years (unless for cause or in accordance with clause 33.2) per Manufacturing Site and in any event on not less than thirty (30) days’ prior written notice (unless for cause in which case the Purchaser shall provide reasonable notice), to enter and inspect the Manufacturing Site and any related plant, utilities, machinery and equipment used in the Manufacture of Products for the purposes of conducting an audit of compliance with the terms of this Agreement, the Quality Agreement and Applicable Law, including cGMP; provided, that such audit shall be conducted in accordance with the terms set forth in clauses 31.1 to 31.5 (inclusive) and shall be completed on or before the date that is seven (7) days after its initiation unless otherwise agreed by the owner and operator of the relevant Manufacturing Site.

 

33.2                         The Purchaser or its authorised representative shall also be entitled to carry out follow-up audits within two (2) Contract Years of the preceding audit if any critical observations have been noted during any audit conducted pursuant to clause 33.1.

 

33.3                         As far as reasonably practicable, the Purchaser or its authorised representative shall coordinate any audits conducted pursuant to this clause 33 ( Audit and Inspection Rights ) so as to minimise disruption to the Supplier and/or the Permitted Subcontractor.

 

33.4                         The Supplier shall, and shall procure that the Nominated Supplier or Permitted Subcontractor shall, use its Commercially Reasonable Efforts to ensure that any corrective and preventative actions identified in any audit (or follow-up audit) conducted pursuant to clause 33.1 or clause 33.2 are carried out as soon as reasonably practicable.

 

33.5                         In the event of a conflict or inconsistency between the provisions of clauses 33.1 to 33.4 (inclusive) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall (to the extent of such conflict or inconsistency) prevail.

 

33.6                         Subject to clause 33.7, the Purchaser shall be entitled, not more than once in each Calendar Year during the Term, to conduct an audit of records required to determine the correct calculation of Total Product Costs on which Supply Prices are based and the calculation upon which any other payment due under this Agreement is based.  In the first such audit the Purchaser shall also be entitled to audit any orders placed (or deemed placed) prior to the Effective Date that are scheduled to be delivered on or after the Effective Date.  In respect of Total Product Costs, each audit shall relate only to such Total Product Costs as have been set or revised since the Effective Date.

 

33.7                         Any audit undertaken pursuant to clause 33.6 shall be subject to the following conditions:

 

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(A)           the audit shall be performed by an internationally recognised independent auditor reasonably acceptable to both Parties acting under such obligations of confidentiality owed to the Supplier as the Supplier may reasonably require;

 

(B)           the Supplier shall be given not less than forty five (45) Business Days’ notice of any proposed audit under clause 33.6 and each such audit shall be conducted during Working Hours and completed on or before the date that is seven (7) days after such audit’s initiation unless otherwise agreed by the Supplier;

 

(C)           an audit with respect to the Supply Prices or Total Product Costs in any Calendar Year must be notified to the Supplier and initiated by the independent auditor prior to the end of the following Calendar Year and shall only extend to one Calendar Year;

 

(D)           the independent auditor shall, prior to its delivery to the Purchaser, provide a draft copy of any report to the Supplier for comment.  Any final report issued by the independent auditor will be made available to both Parties simultaneously promptly upon its completion (and the independent auditor shall take care not to disclose in that report any information or data in respect of which the Supplier owes a duty of confidence to a Third Party);

 

(E)            the Supplier shall provide the independent auditor with such documents and information as the independent auditor may require in order to determine whether the relevant Supply Prices accord with the relevant provisions of this Agreement;

 

(F)            if the independent auditor determines that any Supply Prices do not accord with the relevant provisions of this Agreement, and this discrepancy has led to the Supplier over-charging or under-charging the Purchaser for Products of any Product Technology Manufactured at any Manufacturing Site by an amount that is in aggregate not less than three (3%) of the sums paid by the Purchaser (or its Affiliates) to the Supplier for all Products of such Product Technology Manufactured at such Manufacturing Site in the twelve (12) months prior to the audit, then:

 

(i)             the Supplier shall issue a credit note or debit note (as applicable) to the Purchaser in respect of such difference; and

 

(ii)            the Supplier shall pay the fees of the independent auditor and all documented and reasonable costs incurred by the Purchaser in connection with that audit or inspection; and

 

(G)           subject to clause 33.7(F)(ii), the Purchaser shall pay the fees of the independent auditor.

 

33.8                        If pursuant to clause 33.7 the Supplier:

 

(A)           issues a debit note in respect of any under-charging, the Purchaser shall pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing; and

 

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(B)                                issues a credit note in respect of any over-charging, the Supplier shall (or shall procure that the Nominated Supplier shall), at the Purchaser’s option either:

 

(i)                                      apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliate ( provided that the offset may only be applied in the original currency and as between the original parties to the supply relationship and not other members of their respective Groups); or

 

(ii)                                   pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing.

 

33.9                         For the avoidance of doubt, clauses 33.6 to 33.8 (inclusive) do not apply to or include any Manufacturing audit or inspection, to which clauses 33.1 to 33.5 (inclusive) and the Quality Agreement apply.

 

34.                                ETHICAL STANDARDS AND HUMAN RIGHTS

 

34.1                         The Supplier warrants, to the best of its knowledge and belief, that in relation to its performance of this Agreement and unless otherwise required or prohibited by Applicable Law:

 

(A)                                it does not employ engage or otherwise use any child labour in circumstances such that the tasks performed by any such child labour could reasonably be foreseen to cause either physical or emotional impairment to the development of such child;

 

(B)                                it does not use forced labour in any form (prison, indentured, bonded or otherwise) and its employees are not required to lodge papers or deposits on starting work;

 

(C)                                it provides a safe and healthy workplace, presenting no immediate hazards to its employees.  Any housing provided by the Supplier to its employees is safe for habitation.  The Supplier provides access to clean water, food, and emergency healthcare to its employees in the event of accidents or incidents at the Supplier’s workplace;

 

(D)                                it does not discriminate against any employees on any ground (including race, religion, disability or gender);

 

(E)                                 it does not engage in or support the use of corporal punishment, mental, physical, sexual or verbal abuse and does not use cruel or abusive disciplinary practices in the workplace;

 

(F)                                  it pays each employee at least the minimum wage or a fair representation of the prevailing industry wage (whichever is the higher) and provides each employee with all legally mandated benefits;

 

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(G)                                it complies with Applicable Laws on working hours and employment rights in the countries in which it operates; and

 

(H)                               it is respectful of its employees’ right to join and form independent trade unions and freedom of association.

 

34.2                         In relation to its performance of this Agreement, the Supplier complies with and shall continue to comply with the Supplier Code set out in Exhibit 10 ( Standards and Policies ) and hereby gives the agreements, representations and covenants contained in that Exhibit.

 

34.3                         The Supplier is responsible for controlling its own supply chain and shall encourage compliance with ethical standards and human rights by any supplier of goods and services (including Materials) that are used by the Supplier when performing its obligations under this Agreement (including the Nominated Suppliers and Permitted Subcontractors).

 

34.4                         The Supplier shall ensure that it has ethical and human rights policies and an appropriate complaints procedure to deal with any breaches of such policies.  In the case of any complaints, the Supplier shall report the alleged complaint and proposed remedy to the Purchaser.

 

34.5                         The Purchaser reserves the right upon reasonable notice (unless inspection is for cause, in which case no notice shall be necessary) to enter the Supplier’s premises to monitor compliance with the provisions of this clause 34 ( Ethical Standards and Human Rights ) and Exhibit 10 ( Standards and Policies ) and the Supplier shall, subject to compliance with Applicable Laws, provide the Purchaser with any relevant documents requested by the Purchaser in relation thereto.

 

35.                                SAFETY HAZARDS

 

35.1                         The Supplier shall (or shall procure that the Nominated Suppliers and Permitted Subcontractor will) inform and keep the Purchaser informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Supplier (or the Nominated Suppliers or Permitted Subcontractor) knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of Product or any Materials.

 

35.2                         The Supplier shall ensure that all consignments of Product are safe, packaged and labelled so as to prevent any health risk to persons, property or the environment and properly marked with the appropriate internationally recognised danger symbols and that prominent hazard warnings appear in English (and/or any other language specified by the Purchaser) on all packages and documents.

 

35.3                         Without prejudice to its other obligations under this Agreement, the Supplier shall, and shall procure that the Nominated Suppliers or Permitted Subcontractor shall, comply with the Additional HSE Requirements in all matters relating to the performance of this Agreement.

 

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36.                                WARRANTIES

 

36.1                         The Supplier hereby warrants and undertakes that the Products supplied under this Agreement:

 

(A)                                shall conform to the applicable Specifications at the time of Delivery;

 

(B)                                shall be Manufactured in accordance with Applicable Law, including current Good Manufacturing Practice, the Quality Standards and terms set out in the Quality Agreement; and

 

(C)                                at Delivery in accordance with the Delivery Terms the shelf life of each Product shall meet the Minimum Remaining Shelf Life requirements.

 

36.2                         Except as expressly set out in this Agreement or another Transaction Document, none of the Supplier, the Purchaser or their respective Affiliates provides in respect of any Product or its Manufacture or supply under this Agreement any further or additional warranty or representation of any kind, express or implied and any warranties, representations, conditions or other terms that may be implied by statute or general law are, to the fullest extent permitted by law, excluded from this Agreement, including any implied warranties of merchantability or fitness for purpose.

 

36.3                         Each Party has obtained all corporate authorisations and (other than to the extent any such consent, license or authorisation constitutes a Global Condition (as defined in the Separation Agreement)) all other governmental, statutory, regulatory or other consents, licences or authorisations required to empower it to enter into and perform its obligations under this Agreement where failure to obtain them would adversely affect to a material extent such Party’s ability to enter into or perform its obligations under this Agreement.

 

37.                                INDEMNITY AND LIABILITY

 

37.1                         The Supplier shall be liable for and shall indemnify each member of the Purchaser’s Group (on an after-Tax basis) and defend the Purchaser and its Affiliates from and against any Third Party actions, proceedings, claims and demands brought against or incurred or suffered by the Purchaser and/or any of its Affiliates in respect of (i) death, illness or injury to any Third Party or for loss or damage to any Third Party’s property which arise directly as a result of a breach by the Supplier (or any Nominated Supplier or Permitted Subcontractor) of the provisions of this Agreement or the Quality Agreement or (ii) a violation of Applicable Law by Supplier (or any Nominated Supplier or Permitted Subcontractor), but in each case excluding to the extent that the same arise directly as a result of breach by the Purchaser or its Affiliates of its obligations under this Agreement or another Transaction Document.

 

37.2                         The Purchaser shall be liable for and indemnify each member of the Supplier’s Group (on an after-Tax basis) and defend the Supplier and its Affiliates from and against any Third Party actions, proceedings, claims and demands brought against or incurred or suffered by the Supplier and/or any of its Affiliates in

 

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respect of death, illness or injury to any Third Party or for loss or damage to any Third Party’s property which arise directly as a result of:

 

(A)                                the use, storage, sale, distribution or marketing of Products after Delivery by the Purchaser, its Affiliates and/or distributors (excluding the Supplier and its Affiliates); and/or

 

(B)                                any wilful default or gross negligence on the part of the Purchaser or its Affiliates arising under or in connection with the performance of this Agreement or the Quality Agreement,

 

but in each case excluding to the extent that the same arise directly as a result of breach by the Supplier or its Affiliates of its obligations under this Agreement or another Transaction Document.

 

37.3                         Subject to clauses 37.4, 37.5 and 37.6,

 

(A)                                for all Products other than the Viscoelastics Products, each Party’s liability under or in connection with this Agreement shall be limited in any Contract Year during the Term, whether in contract, tort or otherwise, to one hundred per cent. (100%) of the aggregate annual sales, at the Supply Price, of the Products supplied under this Agreement during that Contract Year (or in the first Contract Year, Products to be supplied to the Purchaser as set out in the Forecast Schedule); and

 

(B)                                for Viscoelastics Products, each Party’s liability under or in connection with this Agreement shall be limited in any Contract Year during the Product Term for the Viscoelastics Products, whether in contract, tort or otherwise, to the greater of: (i) USD$90 million or (ii) one hundred per cent. (100%) of the aggregate annual sales, at the Supply Price, of the Products supplied under this Agreement during that Contract Year (or in the first Contract Year, Products to be supplied to the Purchaser as set out in the Forecast Schedule) less the amount of any payments made or payable to the Purchaser under clause 37.3(A) in that Contract Year.

 

37.4                         Subject to clause 37.5, neither Party shall be liable to the other Party under or in relation to this Agreement or any other document issued or entered into under or in connection with this Agreement, in tort, as a result of negligence or wilful default, or otherwise howsoever (including, for the avoidance of doubt, under or in relation to any indemnity given in this Agreement) for:

 

(A)                                loss of profit;

 

(B)                                loss of anticipated savings;

 

(C)                                loss of business or business opportunities;

 

(D)                                loss of or damage to goodwill;

 

(E)                                 any indirect or consequential loss or damage; or

 

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(F)                                  any punitive or exemplary damages.

 

37.5                         Notwithstanding any other provision of this Agreement, nothing in this Agreement shall exclude or limit either Party’s liability for:

 

(A)                                the Purchaser’s liability to pay the Supply Price  under this Agreement;

 

(B)                                death or personal injury resulting from that Party’s or its Affiliate’s negligence or that of their respective officers, employees, agents or sub-contractors (as applicable);

 

(C)                                fraud or fraudulent misrepresentation by it, its Affiliates, or their respective officers or employees; or

 

(D)                                any other liability to the extent the same may not be excluded or limited as a matter of Applicable Law.

 

37.6                         The Parties agree that nothing in this Agreement is intended to limit the rights and obligations of any Party or its Affiliates under the Separation Agreement.

 

38.                                INSURANCE

 

Each Party shall procure and maintain at its own cost adequate insurance, which may be by means of self-insurance, reasonably necessary to cover its actual and potential liabilities under this Agreement (including in respect of the Supplier, any actions of its sub-contractors).

 

39.                                INTELLECTUAL PROPERTY

 

39.1                         On and subject to the terms set out in this Agreement, the Purchaser hereby grants to, and shall procure that each of its Affiliates grants to, the Supplier a non-exclusive, fully paid-up, worldwide, royalty-free licence (or sub-licence, as appropriate) during the Term to use the Intellectual Property Rights owned by or licensed to the Purchaser or any of its Affiliates for the purposes of performing its obligations under this Agreement.  The Supplier shall only use the Intellectual Property Rights of the Purchaser to the extent necessary for, and for the sole purpose of, Manufacturing and supply of the Products in accordance with the terms of this Agreement.

 

39.2                         The licence granted under clause 39.1 shall not apply in respect of any Intellectual Property Rights owned by or licensed to the Purchaser or any of its Affiliates which are licensed to the Supplier’s Group under any Transaction Document on terms that permit the use of such Intellectual Property Rights for the Manufacture and supply of Products pursuant to this Agreement.

 

39.3                         The Supplier may sub-license and/or assign to its Affiliates and Permitted Subcontractors any licences (or sub-licences, as appropriate) granted to it pursuant to clause 39.1.

 

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39.4                         The rights in and title to Improvements made after the Effective Date which give rise to Intellectual Property Rights shall be owned as follows:

 

(A)                                Intellectual Property Rights in an Improvement that is made solely by the Supplier and/or its Affiliates, without use of or reference to any Purchaser’s Group’s Intellectual Property Rights, shall be owned solely by the Supplier or its Affiliate;

 

(B)                                all Intellectual Property Rights in an Improvement that is made solely by the Purchaser and/or its Affiliates, without use of or reference to any Supplier’s Group’s Intellectual Property Rights, shall be owned solely by the Purchaser or its Affiliate.

 

(C)                                all Intellectual Property Rights in an Improvement that is made by either Party with use of or reference to the other Party’s Group’s Intellectual Property Rights, shall:

 

(i)                                      if it is capable of being used independently of the Purchaser’s Group’s Intellectual Property Rights but is not capable of being used independently of the Supplier’s Group’s Intellectual Property Rights, be owned by the Supplier or its Affiliate, and the Purchaser hereby assigns and undertakes to assign (and to procure that its Affiliates shall assign) all its rights in relation to such Improvements to the Supplier or its nominated Affiliate;

 

(ii)                                   if it is capable of being used independently of the Supplier’s Group’s Intellectual Property Rights but is not capable of being used independently of the Purchaser’s Group’s Intellectual Property Rights, be owned by the Purchaser or its Affiliate, and the Supplier hereby assigns and undertakes to assign (and to procure that its Affiliates shall assign) all its rights in relation to such Improvements to the Purchaser or its nominated Affiliate; and

 

(iii)                                if it is capable of being used independently of both the Purchaser’s Group’s Intellectual Property Rights and the Supplier’s Group’s Intellectual Property Rights, or if it is incapable of being used independently of either the Purchaser’s Group’s Intellectual Property Rights or the Supplier’s Group’s Intellectual Property Rights, be owned jointly by the Purchaser (or its Affiliate) and the Supplier (or its Affiliate).

 

39.5                         The Purchaser hereby grants (and shall procure that each of its Affiliates grants) to the Supplier and its Affiliates a non-exclusive, worldwide, royalty-free licence (with the right to grant sub-licences to Permitted Subcontractors) during the Term to use for the purposes of Manufacturing Products and otherwise performing its obligations and exercising its rights under this Agreement any Purchaser Improvement IP that would, but for the grant of such licence, be infringed by the Supplier, its Affiliates and/or its Permitted Subcontractors in performing those obligations or exercising those rights.

 

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39.6                         The Supplier hereby grants (and shall procure that each of its Affiliates grants) to the Purchaser and its Affiliates a non-exclusive, royalty-free licence to use for the purposes of commercialising the Products (or, as applicable, Finished Products manufactured using Products) in the Territory and otherwise performing its obligations and exercising its rights under this Agreement any Supplier Improvement IP that would, but for the grant of such licence, be infringed by the Purchaser and/or its Affiliates in performing those obligations or exercising those rights or in so commercialising the Products (or, as applicable, Finished Products manufactured using Products).

 

39.7                         Each Party hereby grants (and shall procure that each of its Affiliates grants) to the other Party and its Affiliates such non-exclusive, royalty-free, worldwide, sub-licensable (save as prohibited under clause 39)  perpetual, irrevocable and assignable licences, permissions or consents as may be required to confer on that other Party and its Affiliates the right:

 

(A)                                to use (and to license the use of) without restriction and free of charge throughout the world for any purpose;

 

(B)                                assign (or otherwise transfer) its interest in; and/or

 

(C)                                charge (or otherwise encumber) its interest in,

 

any Joint Improvement IP.

 

39.8                         With respect to all such Joint Improvement IP:

 

(A)                                the Parties shall cooperate in good faith, using counsel mutually agreed upon by the Parties and at the Parties shared (50%/50%) cost and expense, to diligently prosecute and maintain any patent rights contained therein;

 

(B)                                The Parties shall collaborate in good faith with respect to establishing and implementing a litigation strategy for enforcement of any Intellectual Property Rights contained therein against any infringement of such rights by a Third Party, (“ Third Party Infringement ”) which strategy shall at a minimum provide for:

 

(i)                                      where the Parties jointly agree to enforce such rights against such Third Party Infringement, (a) the Parties will join in, or be named as a party to such enforcement, (b) the costs and expenses of such enforcement shall be shared (50%/50%), and (c) the proceeds of any such enforcement shall be similarly shared (50%/50%);

 

(ii)                                   where a Party elects not to jointly enforce such rights against such Third Party Infringement, (a) the non-enforcing Party shall assist and cooperate with the enforcing Party, as such enforcing Party may reasonably request from time to time, including joining in, or being named as a party to, such enforcement, (b) the enforcing Party shall bear 100% of the costs and expenses of such enforcement, including the reasonable costs and expenses incurred by the non-enforcing Party

 

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in cooperating with and joining in such enforcement; and (c) 100% of the proceeds of any such enforcement shall accrue solely to the benefit of the enforcing Party; and

 

(iii)                                in no event shall either Party grant any licenses to or otherwise settle with any Third Party Infringement or potential Third Party Infringement without the other Party’s prior written approval such approval not to be unreasonably withheld, delayed, or conditioned.

 

39.9                         If a Party becomes aware of any claim alleging infringement of any Third Party Intellectual Property Rights related to a Product supplied under this Agreement, then it shall as soon as reasonably practicable notify the other Party.

 

40.                                DURATION AND TERMINATION

 

40.1                         This Agreement shall continue in force from the Commencement Date and shall automatically terminate as a whole on the date the last Product Term(s) expire unless terminated earlier in accordance with this clause 40 ( Duration and Termination ) or extended by written agreement of the Parties (the “ Term ”).

 

40.2                         Product Term for Droptainer Products in the Long Term Transfer Plan : the Long Term Transfer Plan aims to achieve successful completion of technical transfers of the Droptainer Products listed in it within five (5) years of the Commencement Date in order to achieve Separation of the Droptainer Product portfolio and balance capacity utilisation between the Puurs, Barcelona, Singapore and Aspex/Fort Worth Manufacturing Sites. Unless terminated earlier in accordance with this clause 40,  Droptainer Products in the Long Term Transfer Plan shall have a Product Term with a designated termination date of no more than five (5) years from the Commencement Date (with the last date of Manufacture of each Droptainer Product in the Long Term Transfer Plan being designated for the relevant Manufacturing Site and successful completion of technical transfer of each such Droptainer Product occurring within that five (5) year term), subject to any modifications to the Long-Term Transfer Plan as mutually agreed by the Technical Transfer Team in accordance with clause 15 ( Relationship Management ).

 

40.3                         Product Term and convenience termination for all Products not included in the Long Term Transfer Plan, other than Products at the Delayed Site: unless terminated earlier in accordance with this clause 40, the term of this Agreement for each such Product will be a fixed period of three (3) years from the Commencement Date (“ Initial Term ”) and shall continue thereafter in respect of such Product until this Agreement is terminated for convenience as follows:

 

(A)                                by the Purchaser (in whole or in part, including on a Product-by-Product basis) giving at least three (3) years’ prior notice to the Supplier, such notice not to be served prior to the end of the Initial Term; and

 

(B)                                by the Supplier (in whole or in part, including on a Product-by-Product basis) giving at least five (5) years’ prior notice to the Purchaser, such notice not to be served prior to the end of the Initial Term;

 

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provided, that for any New Product SKU (i) if the Commencement Date for such New Product SKU is a date prior to the third (3rd) anniversary of the Effective Date, the Initial Term shall begin on the Commencement Date and end on the third (3rd) anniversary of the Effective Date; and (ii) if the Commencement Date for such New Product SKU is a date after the third (3rd) anniversary of the Effective Date, there shall be no Initial Term and this Agreement may be terminated on notice in accordance with clauses (A) and (B) above or such earlier date where notice of termination of this Agreement as a whole  in respect of the Original Product has been given prior to the New Product SKU Commencement Date.

 

40.4                         Product Term and convenience termination for Products at the Delayed Site : unless terminated earlier in accordance with this clause 40, the term of this Agreement for each such Product will be a fixed period of three (3) years from the Effective Date (“ Delayed Product Initial Term ”) and shall continue in relation to each such Products thereafter in respect of such Product until this Agreement is terminated for convenience by either Party (in whole or in part, including on a Product-by-Product basis) on giving at least three (3) years’ prior notice to the other Party, such notice not to be served prior to the end of the Delayed Product Initial Term.

 

40.5                         Convenience termination of a Product at a Manufacturing Site by the Purchaser: the Parties shall enter good faith discussions (each acting reasonably) with a view to the early termination of a Product at a Manufacturing Site by the Purchaser of that Product where the Purchaser can demonstrate that it can mitigate the removal of that volume of Product from this Agreement for the balance of the Initial Term or Delayed Site Initial Term (as applicable) and the contemplated three year notice period with either (i) the substitution of other products of the same Product Technology to be Manufactured for the Purchaser at that Manufacturing Site; or (ii) an increase in volumes of other Products of the same Product Technology Manufactured at the Manufacturing Site.

 

40.6                         The terms referred to in clauses 40.2 to 40.5 shall each be referred to in this Agreement as a “Product Term” in respect of the Product(s) referred to in the relevant clause.

 

40.7                         The Parties may jointly terminate this Agreement (in whole or in part, including on a Product-by-Product basis) at any time by mutual written agreement.  In the event that the Parties jointly terminate this Agreement in respect of a specific Product, such Product shall be deemed to be removed from the definition of “Products” and this Agreement shall be amended accordingly.

 

40.8                         The Purchaser may terminate this Agreement (in whole or in part, including on a Product-by-Product basis) immediately on written notice to the Supplier if the Supplier, or any Nominated Supplier or any Permitted Subcontractor breaches or fails to comply with Quality Standards to a material extent and/or repeatedly or persistently fails to comply with the Quality Standards.

 

40.9                         Without prejudice to clause 40.8, if either Party (the “Defaulting Party” ) commits any material breach of this Agreement or Applicable Law  and, if the breach is

 

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capable of remedy, does not remedy that breach following receipt of a request from the other Party (the “Non-Defaulting Party” ) to do so within thirty (30) days, the Non-Defaulting Party may terminate this Agreement (in whole or, in the Non-Defaulting Party’s discretion, in respect of the Product affected by the breach) immediately (subject to the thirty (30) day cure period) by written notice to the Defaulting Party.

 

40.10                  If an Insolvency Event or an Insolvency Proceeding occurs (save as part of a bona fide reorganisation not involving insolvency) in respect of a Party or its ultimate parent, that Party shall promptly notify the other Party in writing, giving particulars of the circumstances.  In such circumstances (whether or not notified in accordance with this clause 40.10), the Party which is not the subject of the Insolvency Event or Insolvency Proceeding may terminate this Agreement immediately by notice in writing.

 

40.11                  Either Party may terminate this Agreement (in whole or in part, including on a Product-by-Product basis) in accordance with clause 32.4.

 

40.12                  If the Marketing Authorisation for a Product in a Territory is revoked by a Governmental Entity due to a health, safety or efficacy concern then either Party may terminate this Agreement in respect of such Product.

 

40.13                  If any Governmental Entity intervenes to prevent Manufacture for a significant technical or regulatory reason (a “ Material Safety Issu e”) either Party may (a) suspend, or require the suspension of, any activities under this Agreement impacted by the relevant Material Safety Issue with respect to such Product and (b) refer the matter to the relevant Governmental Entity as soon as reasonably practicable (and never later than any required regulatory reporting timeline). If a Party disputes that there is a Material Safety Issue or has a good faith belief that the root cause of the Material Safety Issue is resolvable within a reasonable timeframe then the following will apply:

 

(A)                                if the Governmental Entity determines that there is a Material Safety Issue and it is not resolvable within a reasonable timeframe, its decision shall be binding on the Parties and either Party may terminate this Agreement in respect of such Product;

 

(B)                                if the Governmental Entity determines that no Material Safety Issue exists, neither Party may terminate this Agreement in respect of such Product for such purported Material Safety Issue; and

 

(C)                                if the Governmental Entity determines that the root cause of the Material Safety Issue is resolvable within a reasonable timeframe, with respect to such Product, then the Party seeking to terminate this Agreement may, if it continues to have a reasonable and substantiated good faith belief that there is a Material Safety Issue in relation to the Product, require the continued suspension of the Agreement in respect of such Product until satisfactory remediation activity has been undertaken in relation to the Material Safety Issue to the satisfaction of the Governmental Entity in which case the Agreement shall continue in respect of such Product,

 

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provided, that the suspension of activities under this Agreement, or the termination of this Agreement, pursuant to this clause 40.13 shall not in any way diminish or limit the rights or remedies of either Party to recover for the other Party’s breach of its obligations under this Agreement that caused such Material Safety Issue.

 

41.                               CONSEQUENCES OF TERMINATION

 

41.1                        Expiry or termination of this Agreement shall be without prejudice to the continuation in force of any of its provisions which are intended to continue to have effect after it has come to an end, including clauses 13 ( Quality Control ), 19 ( Documentation and Reports ), 25 ( Write Off Costs ), 29 ( Product Action ), 31 ( Confidentiality ), 33 ( Audit and Inspection Rights ), 36 ( Warranties ), 37 ( Indemnity and Liability ), 41 ( Consequences of Termination ), 42 ( Technical Transfer ), 43 ( Bridging Stock ), 46 ( Survival of Rights and Obligations ), 48 ( Whole Agreement ), 49 ( Third Party Rights ) and 50 ( Governing Law and Arbitration ).

 

41.2                        After expiry or termination, the Parties shall provide each other with reasonable support with respect to any investigation carried out by a Governmental Entity with respect to the Manufacture of any Product under this Agreement, provided that the reasonable costs of the assisting Party in providing such assistance shall be reimbursed by the Party requesting such assistance.

 

41.3                        Expiry or termination of this Agreement (or termination of this Agreement in respect of any Product) pursuant to clause 40 ( Duration and Termination ) will not affect the accrued rights, remedies (including a remedy in damages) and liabilities of the Parties under this Agreement or the enforceability of this clause 41 ( Consequences of Termination ) or any other provisions of the Agreement that are intended to remain in force after its termination.

 

41.4                        The Purchaser will:

 

(A)                               continue to pay the Supply Price and any costs due under this Agreement for Firm Orders as long as the supply of Products continues, despite a notice of termination having been given;

 

(B)                               reimburse the Supplier for the cost of any Capital Expenditure or Development Work undertaken by the Supplier and for which the Purchaser is, pursuant to the terms of this Agreement, required to reimburse the Supplier in the event of a termination of this Agreement by the Supplier under clauses 32 ( Force Majeure ), 40.9 or 40.10, provided that the Supplier shall use Commercially Reasonable Efforts to minimise the costs required to be reimbursed by the Purchaser pursuant to this clause 41.4(B), including, if agreed by the Parties (each acting reasonably), by abandoning any relevant Capital Expenditure or Development Work that relates exclusively to the Products if doing so would be less costly than continuing with such Capital Expenditure or Development Work.

 

41.5                        Without prejudice to clause 43 ( Bridging Stock ), in the event of expiry or termination of this Agreement, the Purchaser shall purchase in accordance with

 

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the terms and conditions of this Agreement any Products that comply with the Specifications and Quality Standards and meet the Minimum Remaining Shelf Life requirements and other requirements of this Agreement, save that the Purchaser shall only be obliged to purchase any Product under this clause 41.5 for which Purchaser has placed a Firm Order. The Purchaser shall be responsible for any additional write-off costs agreed to be paid by the Purchaser on termination of this Agreement (including in respect of Materials which have not yet been used in the Manufacture of Products) in accordance with clause 25.1(A) but only in connection with Forecast Schedules delivered prior to the delivery of any notice of termination of this Agreement.

 

41.6                        The provisions of this clause 41 ( Consequences of Termination ) shall apply to the termination of this Agreement in part in respect of any particular Product mutatis mutandis and such Product shall no longer be a Product for the purposes of this Agreement from the date of such termination.

 

42.                               TECHNICAL TRANSFER

 

Long Term Transfer Plan:

 

42.1                        The initial Long Term Transfer Plan for Droptainer Products being transferred between Manufacturing Sites to achieve Separation (excluding Droptainer Products at the Delayed Site) is appended to this Agreement at Exhibit 15 (the “ Long Term Transfer Plan ”). The plan will demonstrate the intended status of technical transfers for Products in the Long Term Transfer Plan up to 01.01.2023.

 

42.2                        Products not listed in the Long Term Transfer Plan are those Droptainer Products which cannot be easily Separated due to transfer complexities and/or commercial requirements and where Separation is unlikely to be achieved by the end of 2023. These Droptainer Products are not included as technical transfers contemplated in the Long Term Transfer Plan and references in this Agreement to Products in the Long Term Transfer Plan shall not be deemed to include them.

 

42.3                        The Commencement Date is deemed to be the date of initiation of technical transfer for all Droptainer Products in the Long Term Transfer Plan and each Party shall respectively each use their Commercially Reasonable Efforts to agree the budget and timelines for the Technical Transfer Milestones in respect of each such Droptainer Product and implement the same in order to determine and  monitor the progress of the relevant Technical Transfer Milestones and implement successful completion of each of the technical transfers contemplated in the Long Term Transfer Plan (with the “successful completion of a technical transfer” of a Product under this Agreement being deemed to be when the first approval of a variation to the CMC (Marketing Application Core Dossier) to reflect the change of source of Manufacture of any Product in a  Product Technology is completed in any jurisdiction in which such submission is made as part of the Technical Transfer) (“ First Approval ”). Save where otherwise agreed by the Parties, any Technical Transfer Milestones that relate to a Product shall be deemed included in the relevant Long Term Transfer Plan for that Product and shall form the basis for the sequencing of that technical transfer.

 

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42.4                        The Parties shall monitor and update the Long Term Transfer Plan (including the budget and which Products should form part of the Long Term Transfer Plan) through the Manufacturing and Supply Team, but shall take due account of the Gating Plan and any other applicable capacity baseline requirements (addressing product volumes and Bridging Stock). The Long Term Transfer Plan shall also contain commitments where reasonably required, on both Parties with respect to certain agreed volumes of Bulk Products. Without prejudice to the right of the Parties to adjust the Long Term Transfer Plan as required from time to time through the Technical Transfer Team the Parties intend to issue a fully updated Long Term Transfer Plan no less than once in each Calendar Year.

 

Additional Specific Technical Transfers

 

42.5                        On a Product-by-Product basis, for Products not addressed in the Long Term Transfer Plan upon request from Purchaser at any time during the applicable Term for that Product or in the event of expiration or termination of this Agreement for any reason the Parties shall each use their respective Commercially Reasonable Efforts to agree a technical transfer plan, with applicable Technical Transfer Milestones and a technical transfer budget for the relevant Product(s) within three (3) months of the notice of termination, notice of request for a technical transfer or the expiration of this Agreement (as applicable) (each a “ Specific Technical Transfer ”).

 

Terms applying to all Technical Transfers (for Products in the Long Term Transfer Plan and Products not in it)

 

42.6                        References in clauses 42.6 to 42.16 and Exhibit 15 to a “ Technical Transfer Plan” shall include the arrangements in the Long Term Transfer Plan and each technical transfer plan referenced in clause 42.5, as applicable. In each case the Parties shall cooperate to enable the Supplier to provide or cause to be provided, technical transfer services to support a smooth and efficient transfer of Manufacturing of each of the Products or if legally permissible a component thereof from the Supplier, its Affiliate(s) and/or Permitted Subcontractor(s) to the Purchaser or its designee(s) in accordance with Applicable Laws and any regulatory requirements arising from, or connected to, such technical transfer services. Each Party shall use its respective Commercially Reasonable Efforts to:

 

(A)                               undertake the activities allocated to that Party in the relevant Technical Transfer Plan (including, without limitation, those in the applicable technical transfer support budget to be agreed by the Parties);

 

(B)                               undertake such activities in a manner that facilitates the satisfaction of the applicable Technical Transfer Milestones; and

 

(C)                               otherwise provide such assistance and support to the other Party as is reasonably necessary to meet each applicable Technical Transfer Milestone on or before the date specified for that Technical Transfer Milestone (provided that neither Party shall be liable to the extent such failure is caused by a failure of the other Party to perform their obligations).

 

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42.7                        Without limiting the foregoing, if the Purchaser is in good faith pursuing an ongoing technology transfer with respect to Manufacturing of a Product at the time of any expiration or termination of this Agreement, the Parties shall consider in good faith on a Product-by-Product basis, an extension of the Product Term for an additional period of up to the earlier of (i) a maximum of two years with respect to such Product or (ii) successful completion of a technical transfer of such Product, provided that it shall be reasonable to grant such an extension in the event of (a) a regulatory or legitimate unforeseen delay to the technical transfer outside either Parties’ control or (b) where the Supplier has been grossly negligent in its execution of the Technical Transfer Plan and the Purchaser is not at fault, but any build-up of Bridging Stock and the condition of any relevant Manufacturing line shall be taken into account in determining the length of any extension of the Product Term, it being acknowledged that the Supplier shall not incur any Capital Expenditure in relation to any Manufacturing line in order to accommodate an extension of the Product Term for any Product.

 

42.8                        Both Parties acknowledge that the Purchaser may need to be supplied with certain quantities of stock (whether Materials or Products) in order to meet the requirements of any Technical Transfer Plan/Long Term Transfer Plan and to meet the date of the expiry of the Product Term in respect of a particular Product.  Accordingly such requirements for quantities of Bridging Stock as are reasonably necessary (including with respect to shelf life for the relevant markets, Delivery dates, MOQ, Lead Times) shall be agreed in good faith by the Parties (each acting reasonably) and included in the applicable Technical Transfer Plan/Long Term Transfer Plan. For the avoidance of doubt, (i) such Bridging Stock shall be included in the relevant Forecast Schedule of the Purchaser, (ii) shall not amount to more than one (1) years’ worth of volume of Product in the prior Gating Year, (iii) shall be counted in the Gating Plan or volume requirements for that Product in that Calendar Year, (iv) shall be supplied on the terms of this Agreement and (v) any plans of the Supplier to retire or decommission any line required for the Manufacture of such Bridging Stock shall be taken into account in the determination of such Bridging Stock quantities. If an agreement is reached to Manufacture an amount of Bridging Stock the Purchaser shall be obliged to purchase such Bridging Stock on the terms of this Agreement as if it were a Firm Order for the full amount of such Bridging Stock.

 

42.9                        As referenced in clause 42.6 each Party shall use its respective Commercially Reasonable Efforts to implement each Technical Transfer Plan and such plans shall set out the activities to be performed by each Party with respect to the relevant technical transfer. The activities in the Technical Transfer Plan shall (without limitation) include, in each case subject to Clause 31 ( Confidentiality ) and any mandatory restrictions imposed by Applicable Law (including, without limitation, restrictions relating to anti-trust or restrictions imposed under any binding agreement then in force between the Supplier or Purchaser (as applicable) and a third party):

 

(A)                               in the case of the Supplier: transfer by the Supplier of all required technical documentation, specifications and procedures, know-how owned or controlled by Supplier and its Affiliates (including where it is not reduced to writing or otherwise incorporated in a tangible embodiment), access to a sufficient number

 

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of qualified scientists, production and QA personnel and engineers, as well as QC personnel, reasonable access to the Manufacturing Sites, Nominated Affiliates and Permitted Subcontractors during Product Manufacturing runs and any other support or training reasonably requested by Purchaser; and

 

(B)                               the case of the Purchaser : provision of access to a sufficient number of appropriately qualified personnel of the Purchaser) to facilitate the transfer of relevant know-how; allowing access to the Manufacturing Site and equipment that will be used by the Purchaser for manufacture of the relevant Product; disclosing relevant information relating to the Product and the Purchaser’s planned method of manufacture for the Product (subject to any mandatory restrictions imposed by Applicable Law); procuring such materials and licences as are required for the validation process and the Manufacture of the Products by the Purchaser.

 

42.10                 The Parties shall coordinate regarding technical transfer matters through the Technical Transfer Planning Team.

 

42.11                 The Parties shall mutually agree the timing of technical transfer services, provided that such technical transfers shall be staged to prioritize the technical transfer of certain Products as reasonably requested by Purchaser and as agreed by the Parties in the Long Term Transfer Plan. The Long Term Transfer Plan shall identify the last date of Manufacture for the Products addressed by that Long Term Transfer Plan.

 

42.12                 The Parties agree that the key technical transfer milestones that need to be established in respect of each Product included in the Long Term Transfer Plan or a specific Technical Transfer Plan (as applicable) are as follows:

 

(A)                               joint kick-off meeting;

 

(B)                               creation of Data Pack in accordance with Exhibit 12 ( Data Pack Requirements ) including any new regulatory data needed for submission;

 

(C)                               method transfer (analytical, cleaning, sterilization, etc.) (if applicable);

 

(D)                               stability batches (if applicable);

 

(E)                                validation batches (if applicable);

 

(F)                                 regulatory dossier package preparation;

 

(G)                               regulatory dossier submission (market specific); and

 

(H)                              First Approval is obtained for that Product in any country,

 

(individually and together, the “ Technical Transfer Milestones ”).

 

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42.13                 The Long Term Transfer Plan and each Specific Transfer Plan shall take due account of all relevant factors and circumstances in each case, with a view to ensuring that:

 

(A)                               there is a smooth, orderly and efficient transfer, on a Product-by-Product basis, of the Manufacturing of such Product from the Supplier to the Purchaser or its designee(s);

 

(B)                               the availability of each Party’s relevant personnel to support the technical transfer of the Manufacturing of such Product;

 

(C)                               unless otherwise agreed (and without prejudice to clauses 40.1, 40.2 and 42.7) the Supplier will cease to Manufacture (or have Manufactured) each Product not later than the expiry of the applicable Product Term;

 

(D)                               continuity of supply or availability of each Product to the Purchaser’s Group is maintained throughout the technical transfer process in relation to the Manufacture of such Product; and

 

(E)                                access to sites and documents necessary to support the technical transfer process is controlled and limited to authorised personnel only.

 

(F)                                 The technical transfers contemplated in the Long Term Transfer Plan and otherwise under Technical Transfer Plans agreed pursuant to this clause 42 ( Technical Transfer ) shall not involve the transfer of physical assets and equipment save in relation to the Shared Moulds identified to be transferred under the Long Term Transfer Plan on the terms set out in Exhibit 9 ( Shared Moulds ).

 

Technical Transfer costs

 

42.14                 The terms of Exhibit 15, Part B shall apply in relation to the allocation and reimbursement of certain costs and expenses incurred in relation to the implementation of a Technical Transfer Plan for each Product.

 

42.15                 At the either Party’s request, the Parties (each acting reasonably and in good faith) shall discuss whether, in connection with the transfer of Manufacture of a Product, the Supplier should procure the assignment or novation, in whole or in part, to a member of the Purchaser’s Group of any agreements between the Supplier and Third Parties relating to the Manufacture of that Product, including the supply of Materials used in such Manufacture and/or the licensing of any technology required for use in such Manufacture.

 

42.16                 If (i) the Parties agree that the Supplier shall assign, transfer or novate an agreement, in whole or in part, to the Purchaser’s Group pursuant to clause 42.15 and (ii) such agreement cannot effectively be assigned, novated or transferred to the Purchaser except by an agreement, transfer or novation with the consent of the relevant counterparty thereto:

 

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(A)                               the Supplier shall use Commercially Reasonable Efforts to procure consent to the novation, transfer or assignment in accordance with timeframe necessary to align that novation, transfer or assignment with the technical transfer of the relevant Product in accordance with the Technical Transfer Plan; and

 

(B)                               until the relevant contract is novated, transferred or assigned, or (if earlier) until the relevant contract can be terminated by Supplier without incurring any financial detriment, the Supplier shall hold the benefit of such contract on trust for the Purchaser absolutely and the Purchaser shall (if such sub-contracting is possible under the contract), as the Supplier’s sub-contractor, perform all the obligations of the Supplier that relate to the Manufacture of the relevant Product under the contract in accordance with the provisions of Exhibit 8 ( Purchaser Materials ).

 

43.                               BRIDGING STOCK

 

43.1                        In connection with the technical transfer of the Manufacture of any Product under this Agreement and always subject to the capacity as may be agreed pursuant to clause 4 ( Capacity Baseline and Gating Plan ) in respect of the relevant Manufacturing Site or Product, the Purchaser may request that the Supplier shall Manufacture (or have Manufactured) and the Purchaser shall purchase (or procure the purchase of), an additional quantity of the affected Product (including any New Product SKU introduced under this Agreement pursuant to clause 21 ( New Product SKUs )) ( “Bridging Stock” ) prior to the expiry of the Term.

 

43.2                        Any quantity of Bridging Stock that may be requested by the Purchaser and other relevant terms of Manufacture and Delivery (including with respect to shelf life, order quantities and lead times) and, if relevant, any revisions to Artwork that may be required in respect of some or all of the Bridging Stock in respect of a Product (including in anticipation of Marketing Authorisation transfer or Marketing Authorisation re-registration) shall be mutually agreed by the Parties on a basis entirely consistent with the terms of this Agreement and the relevant parameters for such supply of Bridging Stock shall be agreed between the Parties, taking into consideration the Supplier’s available Manufacturing capacity and ongoing operations at Manufacturing Sites.

 

43.3                        Once mutually agreed, quantities of Bridging Stock and the applicable Delivery Dates shall be reflected in the applicable Forecast Schedule and, except as otherwise mutually agreed between the Parties, the Purchaser shall be deemed to have provided a purchase order for such Bridging Stock on the date on which the Firm Zone for such Bridging Stock would commence in accordance with the Forecast Schedule, having regard to the due date for Delivery of such Bridging Stock mutually agreed between the Parties.

 

43.4                        Where Bridging Stock is requested by the Supplier (including for example, where it is required in relation to an artwork change) any costs associated with that Bridging Stock shall be borne by the Supplier.

 

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44.                               RISK MANAGEMENT

 

44.1                        Consistent with diligent risk management practices, the Supplier will develop, implement and keep current a risk management program including a Business Continuity Plan for each of its Manufacturing Sites in accordance with its corporate policies and procedures. The Business Continuity Plan shall include adequate security and protective measures to ensure business continuity in case of any potential disruptive events on the supply chain of the Products. The Business Continuity Plan does not relieve the Supplier from any liability under this Agreement and, for the avoidance of doubt, does not increase the Supplier’s obligations under this Agreement.

 

44.2                        Once in any Calendar Year or at such other frequency as the Purchaser reasonably deems to be appropriate, the Supplier will conduct a test and evaluation of the Business Continuity Plan which, upon the Purchaser’s request, may be witnessed by the Purchaser representatives.

 

44.3                        The Parties agree that any issues arising from the risk and business continuity management will be promptly communicated to the other Party.

 

44.4                        The costs of business continuity requests initiated after the Commencement Date shall be borne by the requestor (i.e. materials, validations, stability batches, etc for dual sourcing). The non-requesting Party agrees to support a requestor’s reasonable request provided such efforts and resources are not detrimental to the non-requesting Party’s other obligations under this Agreement.

 

44.5                        Dual sourcing shall be established for a select number of Products and Shared Chemical/API Products as set out in Exhibit 20 (Dual Sourcing) and the Supplier shall be supportive of such sourcing activity. Cost incurred to maintain dual sourcing (including cost of stability batches) will be borne by the Party requesting the dual sourcing. The Supplier shall, to the extent reasonably practicable, give advance notice to the requesting Party of any costs arising in connection with the dual sourcing before such costs are incurred. The Parties shall once per Calendar Year meet to align the list of dual sourced Products and Shared Chemical/API Products to determine whether, as a result of the Long Term Transfer or otherwise, the requesting Party should still be entitled to require the dual sourcing to be maintained and the revised list of dual sourced products shall be approved by the Manufacturing and Supply Team.

 

45.                               NOTICE

 

45.1                        Any notice in connection with this Agreement (a “ Notice ”) shall be:

 

(A)                               in writing in English; and

 

(B)                               delivered by hand or by courier using an internationally recognised courier company.

 

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45.2                        A Notice to the Supplier shall be sent to such Party at the following address, or such other person or address as the Supplier may notify to the Purchaser from time to time:

 

Novartis Pharma AG

Lichtstrasse 35

4056 Basel,

Switzerland

 

Attention: Supplier Contract Execution Manager

 

Copy (which shall not constitute Notice) to:

 

Novartis Pharma AG

Fabrikstrasse 4

Novartis Campus

CH-4056, Basel

 

Attention: General Counsel NTO & Group Quality

 

45.3                        A Notice to the Purchaser shall be sent to such Party at the following address, or such other person or address as the Purchaser may notify to the Supplier from time to time:

 

Alcon Inc.

c/o Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, TX 76134, USA

 

Attention: Purchaser Contract Execution Manager

 

Copy (which shall not constitute Notice) to:

 

Alcon Inc.

c/o Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, TX 76134, USA

 

Attention: General Counsel

 

45.4                        A Notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery provided that any notice deemed to be received outside of Working Hours shall be effective at the start of the next period of Working Hours.

 

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46.                               SURVIVAL OF RIGHTS AND OBLIGATIONS

 

Termination or expiry of this Agreement shall not release either Party from any liability or right of action which, at the time of termination or expiry, has already accrued to a Party or which may thereafter accrue in respect of any act or omission prior to such termination or expiry.  Such rights may include the recovery of any monies due.

 

47.                               ASSIGNMENT

 

47.1                        The Purchaser may, by notice in writing to the Supplier, assign the whole or any part of this Agreement to any Affiliate of the Purchaser, provided that the Purchaser shall remain liable to the Supplier in its capacity as principal obligor.

 

47.2                        The Supplier may, by notice in writing to the Purchaser, assign the whole or any part of this Agreement to any Affiliate of the Supplier, provided that the Supplier shall remain liable to the Purchaser in its capacity as principal obligor.

 

47.3                        Save as provided in clause 47.5, neither Party may assign or novate its rights or obligations under this Agreement at any time to any Third Party, or novate the whole or any part of this Agreement to any of its Affiliates, without the prior written consent of the other Party.

 

47.4                        The provisions of this clause 47 ( Assignment ) are without prejudice to the Parties’ rights under clause 40 ( Duration and Termination ).

 

47.5                        Either Party (the “ Assigning Party ”) may, with the prior written consent of the other Party, such consent not to be unreasonably, withheld, conditioned or delayed, assign or transfer this Agreement (in whole or in part) to a Third Party: (i) in connection with the sale or disposal of all or part of the assets of the Assigning Party or its Affiliates which includes the sale or disposal of any Products; or (ii) if the Assigning Party or an Affiliate of the Assigning Party otherwise divests, out-licenses or disposes of any Product(s), without prejudice to its respective right of termination under clause 40 ( Duration and Termination ), provided always that no Shared Moulds shall be transferred to such Third Party pursuant to this clause 47 ( Assignment ).

 

48.                               WHOLE AGREEMENT

 

48.1                        This Agreement, together with the Transaction Documents, constitutes the entire agreement and understanding between the Parties relating to the subject matter of this Agreement at the date hereof to the exclusion of any terms implied by law which may be excluded by contract and supersedes any previous written or oral agreement between the Parties in relation to the matters dealt with in this Agreement. The Parties further agree that the terms and conditions of this Agreement will apply to the exclusion of any terms and conditions of sale or purchase submitted at any time by either Party, whether printed or sent with any acknowledgement of any Delivery of Product or otherwise.

 

48.2                        Each Party acknowledges that, in entering into this Agreement, it is not relying on any representation, warranty or undertaking not expressly incorporated into it.

 

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48.3                        Except as expressly stated herein, each of the Parties agrees and acknowledges that its only right and remedy in relation to any representation, warranty or undertaking made or given in connection with this Agreement shall be for breach of the terms of this Agreement and each of the Parties waives all other rights and remedies (including those in tort or arising under statute) in relation to any such representation, warranty or undertaking.

 

48.4                        Nothing in this clause 48 ( Whole Agreement ) excludes or limits any liability for fraud (including the making of any statements fraudulently).

 

48.5                        A Party shall be entitled to make more than one claim under this Agreement arising out of the same subject matter, fact, event or circumstance but shall not be entitled to recover under this Agreement or any relevant Transaction Document or otherwise more than once in respect of the same Liabilities suffered or amount for which the Party is otherwise entitled to claim (or part of such Liabilities or amount), regardless of whether more than one claim arises in respect of it. No amount (including any relief) (or part of any amount) shall be taken into account, set off or credited more than once under this Agreement or any relevant Transaction Document or otherwise, with the intent that there will be no double counting under this Agreement or any Transaction Document or otherwise. For the avoidance of doubt any claims in relation to testing services provided under the Transitional Services Agreements must be brought under the relevant Transitional Services Agreement.

 

49.                               THIRD PARTY RIGHTS

 

49.1                        Subject to clause 49.2, the Parties do not intend that any term of this Agreement should be enforceable, by virtue of the Contracts (Rights of Third Parties) Act 1999, by any person who is not a party to this Agreement.

 

49.2                        Certain provisions of this Agreement confer benefits on the Affiliates of the Purchaser and the Affiliates of the Supplier and, subject to clause 49.3, are intended to be enforceable by each such Affiliate by virtue of the Contracts (Rights of Third Parties) Act 1999.

 

49.3                        Notwithstanding clause 49.2, this Agreement may be varied in any way and at any time without the consent of any Affiliate who is entitled to enforce this Agreement under clause 49.2.

 

50.                               GOVERNING LAW AND ARBITRATION

 

50.1                        This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

50.2                        Nothing contained in this clause 50 ( Governing Law and Submission to Jurisdiction ) shall limit the right of either Party to seek an injunction in any other competent jurisdiction in which a Product is Manufactured, marketed or sold, nor

 

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shall the seeking of an injunction in on one or more jurisdiction preclude the seeking of an injunction in any other jurisdiction, whether concurrently or not.

 

50.3                        Clauses 50.3 to 50.8 shall apply to any dispute, controversy or claim arising out of, relating to, or in connection with this Agreement, including, without limitation, any dispute relating to the existence, validity or termination of this Agreement and a dispute which could not be resolved through the processes set out in clause 16 (each, a “ Dispute ).

 

50.4                        Before entering into any arbitration pursuant to clauses 50.6 or 50.6(A), a Party shall give written notice of a Dispute to the other Party (a “ Dispute Notice ). The Dispute Notice shall:

 

(A)                               state that it is a Dispute Notice being submitted pursuant to clause 50.3 of this Agreement;

 

(B)                               identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(C)                               set out any steps taken by that Party or its Affiliates to resolve it.

 

50.5                        Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within  the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the “ Resolution Period” ).  The time limit specified in this clause 50.5 may be extended by the written agreement of the Parties.

 

50.6                        If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(A)                               the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the “ LCIA Rules” );

 

(B)                               the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(C)                               the seat of arbitration shall be London; and

 

(D)                               the written and spoken language to be used in the arbitral proceedings shall be English.

 

50.7                        Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Transaction Document, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties

 

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hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with clause 50.6.

 

50.8                        The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this clause 50.8 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

51.                               VARIATION OR WAIVER

 

51.1                        No variation of this Agreement shall be effective unless in writing and signed by or on behalf of each of the Parties.

 

51.2                        No failure or delay by a Party in exercising any right or remedy provided by Applicable Law or under this Agreement or any Transaction Document shall impair such right or remedy or operate or be construed as a waiver or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

52.                               COSTS

 

Each Party shall bear all costs incurred by it and its Affiliates in connection with the preparation and negotiation of, and the entry into, this Agreement.

 

53.                               INTEREST

 

Without prejudice to clause 11.5, if any Party defaults in the payment when due of any sum payable under this Agreement, the liability of that Party shall be increased to include interest on such sum from the date when such payment is due until the date of actual payment (as well after as before judgment) at a rate of two per cent. (2%) above LIBOR per annum. Such interest shall accrue from day to day. The Parties acknowledge that the provisions of this clause provide a substantial contractual remedy for the late payment of such sums due under this Agreement.

 

54.                               PAYMENTS

 

54.1                        Subject to clause 54.2, any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or otherwise agreed).

 

54.2                        If any deductions or withholdings are required by Applicable Law to be made from any of the sums payable pursuant to this Agreement then, except to the extent that the sum constitutes interest, the payer shall be obliged to pay to the recipient

 

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such sum as will, after the deduction or withholding has been made, leave the recipient with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding.

 

54.3                        If a person makes an increased payment pursuant to clause 54.2 and the recipient receives and utilises a credit, relief or repayment in respect of the Tax that gave rise to such increased payment, the recipient shall reimburse the payer such amount as shall leave the recipient in the same position as the recipient would have been in had no such deduction or withholding been required to be made.

 

55.                               INVALIDITY

 

55.1                        If any provision in this Agreement shall be held to be illegal, invalid or unenforceable, in whole or in part, the provision shall apply with whatever deletion or modification is necessary so that the provision is legal, valid and enforceable and gives effect to the commercial intention of the Parties.

 

55.2                        To the extent that it is not possible to delete or modify the provision, in whole or in part, under clause 55.1, then such provision or part of it shall, to the extent that it is illegal, invalid or unenforceable, be deemed not to form part of this Agreement and the legality, validity and enforceability of the remainder of this Agreement shall, subject to any deletion or modification made under clause 55.1, not be affected.

 

56.                               COUNTERPARTS

 

This Agreement may be entered into in any number of counterparts, all of which taken together shall constitute one and the same instrument.  Any Party may enter into this Agreement by executing any such counterpart. Delivery of a counterpart of this Agreement by email attachment shall be an effective mode of delivery.

 

57.                               RELATIONSHIP OF THE PARTIES

 

57.1                        Nothing in this Agreement, and no action taken by the Parties pursuant to this Agreement, will be deemed to constitute a relationship between the Parties of partnership, joint venture, principal and agent or employer and employee.  Neither Party has, nor may it represent that it has, pursuant to this Agreement, any authority to act or make any commitments on the other Party’s behalf.  Neither Party will have the authority or power to bind the other or to contract in the name of or create liability against the other in any way or for any purpose.

 

57.2                        Each of the Supplier and the Purchaser shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

58.                               FURTHER ASSURANCE

 

58.1                        Without prejudice to any restriction or limitation on, and without extending the scope of, the extent of any Party’s obligations under this Agreement, each Party

 

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(the “first Party” ) shall from time to time, so far as each is reasonably able, do or procure the doing of all such acts and/or execute or procure the execution of all such documents (including in relation to any relevant regulatory filings) in a form reasonably satisfactory to the other Party (the “other Party” ) as that other Party reasonably requests to give such other Party the full benefit of its rights or the first Party’s obligations under this Agreement.

 

58.2                        Without prejudice to the generality of clause 58.1, if either Party identifies any error in or omission from any of the Exhibits, it may notify the other Party of such error(s) or omission(s) and the Parties shall agree in writing such revisions to the affected Exhibit(s) as may be required to correct the error(s) or omission(s) in question.

 

signature page follows

 

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SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS PHARMA AG

 

 

 

 

 

 

 

 

/s/ Anne Vuillemin

 

/s/ Christian Klemm

 

 

 

Name:

Anne Vuillemin

 

Name:

Christian Klemm

 

 

 

 

 

Title:

Sr Project Manager NTO Deal Execution

 

Title:

General Counsel, Novartis Technical Operations

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ John Reding

 

 

 

Name:

David Murray

 

Name:

John Reding

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

92


Exhibit 99.5

 

 

Execution Copy

 

DATED 8 APRIL 2019

 

NOVARTIS PHARMA AG

 

and

 

ALCON INC.

 


 

MANUFACTURING AND SUPPLY AGREEMENT
relating to the separation of the Alcon
surgical and vision care business

 

Aspex/Fort Worth/Singapore

 


 


 

MANUFACTURING AND SUPPLY AGREEMENT

 

 

 

Page

 

 

 

1.

DEFINITIONS AND INTERPRETATION

1

 

 

 

2.

MANUFACTURE AND SUPPLY

19

 

 

 

3.

FORECASTS AND ORDERS

23

 

 

 

4.

CAPACITY BASELINE AND GATING PLAN

26

 

 

 

5.

TOLL MANUFACTURE

30

 

 

 

6.

PRODUCTS MANUFACTURED USING MATERIALS PURCHASED FROM PURCHASER

32

 

 

 

7.

SHARED CONTRACTS

32

 

 

 

8.

SHARED CHEMICAL/API PRODUCT/SHARED PACKAGING MATERIAL

33

 

 

 

9.

DELIVERY OF PRODUCT

33

 

 

 

10.

PRICE AND PRICE ADJUSTMENTS

37

 

 

 

11.

INVOICE, PAYMENT AND CURRENCY CONVERSION

41

 

 

 

12.

ELECTRONIC SYSTEMS

42

 

 

 

13.

QUALITY CONTROL

43

 

 

 

14.

KEY PERFORMANCE INDICATORS

43

 

 

 

15.

RELATIONSHIP MANAGEMENT

45

 

 

 

16.

DISPUTE ESCALATION

46

 

 

 

17.

ACCEPTANCE OF PRODUCT

47

 

 

 

18.

REGULATORY MATTERS

49

 

 

 

19.

DOCUMENTATION AND REPORTS

50

 

 

 

20.

PRODUCT SPECIFICATIONS

51

 

 

 

21.

NEW PRODUCT SKUS

51

 

 

 

22.

CAPITAL EXPENDITURE AND COSTS OF DEVELOPMENT WORK

53

 

i


 

23.

DEVELOPMENT WORK

54

 

 

 

24.

CONTINUOUS IMPROVEMENT PROGRAMME

55

 

 

 

25.

WRITE OFF COSTS

55

 

 

 

26.

ARTWORK AND SHARED MOULDS

56

 

 

 

27.

SERIALISATION, AGGREGATION AND OTHER ANTI-FALSIFICATION REGULATIONS

57

 

 

 

28.

PHARMACOVIGILANCE

57

 

 

 

29.

PRODUCT ACTION

58

 

 

 

30.

SUPPLIERS OF MATERIALS AND SHARED PACKAGING MATERIALS

58

 

 

 

31.

CONFIDENTIALITY

59

 

 

 

32.

FORCE MAJEURE

61

 

 

 

33.

AUDIT AND INSPECTION RIGHTS

62

 

 

 

34.

ETHICAL STANDARDS AND HUMAN RIGHTS

64

 

 

 

35.

SAFETY HAZARDS

65

 

 

 

36.

WARRANTIES

66

 

 

 

37.

INDEMNITY AND LIABILITY

66

 

 

 

38.

INSURANCE

68

 

 

 

39.

INTELLECTUAL PROPERTY

68

 

 

 

40.

DURATION AND TERMINATION

71

 

 

 

41.

CONSEQUENCES OF TERMINATION

73

 

 

 

42.

TECHNICAL TRANSFER

75

 

 

 

43.

BRIDGING STOCK

80

 

 

 

44.

RISK MANAGEMENT

80

 

 

 

45.

NOTICE

81

 

 

 

46.

SURVIVAL OF RIGHTS AND OBLIGATIONS

82

 

ii


 

47.

ASSIGNMENT

82

 

 

 

48.

WHOLE AGREEMENT

83

 

 

 

49.

THIRD PARTY RIGHTS

84

 

 

 

50.

GOVERNING LAW AND ARBITRATION

84

 

 

 

51.

VARIATION OR WAIVER

85

 

 

 

52.

COSTS

86

 

 

 

53.

INTEREST

86

 

 

 

54.

PAYMENTS

86

 

 

 

55.

INVALIDITY

86

 

 

 

56.

COUNTERPARTS

87

 

 

 

57.

RELATIONSHIP OF THE PARTIES

87

 

 

 

58.

FURTHER ASSURANCE

87

 

iii


 

THIS MANUFACTURING AND SUPPLY AGREEMENT   is made the 8th day of April 2019 (the “Effective Date” )

 

BETWEEN:

 

(1)                                 ALCON INC., a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (the “ Supplier ”);

 

AND

 

(2)                                 NOVARTIS PHARMA AG, a corporation (Aktiengesellschaft) incorporated in Switzerland whose registered office is at Lichtstrasse 35, 4056 Basel, Switzerland (the “ Purchaser ”),

 

(each a “Party” and together the “Parties” ).

 

WHEREAS:

 

(A)                               By the Separation Agreement (as defined below) the Alcon surgical and vision care business will be transferred from its existing ownership structure under the ultimate control of Novartis AG to be held on a standalone basis under the Supplier on the terms and conditions set out in the Separation Agreement.

 

(B)                               In the Separation Agreement, the parties to the Separation Agreement have agreed to enter into this Agreement (or procure the Parties hereto enter into this Agreement) for the Manufacture of Products by the Supplier and the supply of those Products to the Purchaser.

 

(C)                               The Purchaser wishes to have Manufactured and to purchase, and the Supplier wishes to Manufacture or have Manufactured and supply, the Products subject to the terms and conditions of this Agreement.

 

NOW IT IS AGREED as follows:

 

1.                                      DEFINITIONS AND INTERPRETATION

 

1.1                               In this Agreement:

 

“Additional HSE Requirements” means the Purchaser’s requirements for the Supplier with respect to environmental, health and safety matters associated with the Manufacture of Products under this Agreement, as set out in Part A, Exhibit 10 ( Standards and Policies ). For the avoidance of doubt, Additional HSE Requirements do not include the Purchaser’s internal HSE policies and procedures.

 

“Affected Products” has the meaning given to it in clause 4.9.

 

“Affected Site” has the meaning given to it in clause 4.8.

 

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Affiliate means with respect to any person, any such person that controls, is controlled by or is under common control with such person, and “Affiliates” shall be interpreted accordingly. For purposes of this definition, “control” means the power to direct the management and policies of a person (directly or indirectly), whether through ownership of voting securities, by contract or otherwise (and the terms “controlled by” and “under common control” shall be interpreted accordingly).

 

“Agreement” means this agreement and the Exhibits and Annexures attached thereto.

 

“Alcon Group” means Alcon, Inc. and its Affiliates from time to time.

 

“Allocation” has the meaning given to it in clause 4.9.

 

Anti Falsification Regulations means the serialisation and other traceability requirements under the EU Falsified Medicines Directive 2011/62/EU (EUFMD) (and delegated legislation including Regulation (EU) 2016/161) and the Drug Supply Chain Security Act and any successor legislation or materially equivalent legislation enacted or adopted as of the date hereof in any Territory.

 

“API” means, on a Product-by-Product basis, the active pharmaceutical ingredient or drug substance, as applicable, for such Product (or constituting such Product, in the case of Shared Chemical/API Products).

 

“API Supplier” means, with respect to a Product, the supplier of any API used in the Manufacture of such Product as at the Effective Date and any additional supplier of such API subsequently approved by the Purchaser.

 

“Applicable Law” means, to the extent applicable to the Parties or their activities under this Agreement, any supra-national, European Union, federal, national, state, municipal or local statute, law, ordinance, regulation, rule, code, order (whether executive, legislative, judicial or otherwise), judgment, injunction, notice, decree, or other requirement or rule of law or legal process (including common law), or any other order of, or agreement issued, promulgated or entered into by, any Governmental Entity, any applicable Codes of Conduct, or any rule or requirement of any national securities exchange, including cGMP, each as may be amended from time to time.

 

“Artwork” means, with respect to a Product and an applicable Territory, the artwork (including the electronic files from which printed components are generated, including technical specifications, graphic files, technical drawings and reproduction files and materials), labelling and packaging for such Product in such Territory, and references to “ Artwork ” shall include a reference to each component of such artwork.

 

“Aspex Droptainer Products” has the meaning set out in clause 4.3.

 

“Aspex Requirements” has the meaning set out in clause 4.3.

 

Batch Constrained Products has the meaning set out in clause 3.3(E).

 

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“Batch Record” means a document that records the details required by cGMP and the Quality Agreement about the Manufacture of a batch of a Product, in the form prescribed by the Quality Agreement.

 

“Base Price” has the meaning set out in clause 10.2.

 

“Bridging Stock” has the meaning set out in clause 43 ( Bridging Stock ).

 

“Bulk Product” means:

 

(A)                               each of the SKUs listed in Part B of Exhibit 1 (Products);

 

(B)                               any applicable New Product SKU introduced under this Agreement as a Bulk Product,

 

in each case, requiring further primary and/or secondary packaging or other manufacture prior to being commercialised, and “Bulk Products” shall be construed accordingly.

 

“Business Continuity Plan” shall mean a plan clearly defining and documenting a set of measures designed to (i) allow a quick response to a disruptive event so that the business process is restored to a minimum required operational level; (ii) recover the business process in a defined time frame and/or (iii) address dual sourcing requirements for specific Products (as agreed by the Parties), such plan shall cover in particular all key personnel, resources, services and actions which are required to manage the business continuity management process.

 

“Business Day” means a day which is not a Saturday, a Sunday or a public holiday in the canton of Basel-Stadt (Switzerland), Fort Worth, Texas (USA), or a jurisdiction in which a relevant obligation under this Agreement is to be performed, but excluding any day in the period 24 December to 1 January (inclusive).

 

“Business Review Meetings” has the meaning given to it in clause 15.3.

 

“Calendar Year” means any period of twelve (12) months commencing on 1 January.

 

“Capital Expenditure” means a capital expenditure made in respect of the Manufacture of Products under this Agreement.

 

“Certificate of Analysis” means a certificate signed by a qualified person pursuant to the Quality Agreement confirming that the batch of Products to which it relates meet the applicable Specifications.

 

“Certificate of Compliance” means a certificate signed by a qualified person pursuant to the Quality Agreement confirming that the batch of Products to which it relates has been manufactured in accordance with the relevant Marketing Authorization and cGMP.

 

“Chemicals” means, on a Product-by-Product basis, all non API ingredients used in the applicable formulation for such Product.

 

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“Commencement Date” means the Effective Date, except in respect of a New Product SKU, for which it means the applicable NPS Commencement Date.

 

“Commercially Reasonable Efforts” means, with respect to the efforts (including financial spend) to be expended by a Party to achieve any objective, all reasonable, diligent commercial efforts to accomplish such objective that a person with operations of a similar scale and standing in the pharmaceutical industry would normally use when conducting an on-going business for its own benefit to accomplish a similar objective under similar circumstances.

 

“Confidential Information” means, subject to clause 31.5, all information (including all oral and visual information, and all information recorded in writing or electronically, or in any other medium or by any other method) directly or indirectly disclosed to or obtained by one Party or its Affiliates from the other Party or its Affiliates, or a Third Party acting on that Party’s behalf that either (i) the disclosing party designates as being confidential or (ii) which, under the circumstances surrounding disclosure, ought reasonably to be treated as confidential, including the following information:

 

(A)                               any information relating to the business of either Party including, any ideas; business methods; finance; prices, business, financial, sales, marketing, development or manpower plans or forecasts; customer lists or details; computer systems and software; products or services; know-how or other trade secrets; processes; marketing opportunities; other matters connected with the Products or services Manufactured, marketed, provided or obtained by either Party; information concerning either Party’s relationships with actual or potential clients, customers or suppliers and the needs and requirements of either Party and of such persons; information relating to the packaging and admission of Products, including packaging methods, testing methods and results, and storage and transportation details;

 

(B)                               any information ascertainable by the inspection or analysis of samples;

 

(C)                               any information disclosed pursuant to the Quality Agreement; and

 

(D)                               any other information which the disclosing Party has reasonably advised the non-disclosing Party in writing would, if disclosed in breach of the confidentiality obligation being imposed under this Agreement, be liable to cause material harm to the Party whose information is disclosed.

 

“Contract Year” means a period of twelve (12) months commencing on the Effective Date or any anniversary thereof ( provided that the last Contract Year for each Product shall end on the date of expiry or termination of this Agreement in respect of that Product).

 

Contract Execution Manager ” has the meaning given to it in clause 15.2.

 

Control ” means, in relation to a person, the ability of another person to ensure that the activities and business of the first mentioned person are conducted in accordance with the wishes of that other person (whether by exercise of contractual rights, ownership of shares or otherwise), and a person shall be deemed to have “Control” of a body

 

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corporate if that person has the contractual right to procure that the activities and business of that body corporate are conducted in accordance with that person’s wishes or if that person possesses the majority of the issued share capital or the voting rights in that body corporate or the right to receive the majority of the income of that body corporate on any distribution by it of all of its income or the majority of its assets on a winding up.

 

“Conversion Cost” means, in respect of a Product, the Total Product Cost of that Product less, to the extent included therein, the Materials Costs (excluding production consumables) representing third party and intercompany landed costs and excluding testing costs and material handling costs.

 

“current Good Manufacturing Practice” or “cGMP” means all applicable standards relating to current good manufacturing practice for fine chemicals, intermediates, active pharmaceutical ingredients, bulk products and/or finished pharmaceutical/medical device products (as appropriate) required by:

 

(A)                               the provisions of Commission Directive 2003/94/EC together with the guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use contained in Volume 4 “Guidelines for good manufacturing practices for medicinal products for human and veterinary use” of “The Rules Governing Medicinal Products in the European Union” (as the same may be amended from time to time);

 

(B)                               the then-current standards, practices and procedures required, promulgated or endorsed by the FDA as defined in the provisions of 21 U.S.C. § 351(a)(2)(B) and 21 C.F.R. Parts 210-211 and 600-680; and

 

(C)                               the equivalent Applicable Law in any relevant country,

 

in each case, as applicable to the relevant Manufacturing Site or the Product or both.

 

“Customer Relationship Manager” has the meaning given to it in clause 15.1.

 

“Data Pack” means, in respect of a Product, a data pack containing such of the technical information listed in Exhibit 12 ( Data Pack Requirements ) that is in the possession of the Supplier’s Group, that is not in the possession of the Purchaser’s Group, and that is required to accomplish the technical transfer of such Product.

 

“Default Delivery Terms” means FCA Delivery Terms.

 

“Defaulting Party” has the meaning given in clause 40.8.

 

“Defective” means, with respect to a Product, that such Product did not, at the time of Delivery, meet the representations, warranties or covenants set out in this Agreement with respect to Products Manufactured and supplied to the Purchaser under this Agreement, including as set out in clause 2.3, or the quality requirements set out in the Quality Agreement (but excluding, for clarity, any such failure to meet such representations, warranties, covenants, or requirements as a result of any action or omission of the Purchaser or its Affiliates), and “Defect” shall be construed accordingly.

 

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“Delivery Failure” has the meaning given in clause 9.3(A).

 

“Delivery Terms” means, in respect of each Product, the Default Delivery Terms or such other delivery terms as are set out with respect to such Product in Exhibit 1 ( Products ) or as the Parties may otherwise agree from time to time, and “Deliver” , “Delivery” and “Delivered” shall be construed accordingly as applicable.

 

“Development Work” means, in respect of a Product, any analysis, testing, reformulation, redesign or other research and development activity (including the preparation of reports in relation to those activities), but excluding any such activities that:

 

(A)                               are required for the Manufacture or supply of that Product as at the Effective Date;

 

(B)                               are required to be undertaken in relation to that Product by the Quality Agreement;

 

(C)                               are agreed by the Parties pursuant to clauses 23 ( Development Work ) and 24 ( Continuous Improvement Programme ); or

 

(D)                               comprise a change of Artwork in accordance with clause 26 ( Artwork and Shared Moulds ).

 

Dispute ” has the meaning given in clause 50.3.

 

Dispute Notice ” has the meaning given in clause 50.4.

 

“Droptainer Products” means those Products set out in Part A of Exhibit 1 ( Products ).

 

“Effective Date” has the meaning given on the first page of this Agreement.

 

“Executive Officers” means, for the Supplier the Head of Novartis Technical Operations and Senior Vice President, Global Manufacturing and Technical Operations of the Purchaser, or their respective designees.

 

“Export Documentation” means, in respect of each Product, shipping documentation evidencing the export of such Product from the territory in which the relevant Manufacturing Site is located.

 

“FCA Delivery Terms” means FCA ( Insert Manufacturing Site ) (Incoterms 2010), as the case may be.

 

“FDA” means the United States Food and Drug Administration, or any successor agency thereto.

 

“Finished Product” means:

 

(A)                               each of the SKUs listed in Part A of Exhibit 1 ( Products ); and

 

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(B)                               any applicable New Product SKU introduced under this Agreement as a Finished Product,

 

and “ Finished Products ” shall be construed accordingly.

 

“Firm Order” has the meaning given in clause 3.2(C).

 

“Firm Zone” means in respect of each Product the first four (4) months of each Forecast Schedule for each such Product or such other period as may be agreed between the Parties on a Product-by-Product basis.

 

First Approval ” has the meaning set out in clause 42.3;

 

“Forecast Schedule” has the meaning given in clause 3.1(C).

 

“Force Majeure” means, any cause or circumstance preventing, hindering or delaying either Party performing all or part of its obligations under this Agreement which arises from or is attributable to acts, events, omissions or accidents beyond the reasonable control of the Party so prevented, including any of the following:

 

(A)                               war, threat of or preparation for war, armed conflict;

 

(B)                               terrorist attack, civil war, civil commotion or riots;

 

(C)                               epidemic or pandemic;

 

(D)                               any law or governmental order, rule, regulation or direction, or any action taken by a Governmental Entity, including but not limited to imposing an embargo, export or import restriction, quota or other restriction or prohibition, in each case, of general application or generally affecting the industries in which the Parties participate;

 

(E)                                any flood, earthquake, hurricane or other natural disaster, weather-related conditions, explosions or fires; and

 

(F)                                 to the extent beyond the reasonable control of the relevant Party (or, as applicable, the Permitted Subcontractor), any labour dispute, including strikes, industrial action or lockouts.

 

For the purposes of this definition of Force Majeure neither increasing costs (unless in excess of market norms due to acts, events, omissions or accidents beyond the reasonable control of the Party affected) nor a lack of funds will be interpreted as putting the event beyond the reasonable control of the Party affected.

 

“Gating Plan” has the meaning given to it in clause 4.1.

 

“Gating Volumes” means in relation to a Product Technology for each Calendar Year of the relevant Product Term for that Product, the aggregate volume of that Product Technology to be Manufactured by (or for) Supplier’s Group during that Calendar Year

 

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as set out in the Gating Plan for that Calendar Year or as otherwise agreed by the Manufacturing and Supply Team in accordance with clause 4.1.

 

“Gating Year” means a Calendar Year in the Gating Plan (provided that the last Gating Year for each Product shall end on the date of expiry or termination of this Agreement in respect of that Product).

 

Global PV Agreement ” means the pharmacovigilance agreement in relation to (among other things) the Products entered into between the Supplier (and/or its Affiliate), the Purchaser (and/or its Affiliate) on the Effective Date.

 

“Governmental Entity” means any supra-national, European Union, federal, national, state, county, local, municipal or other governmental, regulatory or administrative authority, agency, commission or other instrumentality, any court, tribunal or arbitral body with competent jurisdiction, or any national securities exchange or automated quotation service including, any governmental regulatory authority or agency responsible for the grant approval, clearance, qualification, licensing or permitting of any aspect of the research, development, Manufacture, marketing, distribution or sale of the Products including (as applicable) the FDA, the European Medicines Agency, or any successor agency thereto.

 

“Group” means the Supplier’s Group and/or the Purchaser’s Group (as the context requires).

 

“IFRS” means the edition of the International Financial Reporting Standards as published by the International Accounting Standards Board that is effective at the time that any cost to be calculated by reference to these standards hereunder is recognized.

 

“Improvement” means any new or improved process, technique, method, formula, invention or know-how that arises out of a continuous improvement programme agreed by the Parties pursuant to clause 24 ( Continuous Improvement Programme ) or any Development Work or Artwork, in each case devised, made or reduced to practice either by the Supplier or the Purchaser during the Term.

 

“Independent Expert” means a laboratory or expert mutually agreed upon by the Parties or, if no such agreement can be reached within twenty (20) Business Days of either Party proposing the referral of a dispute under clause 17 ( Acceptance of Product ) or Exhibit 7 ( Toll Manufacture Provisions ) for the determination by (or recommendation in respect of, as applicable) an independent expert, a laboratory or expert appointed by the President of the International Chamber of Commerce or his nominee upon the application of either Party.

 

Inflation Adjustment ” has the meaning given to it in clause 10.4(A).

 

Inflation Reconciliation ” has the meaning given to it in clause 10.7(B).

 

“Information Access Agreement” means the information access agreement to be entered into between Novartis AG and Alcon Inc. on or about the date of this Agreement.

 

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“Initial Term” has the meaning given to it in clause 40.3.

 

“Insolvency Event” means, in relation to a person:

 

(A)                               it is, or is deemed for the purpose of any Applicable Law to be, insolvent or unable to pay its debts as they fall due;

 

(B)                               it admits an inability to pay debts as they fall due;

 

(C)                               it suspends making payments on any of its debts or announces an intention to do so;

 

(D)                               by reason of actual or anticipated financial difficulties, it begins negotiations with any creditor for the rescheduling of any of its indebtedness outside the ordinary course of business;

 

(E)                                it is in breach of any covenant or other term of a loan or financial facility and a counterparty under such loan or financial facility accelerates, or calls for repayment of, any outstanding indebtedness as a result of such breach;

 

(F)                                 the fair value of its assets is less than its liabilities (taking into account contingent and prospective liabilities and disregarding inter-company loans between Affiliates); or

 

(G)                               a moratorium is declared in respect of any indebtedness; or

 

(H)                              any event occurs, or proceeding is taken, with respect to the person in any jurisdiction in which it has assets and to which it is subject, that has an effect equivalent to any of the events mentioned in (A) to (G) above.

 

“Insolvency Proceeding” means, in relation to a person:

 

(A)                               any step is taken with a view to entering into a moratorium or a composition or similar arrangement with its creditors;

 

(B)                               a meeting of its shareholders or directors is convened for the purpose of considering any resolution for, to bring an application for, or to file documents with a court or any registrar for, its winding-up, judicial management or dissolution or any such resolution is passed;

 

(C)                               any person brings an application for, or files documents with a court or any registrar for, its winding-up, judicial management or dissolution or such order is made; or

 

(D)                               a liquidator, judicial manager, administrator or similar officer is appointed in respect of any of its assets.

 

“Intellectual Property Rights” means all: (i) patents; (ii) know-how and trade secrets; (iii) trademarks; (iv) internet domain names; (v) copyrights; (vi) rights in designs; (vii) database rights; and (viii) all rights or forms of protection, anywhere in the world, having

 

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equivalent or similar effect to the rights referred to in paragraphs (i) to (vii) above, in each case whether registered or unregistered and including applications for registration of any such thing.

 

“Invoice Currency” means (i) U.S Dollar (USD); or (ii) in circumstances where the U.S Dollar (USD) is not the applicable operating currency of the Supplier or Nominated Supplier (as the case may be), the applicable operating currency of the Supplier or Nominated Supplier (as the case may be) that issues the invoice, as determined by the Supplier or Nominated Supplier and indicated in an applicable invoice.

 

ISRM Security Standards ” means the ISRM security standards of Novartis as may be updated from time to time.

 

“Joint Improvement IP” means any Intellectual Property Rights allocated to the joint ownership of the Parties (or their respective Affiliates) in accordance with clause 39.4(C)(iii).

 

“Key Performance Indicators” or “KPIs” means the key performance indicators set out in Exhibit 4 ( Key Performance Indicators ) or otherwise agreed by the Parties from time to time in accordance with clause 14 ( Key Performance Indicators ).

 

“KPI1 (ASP)” has the meaning set out in Exhibit 4, Part A ( Key Performance Indicators ).

 

“KPI2 (SDP)” has the meaning set out in Exhibit 4, Part A ( Key Performance Indicators ).

 

“Latent Defect” means any Defect that is not readily determinable upon a reasonable inspection of the Product, based on visual inspection or other agreed inspection method (without the obligation to open the packaging) and review of the Certificate of Analysis, Certificate of Compliance and/or Batch Record (if applicable).

 

“Lead Time” means, in respect of each Product, the minimum number of days between when a Firm Order must be placed to when it can be shipped, as set out against such Product in Exhibit 1 ( Products ) or, as applicable, agreed pursuant to clause 21 ( New Product SKUs ) or agreed following implementation of the Lead Time reduction contemplated in clause 3.3(D).

 

“LIBOR” means the London interbank offered rate, being the interest rate offered in the London inter-bank market for three month US dollar deposits or any equivalent interest rate agreed by the Parties in good time prior to LIBOR ceasing to exist if LIBOR ceases to exist.

 

“Long Term Transfer Plan” has the meaning set out in clause 42.1.

 

“Manufacture” means the planning, purchasing of materials for, manufacturing, producing, processing, compounding, holding and storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality assurance and release, sample retention and quality testing of Product.

 

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“Manufacturer’s Batch Certificate” means a certificate attesting that a Product batch has a Certificate of Analysis and a Certificate of Compliance.

 

“Manufacturing and Supply Team” has the meaning given to it in clause 15.2

 

“Manufacturing Licences” means any certificates, permits, licences and approvals issued by any relevant Governmental Entity in connection with Manufacture by or on behalf of the Supplier at the Manufacturing Sites.

 

“Manufacturing Sites” means facilities of the Supplier and/or its Affiliates or Permitted Subcontractors:

 

(A)                               at which the Products listed against such facilities in Exhibit 1 ( Products ) are Manufactured as at the Effective Date, as further summarised in Exhibit 2 ( Manufacturing Sites );

 

(B)                               in relation to which the Supplier has, as at the Effective Date, entered into a binding agreement for the Manufacture of Products, as set out in Exhibit 2 ( Manufacturing Sites ); and

 

(C)                               such other manufacturing facilities as the Parties may agree from time to time in writing in accordance with clause 2.7 or clause 2.8.

 

For each of the facilities included under (A) and (B) above, Exhibit 2 ( Manufacturing Sites ) shall set out the identity of the Supplier entity or Permitted Subcontractor which owns and operates such facility.

 

“Margin” has the meaning set out in Exhibit 16, Part C.

 

“Marketing Authorisations” means, in respect of a Product, such marketing authorisation, approval, licence, registration or other authorisations issued by a Governmental Entity from time to time in connection with the placing of that Product on the market in the relevant Territory (or, as applicable, a finished product manufactured using that Product), and Marketing Authorisation” shall be construed accordingly.

 

“Marketing Authorisation Holder” means, in respect of a Marketing Authorisation, the holder of such Marketing Authorisation from time to time.

 

“Materials” means, as applicable and to the extent used in the Manufacture of the Products, any materials, compounds or components including, without limitation: (a) raw ingredients, (b) intermediates, (c) excipients, (d) processing aids, (e) Chemicals, (f) with respect to Bulk Products and Finished Products, API, and (g) with respect to Bulk Products (as applicable) and Finished Products, packaging and labelling materials and components (including printed and non-printed components) thereof

 

Materials Adjustment ” has the meaning given to it in clause 10.4(B).

 

“Materials Cost” means the costs of Manufacture that relate to the Materials including the purchase prices, inbound freight, customs and insurance charges and non-deductible tax charges.

 

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“Minimum Order Quantity” or “MOQ” means, in respect of each Product, the volume of that Product set out in Exhibit 1 ( Products ) or, as applicable, agreed pursuant to clause 21 ( New Product SKUs ).

 

“Minimum Remaining Shelf Life” has the meaning given to it in clause 3.4(B).

 

“Minimum Target Volume” has the meaning given to it in clause 4.2.

 

“New Product Launches” has the meaning given to it in clause 21.

 

“New Product SKU” means:

 

(A)                               a new SKU for an existing Product that does not require the performance of Development Work, packaging or transportation testing, or generation of new stability data (such as, by way of example, a line extension of an existing Product requiring only changes to pack sizes and/or labelling or other Artwork to allow for sales in different markets);

 

(B)                               a SKU comprising a Bulk Product that is already Manufactured by the Supplier or the Permitted Subcontractor in the course of Manufacturing an existing Finished Product for the Purchaser; or

 

(C)                               a SKU comprising a Shared Chemical/API Product or a Shared Packaging Material that is already Manufactured under the terms of a Shared Contract in the course of Manufacturing an existing Finished Product or Bulk Product for the Purchaser, and ,

 

in each case the existing Product, Finished Product or Bulk Product in (A) to (C) shall be referred to as the “ Original Product ”).

 

“Nominated Supplier” means any member of the Supplier’s Group to whom the Supplier sub-contracts the Manufacture or supply of Products to the Purchaser (including invoicing).

 

“Non-Defaulting Party” has the meaning given to it in clause 40.8.

 

“Notice” has the meaning given to it in clause 45.1.

 

Novartis Control Manual ” means the Novartis control manual as set out in Appendix 1 to Exhibit 16 ( Supply Price Adjustment and  Catalogue ).

 

“Novartis Group” means Novartis AG and its Affiliates from time to time.

 

“NPS Commencement Date” means, in respect of a New Product SKU, the first date that such New Product SKU is added to this Agreement pursuant to clause 21.5.

 

“Ointments Products” means those Products identified as an ointment product set out in Part A of Exhibit 1 ( Products ).

 

“Payment” has the meaning given to it in clause 1.2(O).

 

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“Permitted Subcontractor” means a Third Party to whom the Supplier directly or indirectly sub-contracts in whole or in part the Manufacture of one or more Products and that is approved or deemed approved by the Purchaser in accordance with clause 2.6 of this Agreement and listed under Annex E of the Quality Agreement.

 

“Product” means, as applicable, a Finished Product, a Bulk Product, a Shared Chemical/API Product or a Shared Packaging Material (including in each case, if applicable and with effect from the relevant Commencement Date, any a New Product SKU) in each case as set out in Exhibit 1 ( Products ) and in each case, Manufactured and supplied under this Agreement, and “ Products ” shall be construed accordingly.

 

“Product Action” means a recall or withdrawal with respect to any Product supplied under this Agreement, whether such recall or withdrawal pertains to Products held by end customers, held by the Supplier or the Purchaser in storage, or at any other point in the supply chain.

 

Product Technology ” means the following categories of Finished Product (as indicated for each Finished Product in Exhibit 1 to this Agreement):

 

(A)                               Droptainer Product; and

 

(B)                               Ointment Products.

 

each a Product Technology and together the “ Product Technologies ”.

 

“Product Term” has the meaning given to it in clause 40.5.

 

“Purchaser” has the meaning given to it in the preamble.

 

“Purchaser’s Group” means the Novartis Group.

 

“Purchaser Improvement IP” means any Intellectual Property Rights subsisting in an Improvement, ownership of which is allocated to the Purchaser or its Affiliates in accordance with clause 39.4(C)(ii), and excluding, for the avoidance of doubt, any Joint Improvement IP.

 

“Purchaser Material” means in respect of a Product or other Material purchased by or on behalf of the Supplier from a member of the Purchaser’s Group or a Shared Contract CMO for use in the Manufacture of a Product to be supplied to the Purchaser (or its Affiliate) under this Agreement as listed in Exhibit 8 ( Purchaser Materials ) and “ Purchaser Materials ” shall be construed accordingly.

 

“Quality Agreement” means, in respect of a Product, the quality assurance agreement relating to the Manufacture and supply of Products in substantially the form attached to this Agreement at Exhibit 3 ( Quality Agreement ) entered into between the Purchaser or its Affiliate and the Supplier or its Affiliate on the Effective Date (together with, in respect of each Product, a Product-specific annex setting out specific details in relation to that Product), each as may be amended by the Parties from time to time during the Term.

 

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“Quality Management System” means the Supplier’s Group’s system of quality management controls designed to ensure regulatory compliance and to assure product safety, quality and efficacy in the Supplier’s Group’s operations with regard to the manufacture and supply of investigational materials or products for sale or distribution.

 

“Quality Standards” means, in respect of each Product, the more stringent of either:

 

(A)                               the Supplier’s Group’s quality standards in respect of the Manufacture of the Products and the traceability of API used in the Products, in each case as at the Effective Date; or

 

(B)                               the quality standards in respect of the Products and the traceability of API used in the Products, in each case as prescribed from time to time during the Term by Applicable Law, including cGMP and applicable industry codes,

 

provided that the same shall always be in compliance with Applicable Law, including cGMP.

 

“S&OP Meetings” has the meaning given to it in clause 15.1.

 

“Sales Tax” means any sales, goods, services, turnover, value-added, or similar Tax and any Tax charged on the import or export of any goods or services.

 

“Sanctions and Export Controls” means any Applicable Law that prohibits or places restrictions on the supply of certain products, materials, equipment, technology, software, know-how and/or information to certain markets and/or that prohibits or places restrictions on other dealings (including financial transactions) with certain territories or with particular persons or organisations within certain territories.

 

“Separation” has the meaning set out in the Separation Agreement.

 

“Separation Agreement” means the Separation Agreement entered into by and between Novartis AG and Alcon Inc., on or about the date of this Agreement.

 

“Shared Chemical/API Product” means:

 

(A)          each of the SKUs listed in Part C of Exhibit 1 ( Products );

 

(B)          any applicable New Product SKU introduced under this Agreement as a Shared Chemical/API Product in accordance with clause 21 ( New Product SKUs ),

 

in each case, comprising an API or Chemical for use in the manufacture of pharmaceutical products (as applicable) by or for the Purchaser or its Affiliates, and “Shared Chemical/API Products” shall be construed accordingly.

 

“Shared Contract” means any contract that has not been Separated, is in effect as at the Effective Date and provides for  the supply of the Shared Chemical/API Products, Shared Packaging Materials and/or Purchaser Materials listed in Exhibit 1 ( Products ) or Exhibit 8 ( Purchaser Materials ).

 

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“Shared Packaging Material” means packaging and labelling materials and components (including printed and non-printed components) supplied for use in the manufacture of Product and/or any equivalent Purchaser Materials in each case listed in Exhibit 1 ( Products ) or Exhibit 8 ( Purchaser Materials ).

 

“Site Volume Reconciliation” has the meaning given to it in clause 10.7.

 

“SKU” means stock-keeping unit.

 

“Specifications” means, in respect of a Product, or a Material used in the Manufacture of that Product:

 

(A)                               the specifications for that Product or Material (as applicable) registered or approved in the relevant Marketing Authorisation; or

 

(B)                               if there is no Marketing Authorisation in respect of the Product (because such Product can, in accordance with Applicable Law be put on the market without a Marketing Authorisation) or if the Marketing Authorisation in respect of that Product does not contain any specifications for that Product or Material (as applicable), the specifications for that Product or Material as set out in the relevant Annex to the Quality Agreement (as amended from time to time in accordance with the Quality Agreement).

 

“Specific Technical Transfer” has the meaning given to it in clause 42.5.

 

“Supplier” has the meaning given to it in the preamble.

 

Supplier Code ” means the Novartis Supplier Code as set out in Exhibit 10 ( Standards and Policies ).

 

“Supplier Improvement IP” means any Intellectual Property Rights subsisting in an Improvement, ownership of which is allocated to the Supplier or its Affiliates in accordance with clause 39.4(C)(i), and excluding, for the avoidance of doubt, any Joint Improvement IP.

 

“Supplier’s Group” means the Alcon Group.

 

“Supplier System IP” means any and all Intellectual Property Rights subsisting in the Supplier’s System that is owned by or licensed to the Supplier’s Group.

 

“Supply Price” means, in respect of each Product, the supply price determined in accordance with clause 10 ( Price and Price Adjustments ).

 

“Target Gating Volume” has the meaning set out in clause 4.1(A).

 

“Tax” means all taxes, levies, duties, imposts, charges and withholdings of any nature whatsoever together with all penalties, charges and interest relating to any of them or to any failure to file any return required for the purposes of any of them.

 

“Technical Transfer Milestones” has the meaning set out in clause 42.12 .

 

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“Technical Transfer Team” means the representatives of each Party nominated as being responsible for the oversight and implementation of the Long Term Transfer Plan.

 

“Term” has the meaning set out in clause 40.1.

 

“Territory” means:

 

(A)                               in respect of each Finished Product, the country (or countries) in which that Finished Product is placed on the market (and where, if applicable, there is a granted Marketing Authorisation for such Product from time to time) and as set out in Part A of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties);

 

(B)                               in respect of each Bulk Product or Shared Packaging Material, the country (or countries) in which products Manufactured using such Bulk Product or Shared Packaging Material are placed on the market (and where, if applicable, there is a granted Marketing  Authorisation for such product from time to time) and as set out in Part B of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties); and

 

(C)                               in respect of each Shared Chemical/API Product, the country (or countries) in which products Manufactured using such Shared Chemical/API Product are placed on the market (and where, if applicable, there is a granted Marketing Authorisation for such product from time to time) and as set out in Part C of Exhibit 1 ( Products ) (as amended from time to time by agreement between the Parties).

 

“Third Party” means from any company other than the Purchaser and its Affiliates and the Supplier and its Affiliates.

 

“Toll Manufacturing Basis” has the meaning set out in clause 5.1.

 

“Toll Material” has, in respect of a Tolled Product, the meaning set out in Exhibit 7 ( Toll Manufacture Provisions ).

 

“Tolled Product” has the meaning set out in Exhibit 7 ( Toll Manufacture Provisions ).

 

“Total Product Cost” means, in respect of a Product, the fully-absorbed cost of Manufacture as calculated in a manner consistent with IFRS and the Total Product Costing methodology employed by the Supplier and its Affiliates for other products, including (without limitation) the costs of Materials, direct labour, ordinary course quality assurance costs, equipment maintenance costs, and other costs variable with production, plus an allocation of the Manufacturing Site’s fixed overhead consistent with the Supplier’s Total Product Cost calculated in accordance with the Novartis Control Manual, but excluding any profit made by the Supplier or any of its Affiliates through the application of transfer pricing. For the avoidance of doubt, the Total Product Cost of each Product for 2019 is reflected in Exhibit 1 ( Products ) as such Product’s Base Price.

 

“Transaction Documents” means this Agreement, the Separation Agreement, the Consignment Sales Agreement (India), the Transitional Distribution Services Agreement

 

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(Legacy Ciba), the Global Transitional Services Agreement, the Quality Agreement, the Global Pharmacovigilence Agreement, the Pharmacovigilence Services Agreement, the MA Transfer Agreement, the TRD Pilot Plant Services Agreement, Fort Worth Pilot Plant Lease Agreement, the Brand Licence Agreement, the IP Assignment Agreement, Information Access Agreement, Tax Matters Agreement and any document or instrument entered into or delivered pursuant hereto or thereto.

 

“Transitional Services Agreements” means the Global Transitional Services Agreement, the Pilot Plant Services Agreement dated on or around the Effective Date between a member of the Supplier’s Group (as the provider of services) and a member of the Purchaser’s Group (as the recipient of services).

 

“Trigger Date” means the date with effect from which the relevant Product (or proposed New Product SKU) shall be Manufactured on a toll (zero cost, consignment) manufacturing basis.

 

Volume Based Adjustment ” has the meaning set out in clause 10.4(C).

 

“Working Hours” means, in relation to a notice served or audit performed under this Agreement, 09:00 to 17:00 in the place of receipt of such notice or place of such audit on a Business Day.

 

1.2                               In this Agreement, unless specified otherwise:

 

(A)                               references to clauses, paragraphs, Exhibits and Annexes are to clauses and paragraphs of, and Exhibits and Annexes to, this Agreement;

 

(B)                               headings to clauses, Exhibits, Annexes and paragraphs are for convenience only and do not affect the interpretation of this Agreement;

 

(C)                               the Exhibits and Annexes form part of this Agreement and shall have the same force and effect as if expressly set out in the body of this Agreement, and any reference to this Agreement shall include the Exhibits and Annexes;

 

(D)                               a reference to any statute, regulation or statutory provision shall be construed as a reference to the same as in effect at the applicable time, including as it may have been, or may from time to time be, consolidated, amended, modified, extended or re-enacted and any successor or materially equivalent legislation enacted or adopted;

 

(E)                                references to a “company” shall be construed so as to include any firm, company, corporation, legal entity or body corporate;

 

(F)                                 references to a “person” shall be construed so as to include any individual, company, government, state or agency of a state, local or municipal authority or government body or any joint venture, association or partnership (whether or not having separate legal personality);

 

(G)                               use of any gender includes the other genders;

 

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(H)                              references to the singular shall include the plural and vice-versa;

 

(I)                                   references to writing shall include any modes of reproducing words in a legible and non-transitory form, and accordingly shall exclude e-mail and other transitory modes;

 

(J)                                   any reference to a “day” (including within the phrase “Business Day” ) shall mean a period of 24 hours running from midnight to midnight;

 

(K)                               references to any English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than England, be treated as including what most nearly approximates in that jurisdiction to the English legal term;

 

(L)                                the word “registered” , when used in connection with Materials or with any process, is to be construed as a reference to the fact that details of such Materials or process have been (and/or are required to be) registered with any applicable Governmental Entity (whether in a Marketing Authorisation or otherwise);

 

(M)                            (i)             the rule known as the ejusdem generis rule shall not apply and accordingly general words introduced by the word “other” shall not be given a restrictive meaning by reason of the fact that they are preceded by words indicating a particular class of acts, matters or things;

 

(i)             the use of the phrase “ not unreasonably withheld ” and similar constructions shall be deemed to mean “not to be unreasonably withheld, conditioned or delayed”;

 

(ii)            the use of the words “includes” or “including” shall be deemed to say also “without limitation” ; and

 

(iii)           general words shall not be given a restrictive meaning by reason of the fact that they are followed by particular examples intended to be embraced by the general words;

 

(N)                               each Party may satisfy its obligations under this Agreement either directly or indirectly through one or more members of its Group (including, in the case of the Supplier, through a Nominated Supplier), whether or not expressly stated, provided that each Party shall remain the principal obligor for the performance of its obligations hereunder;

 

(O)                               any indemnity or covenant to pay (the “Payment Obligation” ) being given on an “after-Tax basis” or expressed to be “calculated on an after-Tax basis” means that the amount payable pursuant to such Payment Obligation (the “Payment” ) shall be calculated in such a manner as will ensure that, after taking into account:

 

(i)             any Tax required to be deducted or withheld from the Payment;

 

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(ii)            the amount and timing of any additional Tax which becomes payable by the recipient of the Payment (or a member of the Supplier’s Group or the Purchaser’s Group, as the case may be) as a result of the Payments being subject to Tax in the hands of that person; and

 

(iii)           the amount and timing of any Tax benefit which is obtained by the recipient of the Payment (or a member of the Supplier’s Group or the Purchaser’s Group, as the case may be) to the extent that such Tax benefit is attributable to the matter giving rise to the Payment Obligation or to the receipt of the Payment,

 

which amount and timing is to be determined by the auditors of the recipient at the shared expense of both Parties and is to be certified as such to the Party making the Payment, the recipient of the Payment is in the same position as that in which it would have been if the matter giving rise to the Payment Obligation had not occurred;

 

(P)                                 unless specified to the contrary, references to “indemnify” and “indemnifying” any person against any circumstance include indemnifying and holding that person harmless on an after-Tax basis and:

 

(i)             the provisions of clause 37 ( Indemnity and Liability ) shall apply to such indemnification;

 

(ii)            references to the Supplier indemnifying each member of the Purchaser’s Group shall constitute undertakings by the Supplier to Purchaser for itself and on behalf of each other member of the Purchaser’s Group; and

 

(iii)           references to the Purchaser indemnifying each member of the Supplier’s Group shall constitute undertakings by the Purchaser to the Supplier for itself and on behalf of each other member of the Purchaser’s Group;

 

(Q)                               unless specified to the contrary, any amount to be paid or provided under any clause of this Agreement for any supply made under or in connection with this Agreement is exclusive of Sales Tax; and

 

(R)                               references to “ costs ” and “ expenses ” incurred by a person shall include any Sales Tax or amount in respect thereof comprised in such costs or expenses, other than Sales Tax or amounts in respect thereof for which that person or, if relevant, any other member of its Group for the relevant Sales Tax purposes is entitled to credit or repayment.

 

2.                                      MANUFACTURE AND SUPPLY

 

2.1                               On and subject to the provisions of this Agreement, the Supplier shall Manufacture and supply, or have Manufactured and supplied, to the Purchaser, and the Purchaser shall purchase, or procure the purchase by an Affiliate of the Purchaser of, the Products for which a Firm Order is placed until the end of the

 

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applicable Product Term in accordance with clause 3 ( Forecasts and Orders ) in respect of all Products.

 

2.2                               The Purchaser may commence purchasing each Product under this Agreement from the applicable Commencement Date, unless otherwise agreed in writing by the Parties.

 

2.3                               The Supplier shall (or, subject to clause 2.6, shall procure that a Permitted Subcontractor or Nominated Supplier will) Manufacture the Products at the Manufacturing Sites in accordance with:

 

(A)           the applicable Specifications on the Effective Date (unless changed in accordance with clause 20 ( Product Specifications ));

 

(B)                               current Good Manufacturing Practice and responsible procurement guidelines;

 

(C)                               the applicable Manufacturing Licences;

 

(D)                               the applicable Marketing Authorisations (in the case of Shared Chemical/API Products, to the extent relevant);

 

(E)                                the Quality Agreement and the applicable Quality Standards;

 

(F)                                 Firm Orders;

 

(G)                               Applicable Law in the country of Manufacture relevant to the Manufacture of the Product; and

 

(H)           Applicable Law in the Territory where the Product (or in the case of Shared Chemical/API Products or Shared Packaging Materials, any product incorporating such Products or Materials) is to be sold in relation to the Manufacture of such Product.

 

2.4                               During the Term, the Supplier shall (or, subject to clause 2.6 shall procure that a Permitted Subcontractor or Nominated Supplier will) obtain (where not held already) and maintain all necessary Manufacturing Licences from the relevant Governmental Entity as are required for the Manufacture of the Products at the Manufacturing Sites.

 

2.5                               The Parties hereby acknowledge that the Supplier may, on prior written notice to the Purchaser, nominate any of its Affiliates to act as its Nominated Supplier under this Agreement to Manufacture and supply Products to, and receive payment from, the Purchaser (or its Affiliate), provided that :

 

(A)                               the Supplier shall remain primarily liable to the Purchaser as principal obligor for the performance of its obligations under this Agreement in respect of such supply; and

 

(B)                               such entity shall cease to be a Nominated Supplier if it ceases to be an Affiliate of the Supplier and the Supplier shall be required to either perform the

 

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obligations of such former Affiliate or procure its replacement by another Affiliate prior to it ceasing to be an Affiliate.

 

The Supplier may change the Nominated Supplier from time to time by notice in writing to the Purchaser (provided always that such Nominated Supplier is an Affiliate of the Supplier) subject to the terms set forth in clause 40 ( Technical Transfer ).  References in this Agreement to the Supplier shall be deemed to include any appointed Nominated Suppliers.

 

2.6                               The Supplier may not sub-contract the Manufacture of Products (or any part thereof) to a Third Party without the prior written consent of the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed), provided that each Third Party arrangement set out in Annex E of the Quality Agreement shall be deemed to have been given the prior written consent of the Purchaser and the Third Party listed shall be a Permitted Subcontractor. Any Third Party sub-contractor engaged by the Supplier with the prior written consent of the Purchaser in accordance with this clause 2.6 shall be deemed to be a Permitted Subcontractor. The Supplier will ensure that all Permitted Subcontractors and all Nominated Suppliers act in compliance with the terms and conditions of this Agreement, including but not limited to, complying with all Applicable Laws, and shall ensure that the Permitted Subcontractors and Nominated Suppliers are subject to confidentiality obligations that are no less restrictive than those found at clause 31 ( Confidentiality ) and, to the extent practicable, grant the Purchaser audit and inspection rights substantially equivalent to those set out in clause 33 ( Audit and Inspection Rights ).  The engagement of Permitted Subcontractors and Nominated Suppliers shall not relieve the Supplier from any of its liabilities or obligations under this Agreement and the Supplier shall remain liable as primary obligor to the Purchaser for the acts or omissions of all Permitted Subcontractors and Nominated Suppliers as if they were the acts or omissions of the Supplier.

 

2.7                               The Supplier may not:

 

(A)                               change a Permitted Subcontractor;

 

(B)           make any material amendments to contracts with Permitted Subcontractors relating to the Manufacture or supply of Products (including any amendment that would adversely affect the Purchaser or require an amendment to a Marketing Authorisation or permit held by the Purchaser) except where such changes are required by a Governmental Entity (and in such case, only upon reasonable advance notice to the Purchaser); or

 

(C)                               in respect of a Product, change (or permit a Nominated Supplier or Permitted Subcontractor to change) the API Supplier or the supplier of any registered Materials,

 

in each case without the prior written consent of the Purchaser (such consent not to be unreasonably withheld or delayed) and in accordance with any applicable change control provisions set out in the Quality Agreement.

 

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2.8                               The Supplier may not change or permit the change of any Manufacturing Site other than as provided for in the Long Term Transfer Plan without the prior written consent of the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed), provided that any change of any Manufacturing Site (other than any provided for in the Long Term Transfer Plan) shall:

 

(A)                               be subject to any applicable change control provisions set out in the Quality Agreement; and

 

(B)                               comply with Applicable Law.

 

2.9                               In the event that Applicable Law or a Governmental Entity or local customs office requires that the Parties (or their Affiliates) enter into a local agreement in relation to the Manufacture or supply of a particular Product by the Supplier (or its Nominated Supplier) to the Purchaser (or its designated Affiliate), the Parties shall negotiate in good faith and enter into such local agreements on a Product-by-Product and country-by-country basis to give effect to the transactions contemplated by this Agreement in relation to such Product in such country, provided that :

 

(A)                               the Parties shall only enter into such local agreements where required by Applicable Law or a Governmental Entity or local customs office to do so;

 

(B)                               each such local agreement shall be limited in scope to those matters for which it is necessary for the Parties (or their Affiliates) to contract locally;

 

(C)                               subject to clause 2.9(B), each local agreement shall be consistent with the terms of this Agreement and not have an disproportionate adverse effect on either Party;

 

(D)                               the Parties shall procure that, in respect of any Product, such local agreement is terminated in the event that this Agreement expires or is terminated in relation to such Product; and

 

(E)                                subject to clause 2.9(A) and any requirements of Applicable Law, in the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of such a local agreement, the provisions of this Agreement shall prevail.

 

Without prejudice to the rights and obligations of the Parties under clause 10 ( Price and Price Adjustments ), to the extent there is an inconsistency between the provisions of this Agreement and the provisions of any local agreement, either Party may refer the matter to the Manufacturing and Supply Team which may agree a mechanism to address any such inconsistency.

 

2.10                        The Supplier shall not be obliged to Manufacture and/or supply, and the Purchaser shall not be obliged to purchase, any Product if such Manufacture, supply or purchase would cause that Party to be in breach of Sanctions and Export Controls (including but not limited to debarred individuals and ITAR). U.S. export control and economic sanctions laws and the export control and economic

 

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sanctions laws of other countries, including but not limited to EU Member States, Singapore, and Switzerland, may govern the export, sale, and/or use of Products. The Purchaser shall be responsible for obtaining any required government authorisations under the relevant Sanctions and Export Controls.  Each Party to this Agreement agrees to comply fully with all relevant Sanctions and Export Controls to assure that no Product or any portion thereof is exported, sold, or otherwise transferred directly or indirectly, in violation of Applicable Law.

 

3.                                      FORECASTS AND ORDERS

 

3.1                               Forecasting and ordering of Product(s) under this Agreement shall be conducted:

 

(A)                               on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or

 

(B)                               on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 ( Toll Manufacture ) and Exhibit 7 ( Toll Manufacturing Provisions ), and

 

(C)                               on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “ Forecast Schedule ”).

 

3.2

 

(A)                               Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.

 

(B)                               The initial Forecast Schedule is attached to this Agreement at Exhibit 14 ( Initial Product Forecast Schedule ) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.

 

(C)                               Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order” ). Each

 

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Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity.  If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).

 

(D)                               The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply.  Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 ( Products ).

 

(E)                                The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):

 

(i)             within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and

 

(ii)            within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required.

 

In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments.  If the Purchaser:

 

(iii)           accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or

 

(iv)           rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection.

 

The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clause

 

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16 ( Dispute Escalation ), in which case such matter shall be determined in accordance with clause 16 ( Dispute Escalation ).

 

(F)                                 The Purchaser, either electronically or by such other means determined by the Manufacturing and Supply Team, shall deliver to the Supplier purchase orders corresponding to the Product volumes shown in the Firm Orders to such location as reasonably requested by the Supplier in writing. The purchase order shall be in such form as is mutually agreed by the Manufacturing and Supply Team and shall specify the Product(s) and country(ies) to which it relates; have assigned to it a number which shall be used by the Parties in all correspondence relating thereto and shall be submitted in accordance with the Lead Times set out in Exhibit 1 ( Products ) and the applicable Firm Zone for the Product(s) shown in each Firm Order so that the Supplier may process the Firm Orders.

 

(G)                               The Supplier will supply Product in accordance with Firm Orders that comply with this clause 3.2 and the applicable Gating Plan and for which the Supplier receives purchase orders in accordance with clause 3.2(F), unless such requirements are changed in accordance with clause 3.2(H) or clause 3.2(I).

 

(H)                              Without prejudice to the Parties’ obligations with respect to the Firm Zone of any Forecast Schedule, if discussion of the relevant requirements of a Firm Order is requested by the Supplier, then the relevant planning personnel from both Parties will discuss in good faith, provided that the Supplier shall have no obligation to agree any production schedule or Delivery timetable which would exceed the applicable Gating Volumes for the relevant Product as set out in the Gating Plan for that Gating Year.

 

(I)                                   The Purchaser and the Supplier shall each establish a single point of ordering and forecasting in respect of Products for the purposes of carrying out its obligations under this clause 3.2, subject to any agreed delegation of supply and/or invoicing and/or payment to Nominated Suppliers or other Affiliates of a Party in accordance with this Agreement.

 

3.3                               Other requirements

 

(A)                               Bridging Stock shall not be treated on a different basis to any standard order of Product in the Forecast Schedules provided pursuant to this clause 3 ( Forecasts and Orders ). The Parties acknowledge that through long term S&OP planning, arrangements will be made to manage and record long term planning of Bridging Stock.

 

(B)                               Subject to clause 3.4(C) the Supplier shall ensure that on the day of Delivery in accordance with the Delivery Terms and clause 9 ( Delivery of Product ), and unless (i) agreed otherwise between the Parties on a Product-by-Product basis or (ii) a different percentage of registered shelf life is set forth on Exhibit 1 ( Products ) for the applicable Product, each Product shall have remaining at least seventy-five per cent. (75%) of their registered shelf life (with respect to each Product, the “ Minimum Remaining Shelf Life ”).

 

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(C)                               Other than in relation to an agreed list of exceptional circumstances there shall be no requirement for the Supplier to maintain a specific level of safety stock of Products or Materials. Where any exceptional agreement is reached for the maintenance of any safety stock for Materials, the Purchaser requesting the provision of such safety stock will: (A) at the discretion of the Supplier, bear the carrying cost (calculated at 7% financial interest plus actual warehousing costs if any) associated with such safety stock, and (B) bear the associated risk for such safety stock, in each case due to (i) the expiry or termination of this Agreement in respect of any relevant Product; (ii) a change in the Forecast Schedule in respect of such Product; or (iii) a change in any Product requirements to the extent that any Materials comprising the safety stock do not comply with the applicable Specifications and Quality Standards or meet the other requirements of this Agreement, provided that the Supplier shall use reasonable endeavours to mitigate such risk (for example, and without limitation, by applying a First in First Out inventory management system).

 

(D)                               The Parties acknowledge that the Lead Time of one hundred and twenty (120) calendar days applicable to Products in Exhibit 1 ( Products ) on the Effective Date should be improved over time and the Supplier has resolved to use its Commercially Reasonable Efforts to reduce the Lead Time for all Product Technologies supplied under this Agreement to one hundred (100) calendar days within two (2) years from the Effective Date.

 

(E)                                In relation to any Products that are (i) the subject of an ongoing technical transfer pursuant to this Agreement and (ii) have been identified in Exhibit 1 ( Products ) as Products where a full batch of such Product must be ordered (“ Batch Constrained Products ”), if during the implementation of the relevant technical transfer the Purchaser orders Batch Constrained Product at a quantity below the batch size set out against such Batch Constrained Product in Exhibit 1 ( Products ) or the requirements for a particular Manufacturing run of such Product does not consume a full batch, then the Parties shall discuss in good faith how to mitigate the potential wastage of unused Materials used in the proposed Manufacture of such Batch Constrained Product. If the Supplier agrees to proceed with the Manufacture of any Batch Constrained Product it shall be on the basis that the Supplier shall be entitled to charge the Purchaser for the cost (without applying any mark-up) of the unused Materials that cannot be recovered.

 

(F)                                 The provisions of this clause 3 ( Forecasts and Orders ) are subject to the provisions of clause 4 ( Capacity Baseline and Gating Plan ) in the event that an Allocation is required to be made.

 

4.                                      CAPACITY BASELINE AND GATING PLAN

 

4.1                               Within the third Quarter of each Calendar Year following the Effective Date during the Term, the Parties shall meet (the “ Gating Meeting ”) to agree on a gating plan specifying the Manufacturing capacity for each Product Technology to be allocated to the Purchaser by the Supplier at each Manufacturing Site for each month within the next Calendar Year (each a “ Gating Year ”) based on:

 

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(A)                               a baseline indication of the Purchaser’s Group’s volume requirements (calculated on the basis of Products to be Delivered as opposed to Products ordered) as supplied in advance by the Purchaser to the Gating Meeting (the “ Target Gating Volume ”);

 

(B)                               current available capacity at the relevant Manufacturing Sites supplied by the Supplier in advance to the Gating Meeting, taking due account of any actual or anticipated constraints on the capacity at any such Manufacturing Site for the Manufacture of relevant Products (including with reference to the applicable then-current Forecast Schedule and the Supplier’s other actual or anticipated operations at such Manufacturing Site) and taking account of any agreed New Product SKU volumes;

 

(C)                               the then current Aspex Requirements; and

 

(D)                               planned transfers of Product under the Long Term Transfer Plan and any Specific Technology Transfers,

 

in each case for each of the Product Technologies at the relevant Manufacturing Sites for the relevant Gating Year under consideration (each a “ Gating Plan ”). The Gating Plan shall be approved by the Manufacturing and Supply Team. The initial Gating Plan for all Product Technologies and containing, inter alia, the Aspex Requirements, is set out in Exhibit 6 (Initial Gating Plan ) to this Agreement. Following a request from the Supplier (as an exception in the 2019 Gating Year to the Gating Plan mechanism set out in this Agreement) the Parties agree that, due to capacity constraints, the Supplier shall not be obliged to offer the full 10% flexibility above the monthly Target Gating Volumes for the Aspex Requirements in the 2019 Gating Year and that the volume per month that the Supplier commits to accept above the monthly Target Gating Volumes is as set out in the Initial Gating Plan for the Aspex Manufacturing Site in the 2019 Gating Year at Exhibit 6.

 

For the avoidance of doubt Gating Plans shall not include volumes of any Shared Chemical/API Product or Shared Packaging Material supplied under this Agreement. Further, even though the Aspex Requirements are set on an annual basis for a five (5) year period, the Parties shall seek to agree the applicable monthly allocation of such Gating Volumes of the Aspex Requirements for the applicable Gating Year at the relevant Gating Meeting.

 

4.2                               The Purchaser (or one of its Affiliates) shall place orders for Products for up to 90% of the Gating Volume for each Product Technology in the Gating Plan for the relevant Gating Year (“ Minimum Target Volume ”) on a take or pay basis, meaning that the Purchaser shall be obligated to pay the full Conversion Cost for all such Product up to the Minimum Target Volume for the relevant Product Technology irrespective of whether an order is placed for such Product, provided that the foregoing shall not apply:

 

(A)                               if the Parties agree in writing in advance to mitigate the order shortfall by substituting or increasing an alternative volume of Product (whether from another Product Technology or a New Product SKU);

 

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(B)                               in circumstances where the Supplier, through no fault of the Purchaser, is unable to or otherwise does not supply the Products within the Product Technology up to the Minimum Target Volume; or

 

(C)                               where the Supplier Delivers Products for that Product Technology that are Defective, or if such Product becomes Defective after Delivery to the Purchaser or its Affiliate, and in either case, the Supplier is unable to or otherwise does not supply replacement non-Defective Product in accordance with this Agreement.

 

If the Purchaser gives at least three (3) months’ advance notice in writing that it is not likely to meet the Minimum Target Volume for a Product Technology in a Gating Year the Parties agree to discuss any reasonable mitigation proposals in good faith (including the extent of any write-off of Materials) in the next S&OP Meeting and, if the Parties do not agree, the issue may be escalated in accordance with clause 4.5.

 

4.3                               The Parties shall agree a fixed Gating Volume for each of the five (5) Gating Years after the Effective Date (2019 to 2023) for the Droptainer Products Manufactured at the Aspex Manufacturing Site (“ Aspex Requirements ”) as part of the initial Gating Plan.

 

4.4                               In addition and subject to the Aspex Requirements, the Purchaser may request that the Gating Volumes for all other Product Technologies in any subsequent Gating Year’s Gating Plan at least match the capacity of a Product Technology available at a particular Manufacturing Site in the current Gating Year’s Gating Plan and the Parties shall consider such request in good faith, save that the Parties shall take account of actual usage of the previous year’s allocated capacity; agreed constraints on or commitments in relation to capacity; any Product divestments planned and mutually agreed upon by the Parties and the movement of Products in the Long Term Transfer Plan.

 

4.5                               If the Parties do not agree the Gating Plan by 30 September in the preceding Calendar Year to the Gating Year of the relevant Gating Plan or any matters relating to the Long Term Transfer Plan the matter shall be referred to the Manufacturing and Supply Team for resolution who shall respectively endeavour in good faith to resolve the matter presented to them as expeditiously as possible and shall take account of the factors set out in clauses 4.1, 4.7 and 4.8 to 4.10 . If any dispute related to the Gating Plan or Long Term Transfer Plan cannot be resolved within the Manufacturing and Supply Team within thirty (30) days after such request for referral, then the Manufacturing and Supply Team shall refer such dispute to the Executive Officers of each Party for resolution. If a referral is made to the Executive Officers, they shall meet by telephone or in person promptly to discuss the matter submitted and to determine a resolution in accordance with clause 16 ( Dispute Escalation ).

 

4.6                               Save as is provided in clause 4.3, once agreed in writing by the Parties by the Manufacturing and Supply Team, a Gating Plan for a Gating Year shall become binding on the Parties and Firm Orders shall be placed in accordance with the applicable Gating Volumes set out in such Gating Plan, except that Purchaser shall be entitled to place Purchase Orders deviating from the Gating Volumes of

 

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Product (aggregated on a Product Technology basis) agreed in the Gating Plan for that Gating Year by no more than an aggregate + / - 10% for the balance of the Gating Year provided however, that volumes agreed in any Firm Order already placed may not be varied.

 

4.7                               If in any Gating Year the Purchaser requests a volume increase in respect of a Product Technology of a Product by more than 10% above the Gating Volumes agreed for the Product Technology in the Gating Plan for the applicable period, the Supplier shall use Commercially Reasonable Efforts to ensure it has  sufficient Manufacturing capacity at the applicable Manufacturing Site to satisfy the Purchaser’s requested increase in volumes of such Product Technology, subject always to the overall capacity constraints of the relevant Manufacturing Site(s) and the considerations set out in clauses 4.8 to 4.10 below. For the avoidance of doubt, the Supplier shall have no obligation to supply Product in excess of 110% of the Gating Volumes of relevant Product set out in the Gating Plan for the relevant period in the relevant Gating Year if unable to do so despite having used Commercially Reasonable Efforts to supply up to 110% of the Gating Volumes referred to above.

 

4.8                               The Supplier shall ensure that it has sufficient capacity over the applicable Product Term to meet the demand which will be agreed for a Product in the Gating Plan. If the Supplier, a Nominated Supplier or a Permitted Subcontractor is unable to Manufacture the quantities of Products forecasted or ordered by the Purchaser in accordance with this Agreement as a result of:

 

(A)                               shortages of Materials that are used both in the Manufacture of Products and in the manufacture of products for the Supplier’s Group or its Third Party customers; or

 

(B)                               constraints on the capacity at:

 

(i)                                     the Manufacturing Site; or

 

(ii)                                  any manufacturing site operated by the Supplier’s Group at which any Materials are manufactured,

 

(the “Affected Site” ), in each case including as a result of any repair or remediation being required in respect of the Affected Site or any equipment at the Affected Site that is used in the Manufacture of Products or Materials (as applicable), then, without prejudice to the capacity threshold in the Gating Plan and clause 32 ( Force Majeure ), clauses 4.9 and 4.10 shall apply.

 

4.9                               In the circumstances contemplated by clause 4.8, the Supplier shall (or shall procure that the Nominated Supplier or Permitted Subcontractor shall) refer the decision as to how to allocate the available Materials, or available capacity at the Affected Site to the Manufacturing and Supply Team who shall make such allocation, between:

 

(A)                               the Products;

 

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(B)                               products manufactured by the Supplier’s Group for commercialisation by the Supplier’s Group that rely on the same Materials or Affected Site; and

 

(C)                               products manufactured by the Supplier’s Group for commercialisation by its Third Party customers that rely on the same Materials or Affected Site,

 

(collectively, the “ Affected Products ”) in a fair and reasonable manner as if all Affected Products were to be commercialised by and for the sole benefit of the Supplier’s Group, taking account of all relevant factors, including the indications of each Affected Product, the risk and likely duration of any stock out of each Affected Product, the availability in the relevant jurisdiction of alternatives to each Affected Product and whether or not each Affected Product is medically critical (the “ Allocation ”).

 

4.10                        In the circumstances contemplated by clause 4.8:

 

(A)                               the Purchaser shall, on request, provide the Manufacturing and Supply Team and the Supplier, Nominated Supplier or Permitted Subcontractor with such information as the Supplier, Nominated Supplier or Permitted Subcontractor may reasonably require in order to determine the Allocation in accordance with clause 4.9;

 

(B)                               notwithstanding anything to the contrary in clause 3 ( Forecasts and Orders ), each Firm Order shall be deemed to be revised (as to quantities of Products and/or Delivery dates, as applicable) to the extent necessary to accord with the Allocation as determined by the Manufacturing and Supply Team (and the Purchaser shall be deemed to agree with such revision) and the provisions of clause 25 ( Write Off Costs ) shall not apply to such change in volume; and

 

(C)                               for the purposes of clause 9 ( Delivery of Product ), the due date for Delivery in respect of any Firm Order shall reflect any revision to such Firm Order made pursuant to this clause 4.10.

 

4.11                        The Purchaser shall ensure that the quantities of Product shown in the Forecast Schedule do not, at the time such quantities first appear in the Firm Zone, exceed, on an annual basis, the available capacity at the relevant Manufacturing Site as mutually agreed in the Gating Plan and that Purchaser shall order and acquire ninety per cent (90%) of the Gating Volumes in any Gating Plan.

 

5.                                      TOLL MANUFACTURE

 

5.1                               The Parties agree that at any time during the Term, the Purchaser may propose that a Product (including a New Product SKU introduced, or proposed to be introduced, pursuant to clause 21 ( New Product SKUs )) shall be Manufactured on a Toll Manufacturing Basis) and any such proposal must identify the Materials that the Purchaser proposes to supply to the Supplier on a Toll Manufacturing Basis.

 

5.2                               The Supplier shall consider each proposal made pursuant to clause 5.1 in good faith and shall not unreasonably refuse to Manufacture (or have Manufactured)

 

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the proposed Product(s) on a Toll Manufacturing Basis. The Parties agree that a refusal to Manufacture on a Toll Manufacturing Basis due to lack of site-readiness shall be deemed to be unreasonable; provided, that the Supplier may condition its acceptance of any proposal to Manufacture on a Toll Manufacturing Basis on the Supplier being given a reasonable amount of time, which shall be no less than three (3) months in length, to prepare any applicable Manufacturing Site for Manufacturing on a Toll Manufacturing Basis and the Purchaser shall cooperate with and provide such information as is reasonably necessary for such preparations.).

 

5.3                               If the Parties agree that a Product shall be Manufactured on a Toll Manufacturing Basis it shall be Manufactured in accordance with this clause 5 ( Toll Manufacture ) and the terms set out in Part 1 of Exhibit 7 ( Toll Manufacture Provisions ) and further the Parties shall (each acting reasonably and in good faith) agree and execute a Tolled Product Exhibit in the form attached to this Agreement in Part C of Exhibit 7 ( Form of Tolled Product Exhibit ) (a form of which is annexed to this Agreement at Part B of Exhibit 7 ( Form of Bulk Tolled Product Exhibit ) for the Bulk Tolled Products that are Tolled Products as at the Effective Date), Each Tolled Product Exhibit shall specify (among other things):

 

(A)                               the Trigger Date with effect from which the relevant Product (or proposed New Product SKU) shall be Manufactured on a Toll Manufacturing Basis;

 

(B)                               if applicable (in accordance with paragraph 4 of Part 1 of Exhibit 7 (Toll Manufacture Provisions)), the Existing Materials Cost (as defined in Exhibit 7) at which the Purchaser shall purchase from the Supplier any stock-on-hand of the Materials that will, with effect from the Trigger Date, be supplied by the Purchaser on a Toll Manufacturing Basis, which Existing Materials Cost shall be calculated in accordance with paragraph 4.1 of Exhibit 7 (Toll Manufacture Provisions); and

 

(C)                               the Supply Price (and the applicable Invoice Currency) at which the Supplier shall supply the relevant Tolled Product to the Purchaser when Manufacturing using Materials supplied on a Toll Manufacturing Basis, which Supply Price shall be calculated in accordance with clause 10.1, save that in calculating the Total Product Cost of any Tolled Product Manufactured on a Toll Manufacturing Basis, the Actual Cost (as defined in Exhibit 7)  paid (or payable) by the Purchaser or its Affiliates for Toll Materials shall be disregarded in calculating the Total Product Cost of that Tolled Product.

 

5.4                               With effect from the Effective Date in relation to the Bulk Tolled Products and the Trigger Date for all other Products to be manufactured on a Toll Manufacturing Basis, the provisions of Exhibit 7 ( Toll Manufacture Provisions ) shall apply in respect of the Manufacture of the relevant Product.  Any product agreed to be supplied as a Tolled Product shall continue to be supplied on a Toll Manufacturing Basis unless mutually agreed by the Parties.

 

5.5                               In respect of the Bulk Tolled Product, the Parties acknowledge that as at the Effective Date the Supplier and Purchaser for the purposes of such Manufacture rely on interim systems, procedures and processes to manage such Manufacture

 

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on a Toll Manufacturing Basis (or with an equivalent capability in relation to the management of Manufacturing on a Toll Manufacture Basis) (the Interim Toll Manufacture Systems ”). The Parties agree that the Supplier shall be entitled to continue to Manufacture (or have Manufactured) that Product on a Toll Manufacturing Basis under this Agreement using those Interim Toll Manufacture Systems until the Parties have the capability to enable the Manufacture of the relevant Product(s) using new systems, procedures and processes that would enable the Manufacture of such Product(s) to continue to be undertaken on a Toll Manufacturing Basis taking account of the IT systems changes being implemented by both Parties after the Effective Date and both Parties shall use their Commercially Reasonable Efforts to implement and operate such new systems, processes and procedures as the Supplier may reasonably require (taking account of any updates to relevant IT systems) as soon as reasonably practicable in respect of any Bulk Tolled Products following a request from the Supplier.

 

6.                                      PRODUCTS MANUFACTURED USING MATERIALS PURCHASED FROM PURCHASER

 

6.1                               If, in respect of a Product, a member of the Purchaser’s Group is at any time during the Term:

 

(A)                               the supplier to the Supplier (or its Permitted Subcontractor) of any Materials used in the Manufacture of that Product; and

 

(B)                               the Supplier (or its Permitted Subcontractor) purchases and takes title to such Materials from the Purchaser or its Affiliate,

 

the provisions of Exhibit 8 ( Purchaser Materials ) shall apply in respect of the Manufacture of the relevant Product. Products which contain Purchaser Materials shall be identified as such on Exhibit 1 ( Products ).

 

6.2                               For the avoidance of doubt, neither this clause 6 ( Products Manufactured using Materials Purchased from Purchaser ) nor Exhibit 8 ( (Purchaser Materials ) shall apply in respect of any Product for which the Purchaser’s Group supplies Materials on a Toll Manufacturing Basis.

 

7.                                      SHARED CONTRACTS

 

7.1                               The Parties have agreed the following to achieve a Separation of the relevant part of each Shared Contract after Separation in accordance with 7.1(A) and 7.1(B) below. Until satisfactory Separation of a Shared Contract the Supplier and the Purchaser shall respectively use their Commercially Reasonable Efforts to maintain relationships under the Shared Contracts and continue to operate the Shared Contracts, including without limitation fulfilling all their respective obligations under such Shared Contracts in the same manner as applied for the twelve months prior to the Separation in accordance with the terms of the Separation Agreement (where it is acknowledged that the obligation to transfer or separate the Shared Contracts has been delayed).

 

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(A)                               Where the Purchaser requires the Supplier to continue to procure a Chemical/API or Shared Packaging Material which is subject to a Shared Contract under the terms of a Shared Contract for incorporation in a Product being supplied under this Agreement then such Shared Chemical/API will be deemed to comprise a “Purchaser Material” under this Agreement and the terms of clause 6 and Exhibit 8 ( Purchaser Materials ) shall apply.

 

(B)                               Where the Purchaser requires the Supplier to continue to procure a Chemical/API or Shared Packaging Material which is subject to a Shared Contract under the terms of a Shared Contract for incorporation in a product of the Purchaser that will not be Manufactured under this Agreement, then such Chemical/API will be deemed to comprise a “Shared Chemical/API Product” or a Shared Material under this Agreement and the terms of clause 8 shall apply.

 

8.                                      SHARED CHEMICAL/API PRODUCT/SHARED PACKAGING MATERIAL

 

Where the Purchaser requires the Supplier to continue to procure a Chemical or API or any packaging Materials under the terms of a Shared Contract for incorporation into a product of the Purchaser that will not be Manufactured under this Agreement, but requires the Supplier to provide testing or other quality related services in relation to that Shared Chemical/API Product or Shared Packaging Material, then all other terms and conditions of this Agreement apply in respect of that Shared Chemical/API Product or Shared Packaging Material as if it were a Product, save that the Supplier shall not be obliged to incur any greater cost or expense than would apply to the supply of the applicable Shared Chemical/API Product or Shared Packaging Material under the relevant part of the Shared Contract and the terms of Schedule 2 of the Separation Agreement shall apply to any Liabilities incurred under or in respect of, and any rights arising in relation to, the relevant part of such Shared Contract.

 

9.                                      DELIVERY OF PRODUCT

 

9.1                               Under the terms of this Agreement Delivery of Product by the Supplier shall commence on or following the applicable Commencement Date and all provisions of this clause 9 ( Delivery of Product ) (including references to the Product Term) apply from the applicable Commencement Date.

 

9.2                               Delivery Terms

 

The Supplier (or the Nominated Supplier) shall Deliver or procure the Delivery of the Product specified in the Firm Order for that month on the date confirmed for Delivery by the Supplier in the Firm Order, within - eight (8) or +zero (0) days, in accordance with the Delivery Terms, provided that:

 

(A)                               such Firm Order meets the requirements set forth in clause 3 ( Forecasts and Orders ), including the applicable Lead Time requirements as set out in Exhibit 1 ( Products ) for the Products covered by such Firm Order;

 

(B)                               the quantity of Products Delivered by the Supplier (or the Nominated Supplier) may vary by ± ten per cent. (10%) from the quantities specified by the Purchaser in the relevant Firm Order. For the avoidance of doubt, such variance

 

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shall not constitute a breach of this Agreement by the Supplier and, without prejudice to clause 17 ( Acceptance of Product ), the Purchaser (or its relevant Affiliate) shall not be entitled to reject any Delivery on the basis of such variance;

 

(C)                               the Supplier (or the Nominated Supplier) shall notify and confirm with the Purchaser of the actual Delivery date and quantities in accordance with clause 3.2(E) and notify any subsequent anticipated delay in Delivery or change in the actual Delivery date as promptly as practicable.

 

9.3                               Delivery Failure

 

(A)                               Where the quantity of Products Delivered is less than that required by the relevant Firm Order, the Parties shall enter into good faith discussions regarding replacements of such under-Delivered Products (where requested by the Purchaser), and, unless otherwise agreed by the Purchaser, in the event of any such Product shortfall greater than ten per cent. (10%) of a Firm Order or the Products are not delivered on the Delivery date (“ Delivery Failure ”), the Supplier shall use Commercially Reasonable Efforts to Deliver any such Product shortfall as soon as reasonably practicable after the original Delivery date in accordance with such Delivery schedule as may be mutually agreed between the Parties and in any event within ten (10) Business Days of the date specified for Delivery of the relevant Product.

 

(B)                               In the event of a Delivery Failure following the expiration of the period referred to in clause 9.3(A), for any Firm Order (or portion thereof) which cannot be Delivered, the Purchaser shall be entitled to either:

 

(a)                                 cancel such Firm Order (or the relevant portions thereof) without penalty to Purchaser; or

 

(b)                                 purchase replacement Product from a Third Party, and the Supplier shall be obliged to reimburse the Purchaser the difference between the recorded price paid for such replacement Product and the Supply Price that Purchaser would have paid to Supplier for the equivalent quantities of Product;

 

(C)                               In the event of a Delivery Failure following the expiration of the period referred to in clause 9.3(A), additionally or alternatively to the remedies in 9.3(B) above, the Purchaser shall be entitled to recover from Supplier any costs, expenses, fees, loss and liability (including legally binding commitments to pay out of pocket damages to end customers or third party suppliers) actually incurred by the Purchaser as a direct result of such Delivery Failure (subject always to the variance referred to at clause 9.3(B) above and any variation agreed by the Parties); and

 

(D)                               Any delay in Delivery to the extent due to any reason listed below shall not be regarded as Delivery Failure:

 

(a)                                 Force Majeure;

 

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(b)                                 Purchaser’s change of a Firm Order or any gross negligence on the part of the Purchaser; or

 

(c)                                  as specifically provided in respect of Purchaser Materials as set out in Exhibit 8 ( Purchased Materials ).

 

9.4                               The Supplier shall provide or procure the provision to the Purchaser (or its relevant Affiliate) with each Delivery the corresponding Manufacturer’s Batch Certificate (or Certificate of Analysis plus Certificate of Compliance) and any other agreed Delivery documentation (which shall include any documentation required by Applicable Law and, where applicable, the relevant Batch Record).  In respect of Shared Chemical/API Product, and where required by Applicable Law with respect to the Manufacture of Products using such Shared Chemical/API Product, Delivery documentation shall include written confirmation from the relevant Governmental Entity that the Manufacturing Site complies with standards of cGMP at least equivalent to those required for the Manufacture of APIs in the European Union.

 

9.5                               Risk in and title to the Products (other than Tolled Products) shall remain with the Supplier until Delivered in accordance with the Delivery Terms at which point it will pass to the Purchaser (or its relevant Affiliate).  Risk in and title to the Tolled Products shall pass in accordance with paragraph 5.4 of Exhibit 7 (Toll Manufacture Provisions).

 

9.6                               The Purchaser (or its relevant Affiliate as applicable) shall collect the Products Delivered from the agreed Delivery site within five (5) Business Days of the Delivery date set out by the Purchaser in the relevant Firm Order, or within five (7) Business Days of the Delivery date set out in the notice delivered by the Supplier (or the Nominated Supplier) pursuant to this clause 9.1, if different.

 

9.7                               If, pursuant to clause 9.1, the Supplier in any three (3) consecutive month period during the Term delivers quantities of Product that are, in aggregate, in excess of those specified in the relevant Firm Orders (disregarding the ± ten per cent. (10%) variance referred to in clause 9.2(B)), the Purchaser may, at its election and if such aggregate excess is at least equal to the applicable Minimum Order Quantity, delete a quantity equal to that aggregate excess from any pending Firm Order.  For the purposes of clause 3 ( Forecasts and Order ) , the Supplier shall be deemed to have agreed to any change to a Firm Order, or additional Firm Order, that the Purchaser may require pursuant to this clause 9.7.

 

9.8                               Without prejudice to the provisions of clauses 9.2 to 9.7 and subject to clause 9.9, in respect of Products to be exported from the country in which the applicable Manufacturing Site is located:

 

(A)                               Unless the Parties agree otherwise or agree on alternate Delivery Terms for that Product, the Parties acknowledge and agree that in accordance with the FCA Delivery Terms (where applicable):

 

(i)             the Supplier (or the Nominated Supplier) shall be the exporter of record in respect of Products Delivered under this Agreement;

 

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(ii)            the Purchaser (or its relevant Affiliate) shall be the importer of record and shall be responsible for all import formalities and responsible for arranging the transport or shipment of such Products from the territory in which they are Manufactured; and

 

(iii)           from time to time, in order to demonstrate to competent Governmental Entities that the Products have been exported from the territory of Manufacture and that the Supplier has charged the appropriate rate of applicable Sales Tax in respect of such Products, the Supplier may reasonably require original Export Documentation or a copy otherwise acceptable to the applicable Governmental Entity in relation to some or all of the Products Delivered under this Agreement.

 

(B)                               The Purchaser shall:

 

(i)             retain or cause the retention of originals or electronic copies of all Export Documentation in respect of Products Delivered under this Agreement; and

 

(ii)            except as requested by the Supplier pursuant to clause 9.8(A)(iii), require its Third Party logistics service provider to retain originals or electronic copies of all such Export Documentation,

 

in each case until the end of the seventh (7th) Calendar Year following the Calendar Year in which Delivery occurs.

 

(C)                               In the event that the Supplier requires Export Documentation in respect of any Products Delivered under this Agreement, the Supplier shall notify the Purchaser accordingly with reference to the invoice numbers to which the required Export Documentation relates and the Purchaser shall:

 

(i)             provide or procure the provision of electronic copies of such Export Documentation to the Supplier as promptly as reasonably practicable, and in any event within ten (10) Business Days of receipt of notice from the Supplier pursuant to this clause 9.8(C); and

 

(ii)            if so requested by the Supplier, use its Commercially Reasonable Efforts to provide or procure the provision of the following to the Supplier:

 

(a)                                 printed copies (certified to be true copies of the originals) of such Export Documentation as promptly as reasonably practicable and in any event within two (2) weeks of notice from the Supplier pursuant to this clause 9.8(C); and/or

 

(b)                                 originals of such Export Documentation as promptly as reasonably practicable.

 

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9.9                               Clause 9.8 shall not apply if the Parties have agreed that Delivery of Products to be exported shall not occur on the basis of the FCA Delivery Terms, in which case the agreed Delivery Terms shall apply.

 

10.                               PRICE AND PRICE ADJUSTMENTS

 

10.1                        The initial Supply Price for Products for the 2019 Calendar Year shall be set out in Exhibit 1 ( Products ) of this Agreement (calculated as Base Price plus applicable Margin as set out in Exhibit 16, Part C). The Supply Price of each Product for any subsequent Calendar Year shall equal the Base Price for such Calendar Year (as adjusted in accordance with clause 10.4, if applicable) plus the applicable Margin.

 

10.2                        The “ Base Price ” for each Product shall be determined as follows:

 

(A)                               the Base Price for each Product for 2019 as set out in Exhibit 1 ( Products ) in local currency (being the actual price of a relevant Product for 2018 (comprising Total Product Cost and agreed variances from the 2018); and

 

(B)                               in each subsequent Calendar Year the Base Price for each Product shall be equal to the Base Price for that Product in the preceding Calendar Year, as adjusted in accordance with clause 10.4, if applicable.

 

10.3                        The “ Margin ” for each Product shall be determined in accordance with Exhibit 16, Part C.

 

10.4                        Within thirty (30) Business Days of receipt of the Gating Plan for the next Gating Year (as agreed in accordance with clause 4), the Supplier shall notify the Purchaser of the Base Price, the Margin and the Supply Price for each Product for the following Calendar Year during the applicable Term (each such notice, a “ Pricing Notice ”), such Pricing Notice shall include the inflation indices applied under clause 10.4(A) for each country. The Base Price for each Product for the following Calendar Year will be calculated as follows:

 

(A)                               Inflation Adjustments : the part of the then-existing Base Price corresponding to the Conversion Cost, over-head rate and the Supply Price Catalogue shall be adjusted by an amount equal to such part of the then-existing Base Price multiplied by the percentage increase or decrease in the most recently available prior twelve (12) months of the relevant index specified in Exhibit 18 ( Inflation Rate Source ) for the country in which such Manufacture takes place (“ Inflation Adjustment ”), provided, that if the relevant body does not report an index for the relevant country for the relevant period, the source of the relevant index shall be as mutually agreed by the Parties through the Manufacturing and Supply Team. Provided that the Inflation Adjustment will only be made for the country in which such Manufacture takes place if the percentage increase or decrease represented by the Inflation Adjustment exceeds 3% and then only to the extent of the incremental inflation amount above 3%. An illustrative example of the Inflation Adjustment is set out in Part A of Exhibit 16.

 

(B)                               Material Price Adjustments : the part of the then-existing Base Price corresponding to the Materials Cost shall be adjusted on an aggregate basis to

 

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reflect the full amount (and not just the amount above the threshold) of variations in the price of the Material components for the relevant Product Technology if the following thresholds are met by Manufacturing Site and by Product Technology for both the budget for the following Calendar Year and the end of year reconciliation, such thresholds being:

 

(i)                                     Chemicals / APIs +/- $150k

 

(ii)                                  All other Materials +/- 5%

 

(each a “ Materials Adjustment ”).  For purposes of this clause 10.4(B), the variation in the price of the Material components shall be measured based on the average price paid by the Supplier for all volumes of such Material component at such Manufacturing Site.

 

(C)                               Volume Based Price Adjustments : a volume based price adjustment shall be applied to the Base Price as follows:

 

(i)                                     if the Target Gating Volume agreed in the Gating Plan for the next Gating Year for the aggregate of each Product Technology at each Manufacturing Site) deviates by more than +/- 5% compared to the 2018 baseline Gating Volume, the Supply Price per unit shall: (1) where volumes are less than the baseline Gating Volume, be increased; or (2) where volumes are greater than the baseline Gating Volume, decreased, by a percentage of the Conversion Costs (as set out in Exhibit 1 ( Products )) equivalent to the percentage of such entire Gating Volume deviation;

 

(ii)                                  the end of year Site Volume Reconciliation mechanism set out in clause 10.7 will be applied if at the end of Gating Year the actual Gating Volume of each Product Technology at each Manufacturing Site deviates from the Target Gating Volume (the “ Volume Based Adjustment ”).

 

Provided that

 

(iii)                               the Volume Based Adjustment shall not apply to the extent that the Gating Volume deviates downwards due to the Supplier’s inability to supply the relevant Product (including in the event of Force Majeure);

 

(iv)                              Product transfers included in the Long Term Transfer Plan in that Gating Year shall not be considered when calculating the Volume Based Price Adjustments to the Supply Price;

 

(v)                                 in the case of termination by the Supplier pursuant to clause 40 (other than in the case where the Purchaser is in material breach) and a technical transfer plan applies, the mechanism above shall apply (i.e. the Volume Based Adjustment shall not apply to increase the Supply Price on the remaining Products). Similarly, if volume decreases as a result of Supplier request, the Volume Based Adjustment shall not apply to increase the Supply Price on the remaining Products; and

 

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(vi)                              in the case of any termination by the Purchaser pursuant to clause 40 (other than where the Supplier is in material breach), the volume adjustment pricing mechanism described in this clause 10.4(C) applies.

 

(D)                               the Base Price for the following Calendar Year shall be the sum of such adjusted parts of the Base Price calculated pursuant to clause 10.4(A) to 10.4(C). As shown in the illustrative example attached as an Appendix to Exhibit 16 ( Supply Price Adjustment and Catalogue ).

 

10.5                        The Supply Price catalogue indicating what should be included in the calculation of the Supply Price and what should form an additional service to be invoiced separately is set out in Exhibit 16 ( Supply Price Adjustment and Catalogue ).

 

10.6                        The Parties agree to review the Base Price and the application of the Supply Price mechanism referred to above at the end of the Initial Term. If no agreement is reached as to the basis for any such change, the current mechanism shall continue to apply.

 

10.7                        At the end of each Calendar Year, the Supplier shall calculate:

 

(A)                               in respect of each Product Technology:

 

A x CC

 

where:

 

(i)                                     A is the amount by which the actual volume of the relevant Product Technology is either greater than one hundred and five per cent. (105%) of the target Gating Volume (a positive value) or less than ninety-five per cent. (95%) of the target Gating Volume (a negative value); and

 

(ii)                                  CC is the applicable Conversion Cost of the relevant Product Technology,

 

and the results of these calculations shall be aggregated for each Manufacturing Site to determine the “Site Volume Reconciliation” .

 

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(B)                               in respect of each Product Technology the Parties shall undertake a reconciliation of the amount determined through the Inflation Adjustment for that Product Technology against the actual percentage increase or decrease in the  relevant index specified in Exhibit 18  ( Inflation Rate Source ) for the country in which such Manufacture takes place in the previous twelve (12 months) provided, that if the relevant body does not report an index for the relevant country for the relevant period, the source of the relevant index shall be as mutually agreed by the Parties through the Manufacturing and Supply Team in the original Inflation Adjustment (the “ Inflation Reconciliation ”).

 

(C)                               If the aggregate of the Inflation Reconciliation and the Site Volume Reconciliation is:

 

(i)                                     a positive sum, the Supplier shall issue a credit note to the Purchaser in respect of such sum and shall, at the Purchaser’s option, either:

 

(a)                                 apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliate; or

 

(b)                                 pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing; or

 

(ii)                                  a negative sum, the Supplier shall issue a debit note to the Purchaser in respect of such sum and the Purchaser shall pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing,

 

provided that (i) the debit/credit offset set out in this clause 10.7 may only be applied in the original currency of the Supply Price and as between the original parties to the supply relationship and not other members of their respective Groups and (ii) prior to the issuance of any credit note or debit note pursuant to this clause 10.7, the Manufacturing and Supply Team shall convene a meeting to review and discuss the Inflation Reconciliation and the Site Volume Reconciliation.

 

10.8                        The Purchaser shall respond to any Pricing Notice delivered by the Supplier to the Purchaser pursuant to Exhibit 16, Part C within thirty (30) days of receipt of the notice (or by such other date as agreed between the Parties) and such response will either acknowledge the Base Prices of the Products for the following Calendar Year or may, in good faith, propose such amendments as may be reasonably requested in accordance with this Agreement.  Unless otherwise agreed by the Parties, the Purchaser shall be obliged to acknowledge the Base Prices, without proposed amendments, which comply with the requirements of this clause 10 ( Supply Price ).  In the event that the Purchaser fails to respond to the Supplier’s Pricing Notice within thirty (30) days, the Purchaser shall be deemed to have acknowledged the Base Prices for the following Calendar Year.  The Supplier shall respond to any such proposed amendments to the Base

 

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Prices within five (5) Business Days confirming whether it accepts or rejects such proposed amendments.  In the event of any disagreement between the Parties regarding any adjustment to a Base Price, the matter shall be considered by the Manufacturing and Supply Team, in accordance with clause 15 ( Relationship Management ). During the pendency of any good faith dispute regarding an adjustment to a Base Price, the then current Base Price shall apply for all Firm Orders placed in accordance with this Agreement, and following the resolution of such good faith dispute the Supplier shall issue a credit or debit note (as applicable) to the Purchaser to reflect the difference between the Supply Price actually paid during such good faith dispute and the Supply Price that should have been paid had the Base Price from the start of the relevant Contract Year corresponded to the Base Price applicable as a result of such resolution of such good faith dispute.

 

10.9                        The Supply Price and any amounts payable or reimbursed pursuant to a Site Volume Reconciliation shall be exclusive of any Sales Tax or amounts in respect thereof that may be applicable to any payment, transaction or activity contemplated under this Agreement, which the Purchaser shall pay in addition to the Supply Price under presentation by the Supplier or its Nominated Supplier of a valid Sales Tax invoice (where applicable).

 

10.10                 Delivery shall be in accordance with the Default Delivery Terms unless otherwise agreed between the Parties.  Where, irrespective of the relevant Delivery Terms agreed in respect of a Product, the Supplier pays for any expenses, costs and charges in respect of freight, customs clearance (other than the costs of clearance for export under the FCA Delivery Terms) and/or insurance that are not included in the Supply Price, then the Purchaser shall reimburse the Supplier for such expenses, costs and charges.

 

11.                               INVOICE, PAYMENT AND CURRENCY CONVERSION

 

11.1                        From the applicable Commencement Date, the Supplier (or the Nominated Supplier) shall invoice the Purchaser, or any Affiliate of the Purchaser that the Purchaser designates to receive invoices by reasonable advance written notice to Supplier (or the Nominated Supplier), for Products Manufactured and supplied under the terms of this Agreement upon or following Delivery of such Products at the Supply Price in effect at the time the applicable Firm Order was placed.  Each invoice shall be in a form mutually agreed by the Parties, and shall include such information as is reasonably requested by the Purchaser, provided that each invoice issued pursuant to this clause 11.1 shall specify:

 

(A)                               the Purchaser’s (or its Affiliate’s) purchase order number;

 

(B)                               the Supply Price in respect of the Product Delivered denominated in the Invoice Currency;

 

(C)                               the quantity of the Product actually Delivered and SKU reference;

 

(D)                               the amount of Sales Tax due in respect of the Product Delivered; and

 

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(E)                                any other amounts reimbursable to the Supplier or its Nominated Supplier pursuant to this Agreement.

 

11.2                        Any amounts reimbursable to the Supplier or its Nominated Supplier pursuant to this Agreement other than the Supply Price for Product Delivered and any associated Sales Tax may be invoiced and paid separately from any invoice relating to the Supply Price for Product Delivered and any associated Sales Tax.

 

11.3                        The Purchaser shall pay to the Supplier the Supply Price for the Products Delivered following the applicable Commencement Date pursuant to Firm Orders within sixty (60) days of receipt of invoice from the Supplier or its nominated Affiliate (the “ Payment Terms ”).

 

11.4                        The Purchaser shall pay or procure the payment of the invoices issued by the Supplier (or the Nominated Supplier) to the Supplier in the Invoice Currency for that Product within sixty (60) days of receipt of invoice from the Supplier or the Nominated Affiliate (as applicable) by electronic transfer to the account nominated by the Supplier or the Nominated Supplier in the invoice.

 

11.5                        If the Purchaser does not pay or procure the payment of any invoice when due, the Purchaser shall pay (or procure the payment of) to the Supplier (or the Nominated Supplier) interest on any outstanding undisputed amount at the rate set out in clause 53 ( Interest ).

 

11.6                        In the event that:

 

(A)                               either Party is required to pay any sum (other than the Supply Price) to reimburse the other Party for any costs or expenses incurred by that other Party; and

 

(B)                               those costs or expenses are incurred by that other Party in a currency other than the applicable Invoice Currency,

 

the amount to be paid by the first Party by way of reimbursement shall be calculated by the invoicing Party by calculating the United States Dollars (USD) or Invoice Currency (as applicable) equivalent using such invoicing Party’s then-current standard exchange rate methodology as applied in its external reporting.

 

12.                               ELECTRONIC SYSTEMS

 

12.1                        Subject to the Transitional Services Agreement and the Information Access Agreement, each Party shall take reasonable care to ensure that:

 

(A)                               nothing done by it or its Affiliates’ employees shall contaminate, corrupt, impair or adversely affect any of the other Group’s computers, computer software and computer data and, without prejudice to the generality of the foregoing, shall take due care to ensure that no invasive programs, “computer viruses” or “logic bombs” shall be introduced to any of the other Group’s computers, computer software or data; and

 

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(B)                               it operates reasonably up to date commercially available anti-virus software, including regularly updating the virus signature files of such software, and an electronic firewall and such other technical safeguards as good IT practice requires in relation to network or IT infrastructure (in each case, to the extent that such network or infrastructure may connect to the other Group’s information technology) and in accordance with ISRM Security Standards.

 

13.                               QUALITY CONTROL

 

13.1                        The Supplier and the Purchaser shall enter into the Quality Agreement which shall govern matters relating to quality assurance, quality control and quality management systems with respect to the Manufacture of Products as more particularly set out therein.

 

13.2                        The Supplier or any Permitted Subcontractor will perform such quality assurance tests on Products as may be provided for in the Quality Agreement.

 

13.3                        The Supplier shall, or shall procure that any Permitted Subcontractor shall, maintain all records as necessary and appropriate to demonstrate compliance with cGMP and the Quality Standards.

 

13.4                        In the event of any conflict or inconsistency between the provisions of this Agreement and the provisions of the Quality Agreement in respect of quality assurance, quality management and compliance with cGMP, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

14.                               KEY PERFORMANCE INDICATORS

 

14.1                        Subject to clause 14.2, the Parties have agreed for all Products a set of (i) operational Key Performance Indicators and (ii) quality Key Performance Indicators, as set out in Part A and Part B of Exhibit 4 ( Key Performance Indicators ) respectively.

 

14.2                        The Parties acknowledge that in respect of KPI 1 (SDP) and KPI 2 (ASP) set out in Part A of Exhibit 4 ( Key Performance Indicators ) specific KPI targets for the Supplier shall not be implemented prior to 01 January 2020 and thereafter shall only be implemented following the establishment, by mutual agreement of the Parties, of:

 

(A)                               a baseline for KPI performance for KPI 1 (SDP) and KPI 2 (ASP) in the 2019 Contract Year; and

 

(B)                               specific KPI targets for KPI 1 (SDP) and KPI 2 (ASP) for the 2020 and 2021 Contract Years.

 

Either Party may escalate a failure to agree such KPI targets prior to 01 December 2019 through the dispute escalation and resolution process set out in clause 16 ( Dispute Escalation ).

 

14.3                        The Supplier shall use Commercially Reasonable Efforts to achieve:

 

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(A)                               the Key Performance Indicators set out in Exhibit 4 ( Key Performance Indicators ) Part A and B (except for KPI 1 (SDP) and KPI 2 (ASP)), with the specific targets therefor (including any variations for specific Products or Manufacturing Sites);

 

(B)                               subject to agreement of the specific targets for KPI 1 (SDP) and KPI 2 (ASP) in accordance with clause 14.2,  KPI 1 (SDP) and KPI 2 (ASP) from the date of agreement of the specific targets for those Key Performance Indicators; and

 

(C)                               thereafter during the Term, the Key Performance Indicators as mutually agreed between the Parties through the Manufacturing and Supply Team.

 

14.4                        Without prejudice to clause 14.1, the Parties shall monitor the Supplier’s performance against the Key Performance Indicators at the S&OP Meetings in good faith with a view to improving such performance.

 

14.5                        Without limiting the Supplier’s obligation under clause 14.3 to use Commercially Reasonable Efforts, the Parties agree and acknowledge that any failure of the Supplier to meet the Key Performance Indicators shall not in and of itself amount to a breach of this Agreement, save that in respect of  KPI 1 (SDP) and KPI 2 (ASP) the bonus/malus incentive system set out in clause 14.6 and  Exhibit 4, Part C ( Key Performance Indictors ) shall be implemented during the annual budgeting process, once each Calendar Year.

 

14.6                        Subject to agreement of the specific targets for KPI 1 (SDP) and KPI 2 (ASP) in accordance with clause 14.2, the Parties shall calculate the percentage point variance against the agreed specific KPI targets allocated to each of KPI 1 (SDP) and KPI 2 in accordance with Exhibit 4, Part C ( Key Performance Indictors ) and the following adjustment mechanism shall be applied in relation to the aggregate Supply Price for the relevant Calendar Year as part of the annual budgeting process:

 

(A)                               underachievement of the specific annual KPI targets for KPI 1 (SDP) and KPI 2 (ASP) shall lead to a Supply Price reduction by way of a credit note being issued to the Purchaser by the Supplier for an amount calculated in accordance with Exhibit 4, Part C ( Key Performance Indictors ) and the Supplier shall, at the Purchaser’s option, either:

 

(i)                                     apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliates; or

 

(ii)                                  pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing; or

 

(B)                               overachievement of the specific annual KPI targets for KPI 1 (SDP) and KPI 2 (ASP) shall lead to a Supply Price increase by way of a bonus payment payable by the Purchaser to the Supplier for an amount calculated in accordance with Exhibit 4, Part C ( Key Performance Indictors ) in addition to the total annual of

 

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Supply Price paid for that Calendar Year and the Supplier shall issue a debit note to the Purchaser in respect of such sum and the Purchaser shall pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing,

 

provided that (i) the debit/credit offset set out in this clause 14.6(B) may only be applied in the Invoice Currency and (ii) prior to the issuance of any credit note or debit note pursuant to this clause 14.6(B) the Manufacturing and Supply Team shall convene a meeting to review and discuss the adjustments contemplated in this clause 14.6.

 

(C)                               Any amounts payable or reimbursed pursuant to this clause 14.6 shall be exclusive of any Sales Tax or amounts in respect thereof that may be applicable to any payment, transaction or activity contemplated under this Agreement, which the Purchaser shall pay in addition to the Supply Price under presentation by the Supplier or its Nominated Supplier of a valid Sales Tax invoice (where applicable).

 

14.7                        Consequences of underachievement of KPIs.   If the Supplier fails to meet its KPI commitments under clause 14.3, then the Purchaser may request that the Supplier prepare a remediation plan. Upon request from the Purchaser, the Supplier shall, no later than forty (40) Business Days following the request, present a draft remediation plan to the Purchaser to discuss at the S&OP review meetings held in accordance with clause 15 ( Relationship Management ). Following the Purchaser’s approval of that plan, the Supplier shall implement that approved remediation plan, including any specific corrective actions that the Purchaser has requested as part of its approval. If the Supplier does not (i) prepare a remediation plan within forty (40) Business Days following request; or (ii) diligently perform the actions required in the agreed remediation plan in all material respects, then the Purchaser may escalate the non-delivery or non-performance of the remediation plan (as applicable) to the Manufacturing and Supply Team.

 

15.                               RELATIONSHIP MANAGEMENT

 

15.1                        In relation to the Manufacturing Sites, the Parties shall each appoint a Customer Relationship Manager (each a “Customer Relationship Manager” ). The Customer Relationship Managers shall meet once a month for the purposes of sales and operations planning, including but not limited to reviewing and coordinating the forecasting and ordering and supply related activities of each of the Parties, review and discussion of available capacity at the relevant Manufacturing Site, any ongoing technical transfer activities, any ongoing issues (if any) with respect to the performance of this Agreement at that Manufacturing Site, forthcoming proposals for New Product SKUs affecting that Manufacturing Site and performance by the Supplier against Key Performance Indicators in relation to that Manufacturing Site (the “ S&OP Meetings ”).  Other representatives of the Parties (such as technical or quality personnel) shall attend S&OP Meetings at the invitation of either Customer Relationship Manager.

 

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15.2                        The Parties shall, as soon as reasonably practical after the Effective Date, establish a manufacturing and supply team (the “ Manufacturing and Supply Team ”), led by a Contract Execution Manager nominated by each of the Parties (each a “ Contract Execution Manager ”), which shall remain in place from the Effective Date for the duration of this Agreement, for the purposes set out in clause 15.3. The Contract Execution Managers shall have overall oversight of and responsibility for implementation of this Agreement.

 

15.3                        The Manufacturing and Supply Team shall meet from time to time as frequently as is necessary, including as reasonably requested by either Party and shall meet in respect of Manufacture and supply of Products, and all other issues relating to the implementation of this Agreement, at least three (3) times in the first Contract Year and thereafter at least once in each subsequent Contract Year to review and discuss business relationship matters and other matters relating to the implementation of this Agreement (the “ Business Review Meetings ”).

 

15.4                        At the first Business Review Meeting, the Manufacturing and Supply Team shall establish its own terms of reference and those of its sub-teams (if any), including any thresholds for decision-making escalation, and each Party shall appoint regular representatives to attend meetings of the Manufacturing and Supply Team, including the Business Review Meetings.

 

15.5                        Neither the Manufacturing and Supply Team nor any sub-team or committee thereof shall have the authority to:

 

(A)                               amend or modify the terms of this Agreement or any other Transaction Document;

 

(B)                               expand the scope of its or their authority;

 

(C)                               waive any right that either Party may have pursuant to this Agreement or any other Transaction Document; or

 

(D)                               determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or any other Transaction Document.

 

15.6                        The teams and committees established under this clause 15 ( Relationship Management ) shall escalate any matters they are not able to resolve in accordance with the provisions of clause 16 ( Dispute Escalation ).

 

16.                               DISPUTE ESCALATION

 

16.1                        Any dispute or difference that is not the subject of resolution by reference to an Independent Expert under the terms of this Agreement, but which arises between the Parties under this Agreement and cannot be resolved by discussion shall be referred to the Customer Relationship Managers for determination (including upon receipt of a Dispute Notice pursuant to clauses 50.3 to 50.8). If the Customer Relationship Managers are unable to resolve the matter within ten (10) Business Days of its referral thereto, the matter shall be referred to the Contract Execution Managers for resolution.  If the Contract Execution Managers are

 

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unable to resolve the matter within twenty (20) Business Days of its referral thereto, the matter shall be referred to the Manufacturing and Supply Team for resolution. If the matter is not resolved by the Manufacturing and Supply Team within twenty (20) Business Days of its referral thereto, the matter shall be referred to the Executive Officers. If the matter is not resolved by the Executive Officers within twenty (20) Business Days of its referral thereto, the dispute escalation and resolution process under this clause 16 ( Dispute Escalation ) will be deemed to have been exhausted in respect of such matter and, notwithstanding that the time limits for resolution of disputes specified in this clause 16 may be extended by the written agreement of the Parties, each Party shall be free to pursue its rights under clauses 50.3 to 50.8 of this Agreement or Applicable Law in respect of such dispute without further reference to this dispute escalation and resolution process.

 

16.2                        Notwithstanding anything to the contrary herein, any matter referred to the Customer Relationship Managers, Contract Execution Managers, or the Manufacturing and Supply Team (as applicable, the “ Reviewing Body ”) for resolution pursuant to this clause 16 ( Dispute Escalation ) may, upon the determination of the Reviewing Body, be escalated to the next Reviewing Body prior to the expiration of the applicable review period if the Reviewing Body determines that it would be in the best interest of either Party to do so based on the significance of the matter and/or the potential harm caused by delaying such an escalation. The length of any reduced review period for such escalations shall be jointly agreed between the Parties (and ad hoc meetings to discuss such escalation shall be arranged by the relevant Reviewing Body) and conducted in accordance with such pre-defined terms of reference as agreed at the initial Business Review Meeting.

 

17.                               ACCEPTANCE OF PRODUCT

 

17.1                        The Purchaser or its relevant Affiliate shall not be entitled to reject any Delivery of Product except in accordance with this clause 17 ( Acceptance of Product ) or as set out in the Quality Agreement.  For the avoidance of doubt, if the Purchaser or its relevant Affiliate fails to check the Product or notify the Supplier (or the Nominated Supplier) within the agreed timeframes set out in clause 17.3 and the Quality Agreement, the Purchaser shall be deemed to have accepted the relevant Delivery of Product.  Without limiting the foregoing, the Supplier shall inform the Purchaser as soon as reasonably practicable and in any event within forty-eight (48) hours if a Delivery is delayed or stopped for any reason.  In such event, the Parties shall work together to agree on a plan (each acting reasonably and in good faith) to ensure the Delivery takes place as soon as possible thereafter and the Supplier shall implement such plan.

 

17.2                        Subject only to clauses 36 ( Warranties ) and 37 ( Indemnity and Liability ) and any termination rights under clause 40 ( Duration and Termination ), the remedies prescribed under this clause 17 ( Acceptance of Product ) shall be the sole and exclusive remedies of the Purchaser or its relevant Affiliate in relation to the quantity of Product Delivered under this Agreement and/or non-compliant, damaged or Defective Product Delivered.

 

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17.3                        The Purchaser or its Affiliate shall visually inspect (but not be required to open the packaging of) the Product Delivered for variances and Defects and shall notify the Supplier (or, if directed by the Supplier, the Nominated Supplier and/or Permitted Subcontractor) in writing:

 

(A)                               within thirty (30) days of Delivery if there is an apparent Defect in the Product (in which case the Purchaser or its relevant Affiliate shall submit a sample of the allegedly Defective Product with such notice);

 

(B)                               within thirty (30) days of Delivery if there is any shortfall below or excess above the Delivery tolerance agreed in clause 9.1;

 

(C)                               within thirty (30) days of Delivery if there are any other Defects or non-compliance, whether or not this includes any quality or actual Defect; or

 

(D)                               during the relevant Product’s Minimum Remaining Shelf Life within thirty (30) days of discovery of a Defect if there is a Latent Defect.

 

17.4                        Complaints in connection with the Product will be handled in accordance with this Agreement and the Quality Agreement.

 

17.5                        If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor of a Product which is (or is alleged to be) damaged or Defective (including any Latent Defects) under clause 17.3 or under the Quality Agreement, the Purchaser or its Affiliate shall store, at Supplier’s expense, the Product concerned in quarantine in accordance with the Supplier’s, the Nominated Supplier’s or the Permitted Subcontractor’s reasonable instructions and give the Supplier, the Nominated Supplier and/or the Permitted Subcontractor reasonable opportunity to inspect and analyse the Product concerned.  On the Supplier’s request, the Purchaser shall return the Product concerned to the Supplier (or, if so directed by the Supplier, the Nominated Supplier or Permitted Subcontractor), at Supplier’s expense, but the Purchaser and/or its Affiliate shall be entitled to retain a sample for testing.  For the avoidance of doubt, any Product Actions resulting from any notifications made by the Purchaser or its Affiliate to the Supplier, the Nominated Supplier and/or the Permitted Subcontractor pursuant to this clause 17 ( Acceptance of Product ) shall be dealt with in accordance with clause 29 ( Product Action ).

 

17.6                        If the Purchaser or its Affiliate notifies the Supplier, the Nominated Supplier and/or the Permitted Subcontractor under clause 17.3 or under the Quality Agreement, the Parties shall promptly endeavour to agree whether or not the Product in question is damaged or Defective, or if there was a shortfall or excess of Product on Delivery or a delay in Delivery of Product.  If no agreement is reached within twenty (20) days of the Purchaser’s (or its Affiliate’s) notice under clause 17.3 or under the Quality Agreement the matter shall be determined by an Independent Expert and the decision of the Independent Expert shall be final and binding on the Parties.  The Independent Expert’s fees shall be borne by the Party against whom the Independent Expert’s decision is given.

 

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17.7                        To the extent that the Supplier agrees or the Independent Expert finds in favour of the Purchaser, then the Supplier shall either:

 

(A)                               use its Commercially Reasonable Efforts to replace or procure the replacement of the Product(s) referable to the Delivery in question on a timeframe to be agreed between the Parties on a Product-by-Product basis, each acting reasonably and in good faith; or

 

(B)                               at the Purchaser’s election (acting reasonably), or where it is not reasonably practicable for the Supplier to replace or procure the replacement of the Product(s) referable to the Delivery in question within a timeframe acceptable to the Purchaser (and meet any reasonable associated transportation costs), refund the Purchaser for the Supply Price of such Delivery (if already paid); and

 

(C)                               in either case, the Purchaser shall be entitled to recover costs in accordance with clause 9.3(C)

 

and the Supplier shall, at its option, either promptly collect at its own expense any damaged or Defective Product from the Purchaser or its Affiliate or reimburse the Purchaser’s Group for any reasonable costs incurred in its disposal of such Product or in shipping such Product to the Supplier.  For the avoidance of doubt, the Purchaser shall have no obligation to pay the Supplier for any Product agreed or found to be damaged or Defective in accordance with this clause 17 ( Acceptance of Product ) unless such damaged or Defective Product is replaced free of charge pursuant to clause 17.7(A) and the Supplier shall reimburse the Purchaser for any amounts already paid for such Product where such Product is to be refunded and not replaced.

 

17.8                        If the Parties agree, or the Independent Expert finds, that a Delivery of Product complied with the Specification at the time of Delivery and was Manufactured in accordance with cGMP and the Quality Standards, or that there was no shortfall in the volumes Delivered, the Purchaser shall pay for such Delivery in accordance with this Agreement.

 

17.9                        The Parties agree that this clause 17 shall not place a requirement on the Supplier to rework or reprocess rejected Defective Products unless such activity has been expressly approved and authorised in writing by the Purchaser in accordance with the Quality Agreement.

 

18.                               REGULATORY MATTERS

 

18.1                        Each Party shall ensure that it, or shall procure that where relevant, its Affiliate, at its or their own cost, obtains and maintains throughout the Term all Governmental Entity certificates, permits, licences or approvals that it (or the relevant Affiliate) respectively requires for the purposes of this Agreement and for the performance of its obligations (or the obligations of its Affiliates) under this Agreement.

 

18.2                        Without prejudice to clause 18.1, the Supplier shall, or shall procure that the Nominated Supplier or Permitted Subcontractor shall, at its own cost, (A) obtain and maintain throughout the Term any Manufacturing Licences required in

 

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connection with the Manufacture of the Products, and (B) subject to Applicable Laws, provide to the Purchaser promptly upon reasonable request thereof copies of any documentation relating to such Manufacturing Licenses that are required for the Purchaser (or its Affiliate) to obtain or maintain its Governmental Entity certificates, permits, wholesale distribution licences, licences and approvals, including all Marketing Authorisations, referred to in clause 18.3, or to respond to any official requests or CMC-related questions from any Governmental Entity.

 

18.3                        Without prejudice to clause 18.1, the Purchaser shall (or shall procure that its Affiliates shall), at its own cost, obtain and maintain all Governmental Entity certificates, permits, wholesale distribution licences, licences and approvals, including all Marketing Authorisations, necessary for the Purchaser’s Group to export from the Delivery site, import to the destination Territory, distribute, sell and otherwise commercialise each Product (or, as applicable, Finished Products manufactured using Products) in the relevant Territory and is responsible for any interaction with the relevant Governmental Entity regarding such certificates, permits, licences and approvals.

 

18.4                        The Supplier shall notify the Purchaser as soon as reasonably practicable of any Governmental Entity inspection of Manufacturing Sites in respect of a matter relating to the Manufacture of the Products or of any other regulatory action taken or intended to be taken by a Governmental Entity in relation to the Manufacture of the Products in accordance with the Quality Agreement.

 

19.                               DOCUMENTATION AND REPORTS

 

19.1                        The Parties shall comply with the terms of the Information Access Agreement.

 

19.2                        The Supplier shall, or shall procure that any Nominated Supplier or Permitted Subcontractor (as applicable) shall:

 

(A)                               maintain complete and maintain the documentation relating to the Manufacture of each batch of the Products in accordance with cGMP (including, without limitation, Batch Records, analysis and data supporting each Certificate of Analysis and Certificate of Compliance) and in accordance with the Quality Agreement and shall retain such documentation for the periods set out in the Quality Agreement;

 

(B)                               supply to the Purchaser upon reasonable request copies of the documentation referred to in clause 19.2(A);

 

(C)                               keep complete and systematic records of any other documentation generated pursuant to this Agreement; such records to include any operational documentation relating to Manufacture of the Product, any financial records and procedures (including records for compliance with Applicable Laws), distribution and disposition records and all such other documentation relating to the Products and Manufacturing activities under this Agreement;

 

(D)                               preserve all records referred to in clause 19.2(C) in accordance with the relevant retention periods specified in the Quality Agreement (where applicable)

 

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and shall preserve any records not identified in such Quality Agreement for the greater of: (i) five years and (ii) such other period agreed in writing by the Parties; provided that , in the event a legal matter arises requiring preservation of certain records, the Supplier shall suspend destruction of such records as requested by the Purchaser or any Governmental Entity; and

 

(E)                                permit the Purchaser, its Affiliates and their respective representatives access upon reasonable request during Working Hours to all records retained pursuant to this clause 19 ( Documentation and Reports ).

 

19.3                        For the avoidance of doubt, nothing in clause 19.2(E) shall entitle the Purchaser, its Affiliates or their respective representatives to access financial records, which may be accessed only in accordance with clause 33 ( Audit and Inspection Rights ).

 

19.4                        In the event of any conflict or inconsistency between the provisions of this clause 19 ( Documentation and Reports ) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

20.                               PRODUCT SPECIFICATIONS

 

20.1                        None of the Supplier, a Nominated Supplier or any Permitted Subcontractor may undertake any change with respect to the Manufacture of the Products and/or the Specifications unless the change is first agreed between the Parties or is required by a Governmental Entity in accordance with the change control procedure set out in clause 16 of the Quality Agreement.

 

20.2                        Any change with respect to the Manufacture of the Product and/or the Specifications pursuant to clause 20.1 shall be implemented in accordance with the Quality Agreement.

 

20.3                        If a Governmental Entity requires any change to be made with respect to the Manufacture of the Product and/or the Specifications, the Parties shall, each acting reasonably and in good faith, use all reasonable endeavours to agree an action plan in relation to the implementation of such change within fifteen (15) Business Days of receipt of notice from the Governmental Entity of the required change.

 

20.4                        In the event of any conflict or inconsistency between the provisions of this clause 20 ( Product Specifications ) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

 

21.                               NEW PRODUCT SKUS

 

21.1                        The Purchaser may, from time to time and in accordance with this clause 21 ( New Product SKUs ), request that the Supplier Manufacture (or have Manufactured) and supply (or have supplied) New Product SKUs under this Agreement.  Any such request shall be accompanied by reasonable details of:

 

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(A)                               the characteristics of the New Product SKU (including whether it would, if Manufactured and supplied pursuant to this Agreement, be a Product or a Shared Chemical/API Product and, if applicable, dose form, strength and number of doses);

 

(B)                               the anticipated market(s) to supply; and

 

(C)                               a non-binding volume plan for a period equal to the required duration of a Forecast Schedule for a Product or a Shared Chemical/API Product (as applicable) or, if shorter, until the scheduled expiration of the Term.

 

21.2                        The Purchaser must notify any request for a New Product SKU to the Supplier reasonably in advance of the first intended Delivery of such New Product SKU.

 

21.3                        Subject to clauses 21.3(A) and 21.3(B), upon receipt of a request pursuant to clause 21.1, the Supplier will consider such request in good faith and will conduct an impact assessment as soon as reasonably practicable, but in no event more than one (1) month other than in exceptional circumstances following Purchaser’s notice delivered under clause 21.1. Following such impact assessment, the Supplier and the Purchaser, acting through the S&OP Meetings, shall review and, if appropriate depending on the outcome of the impact assessment and subject to any amendments that may be agreed between the Parties, agree upon the proposal for the New Product SKU, on a basis consistent with the terms of this Agreement (including the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Manufacture of such New Product SKU and a budget for the estimated costs to be incurred in connection with such New Product SKU), provided that :

 

(A)                               no member of the Supplier’s Group shall be obliged to incur any Capital Expenditure in connection with the introduction of a New Product SKU (and any Capital Expenditure so incurred shall be at the cost and expense of the Purchaser);

 

(B)                               without prejudice to clause 23 ( Development Work ), any incremental costs incurred by any member of the Supplier’s Group associated with such New Product SKU shall be paid by the Purchaser, provided that (i) such costs are approved in advance in writing by the Purchaser; (ii) all such costs are reasonable and, insofar as they consist of amounts payable to any Third Party, are supported by invoices and (iii) no such costs shall be factored into the calculation of Total Product Cost of the New Product SKU.

 

21.4                        The Purchaser will provide a first non-binding forecast schedule in respect of each New Product SKU introduced in accordance with this clause 21 ( New Product SKUs ) not less than six (6) months prior to the first intended Delivery of such New Product SKU (or, if longer, a period equal to the Firm Zone for the New Product SKU).  Such forecast schedule shall be included in the rolling Forecast Schedule provided under clause 3 ( Forecasts and Orders ).

 

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21.5                        Any New Product SKU that is introduced in accordance with this clause 21 ( New Product SKUs ) shall be subject to the terms of this Agreement and shall, with effect from the date on which the Parties record in writing their agreement to add such New Product SKU to this Agreement, be deemed to be a Product.

 

21.6                        Following the introduction of a New Product SKU in accordance with this clause 21 ( New Product SKUs ), the Supply Price of that New Product SKU shall be adjusted in accordance with clause 10 ( Price and Price Adjustment ); provided, that the initial Supply Price for such New Product SKU shall be reviewed and mutually agreed by the Parties.

 

21.7                        In addition to clause 21.1, the parties have pre-agreed that certain in-flight projects as listed in Exhibit 5 ( New Product SKU — In-Flight Products ) (the “ New Product Launches ”) shall, subject to proposals for the in-flight projects being agreed by the Parties on a basis consistent with the terms of this Agreement (including the applicable MOQ, Lead Time, Specifications, Firm Zone, Total Product Cost, Supply Price, Manufacturing Site and, if applicable, Permitted Subcontractor(s) in respect of the Manufacture of such New Product SKU and a budget for the estimated costs to be incurred in connection with such New Product SKU) and the terms of this clause 21, be Manufactured under the terms of this Agreement.  Where the context permits, references in this Agreement to New Product SKUs shall be deemed to include the New Product Launches.

 

22.                               CAPITAL EXPENDITURE AND COSTS OF DEVELOPMENT WORK

 

22.1                        In the course of the S&OP Meetings and/or Business Review Meetings, the Parties shall discuss in good faith and seek to reasonably determine whether, over the course of the Forecast Schedule and the remaining Term, Capital Expenditure or cost for Development Work at any Manufacturing Site is or is likely to be required to meet anticipated demand and/or to mitigate any capacity constraints that have been identified under clause 3 ( Forecasts and Orders ), clause 4 ( Capacity Baseline and Gating Plan ), and/or clause 15 ( Relationship Management ) over the following twenty-four (24) months or for any other reason. Provided that it is understood by the Parties that standard recapitalisation activity in respect of any Manufacturing line is already captured as part of Total Product Costs of the relevant Products on that Manufacturing line and no further adjustment is required for the Total Product Costs.

 

22.2                        Exhibit 13 ( Agreed Capital Expenditure ) sets out the agreed Capital Expenditure as at the Commencement Date and allocates responsibilities between the Parties for these known costs that are exceptions to the Total Product Cost.

 

22.3                        Where the Parties agree following good faith discussions that Capital Expenditure or cost for Development Work at Manufacturing Sites (in addition to the Agreed Capital Expenditure) is required in respect of the Manufacture of the Products  such Capital Expenditure and cost for Development Work shall to the extent that it relates to requirements arising or related to the period after the Commencement Date be at the Purchaser’s cost and expense, unless any such Capital Expenditure or cost for Development Work:

 

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(A)                               is requested by an applicable Governmental Entity relating to an applicable Manufacturing process in respect of regulatory compliance, in which case the Purchaser shall bear no cost of such Capital Expenditures or cost for Development Work;

 

(B)                               is related to investments for the establishment, maintenance or improvement of cGMP compliance relating to an applicable Manufacturing process, in which case the Purchaser shall bear no cost of such Capital Expenditures or cost for Development Work;

 

(C)                               is triggered by a change in Materials or Manufacturing process requested by Supplier, in which case the Purchaser shall bear no Capital Expenditures or cost for Development Work; or

 

(D)                               does not relate exclusively to the Products and does not fall within clause  22.3(A) or clause 22.3(C) above, in which case the Supplier and the Purchaser shall each bear a proportionate part of the cost of such Capital Expenditures  and costs for Development Work, taking into account the benefit through the Capital Expenditures and Development Work to the Product(s) compared to other products Manufactured or anticipated for Manufacture at that Manufacturing Site, provided that the costs and responsibility for such Capital Expenditures or costs shall be agreed in advance by the Parties.

 

For the avoidance of doubt, the costs and expenses to be borne by the Purchaser for Development Work shall, to the extent incurred by a member of the Supplier’s Group, be invoiced to the Purchaser by the Supplier apart from Total Product Costs.

 

22.4                        Notwithstanding anything else contained herein to the contrary, Purchaser shall not be responsible for costs incurred in connection with any remediation plan(s) required by a Governmental Entity or otherwise relating to legal compliance matters occurring prior to the Commencement Date.

 

22.5                        In the event that the Purchaser does not agree to meet the cost of any Development Work that is to be met by the Purchaser, then the Supplier shall not be under any obligation to undertake Development Work and shall have no obligation to Manufacture Product for the Purchaser where the failure to undertake Development Work would result in the Supplier being in breach of Applicable Law.

 

23.                               DEVELOPMENT WORK

 

23.1                        The Purchaser acknowledges that, with effect from the Effective Date, the Supplier will not be required to perform or procure the performance of any Development Work in respect of the Manufacture of any Product (including variations to Marketing Authorisations required as a result of such work), with the exception that the Supplier shall be obliged to perform any Development Work that is:

 

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(A)                               requested by an applicable Governmental Entity relating to an applicable Manufacturing process in respect of regulatory compliance;

 

(B)                               required by Applicable Law;

 

(C)                               necessary in order to transfer a Marketing Authorisation or as contemplated by the Separation Agreement or the Transitional Distribution Services Agreement;

 

(D)                               agreed between the Parties pursuant to clause 23.2;

 

(E)                                necessary in connection with a technical transfer of the Manufacture of a Product or contemplated in the Long Term Transfer Plan.

 

23.2                        The Parties shall identify and agree on any Development Work that is required by Applicable Law in order to complete a Marketing Authorisation transfer or a Marketing Authorisation re-registration or a technical transfer of the Manufacture of a Product, including in accordance with the Long Term Transfer Plan or pursuant to the Separation Agreement, including with respect to the costs to be borne by each Party, and shall agree on timing for the performance of such Development Work.

 

23.3                        Save as provided in clause 22, any Development Work pursuant to this clause 23 ( Development Work ), and any associated Sales Tax, shall be at the Purchaser’s cost and expense, provided that (i) all such costs are reasonable and, insofar as they consist of amounts payable to any Third Party, are supported by invoices.

 

23.4                        Without prejudice to the generality of clause 23.3 but subject to the provisions of the Separation Agreement, in the event that any variation is required to be made to a Marketing Authorisation as a result of or in connection with any Development Work undertaken pursuant to this clause 23 ( Development Work ), the Purchaser shall bear the costs of such variation.

 

24.                               CONTINUOUS IMPROVEMENT PROGRAMME

 

24.1                        The Parties shall meet regularly, but no less than annually, to discuss potential areas of cost reduction applicable to the Manufacture of Products under this Agreement, including any reduction in Material Costs and any potential Improvements.  The Parties shall agree on potential areas of cost reduction in writing and each Party may from time to time suggest Improvements to the other.  All cost reductions achieved by an Improvement agreed by the Parties shall be shared equally between the Supplier and the Purchaser.  The Parties shall determine (acting reasonably) whether a portion of the benefit of any Improvement accruing to the Purchaser shall be applied by way of a reduction in the Supply Price.

 

25.                               WRITE OFF COSTS

 

25.1                        The Purchaser shall reimburse the Supplier’s Group for any write-off costs (calculated in accordance with IFRS and the Novartis Control Manual) that the

 

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Supplier’s Group incurs for applicable Materials, API, work-in-progress, or Products to the extent caused by:

 

(A)                               any material failure on the part of the Purchaser to purchase the volumes of a Product shown in the Firm Zone  of any Forecast Schedule; or

 

(B)                               any changes to the Manufacture of a Product requested by the Purchaser (including any changes to the Specifications or Artwork in respect of a Product),

 

in each case, such reimbursement to be made only to the extent that:

 

(i)             Materials have been reasonably purchased or ordered (a) in light of the volumes indicated in the Firm Zone of any Forecast Schedule or (b) as safety stock pursuant to clause 3.4(C); and/or

 

(ii)            work-in-progress or Products have been undertaken or Manufactured by or for the Supplier’s Group in light of the volumes indicated in the Firm Zone of any Forecast Schedule.

 

25.2                        Any write-off costs (calculated in accordance with IFRS) that the Supplier’s Group incurs for applicable Materials, API, work-in-progress, or Products held beyond reasonable levels in the context of binding Purchase Orders placed by the Purchaser (and not varied) should be for the account of the Supplier and not the Purchaser.

 

26.                               ARTWORK AND SHARED MOULDS

 

26.1                        The Supplier shall (or shall procure that the Nominated Supplier or Permitted Subcontractor shall) Manufacture the Products incorporating the Artwork used by the Supplier’s Group as at the Effective Date, subject to any subsequent changes made in accordance with Applicable Laws, the Separation Agreement and this clause 26 ( Artwork and Shared Moulds ).

 

26.2                        The Purchaser shall bear the costs of changing the Artwork as required by a Governmental Entity or Applicable Law, or which is otherwise requested by the Purchaser or any of its Affiliates.  If a change in Artwork leads to write off costs for stocks of old Artwork which can no longer be used for the purposes of Manufacturing the Products, such write off costs shall be dealt with under clause 25 ( Write Off Costs ).

 

26.3                        Save as provided in clauses 26.2 and 26.4, the Parties shall mutually agree on provisions regarding responsibility for undertaking any work related to any Artwork changes, including through the addition of any New Product SKU.

 

26.4                        The arrangements made by the Parties for the sharing of certain key moulds and tools by the relevant Manufacturing Sites are as further described in Exhibit 9 ( Shared Moulds ).

 

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27.                               SERIALISATION, AGGREGATION AND OTHER ANTI-FALSIFICATION REGULATIONS

 

27.1                        The Parties will agree responsibility for the application of Anti Falsification Regulations to the Products on a market-by-market basis, provided that serialisation of the Products or other measures implemented pursuant to Anti Falsification Regulations shall be subject to and in accordance with any applicable provisions of the Quality Agreement.

 

27.2                        Any changes to serialisation or other measures implemented pursuant to Anti Falsification Regulations will be carried out in accordance with applicable change control procedures set out in the Quality Agreement.

 

27.3                        Each Party shall bear their own costs in respect of any changes to serialisation or other measures implemented pursuant to Anti Falsification Regulations required, in accordance with Applicable Law, by either Party or any of their respective Affiliates, subject to any Capital Expenditure costs which shall be allocated in accordance with clause 22 (Capital Expenditure and Costs of Development Work) save that it is agreed that:

 

(A)                               equipment costs, IT infrastructure costs and connectivity costs at the Supplier Manufacturing Site (in particular when the Supplier is using a Third Party interface provider) arising in connection with the serialisation of Products or compliance with Anti Falsification Regulations, should be borne by the Supplier;

 

(B)                               connectivity cost at the Purchaser (in particular when the Purchaser is using a Third Party interface provider) arising in connection with the serialisation of Products or compliance with Anti Falsification Regulations should be borne by the Purchaser;

 

(C)                               costs of the Market Authorisation Holder arising in connection with the Anti Falsification Regulations (assuming the Purchaser is the Market Authorisation Holder) should be borne by the Purchaser.

 

27.4                        Serialisation of the Products or other measures implemented pursuant to Anti Falsification Regulations will be carried out in a manner consistent with the Purchaser’s Group’s systems and in accordance with such other technical requirements as may be agreed between the Parties.

 

28.                               PHARMACOVIGILANCE

 

On or prior to the Effective Date, the Parties shall enter (or shall procure that one of their respective duly authorised Affiliates enters) into the PV Agreement.  The PV Agreement will govern all pharmacovigilance obligations arising as a result of entry into and implementation of this Agreement as more particularly set out therein.  Each Party separately and independently undertakes that, if one of its Affiliates enters into the PV Agreement, that Party shall comply with its Affiliate’s obligations under the PV Agreement as if it were a party thereto.

 

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29.                               PRODUCT ACTION

 

29.1                        If a Governmental Entity requires a Product Action, or the Marketing Authorisation Holder deems it necessary under Applicable Law or customary industry practice to initiate a Product Action (whether as a result of a Party’s request or otherwise), each Party shall provide such assistance as the Marketing Authorisation Holder reasonably requests to facilitate such Product Action and, where applicable, in accordance with the PV Agreement.  The Marketing Authorisation Holder shall have final decision making authority with respect to Product Actions and related matters, including communications with Governmental Entities and the public.

 

29.2                        Where a Product Action is necessitated by a failure by the Supplier or its Affiliate to comply with its responsibilities under this Agreement, the Supplier shall at the sole discretion of the Purchaser, either:

 

(A)                               replace the Product recalled; or

 

(B)                               refund the Purchaser for the recalled Product; and

 

within sixty (60) days of receipt of an invoice for the same, reimburse the Purchaser for all documented and reasonable costs incurred by the Purchaser or its Affiliates in carrying out the Product Action.

 

29.3                        Each Party shall promptly provide to the other Party any information obtained by it suggesting that a Product Action is or may be necessary.  Further, the Parties shall cooperate in obtaining any additional information that may bear upon whether to initiate a Product Action and in carrying out the Product Action, including by providing or procuring the provision of any information reasonably requested by the other Party.

 

30.                               SUPPLIERS OF MATERIALS AND SHARED PACKAGING MATERIALS

 

30.1                        The Supplier shall, or shall procure that the Nominated Supplier or Permitted Subcontractor shall, be responsible for obtaining and maintaining all Materials necessary for the Manufacture of Products in accordance with this Agreement and Applicable Law, and shall be responsible for ensuring the quality of Materials provided by its suppliers, in each case, in compliance with cGMP and the Quality Standards.

 

30.2                        The Supplier agrees to use its Commercially Reasonable Efforts to source the Materials at a price and on terms and conditions (if any) that are at least as favourable, when taken as a whole, as the terms and conditions of agreements which the Supplier has entered in respect of the supply of materials for its own products or for another customer of the Supplier’s products in the past 12 months.  The assessment of terms will only apply in relation to the supply of materials for products that are the same in all material respects to the Materials including, but not limited to:

 

(A)                               the same or broadly equivalent specification;

 

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(B)                               of equal or better quality;

 

(C)                               for substantially the same volume;

 

(D)                               to be supplied over the same or broadly equivalent term; and

 

(E)                                delivery of the products to the same geographical area.

 

Without limiting the foregoing, the Supplier will use Commercially Reasonable Efforts to source the Materials at reasonably competitive pricing, terms, and conditions.

 

30.3                        The arrangements for contracts and arrangements relating to the supply of Materials which, as at the Commencement Date, are sourced for both Parties from a single Shared Chemical/API Product Supplier or Shared Packaging Materials Supplier are as further described in clauses 7 to 8 (inclusive) and Exhibit 8 ( Purchaser Materials ).

 

31.                               CONFIDENTIALITY

 

31.1                        No announcement, communication or circular concerning the existence or the subject matter of this Agreement shall be made or issued by or on behalf of any member of the Supplier’s Group or the Purchaser’s Group without the prior written approval of the Supplier and the Purchaser (such consent not to be unreasonably withheld, conditioned or delayed) that contains any information, statement, fact or opinion that is not either (i) in the public domain prior to the date of this Agreement through no fault of any member of the Novartis Group or the Alcon Group, as applicable, or any of its respective directors, officers, employees, agents, accountants, counsel and other advisors and representatives; or (ii) disclosed in the Listing Prospectus, the Registration Statement or any document publicly filed in connection therewith.

 

31.2                        Subject to clause 31.4, each of the Parties shall treat as confidential and not disclose or use any Confidential Information received or obtained as a result of entering into this Agreement which relates to:

 

(A)                               the existence and provisions of this Agreement or the other Transaction Documents; or

 

(B)                               the negotiations relating to this Agreement or the other Transaction Documents.

 

31.3                        Subject to clause 31.4, each of the Parties shall treat as confidential and not disclose any Confidential Information of the other Party, and neither Party will use the other Party’s Confidential Information for any purpose other than to perform its obligations arising out of or in connection with this Agreement.  Each Party will ensure that its Affiliates and their respective officers, employees and Permitted Subcontractors comply with the obligations of confidentiality set out in this clause 31 ( Confidentiality ).

 

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31.4                        This clause 31 ( Confidentiality ) shall not prohibit disclosure or use of any information by a Party if and to the extent:

 

(A)                               the disclosure or use is required by Applicable Law, any Governmental Entity or any stock exchange on which the shares of such Party (or its holding company) are listed;

 

(B)                               the disclosure or use is required to vest the full benefit of this Agreement in such Party;

 

(C)                               the disclosure or use is required for the purpose of any arbitral or judicial proceedings arising out of this Agreement;

 

(D)                               the disclosure is made to a Tax authority in connection with the Tax affairs of such Party;

 

(E)                                the disclosure is made to a ratings agency on a confidential basis in connection with the affairs of such Party;

 

(F)                                 the disclosure is made to professional advisers of such Party on a need to know basis and on terms that are no less restrictive than the provisions of this clause 31 ( Confidentiality );

 

(G)                               the information was lawfully in the possession of such Party or its Affiliates without any obligation of confidentiality prior to such information being received from the other Party hereunder, as evidenced by written records and taking due account of the impact of the Separation on the ownership of such information with a view to preserving any rights of confidentiality that should survive such a Separation;

 

(H)                              the other Party has given prior written approval to the disclosure or use; or

 

(I)                                   such disclosure or use is permitted under clauses 24 ( Continuous Improvement Programme ), 39 ( Intellectual Proper ty) or 42 ( Technical Transfer ) or any Transaction Document,

 

provided that prior to disclosure or use of any information pursuant to clause 31.4(A), (B) or (C), the Party concerned shall, where not prohibited by Applicable Law, promptly notify the other Party of such requirement with a view to providing the other Party with the opportunity to contest such disclosure or use or otherwise to agree the timing and content of such disclosure or use.

 

31.5                        Notwithstanding anything herein to the contrary, Confidential Information shall not include any information in the possession of either Party that:

 

(A)                               is lawfully received by such Party or its Affiliates from a third party, without any obligation of confidentiality;

 

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(B)                               is publicly available (other than by breach of this Agreement, the Separation Agreement, or any other agreement between or among the Parties or their Affiliates); or

 

(C)                               is independently developed by such Party, as evidenced by contemporaneous documentation.

 

31.6                        On termination or expiration of this Agreement and subject to the provisions of clause 42 ( Technical Transfer ), each Party shall (i) return to the disclosing Party all Confidential Information furnished by the disclosing Party to the locations reasonably designated by the disclosing Party and (ii) at the disclosing Party’s sole discretion return, destroy or erase (in each case to the extent reasonably practicable) any copies of the disclosing Party’s confidential information and summaries thereof (whether tangible or intangible and whether or not created or provided by the disclosing Party) in the possession of the receiving Party or any member of the receiving Party’s Group thereof or any of their respective employees, consultants, agents, representatives, contractors or sub-contractors, except: (i) where such Confidential Information is required to be retained by either Party in compliance with Applicable Laws and (ii) that each Party shall be entitled to retain one copy of such Confidential Information, in addition to any archival copies on backup media created automatically in the ordinary course of business, for archival purposes only.

 

32.                               FORCE MAJEURE

 

32.1                        If any Force Majeure event occurs in relation to a Party, a Nominated Supplier or a Permitted Subcontractor which affects or may affect the performance of any of a Party’s obligations under this Agreement, that Party shall promptly notify the other Party as to the nature and extent of the circumstances in question.

 

32.2                        Neither Party shall deemed to be in breach of this Agreement, or shall be otherwise liable to the other Party, by reason only of any delay in performance, or the non-performance of any of its obligations, to the extent that the delay or non-performance is due to any Force Majeure event of which it has duly notified the other Party, and the time for performance of that obligation shall be extended accordingly.

 

32.3                        If the performance by either Party of any of its obligations under this Agreement is prevented or delayed by a Force Majeure event for a continuous period in excess of thirty (30) days, the Parties (or their Affiliates) shall enter into good faith discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable in the circumstances.

 

32.4                        If the performance by either Party of any of its material obligations under this Agreement is prevented or delayed by Force Majeure for sixty (60) days or more, either consecutively or cumulatively in any one Contract Year, then the other Party may terminate this Agreement, in whole or in part with respect to the applicable Product(s), immediately upon written notice.

 

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33.                               AUDIT AND INSPECTION RIGHTS

 

33.1                        Subject to clause 33.5, the Purchaser or its authorised representative shall be entitled, not more than once every two (2) Contract Years (unless for cause or in accordance with clause 33.2) per Manufacturing Site and in any event on not less than thirty (30) days’ prior written notice (unless for cause in which case the Purchaser shall provide reasonable notice), to enter and inspect the Manufacturing Site and any related plant, utilities, machinery and equipment used in the Manufacture of Products for the purposes of conducting an audit of compliance with the terms of this Agreement, the Quality Agreement and Applicable Law, including cGMP; provided, that such audit shall be conducted in accordance with the terms set forth in clauses 31.1 to 31.5 (inclusive) and shall be completed on or before the date that is seven (7) days after its initiation unless otherwise agreed by the owner and operator of the relevant Manufacturing Site.

 

33.2                        The Purchaser or its authorised representative shall also be entitled to carry out follow-up audits within two (2) Contract Years of the preceding audit if any critical observations have been noted during any audit conducted pursuant to clause 33.1.

 

33.3                        As far as reasonably practicable, the Purchaser or its authorised representative shall coordinate any audits conducted pursuant to this clause 33 ( Audit and Inspection Rights ) so as to minimise disruption to the Supplier and/or the Permitted Subcontractor.

 

33.4                        The Supplier shall, and shall procure that the Nominated Supplier or Permitted Subcontractor shall, use its Commercially Reasonable Efforts to ensure that any corrective and preventative actions identified in any audit (or follow-up audit) conducted pursuant to clause 33.1 or clause 33.2 are carried out as soon as reasonably practicable.

 

33.5                        In the event of a conflict or inconsistency between the provisions of clauses 33.1 to 33.4 (inclusive) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall (to the extent of such conflict or inconsistency) prevail.

 

33.6                        Subject to clause 33.7, the Purchaser shall be entitled, not more than once in each Calendar Year during the Term, to conduct an audit of records required to determine the correct calculation of Total Product Costs on which Supply Prices are based and the calculation upon which any other payment due under this Agreement is based.  In the first such audit the Purchaser shall also be entitled to audit any orders placed (or deemed placed) prior to the Effective Date that are scheduled to be delivered on or after the Effective Date.  In respect of Total Product Costs, each audit shall relate only to such Total Product Costs as have been set or revised since the Effective Date.

 

33.7                        Any audit undertaken pursuant to clause 33.6 shall be subject to the following conditions:

 

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(A)                               the audit shall be performed by an internationally recognised independent auditor reasonably acceptable to both Parties acting under such obligations of confidentiality owed to the Supplier as the Supplier may reasonably require;

 

(B)                               the Supplier shall be given not less than forty five (45) Business Days’ notice of any proposed audit under clause 33.6 and each such audit shall be conducted during Working Hours and completed on or before the date that is seven (7) days after such audit’s initiation unless otherwise agreed by the Supplier;

 

(C)                               an audit with respect to the Supply Prices or Total Product Costs in any Calendar Year must be notified to the Supplier and initiated by the independent auditor prior to the end of the following Calendar Year and shall only extend to one Calendar Year;

 

(D)                               the independent auditor shall, prior to its delivery to the Purchaser, provide a draft copy of any report to the Supplier for comment.  Any final report issued by the independent auditor will be made available to both Parties simultaneously promptly upon its completion (and the independent auditor shall take care not to disclose in that report any information or data in respect of which the Supplier owes a duty of confidence to a Third Party);

 

(E)                                the Supplier shall provide the independent auditor with such documents and information as the independent auditor may require in order to determine whether the relevant Supply Prices accord with the relevant provisions of this Agreement;

 

(F)                                 if the independent auditor determines that any Supply Prices do not accord with the relevant provisions of this Agreement, and this discrepancy has led to the Supplier over-charging or under-charging the Purchaser for Products of any Product Technology Manufactured at any Manufacturing Site by an amount that is in aggregate not less than three (3%) of the sums paid by the Purchaser (or its Affiliates) to the Supplier for all Products of such Product Technology Manufactured at such Manufacturing Site in the twelve (12) months prior to the audit, then:

 

(i)                                     the Supplier shall issue a credit note or debit note (as applicable) to the Purchaser in respect of such difference; and

 

(ii)                                  the Supplier shall pay the fees of the independent auditor and all documented and reasonable costs incurred by the Purchaser in connection with that audit or inspection; and

 

(G)                               subject to clause 33.7(F)(ii), the Purchaser shall pay the fees of the independent auditor.

 

33.8                        If pursuant to clause 33.7 the Supplier:

 

(A)                               issues a debit note in respect of any under-charging, the Purchaser shall pay that debit note within sixty (60) days of receipt by electronic transfer to the account nominated by the Supplier (or the Nominated Supplier) in writing; and

 

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(B)                               issues a credit note in respect of any over-charging, the Supplier shall (or shall procure that the Nominated Supplier shall), at the Purchaser’s option either:

 

(i)             apply that credit note to offset the Supply Price in respect of subsequent purchases of Product by the Purchaser or its Affiliate ( provided that the offset may only be applied in the original currency and as between the original parties to the supply relationship and not other members of their respective Groups); or

 

(ii)            pay to the Purchaser or its nominated Affiliate a sum equal to the value of that credit note within sixty (60) days of the date of that credit note by electronic transfer to the account nominated by the Purchaser (or its Affiliate) in writing.

 

33.9                        For the avoidance of doubt, clauses 33.6 to 33.8 (inclusive) do not apply to or include any Manufacturing audit or inspection, to which clauses 33.1 to 33.5 (inclusive) and the Quality Agreement apply.

 

34.                               ETHICAL STANDARDS AND HUMAN RIGHTS

 

34.1                        The Supplier warrants, to the best of its knowledge and belief, that in relation to its performance of this Agreement and unless otherwise required or prohibited by Applicable Law:

 

(A)                               it does not employ engage or otherwise use any child labour in circumstances such that the tasks performed by any such child labour could reasonably be foreseen to cause either physical or emotional impairment to the development of such child;

 

(B)                               it does not use forced labour in any form (prison, indentured, bonded or otherwise) and its employees are not required to lodge papers or deposits on starting work;

 

(C)                               it provides a safe and healthy workplace, presenting no immediate hazards to its employees.  Any housing provided by the Supplier to its employees is safe for habitation.  The Supplier provides access to clean water, food, and emergency healthcare to its employees in the event of accidents or incidents at the Supplier’s workplace;

 

(D)                               it does not discriminate against any employees on any ground (including race, religion, disability or gender);

 

(E)                                it does not engage in or support the use of corporal punishment, mental, physical, sexual or verbal abuse and does not use cruel or abusive disciplinary practices in the workplace;

 

(F)                                 it pays each employee at least the minimum wage or a fair representation of the prevailing industry wage (whichever is the higher) and provides each employee with all legally mandated benefits;

 

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(G)                               it complies with Applicable Laws on working hours and employment rights in the countries in which it operates; and

 

(H)                              it is respectful of its employees’ right to join and form independent trade unions and freedom of association.

 

34.2                        In relation to its performance of this Agreement, the Supplier complies with and shall continue to comply with the Supplier Code set out in Exhibit 10 ( Standards and Policies ) and hereby gives the agreements, representations and covenants contained in that Exhibit.

 

34.3                        The Supplier is responsible for controlling its own supply chain and shall encourage compliance with ethical standards and human rights by any supplier of goods and services (including Materials) that are used by the Supplier when performing its obligations under this Agreement (including the Nominated Suppliers and Permitted Subcontractors).

 

34.4                        The Supplier shall ensure that it has ethical and human rights policies and an appropriate complaints procedure to deal with any breaches of such policies.  In the case of any complaints, the Supplier shall report the alleged complaint and proposed remedy to the Purchaser.

 

34.5                        The Purchaser reserves the right upon reasonable notice (unless inspection is for cause, in which case no notice shall be necessary) to enter the Supplier’s premises to monitor compliance with the provisions of this clause 34 ( Ethical Standards and Human Rights ) and Exhibit 10 ( Standards and Policies ) and the Supplier shall, subject to compliance with Applicable Laws, provide the Purchaser with any relevant documents requested by the Purchaser in relation thereto.

 

35.                               SAFETY HAZARDS

 

35.1                        The Supplier shall (or shall procure that the Nominated Suppliers and Permitted Subcontractor will) inform and keep the Purchaser informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Supplier (or the Nominated Suppliers or Permitted Subcontractor) knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of Product or any Materials.

 

35.2                        The Supplier shall ensure that all consignments of Product are safe, packaged and labelled so as to prevent any health risk to persons, property or the environment and properly marked with the appropriate internationally recognised danger symbols and that prominent hazard warnings appear in English (and/or any other language specified by the Purchaser) on all packages and documents.

 

35.3                        Without prejudice to its other obligations under this Agreement, the Supplier shall, and shall procure that the Nominated Suppliers or Permitted Subcontractor shall, comply with the Additional HSE Requirements in all matters relating to the performance of this Agreement.

 

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36.                               WARRANTIES

 

36.1                        The Supplier hereby warrants and undertakes that the Products supplied under this Agreement:

 

(A)                               shall conform to the applicable Specifications at the time of Delivery;

 

(B)                               shall be Manufactured in accordance with Applicable Law, including current Good Manufacturing Practice, the Quality Standards and terms set out in the Quality Agreement; and

 

(C)                               at Delivery in accordance with the Delivery Terms the shelf life of each Product shall meet the Minimum Remaining Shelf Life requirements.

 

36.2                        Except as expressly set out in this Agreement or another Transaction Document, none of the Supplier, the Purchaser or their respective Affiliates provides in respect of any Product or its Manufacture or supply under this Agreement any further or additional warranty or representation of any kind, express or implied and any warranties, representations, conditions or other terms that may be implied by statute or general law are, to the fullest extent permitted by law, excluded from this Agreement, including any implied warranties of merchantability or fitness for purpose.

 

36.3                        Each Party has obtained all corporate authorisations and (other than to the extent any such consent, license or authorisation constitutes a Global Condition (as defined in the Separation Agreement)) all other governmental, statutory, regulatory or other consents, licences or authorisations required to empower it to enter into and perform its obligations under this Agreement where failure to obtain them would adversely affect to a material extent such Party’s ability to enter into or perform its obligations under this Agreement.

 

37.                               INDEMNITY AND LIABILITY

 

37.1                        The Supplier shall be liable for and shall indemnify each member of the Purchaser’s Group (on an after-Tax basis) and defend the Purchaser and its Affiliates from and against any Third Party actions, proceedings, claims and demands brought against or incurred or suffered by the Purchaser and/or any of its Affiliates in respect of (i) death, illness or injury to any Third Party or for loss or damage to any Third Party’s property which arise directly as a result of a breach by the Supplier (or any Nominated Supplier or Permitted Subcontractor) of the provisions of this Agreement or the Quality Agreement or (ii) a violation of Applicable Law by Supplier (or any Nominated Supplier or Permitted Subcontractor), but in each case excluding to the extent that the same arise directly as a result of breach by the Purchaser or its Affiliates of its obligations under this Agreement or another Transaction Document.

 

37.2                        The Purchaser shall be liable for and indemnify each member of the Supplier’s Group (on an after-Tax basis) and defend the Supplier and its Affiliates from and against any Third Party actions, proceedings, claims and demands brought against or incurred or suffered by the Supplier and/or any of its Affiliates in

 

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respect of death, illness or injury to any Third Party or for loss or damage to any Third Party’s property which arise directly as a result of:

 

(A)                               the use, storage, sale, distribution or marketing of Products after Delivery by the Purchaser, its Affiliates and/or distributors (excluding the Supplier and its Affiliates); and/or

 

(B)                               any wilful default or gross negligence on the part of the Purchaser or its Affiliates arising under or in connection with the performance of this Agreement or the Quality Agreement,

 

but in each case excluding to the extent that the same arise directly as a result of breach by the Supplier or its Affiliates of its obligations under this Agreement or another Transaction Document.

 

37.3                        Subject to clauses 37.4, 37.5 and 37.6, each Party’s liability under or in connection with this Agreement shall be limited in any Contract Year during the Term, whether in contract, tort or otherwise, to one hundred per cent. (100%) of the aggregate annual sales, at the Supply Price, of the Products supplied under this Agreement during that Contract Year (or in the first Contract Year, Products to be supplied to the Purchaser as set out in the Forecast Schedule).

 

37.4                        Subject to clause 37.5, neither Party shall be liable to the other Party under or in relation to this Agreement or any other document issued or entered into under or in connection with this Agreement, in tort, as a result of negligence or wilful default, or otherwise howsoever (including, for the avoidance of doubt, under or in relation to any indemnity given in this Agreement) for:

 

(A)                               loss of profit;

 

(B)                               loss of anticipated savings;

 

(C)                               loss of business or business opportunities;

 

(D)                               loss of or damage to goodwill;

 

(E)                                any indirect or consequential loss or damage; or

 

(F)                                 any punitive or exemplary damages.

 

37.5                        Notwithstanding any other provision of this Agreement, nothing in this Agreement shall exclude or limit either Party’s liability for:

 

(A)                               the Purchaser’s liability to pay the Supply Price  under this Agreement;

 

(B)                               death or personal injury resulting from that Party’s or its Affiliate’s negligence or that of their respective officers, employees, agents or sub-contractors (as applicable);

 

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(C)                               fraud or fraudulent misrepresentation by it, its Affiliates, or their respective officers or employees; or

 

(D)                               any other liability to the extent the same may not be excluded or limited as a matter of Applicable Law.

 

37.6                        The Parties agree that nothing in this Agreement is intended to limit the rights and obligations of any Party or its Affiliates under the Separation Agreement.

 

38.                               INSURANCE

 

Each Party shall procure and maintain at its own cost adequate insurance, which may be by means of self-insurance, reasonably necessary to cover its actual and potential liabilities under this Agreement (including in respect of the Supplier, any actions of its sub-contractors).

 

39.                               INTELLECTUAL PROPERTY

 

39.1                        On and subject to the terms set out in this Agreement, the Purchaser hereby grants to, and shall procure that each of its Affiliates grants to, the Supplier a non-exclusive, fully paid-up, worldwide, royalty-free licence (or sub-licence, as appropriate) during the Term to use the Intellectual Property Rights owned by or licensed to the Purchaser or any of its Affiliates for the purposes of performing its obligations under this Agreement.  The Supplier shall only use the Intellectual Property Rights of the Purchaser to the extent necessary for, and for the sole purpose of, Manufacturing and supply of the Products in accordance with the terms of this Agreement.

 

39.2                        The licence granted under clause 39.1 shall not apply in respect of any Intellectual Property Rights owned by or licensed to the Purchaser or any of its Affiliates which are licensed to the Supplier’s Group under any Transaction Document on terms that permit the use of such Intellectual Property Rights for the Manufacture and supply of Products pursuant to this Agreement.

 

39.3                        The Supplier may sub-license and/or assign to its Affiliates and Permitted Subcontractors any licences (or sub-licences, as appropriate) granted to it pursuant to clause 39.1.

 

39.4                        The rights in and title to Improvements made after the Effective Date which give rise to Intellectual Property Rights shall be owned as follows:

 

(A)                               Intellectual Property Rights in an Improvement that is made solely by the Supplier and/or its Affiliates, without use of or reference to any Purchaser’s Group’s Intellectual Property Rights, shall be owned solely by the Supplier or its Affiliate;

 

(B)                               all Intellectual Property Rights in an Improvement that is made solely by the Purchaser and/or its Affiliates, without use of or reference to any Supplier’s Group’s Intellectual Property Rights, shall be owned solely by the Purchaser or its Affiliate;

 

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(C)                               all Intellectual Property Rights in an Improvement that is made by either Party with use of or reference to the other Party’s Group’s Intellectual Property Rights, shall:

 

(i)             if it is capable of being used independently of the Purchaser’s Group’s Intellectual Property Rights but is not capable of being used independently of the Supplier’s Group’s Intellectual Property Rights, be owned by the Supplier or its Affiliate, and the Purchaser hereby assigns and undertakes to assign (and to procure that its Affiliates shall assign) all its rights in relation to such Improvements to the Supplier or its nominated Affiliate;

 

(ii)            if it is capable of being used independently of the Supplier’s Group’s Intellectual Property Rights but is not capable of being used independently of the Purchaser’s Group’s Intellectual Property Rights, be owned by the Purchaser or its Affiliate, and the Supplier hereby assigns and undertakes to assign (and to procure that its Affiliates shall assign) all its rights in relation to such Improvements to the Purchaser or its nominated Affiliate; and

 

(iii)           if it is capable of being used independently of both the Purchaser’s Group’s Intellectual Property Rights and the Supplier’s Group’s Intellectual Property Rights, or if it is incapable of being used independently of either the Purchaser’s Group’s Intellectual Property Rights or the Supplier’s Group’s Intellectual Property Rights, be owned jointly by the Purchaser (or its Affiliate) and the Supplier (or its Affiliate).

 

39.5                        The Purchaser hereby grants (and shall procure that each of its Affiliates grants) to the Supplier and its Affiliates a non-exclusive, worldwide, royalty-free licence (with the right to grant sub-licences to Permitted Subcontractors) during the Term to use for the purposes of Manufacturing Products and otherwise performing its obligations and exercising its rights under this Agreement any Purchaser Improvement IP that would, but for the grant of such licence, be infringed by the Supplier, its Affiliates and/or its Permitted Subcontractors in performing those obligations or exercising those rights.

 

39.6                        The Supplier hereby grants (and shall procure that each of its Affiliates grants) to the Purchaser and its Affiliates a non-exclusive, royalty-free licence to use for the purposes of commercialising the Products (or, as applicable, Finished Products manufactured using Products) in the Territory and otherwise performing its obligations and exercising its rights under this Agreement any Supplier Improvement IP that would, but for the grant of such licence, be infringed by the Purchaser and/or its Affiliates in performing those obligations or exercising those rights or in so commercialising the Products (or, as applicable, Finished Products manufactured using Products).

 

39.7                        Each Party hereby grants (and shall procure that each of its Affiliates grants) to the other Party and its Affiliates such non-exclusive, royalty-free, worldwide, sub-licensable (save as prohibited under clause 39)  perpetual, irrevocable and

 

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assignable licences, permissions or consents as may be required to confer on that other Party and its Affiliates the right:

 

(A)                               to use (and to license the use of) without restriction and free of charge throughout the world for any purpose;

 

(B)                               assign (or otherwise transfer) its interest in; and/or

 

(C)                               charge (or otherwise encumber) its interest in,

 

any Joint Improvement IP.

 

39.8                        With respect to all such Joint Improvement IP:

 

(A)                               the Parties shall cooperate in good faith, using counsel mutually agreed upon by the Parties and at the Parties shared (50%/50%) cost and expense, to diligently prosecute and maintain any patent rights contained therein;

 

(B)                               The Parties shall collaborate in good faith with respect to establishing and implementing a litigation strategy for enforcement of any Intellectual Property Rights contained therein against any infringement of such rights by a Third Party, (“ Third Party Infringement ”) which strategy shall at a minimum provide for:

 

(i)             where the Parties jointly agree to enforce such rights against such Third Party Infringement, (a) the Parties will join in, or be named as a party to such enforcement, (b) the costs and expenses of such enforcement shall be shared (50%/50%), and (c) the proceeds of any such enforcement shall be similarly shared (50%/50%);

 

(ii)            where a Party elects not to jointly enforce such rights against such Third Party Infringement, (a) the non-enforcing Party shall assist and cooperate with the enforcing Party, as such enforcing Party may reasonably request from time to time, including joining in, or being named as a party to, such enforcement, (b) the enforcing Party shall bear 100% of the costs and expenses of such enforcement, including the reasonable costs and expenses incurred by the non-enforcing Party in cooperating with and joining in such enforcement; and (c) 100% of the proceeds of any such enforcement shall accrue solely to the benefit of the enforcing Party; and

 

(iii)           in no event shall either Party grant any licenses to or otherwise settle with any Third Party Infringement or potential Third Party Infringement without the other Party’s prior written approval such approval not to be unreasonably withheld, delayed, or conditioned.

 

39.9                        If a Party becomes aware of any claim alleging infringement of any Third Party Intellectual Property Rights related to a Product supplied under this Agreement, then it shall as soon as reasonably practicable notify the other Party.

 

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40.                               DURATION AND TERMINATION

 

40.1                        This Agreement shall continue in force from the Commencement Date and shall automatically terminate as a whole on the date the last Product Term(s) expire unless terminated earlier in accordance with this clause 40 ( Duration and Termination ) or extended by written agreement of the Parties (the “ Term ”).

 

40.2                        Product Term for Droptainer Products in the Long Term Transfer Plan : the Long Term Transfer Plan aims to achieve successful completion of technical transfers of the Droptainer Products listed in it within five (5) years of the Commencement Date in order to achieve Separation of the Droptainer Product portfolio and balance capacity utilisation between the Puurs, Barcelona, Singapore and Aspex/Fort Worth Manufacturing Sites. Unless terminated earlier in accordance with this clause 40,  Droptainer Products in the Long Term Transfer Plan shall have a Product Term with a designated termination date of no more than five (5) years from the Commencement Date (with the last date of Manufacture of each Droptainer Product in the Long Term Transfer Plan being designated for the relevant Manufacturing Site and successful completion of technical transfer of each such Droptainer Product occurring within that five (5) year term), subject to any modifications to the Long-Term Transfer Plan as mutually agreed by the Technical Transfer Team in accordance with clause 15( Relationship Management ).

 

40.3                        Product Term and convenience termination for all Products not included in the Long Term Transfer Plan: unless terminated earlier in accordance with this clause 40, the term of this Agreement for each such Product will be a fixed period of three (3) years from the Commencement Date (“ Initial Term ”) and shall continue thereafter in respect of such Product until this Agreement is terminated for convenience as follows:

 

(A)                               by the Purchaser (in whole or in part, including on a Product-by-Product basis) giving at least three (3) years’ prior notice to the Supplier, such notice not to be served prior to the end of the Initial Term; and

 

(B)                               by the Supplier (in whole or in part, including on a Product-by-Product basis) giving at least five (5) years’ prior notice to the Purchaser, such notice not to be served prior to the end of the Initial Term;

 

provided, that for any New Product SKU (i) if the Commencement Date for such New Product SKU is a date prior to the third (3rd) anniversary of the Effective Date, the Initial Term shall begin on the Commencement Date and end on the third (3rd) anniversary of the Effective Date; and (ii) if the Commencement Date for such New Product SKU is a date after the third (3rd) anniversary of the Effective Date, there shall be no Initial Term and this Agreement may be terminated on notice in accordance with clauses (A) and (B) above or such earlier date where notice of termination of this Agreement as a whole  in respect of the Original Product has been given prior to the New Product SKU Commencement Date.

 

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40.4                        Convenience termination of a Product at a Manufacturing Site by the Purchaser: the Parties shall enter good faith discussions (each acting reasonably) with a view to the early termination of a Product at a Manufacturing Site by the Purchaser of that Product where the Purchaser can demonstrate that it can mitigate the removal of that volume of Product from this Agreement for the balance of the Initial Term and the contemplated three year notice period with either (i) the substitution of other products of the same Product Technology to be Manufactured for the Purchaser at that Manufacturing Site; or (ii) an increase in volumes of other Products of the same Product Technology Manufactured at the Manufacturing Site.

 

40.5                        The terms referred to in clauses 40.2 to 40.4 shall each be referred to in this Agreement as a “Product Term” in respect of the Product(s) referred to in the relevant clause.

 

40.6                        The Parties may jointly terminate this Agreement (in whole or in part, including on a Product-by-Product basis) at any time by mutual written agreement.  In the event that the Parties jointly terminate this Agreement in respect of a specific Product, such Product shall be deemed to be removed from the definition of “Products” and this Agreement shall be amended accordingly.

 

40.7                        The Purchaser may terminate this Agreement (in whole or in part, including on a Product-by-Product basis) immediately on written notice to the Supplier if the Supplier, or any Nominated Supplier or any Permitted Subcontractor breaches or fails to comply with Quality Standards to a material extent and/or repeatedly or persistently fails to comply with the Quality Standards.

 

40.8                        Without prejudice to clause 40.7, if either Party (the “Defaulting Party” ) commits any material breach of this Agreement or Applicable Law  and, if the breach is capable of remedy, does not remedy that breach following receipt of a request from the other Party (the “Non-Defaulting Party” ) to do so within thirty (30) days, the Non-Defaulting Party may terminate this Agreement (in whole or, in the Non-Defaulting Party’s discretion, in respect of the Product affected by the breach) immediately (subject to the thirty (30) day cure period) by written notice to the Defaulting Party.

 

40.9                        If an Insolvency Event or an Insolvency Proceeding occurs (save as part of a bona fide reorganisation not involving insolvency) in respect of a Party or its ultimate parent, that Party shall promptly notify the other Party in writing, giving particulars of the circumstances.  In such circumstances (whether or not notified in accordance with this clause 40.9), the Party which is not the subject of the Insolvency Event or Insolvency Proceeding may terminate this Agreement immediately by notice in writing.

 

40.10                 Either Party may terminate this Agreement (in whole or in part, including on a Product-by-Product basis) in accordance with clause 32.4.

 

40.11                 If the Marketing Authorisation for a Product in a Territory is revoked by a Governmental Entity due to a health, safety or efficacy concern then either Party may terminate this Agreement in respect of such Product.

 

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40.12                 If any Governmental Entity intervenes to prevent Manufacture for a significant technical or regulatory reason (a “ Material Safety Issu e”) either Party may (a) suspend, or require the suspension of, any activities under this Agreement impacted by the relevant Material Safety Issue with respect to such Product and (b) refer the matter to the relevant Governmental Entity as soon as reasonably practicable (and never later than any required regulatory reporting timeline). If a Party disputes that there is a Material Safety Issue or has a good faith belief that the root cause of the Material Safety Issue is resolvable within a reasonable timeframe then the following will apply:

 

(A)                               if the Governmental Entity determines that there is a Material Safety Issue and it is not resolvable within a reasonable timeframe, its decision shall be binding on the Parties and either Party may terminate this Agreement in respect of such Product;

 

(B)                               if the Governmental Entity determines that no Material Safety Issue exists, neither Party may terminate this Agreement in respect of such Product for such purported Material Safety Issue; and

 

(C)                               if the Governmental Entity determines that the root cause of the Material Safety Issue is resolvable within a reasonable timeframe, with respect to such Product, then the Party seeking to terminate this Agreement may, if it continues to have a reasonable and substantiated good faith belief that there is a Material Safety Issue in relation to the Product, require the continued suspension of the Agreement in respect of such Product until satisfactory remediation activity has been undertaken in relation to the Material Safety Issue to the satisfaction of the Governmental Entity in which case the Agreement shall continue in respect of such Product,

 

provided, that the suspension of activities under this Agreement, or the termination of this Agreement, pursuant to this clause 40.12 shall not in any way diminish or limit the rights or remedies of either Party to recover for the other Party’s breach of its obligations under this Agreement that caused such Material Safety Issue.

 

41.                               CONSEQUENCES OF TERMINATION

 

41.1                        Expiry or termination of this Agreement shall be without prejudice to the continuation in force of any of its provisions which are intended to continue to have effect after it has come to an end, including clauses 13 ( Quality Control ), 19 ( Documentation and Reports ), 25 ( Write Off Costs ), 29 ( Product Action ), 31 ( Confidentiality ), 33 ( Audit and Inspection Rights ), 36 ( Warranties ), 37 ( Indemnity and Liability ), 41 ( Consequences of Termination ), 42 ( Technical Transfer ), 43 ( Bridging Stock ), 46 ( Survival of Rights and Obligations ), 48 ( Whole Agreement ), 49 ( Third Party Rights ) and 50 ( Governing Law and Arbitration ).

 

41.2                        After expiry or termination, the Parties shall provide each other with reasonable support with respect to any investigation carried out by a Governmental Entity with respect to the Manufacture of any Product under this Agreement, provided

 

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that the reasonable costs of the assisting Party in providing such assistance shall be reimbursed by the Party requesting such assistance.

 

41.3                        Expiry or termination of this Agreement (or termination of this Agreement in respect of any Product) pursuant to clause 40 ( Duration and Termination ) will not affect the accrued rights, remedies (including a remedy in damages) and liabilities of the Parties under this Agreement or the enforceability of this clause 41 ( Consequences of Termination ) or any other provisions of the Agreement that are intended to remain in force after its termination.

 

41.4                        The Purchaser will:

 

(A)                               continue to pay the Supply Price and any costs due under this Agreement for Firm Orders as long as the supply of Products continues, despite a notice of termination having been given;

 

(B)                               reimburse the Supplier for the cost of any Capital Expenditure or Development Work undertaken by the Supplier and for which the Purchaser is, pursuant to the terms of this Agreement, required to reimburse the Supplier in the event of a termination of this Agreement by the Supplier under clauses 32 ( Force Majeure ), 40.8 or 40.9, provided that the Supplier shall use Commercially Reasonable Efforts to minimise the costs required to be reimbursed by the Purchaser pursuant to this clause 41.4(B), including, if agreed by the Parties (each acting reasonably), by abandoning any relevant Capital Expenditure or Development Work that relates exclusively to the Products if doing so would be less costly than continuing with such Capital Expenditure or Development Work.

 

41.5                        Without prejudice to clause 43 ( Bridging Stock ), in the event of expiry or termination of this Agreement, the Purchaser shall purchase in accordance with the terms and conditions of this Agreement any Products that comply with the Specifications and Quality Standards and meet the Minimum Remaining Shelf Life requirements and other requirements of this Agreement, save that the Purchaser shall only be obliged to purchase any Product under this clause 41.5 for which Purchaser has placed a Firm Order. The Purchaser shall be responsible for any additional write-off costs agreed to be paid by the Purchaser on termination of this Agreement (including in respect of Materials which have not yet been used in the Manufacture of Products) in accordance with clause 25.1(A) but only in connection with Forecast Schedules delivered prior to the delivery of any notice of termination of this Agreement.

 

41.6                        The provisions of this clause 41 ( Consequences of Termination ) shall apply to the termination of this Agreement in part in respect of any particular Product mutatis mutandis and such Product shall no longer be a Product for the purposes of this Agreement from the date of such termination.

 

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42.                               TECHNICAL TRANSFER

 

Long Term Transfer Plan:

 

42.1                        The initial Long Term Transfer Plan for Droptainer Products being transferred between Manufacturing Sites to achieve Separation (excluding Droptainer Products at the Delayed Site) is appended to this Agreement at Exhibit 15 (the “ Long Term Transfer Plan ”). The plan will demonstrate the intended status of technical transfers for Products in the Long Term Transfer Plan up to 01.01.2023.

 

42.2                        Products not listed in the Long Term Transfer Plan are those Droptainer Products which cannot be easily Separated due to transfer complexities and/or commercial requirements and where Separation is unlikely to be achieved by the end of 2023. These Droptainer Products are not included as technical transfers contemplated in the Long Term Transfer Plan and references in this Agreement to Products in the Long Term Transfer Plan shall not be deemed to include them.

 

42.3                        The Commencement Date is deemed to be the date of initiation of technical transfer for all Droptainer Products in the Long Term Transfer Plan and each Party shall respectively each use their Commercially Reasonable Efforts to agree the budget and timelines for the Technical Transfer Milestones in respect of each such Droptainer Product and implement the same in order to determine and  monitor the progress of the relevant Technical Transfer Milestones and implement successful completion of each of the technical transfers contemplated in the Long Term Transfer Plan (with the “successful completion of a technical transfer” of a Product under this Agreement being deemed to be when the first approval of a variation to the CMC (Marketing Application Core Dossier) to reflect the change of source of Manufacture of any Product in a  Product Technology is completed in any jurisdiction in which such submission is made as part of the Technical Transfer) (“ First Approval ”). Save where otherwise agreed by the Parties, any Technical Transfer Milestones that relate to a Product shall be deemed included in the relevant Long Term Transfer Plan for that Product and shall form the basis for the sequencing of that technical transfer.

 

42.4                        The Parties shall monitor and update the Long Term Transfer Plan (including the budget and which Products should form part of the Long Term Transfer Plan) through the Manufacturing and Supply Team, but shall take due account of the Gating Plan and any other applicable capacity baseline requirements (addressing product volumes and Bridging Stock). The Long Term Transfer Plan shall also contain commitments where reasonably required, on both Parties with respect to certain agreed volumes of Bulk Products. Without prejudice to the right of the Parties to adjust the Long Term Transfer Plan as required from time to time through the Technical Transfer Team the Parties intend to issue a fully updated Long Term Transfer Plan no less than once in each Calendar Year.

 

Additional Specific Technical Transfers

 

42.5                        On a Product-by-Product basis, for Products not addressed in the Long Term Transfer Plan upon request from Purchaser at any time during the applicable Term for that Product or in the event of expiration or termination of this Agreement

 

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for any reason the Parties shall each use their respective Commercially Reasonable Efforts to agree a technical transfer plan, with applicable Technical Transfer Milestones and a technical transfer budget for the relevant Product(s) within three (3) months of the notice of termination, notice of request for a technical transfer or the expiration of this Agreement (as applicable) (each a “ Specific Technical Transfer ”)

 

Terms applying to all Technical Transfers (for Products in the Long Term Transfer Plan and Products not in it)

 

42.6                        References in clauses 42.6 to 42.16 and Exhibit 15 to a “ Technical Transfer Plan” shall include the arrangements in the Long Term Transfer Plan and each technical transfer plan referenced in clause 42.5, as applicable. In each case the Parties shall cooperate to enable the Supplier to provide or cause to be provided, technical transfer services to support a smooth and efficient transfer of Manufacturing of each of the Products or if legally permissible a component thereof from the Supplier, its Affiliate(s) and/or Permitted Subcontractor(s) to the Purchaser or its designee(s) in accordance with Applicable Laws and any regulatory requirements arising from, or connected to, such technical transfer services. Each Party shall use its respective Commercially Reasonable Efforts to:

 

(A)                               undertake the activities allocated to that Party in the relevant Technical Transfer Plan (including, without limitation, those in the applicable technical transfer support budget to be agreed by the Parties);

 

(B)                               undertake such activities in a manner that facilitates the satisfaction of the applicable Technical Transfer Milestones; and

 

(C)                               otherwise provide such assistance and support to the other Party as is reasonably necessary to meet each applicable Technical Transfer Milestone on or before the date specified for that Technical Transfer Milestone (provided that neither Party shall be liable to the extent such failure is caused by a failure of the other Party to perform their obligations).

 

42.7                        Without limiting the foregoing, if the Purchaser is in good faith pursuing an ongoing technology transfer with respect to Manufacturing of a Product at the time of any expiration or termination of this Agreement, the Parties shall consider in good faith on a Product-by-Product basis, an extension of the Product Term for an additional period of up to the earlier of (i) a maximum of two years with respect to such Product or (ii) successful completion of a technical transfer of such Product, provided that it shall be reasonable to grant such an extension in the event of (a) a regulatory or legitimate unforeseen delay to the technical transfer outside either Parties’ control or (b) where the Supplier has been grossly negligent in its execution of the Technical Transfer Plan and the Purchaser is not at fault, but any build-up of Bridging Stock and the condition of any relevant Manufacturing line shall be taken into account in determining the length of any extension of the Product Term, it being acknowledged that the Supplier shall not incur any Capital Expenditure in relation to any Manufacturing line in order to accommodate an extension of the Product Term for any Product.

 

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42.8                        Both Parties acknowledge that the Purchaser may need to be supplied with certain quantities of stock (whether Materials or Products) in order to meet the requirements of any Technical Transfer Plan/Long Term Transfer Plan and to meet the date of the expiry of the Product Term in respect of a particular Product.  Accordingly such requirements for quantities of Bridging Stock as are reasonably necessary (including with respect to shelf life for the relevant markets, Delivery dates, MOQ, Lead Times) shall be agreed in good faith by the Parties (each acting reasonably) and included in the applicable Technical Transfer Plan/Long Term Transfer Plan. For the avoidance of doubt, (i) such Bridging Stock shall be included in the relevant Forecast Schedule of the Purchaser, (ii) shall not amount to more than one (1) years’ worth of volume of Product in the prior Gating Year, (iii) shall be counted in the Gating Plan or volume requirements for that Product in that Calendar Year, (iv) shall be supplied on the terms of this Agreement and (v) any plans of the Supplier to retire or decommission any line required for the Manufacture of such Bridging Stock shall be taken into account in the determination of such Bridging Stock quantities. If an agreement is reached to Manufacture an amount of Bridging Stock the Purchaser shall be obliged to purchase such Bridging Stock on the terms of this Agreement as if it were a Firm Order for the full amount of such Bridging Stock.

 

42.9                        As referenced in clause 42.6 each Party shall use its respective Commercially Reasonable Efforts to implement each Technical Transfer Plan and such plans shall set out the activities to be performed by each Party with respect to the relevant technical transfer. The activities in the Technical Transfer Plan shall (without limitation) include, in each case subject to Clause 31( Confidentiality ) and any mandatory restrictions imposed by Applicable Law (including, without limitation, restrictions relating to anti-trust or restrictions imposed under any binding agreement then in force between the Supplier or Purchaser (as applicable) and a third party):

 

(A)                               in the case of the Supplier: transfer by the Supplier of all required technical documentation, specifications and procedures, know-how owned or controlled by Supplier and its Affiliates (including where it is not reduced to writing or otherwise incorporated in a tangible embodiment), access to a sufficient number of qualified scientists, production and QA personnel and engineers, as well as QC personnel, reasonable access to the Manufacturing Sites, Nominated Affiliates and Permitted Subcontractors during Product Manufacturing runs and any other support or training reasonably requested by Purchaser; and

 

(B)                               the case of the Purchaser : provision of access to a sufficient number of appropriately qualified personnel of the Purchaser) to facilitate the transfer of relevant know-how; allowing access to the Manufacturing Site and equipment that will be used by the Purchaser for manufacture of the relevant Product; disclosing relevant information relating to the Product and the Purchaser’s planned method of manufacture for the Product (subject to any mandatory restrictions imposed by Applicable Law); procuring such materials and licences as are required for the validation process and the Manufacture of the Products by the Purchaser.

 

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42.10                 The Parties shall coordinate regarding technical transfer matters through the Technical Transfer Planning Team.

 

42.11                 The Parties shall mutually agree the timing of technical transfer services, provided that such technical transfers shall be staged to prioritize the technical transfer of certain Products as reasonably requested by Purchaser and as agreed by the Parties in the Long Term Transfer Plan. The Long Term Transfer Plan shall identify the last date of Manufacture for the Products addressed by that Long Term Transfer Plan.

 

42.12                 The Parties agree that the key technical transfer milestones that need to be established in respect of each Product included in the Long Term Transfer Plan or a specific Technical Transfer Plan (as applicable) are as follows:

 

(A)                               joint kick-off meeting;

 

(B)                               creation of Data Pack in accordance with Exhibit 12 ( Data Pack Requirements ) including any new regulatory data needed for submission;

 

(C)                               method transfer (analytical, cleaning, sterilization, etc.) (if applicable);

 

(D)                               stability batches (if applicable);

 

(E)                                validation batches (if applicable);

 

(F)                                 regulatory dossier package preparation;

 

(G)                               regulatory dossier submission (market specific); and

 

(H)                              First Approval is obtained for that Product in any country,

 

(individually and together, the “ Technical Transfer Milestones ”).

 

42.13                 The Long Term Transfer Plan and each Specific Transfer Plan shall take due account of all relevant factors and circumstances in each case, with a view to ensuring that:

 

(A)                               there is a smooth, orderly and efficient transfer, on a Product-by-Product basis, of the Manufacturing of such Product from the Supplier to the Purchaser or its designee(s);

 

(B)                               the availability of each Party’s relevant personnel to support the technical transfer of the Manufacturing of such Product;

 

(C)                               unless otherwise agreed (and without prejudice to clauses 40.1, 40.2 and 42.7) the Supplier will cease to Manufacture (or have Manufactured) each Product not later than the expiry of the applicable Product Term;

 

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(D)         continuity of supply or availability of each Product to the Purchaser’s Group is maintained throughout the technical transfer process in relation to the Manufacture of such Product; and

 

(E)                                access to sites and documents necessary to support the technical transfer process is controlled and limited to authorised personnel only.

 

(F)                                 The technical transfers contemplated in the Long Term Transfer Plan and otherwise under Technical Transfer Plans agreed pursuant to this clause 42 ( Technical Transfer ) shall not involve the transfer of physical assets and equipment save in relation to the Shared Moulds identified to be transferred under the Long Term Transfer Plan on the terms set out in Exhibit 9 ( Shared Moulds ).

 

Technical Transfer costs

 

42.14                 The terms of Exhibit 15, Part B shall apply in relation to the allocation and reimbursement of certain costs and expenses incurred in relation to the implementation of a Technical Transfer Plan for each Product.

 

42.15                 At the either Party’s request, the Parties (each acting reasonably and in good faith) shall discuss whether, in connection with the transfer of Manufacture of a Product, the Supplier should procure the assignment or novation, in whole or in part, to a member of the Purchaser’s Group of any agreements between the Supplier and Third Parties relating to the Manufacture of that Product, including the supply of Materials used in such Manufacture and/or the licensing of any technology required for use in such Manufacture.

 

42.16                 If (i) the Parties agree that the Supplier shall assign, transfer or novate an agreement, in whole or in part, to the Purchaser’s Group pursuant to clause 42.15 and (ii) such agreement cannot effectively be assigned, novated or transferred to the Purchaser except by an agreement, transfer or novation with the consent of the relevant counterparty thereto:

 

(A)                               the Supplier shall use Commercially Reasonable Efforts to procure consent to the novation, transfer or assignment in accordance with timeframe necessary to align that novation, transfer or assignment with the technical transfer of the relevant Product in accordance with the Technical Transfer Plan; and

 

(B)                               until the relevant contract is novated, transferred or assigned, or (if earlier) until the relevant contract can be terminated by Supplier without incurring any financial detriment, the Supplier shall hold the benefit of such contract on trust for the Purchaser absolutely and the Purchaser shall (if such sub-contracting is possible under the contract), as the Supplier’s sub-contractor, perform all the obligations of the Supplier that relate to the Manufacture of the relevant Product under the contract in accordance with the provisions of Exhibit 8 ( Purchaser Materials ).

 

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43.                               BRIDGING STOCK

 

43.1                        In connection with the technical transfer of the Manufacture of any Product under this Agreement and always subject to the capacity as may be agreed pursuant to clause 4 ( Capacity Baseline and Gating Plan ) in respect of the relevant Manufacturing Site or Product, the Purchaser may request that the Supplier shall Manufacture (or have Manufactured) and the Purchaser shall purchase (or procure the purchase of), an additional quantity of the affected Product (including any New Product SKU introduced under this Agreement pursuant to clause 21 ( New Product SKUs )) ( “Bridging Stock” ) prior to the expiry of the Term.

 

43.2                        Any quantity of Bridging Stock that may be requested by the Purchaser and other relevant terms of Manufacture and Delivery (including with respect to shelf life, order quantities and lead times) and, if relevant, any revisions to Artwork that may be required in respect of some or all of the Bridging Stock in respect of a Product (including in anticipation of Marketing Authorisation transfer or Marketing Authorisation re-registration) shall be mutually agreed by the Parties on a basis entirely consistent with the terms of this Agreement and the relevant parameters for such supply of Bridging Stock shall be agreed between the Parties, taking into consideration the Supplier’s available Manufacturing capacity and ongoing operations at Manufacturing Sites.

 

43.3                        Once mutually agreed, quantities of Bridging Stock and the applicable Delivery Dates shall be reflected in the applicable Forecast Schedule and, except as otherwise mutually agreed between the Parties, the Purchaser shall be deemed to have provided a purchase order for such Bridging Stock on the date on which the Firm Zone for such Bridging Stock would commence in accordance with the Forecast Schedule, having regard to the due date for Delivery of such Bridging Stock mutually agreed between the Parties.

 

43.4                        Where Bridging Stock is requested by the Supplier (including for example, where it is required in relation to an artwork change) any costs associated with that Bridging Stock shall be borne by the Supplier.

 

44.                               RISK MANAGEMENT

 

44.1                        Consistent with diligent risk management practices, the Supplier will develop, implement and keep current a risk management program including a Business Continuity Plan for each of its Manufacturing Sites in accordance with its corporate policies and procedures. The Business Continuity Plan shall include adequate security and protective measures to ensure business continuity in case of any potential disruptive events on the supply chain of the Products. The Business Continuity Plan does not relieve the Supplier from any liability under this Agreement and, for the avoidance of doubt, does not increase the Supplier’s obligations under this Agreement.

 

44.2                        Once in any Calendar Year or at such other frequency as the Purchaser reasonably deems to be appropriate, the Supplier will conduct a test and evaluation of the Business Continuity Plan which, upon the Purchaser’s request, may be witnessed by the Purchaser representatives.

 

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44.3                        The Parties agree that any issues arising from the risk and business continuity management will be promptly communicated to the other Party.

 

44.4                        The costs of business continuity requests initiated after the Commencement Date shall be borne by the requestor (i.e. materials, validations, stability batches, etc for dual sourcing). The non-requesting Party agrees to support a requestor’s reasonable request provided such efforts and resources are not detrimental to the non-requesting Party’s other obligations under this Agreement.

 

44.5                        Dual sourcing shall be established for a select number of Products and Shared Chemical/API Products as set out in Exhibit 17 ( Dual Sourcing ) and the Supplier shall be supportive of such sourcing activity. Cost incurred to maintain dual sourcing (including cost of stability batches) will be borne by the Party requesting the dual sourcing. The Supplier shall, to the extent reasonably practicable, give advance notice to the requesting Party of any costs arising in connection with the dual sourcing before such costs are incurred. The Parties shall once per Calendar Year meet to align the list of dual sourced Products and Shared Chemical/API Products to determine whether, as a result of the Long Term Transfer or otherwise, the requesting Party should still be entitled to require the dual sourcing to be maintained and the revised list of dual sourced products shall be approved by the Manufacturing and Supply Team.

 

45.                               NOTICE

 

45.1                        Any notice in connection with this Agreement (a “ Notice ”) shall be:

 

(A)                                in writing in English; and

 

(B)                               delivered by hand or by courier using an internationally recognised courier company.

 

45.2                        A Notice to the Supplier shall be sent to such Party at the following address, or such other person or address as the Supplier may notify to the Purchaser from time to time:

 

Alcon Inc.

c/o Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, TX 76134, USA

 

Attention: Supplier Contract Execution Manager

 

Copy (which shall not constitute Notice) to:

 

Alcon Inc.

c/o Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, TX 76134, USA

 

Attention: General Counsel

 

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45.3                        A Notice to the Purchaser shall be sent to such Party at the following address, or such other person or address as the Purchaser may notify to the Supplier from time to time:

 

Novartis Pharma AG

Lichtstrasse 35

4056 Basel,

Switzerland

 

Attention: Purchaser Contract Execution Manager

 

Copy (which shall not constitute Notice) to:

 

Novartis Pharma AG

Fabrikstrasse 4

Novartis Campus

CH-4056, Basel

 

Attention: General Counsel NTO & Group Quality

 

45.4                        A Notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery provided that any notice deemed to be received outside of Working Hours shall be effective at the start of the next period of Working Hours.

 

46.                               SURVIVAL OF RIGHTS AND OBLIGATIONS

 

Termination or expiry of this Agreement shall not release either Party from any liability or right of action which, at the time of termination or expiry, has already accrued to a Party or which may thereafter accrue in respect of any act or omission prior to such termination or expiry.  Such rights may include the recovery of any monies due.

 

47.                               ASSIGNMENT

 

47.1                        The Purchaser may, by notice in writing to the Supplier, assign the whole or any part of this Agreement to any Affiliate of the Purchaser, provided that the Purchaser shall remain liable to the Supplier in its capacity as principal obligor.

 

47.2                        The Supplier may, by notice in writing to the Purchaser, assign the whole or any part of this Agreement to any Affiliate of the Supplier, provided that the Supplier shall remain liable to the Purchaser in its capacity as principal obligor.

 

47.3                        Save as provided in clause47.5, neither Party may assign or novate its rights or obligations under this Agreement at any time to any Third Party, or novate the whole or any part of this Agreement to any of its Affiliates, without the prior written consent of the other Party.

 

47.4                        The provisions of this clause 47 ( Assignment ) are without prejudice to the Parties’ rights under clause 40 (Duration and Termination).

 

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47.5                        Either Party (the “ Assigning Party ”) may, with the prior written consent of the other Party, such consent not to be unreasonably, withheld, conditioned or delayed, assign or transfer this Agreement (in whole or in part) to a Third Party: (i) in connection with the sale or disposal of all or part of the assets of the Assigning Party or its Affiliates which includes the sale or disposal of any Products; or (ii) if the Assigning Party or an Affiliate of the Assigning Party otherwise divests, out-licenses or disposes of any Product(s), without prejudice to its respective right of termination under clause 40 ( Duration and Termination ), provided always that no Shared Moulds shall be transferred to such Third Party pursuant to this clause 47 ( Assignment ).

 

48.                               WHOLE AGREEMENT

 

48.1                        This Agreement, together with the Transaction Documents, constitutes the entire agreement and understanding between the Parties relating to the subject matter of this Agreement at the date hereof to the exclusion of any terms implied by law which may be excluded by contract and supersedes any previous written or oral agreement between the Parties in relation to the matters dealt with in this Agreement. The Parties further agree that the terms and conditions of this Agreement will apply to the exclusion of any terms and conditions of sale or purchase submitted at any time by either Party, whether printed or sent with any acknowledgement of any Delivery of Product or otherwise.

 

48.2                        Each Party acknowledges that, in entering into this Agreement, it is not relying on any representation, warranty or undertaking not expressly incorporated into it.

 

48.3                        Except as expressly stated herein, each of the Parties agrees and acknowledges that its only right and remedy in relation to any representation, warranty or undertaking made or given in connection with this Agreement shall be for breach of the terms of this Agreement and each of the Parties waives all other rights and remedies (including those in tort or arising under statute) in relation to any such representation, warranty or undertaking.

 

48.4                        Nothing in this clause 48 ( Whole Agreement ) excludes or limits any liability for fraud (including the making of any statements fraudulently).

 

48.5                        A Party shall be entitled to make more than one claim under this Agreement arising out of the same subject matter, fact, event or circumstance but shall not be entitled to recover under this Agreement or any relevant Transaction Document or otherwise more than once in respect of the same Liabilities suffered or amount for which the Party is otherwise entitled to claim (or part of such Liabilities or amount), regardless of whether more than one claim arises in respect of it. No amount (including any relief) (or part of any amount) shall be taken into account, set off or credited more than once under this Agreement or any relevant Transaction Document or otherwise, with the intent that there will be no double counting under this Agreement or any Transaction Document or otherwise. For the avoidance of doubt any claims in relation to testing services provided under the Transitional Services Agreements must be brought under the relevant Transitional Services Agreement.

 

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49.                               THIRD PARTY RIGHTS

 

49.1                        Subject to clause 49.2, the Parties do not intend that any term of this Agreement should be enforceable, by virtue of the Contracts (Rights of Third Parties) Act 1999, by any person who is not a party to this Agreement.

 

49.2                        Certain provisions of this Agreement confer benefits on the Affiliates of the Purchaser and the Affiliates of the Supplier and, subject to clause 49.3, are intended to be enforceable by each such Affiliate by virtue of the Contracts (Rights of Third Parties) Act 1999.

 

49.3                        Notwithstanding clause 49.2, this Agreement may be varied in any way and at any time without the consent of any Affiliate who is entitled to enforce this Agreement under clause 49.2.

 

50.                               GOVERNING LAW AND ARBITRATION

 

50.1                        This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

50.2                        Nothing contained in this clause 50 ( Governing Law and Submission to Jurisdiction ) shall limit the right of either Party to seek an injunction in any other competent jurisdiction in which a Product is Manufactured, marketed or sold, nor shall the seeking of an injunction in on one or more jurisdiction preclude the seeking of an injunction in any other jurisdiction, whether concurrently or not.

 

50.3                        Clauses 50.3 to 50.8 shall apply to any dispute, controversy or claim arising out of, relating to, or in connection with this Agreement, including, without limitation, any dispute relating to the existence, validity or termination of this Agreement and a dispute which could not be resolved through the processes set out in clause 16 (each, a “ Dispute ).

 

50.4                        Before entering into any arbitration pursuant to clauses 50.6 or 50.6(A), a Party shall give written notice of a Dispute to the other Party (a “ Dispute Notice ). The Dispute Notice shall:

 

(A)                               state that it is a Dispute Notice being submitted pursuant to clause 50.3 of this Agreement;

 

(B)                               identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(C)                               set out any steps taken by that Party or its Affiliates to resolve it.

 

50.5                        Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within  the

 

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relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the “ Resolution Period” ).  The time limit specified in this clause 50.5 may be extended by the written agreement of the Parties.

 

50.6                        If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(A)                               the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the “ LCIA Rules” );

 

(B)                               the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(C)                               the seat of arbitration shall be London; and

 

(D)                               the written and spoken language to be used in the arbitral proceedings shall be English.

 

50.7                        Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Transaction Document, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with clause 50.6.

 

50.8                        The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this clause 50.8 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

51.                               VARIATION OR WAIVER

 

51.1                        No variation of this Agreement shall be effective unless in writing and signed by or on behalf of each of the Parties.

 

51.2                        No failure or delay by a Party in exercising any right or remedy provided by Applicable Law or under this Agreement or any Transaction Document shall impair such right or remedy or operate or be construed as a waiver or variation of it or preclude its exercise at any subsequent time and no single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

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52.                               COSTS

 

Each Party shall bear all costs incurred by it and its Affiliates in connection with the preparation and negotiation of, and the entry into, this Agreement.

 

53.                               INTEREST

 

Without prejudice to clause 11.5, if any Party defaults in the payment when due of any sum payable under this Agreement, the liability of that Party shall be increased to include interest on such sum from the date when such payment is due until the date of actual payment (as well after as before judgment) at a rate of two per cent. (2%) above LIBOR per annum. Such interest shall accrue from day to day. The Parties acknowledge that the provisions of this clause provide a substantial contractual remedy for the late payment of such sums due under this Agreement.

 

54.                               PAYMENTS

 

54.1                        Subject to clause 54.2, any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or otherwise agreed).

 

54.2                        If any deductions or withholdings are required by Applicable Law to be made from any of the sums payable pursuant to this Agreement then, except to the extent that the sum constitutes interest, the payer shall be obliged to pay to the recipient such sum as will, after the deduction or withholding has been made, leave the recipient with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding.

 

54.3                        If a person makes an increased payment pursuant to clause 54.2 and the recipient receives and utilises a credit, relief or repayment in respect of the Tax that gave rise to such increased payment, the recipient shall reimburse the payer such amount as shall leave the recipient in the same position as the recipient would have been in had no such deduction or withholding been required to be made.

 

55.                               INVALIDITY

 

55.1                        If any provision in this Agreement shall be held to be illegal, invalid or unenforceable, in whole or in part, the provision shall apply with whatever deletion or modification is necessary so that the provision is legal, valid and enforceable and gives effect to the commercial intention of the Parties.

 

55.2                        To the extent that it is not possible to delete or modify the provision, in whole or in part, under clause 55.1, then such provision or part of it shall, to the extent that it is illegal, invalid or unenforceable, be deemed not to form part of this Agreement and the legality, validity and enforceability of the remainder of this Agreement shall, subject to any deletion or modification made under clause 55.1, not be affected.

 

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56.                               COUNTERPARTS

 

This Agreement may be entered into in any number of counterparts, all of which taken together shall constitute one and the same instrument.  Any Party may enter into this Agreement by executing any such counterpart. Delivery of a counterpart of this Agreement by email attachment shall be an effective mode of delivery.

 

57.                               RELATIONSHIP OF THE PARTIES

 

57.1                        Nothing in this Agreement, and no action taken by the Parties pursuant to this Agreement, will be deemed to constitute a relationship between the Parties of partnership, joint venture, principal and agent or employer and employee.  Neither Party has, nor may it represent that it has, pursuant to this Agreement, any authority to act or make any commitments on the other Party’s behalf.  Neither Party will have the authority or power to bind the other or to contract in the name of or create liability against the other in any way or for any purpose.

 

57.2                        Each of the Supplier and the Purchaser shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

58.                               FURTHER ASSURANCE

 

58.1                        Without prejudice to any restriction or limitation on, and without extending the scope of, the extent of any Party’s obligations under this Agreement, each Party (the “first Party” ) shall from time to time, so far as each is reasonably able, do or procure the doing of all such acts and/or execute or procure the execution of all such documents (including in relation to any relevant regulatory filings) in a form reasonably satisfactory to the other Party (the “other Party” ) as that other Party reasonably requests to give such other Party the full benefit of its rights or the first Party’s obligations under this Agreement.

 

58.2                        Without prejudice to the generality of clause 58.1, if either Party identifies any error in or omission from any of the Exhibits, it may notify the other Party of such error(s) or omission(s) and the Parties shall agree in writing such revisions to the affected Exhibit(s) as may be required to correct the error(s) or omission(s) in question.

 

signature page follows

 

87


 

SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS PHARMA AG

 

 

 

 

 

 

 

 

/s/ Andreas Brutsche

 

/s/ Christian Klemm

 

 

 

 

 

Name:

Andreas Brutsche

 

Name:

Christian Klemm

 

 

 

 

 

Title:

Head ESO Novartis

 

Title:

General Counsel, Novartis Technical Operations

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ John Reding

 

 

 

 

 

Name:

David Murray

 

Name:

John Reding

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

88


Exhibit 99.6

 

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 


 

TRANSITIONAL SERVICES AGREEMENT

 


 

 


 

Table of Contents

 

1.

Relationship Management

1

 

 

 

2.

Integration

3

 

 

 

3.

Provision of Services

8

 

 

 

4.

Separation and Information Technology Risk Control

10

 

 

 

5.

General Obligations

14

 

 

 

6.

Dependencies

16

 

 

 

7.

Third Party Suppliers

16

 

 

 

8.

Shared Premises

19

 

 

 

9.

Record Keeping

19

 

 

 

10.

Compliance with Laws

20

 

 

 

11.

Intellectual Property Rights

20

 

 

 

12.

Service Charges and Payment

21

 

 

 

13.

Employee Accounts

24

 

 

 

14.

Tax

25

 

 

 

15.

Warranty as to Capacity

26

 

 

 

16.

Liability

26

 

 

 

17.

Term

29

 

 

 

18.

Termination

31

 

 

 

19.

Brazil

32

 

 

 

20.

Consequences of Termination

33

 

 

 

21.

Data Protection

33

 

 

 

22.

Change Management

36

 

 

 

23.

Confidentiality

37

 

 

 

24.

Force Majeure

38

 

 

 

25.

Local Service Agreements

39

 

 

 

26.

Notices

40

 

 

 

27.

Miscellaneous Provisions

41

 

 

 

28.

Governing Law

44

 

 

 

Schedule 1 Definitions and Interpretation

46

 

ii


 

Schedule 2 Employees

55

 

iii


 

TRANSITIONAL SERVICES AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

(1)                                  NOVARTIS AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Basel Stadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland ( Novartis ); and

 

(2)                                  ALCON INC. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland ( Alcon ),

 

(each a Party and, together, the Parties ).

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

Whereas:

 

A.                           The parties have entered into a Separation and Distribution Agreement dated as of 8 April 2019 (the Separation Agreement ) to implement the separation of the Alcon Business from the Novartis Business.

 

B.                           Following the consummation of the transactions contemplated by the Separation Agreement, the Service Recipient requires the Service Provider to provide, or procure the provision of, the Services to the Service Recipient Group.

 

C.                           Subject to the terms of this Agreement, the Service Provider has agreed to provide, or procure the provision of, the Services to the Service Recipient Group and the Service Recipient has agreed to accept and pay, or procure payment, for the Services.

 

D.                           The parties have also agreed to co-operate in the implementation of the Integration Plans and the Integration Projects on the terms of this Agreement.

 

IT IS AGREED:

 

1.                    RELATIONSHIP MANAGEMENT

 

1.1                               Governance. Each Party shall, and shall procure that its Affiliates shall, comply with its obligations under the agreed governance model at Schedule 3 ( Governance ).

 

1.2                               Governance Roles.

 

(a)                                  Immediately on signing this Agreement, the Parties shall each appoint the various governance roles set out in Annex 1 of Exhibit 2, including:

 

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(i)                          ‘Country Operational Leads’ and/or Local Functional Leads’ (as applicable);

 

(ii)                       in the case of Alcon, ‘Regional Leads’;

 

(iii)                    ‘Global Business Service Function Leads’ for the Services (in each case, a Global Function Lead );

 

(iv)                   ‘TSA Leads’ (in each case, a TSA Lead ); and

 

(v)                      ‘Separation Office Heads’,

 

which, in each case, shall have the responsibilities outlined in Annex 1 of Exhibit 2. As set out in Annex 1 of Exhibit 2, the TSA Leads shall: (1) have overall responsibility for overseeing and monitoring the: (A) provision and receipt of the Services and BAU Services; and (B) execution of the In-Flight Projects, Integration Plans and the Integration Projects; and (2) be the principal points of contact between the Parties in relation to issues arising out of this Agreement.

 

(b)                                  As at the Commencement Date, Novartis’s TSA Lead shall be Alicja Zolotar, Senior Director Global Integration /Separation Office,  and Alcon’s TSA Lead shall be David Rea, Moonstone Program Co-Lead.

 

(c)                                   Each TSA Lead shall appoint an alternate in case he or she is unavailable from time to time.  Either Party may change the identity of its TSA Lead or any of its other representatives appointed under Clause 1.2 ( Governance Roles ) at any time by written notice to the other.

 

1.3                               The TSA Leads (or their alternates) shall use reasonable efforts to:

 

(a)                                  co-ordinate regular project meetings as set out in Annex 1 of Exhibit 2, and, in any event, as reasonably necessary to implement the Integration Plans and the Integration Projects in accordance with their terms and this Agreement, and to effect the integration of the systems, operational processes and services contemplated by this Agreement; and

 

(b)                                  provide regular status updates and performance reports relating to each Party’s progress in fulfilling milestones and performing its obligations under this Agreement, including progress on the Integration Plans and the Integration Projects.

 

1.4                               The Parties shall ensure that their respective TSA Lead and other personnel whose decisions are necessary for:

 

(a)                                  the implementation of the Integration Plans and the Integration Projects; or

 

(b)                                  the performance of the Services,

 

are available at reasonable times for consultation on any matter relating to them.

 

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2.                    INTEGRATION

 

2.1                               Responsibility for Integration.

 

(a)                                  The Service Recipient shall:

 

(i)                          be primarily responsible for the Integration of the Services and overseeing the implementation of each Integration Project; and

 

(ii)      use all reasonable efforts to establish its own functions (including the IT environment and IT Systems), at its cost, to enable timely Integration.

 

(b)                                  The Parties shall use Commercially Reasonable Efforts to achieve the Integration of each Service by the end of the relevant Service Term.

 

2.2                               Integration Plans and Integration Projects.

 

(a)                                  With effect from the Commencement Date, the Service Provider shall (and shall procure that its Affiliates shall) provide the Service Recipient with sufficient information about the Services (including information relating to the relevant assets, technology, operations, people, contracts and processes) to enable the Service Recipient to plan for the integration of each of the Services by the Service Recipient (or any of its Affiliates or third party providers) ( Integration ).  For the avoidance of doubt, Integration shall include any and all commercial, operational and technical transition and integration measures or processes, including appropriate training, in each case implemented to exit, transition, migrate and integrate the Services as reasonably required to allow the Service Recipient to operate the business processes that form part of each Service on a standalone basis.

 

(b)                                  The Parties shall in good faith agree and finalize a critical path integration plan and related functional integration plans (collectively, the Integration Plans ) to achieve Integration as soon as reasonably practicable after the Commencement Date, and then implement the Integration Plans in accordance with their terms.  The Integration Plans shall include details of any projects required for Integration (collectively, the Integration Projects ), including the parameters and timelines for, and each Party’s responsibilities in respect of:

 

(i)                          all separation activities and processes to be carried out by the Service Provider, at the Service Recipient’s direction (other than with respect to any activities by Service Provider pursuant to Clause 2.2(b)(i)(A), which shall be at Service Provider’s sole discretion), in relation to the Services and their related functions that are related to, and reasonably required for, the Integration. For IT, this shall include any separation activities and processes within the Service Provider’s IT environment (infrastructure, systems, applications, tools and processes) (collectively, the IT Environment ) and related measures, including:

 

(A)                                any activities required to optimize the shared IT Environment that the Service Provider continues to operate following the separation (including any partial  decommissioning of IT Systems or other equipment);

 

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(B)                                the separation of any electronic data in connection with the separation of the Service Provider’s shared IT Environment. For the avoidance of doubt, the Parties agree that any such separation of electronic data shall form part of the IT separation under this Clause 2.2(b)(i)(B), and not part of the separation of Books and Records pursuant to Clause 2.2(b)(iii);

 

(ii)                       Service transition and cut-over (deliverables, resources and Integration);

 

(iii)     separation, retention and transfer of Books and Records (including redaction) in accordance with the provisions of the Separation Agreement; and

 

(iv)                   in the case of Integration with respect to IT:

 

(A)                                the configuration of a network-to-network connection between the networks of the Parties for the purpose of the provision of the Services and for the purpose of Integration (a Network-to-Network Connection );

 

(B)                                cloning of IT Systems and any dependent interfaces owned or used by Service Provider or its Affiliates including the reasonably required related validation and operational documentation;

 

(C)                                establishment of the Parties’ future IT environment (infrastructure, systems, applications, tools and processes);

 

(D)                                development, planning and implementation of a Network-to-Network Connection);

 

(E)                                 validation and training documentation required for the Service Recipient to receive the Services;

 

(F)                                  development, planning and implementation of a Network-to-Network Connection;

 

(G)                                Costs of wiping assets before they can be physically transferred or decommissioned (if applicable);  and

 

(H)                               IT Systems de-branding and tattoo removal (if applicable);

 

(v)                      relocating assets from the sites of the Service Provider or its Affiliates (if applicable);

 

(vi)     dates and timelines for the Integration and related separation activities and processes (as set out in Clause 2.2(b)(i)) and details of the anticipated Costs related thereto, which shall be borne by the relevant Party in accordance with Clause 2.6 ( Integration Costs );

 

(vii)                Identified Stranded Costs, which shall be borne by the relevant Party in accordance with Clause 2.7 ( Stranded Costs ); and

 

(viii)   the right of the Service Recipient to use Service Materials (as defined in Clause 11.3) beyond the termination or expiry of this Agreement.

 

4


 

(c)                                   Each Party shall, and shall procure that its Affiliates shall:

 

(i)                          provide to the other such documentation as well as separation and Integration assistance as reasonably required to enable the other Party to complete its responsibilities and obligations under the Integration Projects by the dates specified in the Integration Plans in accordance with Clause 2.2(c)(ii); and

 

(ii)      use Commercially Reasonable Efforts to complete the Integration Projects by the dates specified in the Integration Plans and, if not specified, in a timely manner.

 

(d)                                  If the Parties fail to complete the Integration Projects in accordance with Clause 2.2(c) the Parties shall meet and discuss in good faith the measures to be taken to achieve the completion of each Integration Projects as soon as reasonably possible after the date the relevant Integration Project was due to complete.

 

2.3                               Additional Assistance. Subject to Clause 4.2(b), the Service Recipient may request reasonable additional assistance from the Service Provider (including additional Integration assistance from the Service Provider to remedy technical or operational issues relating to the Service Recipient’s IT Systems and to restore them to operation as a result of carrying out the Integration Projects in the Integration Plans) ( Additional Assistance ).  Any request for Additional Assistance from the Service Recipient shall be in writing describing the scope and term of the requested Additional Assistance (not to exceed the Maximum Service Term) and the reason for the request.  The Service Provider shall consider in good faith any such request and shall, in determining whether to provide the requested Additional Assistance and the overall feasibility of such request, be entitled to take into account the following factors:

 

(a)                                  the Service Provider’s then available resources, capabilities and capacity to provide the requested Additional Assistance; and

 

(b)                                  whether the requested Additional Assistance could be provided by any third party providers.

 

If the Service Provider agrees to provide the requested Additional Assistance, the parties shall agree the terms that will apply to the provision of the Additional Assistance and the Service Recipient agrees to pay the Service Provider’s costs in accordance with Clause 2.6(b).  For the avoidance of doubt there shall be no obligation on the Service Provider to provide any Additional Assistance requested by the Service Recipient in accordance with this Clause 2.3 ( Additional Assistance ).

 

2.4                               Integration liability. In respect of any Integration Projects:

 

(a)                                  without limiting either Party’s rights under the Separation Agreement, the Service Recipient acknowledges and agrees that no express condition or warranty of any kind has been given by or on behalf of the Service Provider, and any terms or conditions implied in any jurisdiction are excluded to the fullest extent permitted by Applicable Law (or, if incapable of exclusion, any rights or remedies in relation to them are irrevocably waived), in relation to the effect of any Integration Project (or any documentation, Integration assistance or Additional Assistance provided by the Service Provider in relation to any Integration Project) being carried out under the Integration Plans or any

 

5


 

other Additional Assistance, in each case, with regard to the state of the Service Recipient’s IT Systems, the ability of the Service Recipient to restore such Service Recipient’s IT Systems into operation, or its future use after carrying out the activities in the Integration Plan;

 

(b)                                  the Service Provider shall not, to the fullest extent permitted by Applicable Law, be liable to the Service Recipient, for any Costs that are incurred or payable by the Service Recipient and that arise from the Service Provider satisfying its obligations under the Integration Plan in relation to the Service Recipient’s IT Systems; and

 

(c)                                   the Service Recipient shall not, and shall ensure that the other members of the Service Recipient Group shall not, make or bring any claims against the Service Provider, or any member of the Service Provider Group in relation to such Costs referred to in Clause 2.4(b).

 

2.5                               Services set-up and operationalisation Costs.

 

All Costs relating to the set-up of Services and related operationalisation Costs shall be borne by the Service Provider.

 

2.6                               Integration Costs.

 

(a)                                  The Parties acknowledge and agree that all Costs relating to Integration pursuant to Clause 2.2 ( Integration Plans and Integration Projects ), including all Costs:

 

(i)                          incurred by the Service Provider and its Affiliates in connection with Integration and carrying out, at the Service Recipient’s direction, the Integration Plans and Integration Projects; and

 

(ii)      associated with any Additional Assistance provided by a Service Provider or any of its Affiliates at the Service Recipient’s request under Clause 2.3 ( Additional Assistance ),

 

in each case, whether internal or external Costs (which shall be charged in accordance with Clause 2.6(b)), shall be borne by the Service Recipient, except that:

 

(A)         the Service Provider shall bear all Costs relating to any separation activities or processes conducted in relation to the Services and their related functions pursuant to Clause 2.2(b)(i) (including the Costs of separating any electronic data in connection with the separation of the Service Provider’s shared IT Environment pursuant to Clause 2.2(b)(i)(B)); and

 

(B)                                all Costs relating to the separation (including the cost of modification, transformation and/or redaction, if necessary) and transfer of Books and Records shall be borne by the relevant Party in accordance with clause 17.6 ( Costs Relating to Books and Records ) of the Separation Agreement,

 

6


 

(all such Costs (excluding those under sub-paragraphs (A) and (B)) being the Integration Costs ).

 

(b)                                  Subject to Clause 2.6(c), the Service Provider shall, and shall procure that each of its Affiliates shall, charge for any internal time and effort spent supporting or assisting the Integration or any Additional Assistance in accordance with this Clause 2 ( Integration ) on a time and materials basis without any mark-up, based on the agreed rate card at Exhibit 7 ( Rate Card ).

 

(c)                                   If an Integration Project is not complete within the due date for completion (including, if applicable, the date specified in the Integration Plan) (each delay being an Integration Project Delay ), and provided that such Integration Project Delay is not caused by an act or omission of the Service Provider or any of its Affiliates, the Service Provider’s and its Affiliates’ attributable internal and external reasonable documented costs that are payable in relation to the steps agreed pursuant to Clause 2.2(d) in connection with that Integration Project shall (unless otherwise agreed upon in writing by both Parties) be subject to a mark-up of five per cent (5%) from the date that is thirty (30) days after the due date for completion until the actual completion of that Integration Project.

 

2.7                               Stranded Costs.

 

(a)                                  The Parties shall, while: (i) agreeing and finalizing the scope and operation of the Integration Plans and Integration Projects in accordance with Clause 2.2(b); and (ii) completing the Integration Projects in accordance with Clause 2.2(c), act reasonably and in good faith to avoid, or mitigate to the extent reasonably possible in the circumstances, any stranded or additional costs for the Service Provider as a result of the Integration (the Stranded Costs ).

 

(b)                                  Subject to Clauses 2.7(a) and 2.7(c), the Parties acknowledge and agree that there may be certain identifiable: (i) Stranded Costs; and/or (ii) circumstances that may result in Stranded Costs ((i) and (ii) comprising the Identified Stranded Costs ), and the Party liable for any such Identified Stranded Costs shall be set out in the relevant Integration Plan and/or Integration Project.

 

(c)                                   To the extent that the Service Recipient:

 

(i)                          fails to comply with its obligations under any Integration Plan or Integration Project;

 

(ii)                       requests any change to the implementation of any Integration Plan and/or Integration Project; or

 

(iii)                    takes any other action,

 

which, in each case, results in any additional cost in excess of an estimated Identified Stranded Cost, or any stranded cost that is not an Identified Stranded Cost, the Service Recipient shall bear that additional or stranded cost.

 

7


 

3.              PROVISION OF SERVICES

 

3.1           Provision of Services.

 

(a)            Subject to the other provisions of this Agreement, the Service Provider shall provide (on a non-exclusive basis), or procure the provision of, the Services from the Commencement Date to the Service Recipient (or any other member of the Service Recipient Group as the Service Recipient directs) for the relevant Service Term (as may be extended in accordance with Clause 17.2).

 

(b)            For the avoidance of doubt, the Services shall not include any Excluded Service and, subject to Clause 3.3 ( Omitted Services ), the Parties shall not be required to provide any additional services or service components that are not specified in Exhibit 1 ( Services and Service Charges ) as at the Commencement Date.

 

3.2           Standard of Service.

 

(a)            The Service Provider shall, and shall cause each other Service Provider to, provide, or procure each Service with:

 

(i)     reasonable skill and care; and

 

(ii)    subject to Clause 3.2(b), to the Standard Service Level to the extent that any Service is provided directly by the Service Provider, without any reliance on a Third Party Supplier for the provision of that Service.

 

(b)            Unless otherwise agreed by the Parties, or as otherwise permitted under the terms of this Agreement, no reduction to the scope, volume, quality or content of a Service shall be permitted during any Service Term, except that a Service Provider may provide, or procure the provision of a Service to a different standard to the Standard Service Level if that change is:

 

(i)     required unilaterally by a Third Party Supplier;

 

(ii)    as a result of a unilateral change to or required pursuant to a Third Party Supply Agreement; or

 

(iii)   required by the Service Provider as a result of a service change reasonably implemented across a material proportion of the Service Provider Group (and not solely targeted at the Service being provided to the Service Recipient), provided that, if the change is required under this (iii):

 

(A)           the change does not result in a material diminution in the functionality of the Service provided to the Service Recipient; and

 

(B)           if the change results in a reduction of costs for the Service Provider in providing the Service (a Cost Saving ), the Service Provider will pass on a reasonable proportion of that Cost Saving to the Service Recipient in the form of a reduction to the relevant Service Charge for that Service,

 

8


 

in each case,  provided that any change to the Standard Service Level pursuant to this Clause 3.2(b) will not relieve the Service Provider from its obligations to continue to provide the relevant Service for the applicable Service Term.

 

(c)            The Service Provider shall ensure that the Services are provided in accordance with:

 

(i)     all Applicable Laws that are relevant to the provision of the Services; and

 

(ii)    the Service Provider’s policies and procedures which are notified to the Service Recipient from time to time.

 

3.3           Omitted Services.

 

(a)            The Service Recipient may, during the period from the Commencement Date up to and including the date that is three (3) months after the Commencement Date, request that the Service Provider provides, or procures the provision of, any service that:

 

(i)     is not included in the Services specified in Exhibit 1 ( Services and Service Charges );

 

(ii)    was provided by the Service Provider to the Service Recipient in the twelve (12) month period immediately before the Commencement Date;

 

(iii)   is necessary to ensure the business, research and/or manufacturing continuity of the Service Recipient;

 

(iv)   is not an Excluded Service; and

 

(v)    has not been separately addressed under an internal restructuring project (including under Project Moonstone) intended to separate the Alcon Group and the Novartis Group within the twelve (12) months immediately before the Commencement Date,

 

(each, an Omitted Service ),

 

by providing written notice to Novartis in accordance with Clause 26 ( Notices ).

 

(b)            The Parties shall, as promptly as reasonably practicable after the receipt of a notice under Clause 3.3(a), negotiate in good faith with respect to the duration for which the Omitted Service will be provided (subject, in each case to the Maximum Service Term), and, once agreed, the Parties shall amend Exhibit 1 ( Services and Service Charges ) to include the Omitted Service and the Omitted Service shall be deemed to be part of this Agreement (and deemed included in the definition of Services) from and after the date of that amendment. Unless otherwise expressly agreed in Exhibit 1 ( Services and Service Charges ), the Service Charges for any Omitted Service shall be materially the same as the charges paid by the relevant member(s) of the Service Recipient for the service equivalent to that Omitted Service immediately before the Commencement Date.

 

9


 

3.4           In-Flight Projects.

 

(a)            The Service Recipient shall participate in the In-Flight Projects. The Service Recipient shall pay a proportionate share of the actual costs associated with any relevant In-Flight Project, which, in each case, shall be calculated using the same methodology as has been used to estimate the budgeted cost for the Service Recipient of that In-Flight Project set out in Schedule 6 ( In-Flight Projects ).

 

(b)            Any amounts paid or payable by any member of the Service Recipient Group under Clause 3.4(a) shall be invoiced, treated, and paid for, as if they were Service Charges and shall include a mark-up of five per cent (5%).

 

3.5           BAU Services.

 

(a)            As part of the Services, the Service Provider shall provide, or procure the provision of, the services ordinarily carried out by the Service Provider as business as usual activities, and such other ad hoc measures undertaken by the Service Provider, that are implemented across a material proportion of the Service Provider’s business for its general benefit, to ensure that the Services and any related IT Systems or assets remain compliant with Applicable Laws and the applicable IT and security policies of the Service Provider (together, the BAU Services ).

 

(b)            In relation to each BAU Service, the Service Recipient shall pay, or procure the payment of, a proportionate share of the reasonable documented costs associated with that BAU Service. The proportionate share to be paid by the Service Recipient shall reflect the relative usage of that BAU Service by and/or relative benefit associated with that BAU Service for the Service Recipient, and shall be agreed between the Parties in accordance with the provisions of Clause 22 ( Change Management ) on the same basis as a Change. Any amounts paid or payable by the Service Recipient under this Clause 3.5(b) shall be invoiced, treated, and paid for, as if they were Service Charges and shall include a mark-up of five per cent (5%).

 

3.6           Material Errors.   Following the Commencement Date, if either Party identifies any material errors in the scope, content or description of the Services or the Service Charges (including any errors in the associated assumptions or the charging mechanisms), the Parties, acting reasonably and in good faith, shall correct such material errors as soon as reasonably practicable in accordance with the provisions of Clause 22 ( Change Management ).

 

4.              SEPARATION AND INFORMATION TECHNOLOGY RISK CONTROL

 

4.1           Access.

 

(a)            To prevent unauthorized access to, or use of, any IT Systems, Network-to-Network Connection or any confidential Information or data belonging to the other in connection with the provision or receipt of the Services, each Party shall, and shall procure that its Representatives shall:

 

10


 

(i)          comply, and shall ensure that its personnel, agents and subcontractors comply, with the other Party’s rules regarding access to facilities, premises and automated systems, security, health and safety, and shall procure that its employees, agents and subcontractors engaged in the receipt of the Services comply with these obligations;

 

(ii)         ensure that it has the prior written approval of the other Party before any Network-to-Network Connection is effected;

 

(iii)        prior to any connection between the Parties being effected, perform, and provide evidence of, appropriate penetration testing that demonstrates to both Parties reasonable satisfaction that a Party’s network is and will remain secure;

 

(iv)        subject to Clause 4.2(b)(vi), comply with the other Party’s and its Affiliates’ then current version of its security policies and procedures, including in relation to the maintenance, protection and testing of the connection and connections with third parties, that are notified to it from time to time, provided that the then current version requires the same or greater level of protection as the security policies and procedures at the Commencement Date;

 

(v)         co-operate to assist the other Party in establishing any reasonable security arrangements that the other Party considers necessary to prevent that Party, or any unauthorized third party, from accessing an IT System or data in a manner prohibited by this Agreement;

 

(vi)        use reasonable efforts to continually assess and, where relevant, report to the other Party any threats to the IT Systems;

 

(vii)       ensure that all users to whom access is granted to the other Party’s (or its Affiliates’) IT Systems undertake a controlled authorization process (including an individual confidentiality and non-use agreement) and remove access privileges in a timely manner once they are redundant; and

 

(viii)      in response to a request from the relevant competent body for the other Party (as defined in that Party’s and its Affiliates’ then current version of its security policies and procedures), who acting reasonably, has a legitimate concern relating to the integrity of confidential Information or IT Systems, terminate any connection to the other Party’s IT Systems.

 

(b)            If a Party detects a breach of protective measures that will (or is likely to) have a material impact on the Services or the integrity of any confidential Information or other data, in each case relating to the other Party, on the IT Systems of the detecting Party, including the loss or theft of a Managed Mobile Device (a Security Incident ), it shall:

 

(i)          report the breach to the other Party without undue delay, and in any event within twenty four (24) hours after the Security Incident was confirmed;

 

(ii)         immediately, and in any event within forty eight (48) hours after the Security Incident was confirmed, act to prevent or mitigate the effects of the breach and minimise further exposure of the other Party’s IT Systems, including:

 

11


 

(A)           where applicable, wiping any data on the relevant Managed Mobile Device (or the relevant business contained on the Managed Mobile Device);

 

(B)           stopping inappropriate access or any other inappropriate activities;

 

(C)           restoring normal operations; and

 

(D)           periodically informing the other Party on progress of such remediation actions;

 

(iii)        identify steps to ensure that the breach does not re-occur, report those steps to the other Party and perform those steps; and

 

(iv)        provide a written report to the other Party detailing actions performed and safeguards implemented.

 

(c)            Security Incidents shall be reported to the Parties’ security operations organisations as per the respective contacts and jointly resolved by the Parties if a Security Incident affects both Parties.

 

(d)            Each Party shall notify the other in writing of any change to their respective contacts for the purposes of Clause 4.1(c) from time to time.

 

(e)            Each Party shall maintain, and not disable, reasonable security measures and comply with its obligations in Clause 4.1(a) to protect the other Party’s systems from third parties, and in particular from disruption by any “back door”, “time bomb”, “Trojan Horse”, “worm”, “drop dead device”, “virus”, “keylogging” or other computer software routine intended or designed to:

 

(i)          permit access or use of information technology systems by a third person other than as expressly authorized;

 

(ii)         disable, damage or erase or disrupt or impair the normal operation of any information technology systems; or

 

(iii)        enforce licensing restrictions.

 

(f)             Subject to Clause 4.1(g), as part of the Services, the Service Recipient shall have the right to request that additional (as compared to the number of users of the relevant service (whether on a line item or bundled basis) as at the Effective Date) or replacement users have access to the IT Systems in connection with the receipt of the Services, provided that such access is required for business continuity (including access for replacement employees) as reasonably evidenced by the Service Recipient.

 

(g)            The Parties agree that, where any additional (as compared to the number of users of the relevant service (whether on a line item or bundled basis) as at the Effective Date) or replacement user(s) requested by the Service Recipient in accordance with Clause 4.1(f):

 

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(i)     only results in an increase to any third party costs, expenses, fees or charges associated with the provision of any Service:

 

(A)           the Service Provider may, on notice to the Service Recipient, increase the Service Charges (including, if applicable, as a result of any additional software licenses (as compared to the number of software licenses included in the relevant Service (whether on a line item or bundled basis) as at the Effective Date)) to reflect that increase with effect from the end of the calendar month in which the relevant request is made; and

 

(B)           with effect from the end of the calendar month in which the relevant request is made, Exhibit 1 ( Services and Service Charges ) shall be deemed to be automatically updated to reflect: (1) any such increase to the Service Charges; and (2) to the extent applicable, any additional or replacement user(s) and/or any additional license(s) as a result of that request; and/or

 

(ii)    otherwise requires a new or amended Authorization, it shall be considered a Change and the provisions of Clause 22 ( Change Management ) and Clause 7 ( Third Party Suppliers ) shall apply to that request.

 

4.2           Managed mobile devices.

 

(a)            Without prejudice to Clause 4.1 ( Access ) and subject to Clause 4.2(b), the Service Provider shall, for the duration of the relevant Service Term, allow the Service Recipient to set up and synchronise the Service Recipient’s email, contacts and calendar systems (the Mobile Device Systems ) on mobile devices provided by the Service Provider for use by the Service Recipient in connection with the Service Provider’s Services (the Managed Mobile Devices ).

 

(b)            The Service Recipient acknowledges and agrees that in relation to the set-up, protection and synchronisation of the Mobile Device Systems on the Managed Mobile Devices (the Mobile Device Synchronization ):

 

(i)     the Service Recipient shall be responsible for the Mobile Device Synchronization;

 

(ii)    the Service Provider shall not be required to configure the Managed Mobile Devices or provide the Service Recipient with any other assistance or support in relation to the Mobile Device Synchronization;

 

(iii)   the Service Provider shall not be required to provide any support services (including patches and updates) in relation to any configuration implemented by the Service Recipient in connection with the Mobile Device Synchronization;

 

(iv)   if the Service Recipient encounters any issue in respect of the use of the Mobile Device Systems, it will, in the first instance, contact the Service Provider’s helpdesk, details of which are notified by the Service Provider from time to time. The Service Provider’s helpdesk will follow its standard process of forwarding the call for resolution;

 

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(v)    notwithstanding Clause 7 ( Third Party Suppliers ), the Service Provider shall not be required to obtain or maintain any Authorizations which are necessary for the Mobile Device Synchronization; and

 

(vi)   the Service Provider shall not be required to comply with any policies of the Service Recipient which relate to the Mobile Device Synchronization.

 

4.3           Quality Assurance Services. Each Party shall (or shall procure that its Affiliates shall) enter into one or more compliance quality agreements in the form attached at Exhibit 11 ( E-Quality Requirements ) (each, an eQuality Agreement ) on or around the Commencement Date in relation to the provision of any IT Services and/or IT Systems.  The Parties shall, and shall procure that their Affiliates shall, comply with the terms of any eQuality Agreement.

 

4.4           Interaction between this Agreement and eQuality Agreements: The Parties acknowledge and agree that:

 

(a)            in the event of any conflict between this Agreement and any eQuality Agreement: (i) to the extent that conflict relates to processes or procedures relating to ‘Quality Assurance’ (as defined in the relevant eQuality Agreement), the relevant provision(s) of the applicable eQuality Agreement shall apply; and (ii) in all other respects, the relevant provision(s) of this Agreement shall apply;

 

(b)            neither Party (or their Affiliates) shall be liable for any breach of an eQuality Agreement, except to the extent that breach constitutes a breach of, and gives rise to liability under, this Agreement;

 

(c)            Clause 16 ( Liabilit y) of this Agreement shall apply in relation to each eQuality Agreement, and that Clause shall be construed accordingly; and

 

(d)            any dispute in relation to any aspect of, or failure to agree any matter arising in relation to, any eQuality Agreement shall be deemed to be a Dispute under this Agreement and Clause 27.1 ( Dispute Resolution ) shall apply.

 

5.              GENERAL OBLIGATIONS

 

5.1           The Service Recipient shall:

 

(a)            solely to the extent required by the Service Provider for the purposes of providing the Services under this Agreement:

 

(i)     provided that the relevant employees or contractors have signed or otherwise agreed to the Service Provider’s standard third party non-disclosure and confidentiality undertaking or acknowledgement or such other undertaking or acknowledgment that may be agreed between the Parties in connection with this Agreement, give employees or contractors of the Service Provider or any of its Affiliates access to the facilities, premises or IT Systems of the Service Recipient or its Affiliates during Working Hours on the provision of reasonable advance written notice; and

 

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(ii)    promptly provide reasonable information (including copies of documents and data) and assistance required by the Service Provider;

 

(b)            take reasonable steps to ensure the safety of any employees or contractors of the Service Provider or any of its Affiliates who visit the premises of the Service Recipient or any of its Affiliates; and

 

(c)            not use, or attempt to access or interfere with, any systems or data used by the Service Provider or any of its Affiliates, unless authorized to do so under this Agreement.

 

5.2           The Service Recipient shall indemnify, on demand and hold harmless, the Service Provider and any of its Affiliates against all Costs that result from a breach of Clause 5.1.

 

5.3           The Service Provider shall:

 

(a)            solely to the extent required by the Service  Recipient for the purposes of receiving the Services under this Agreement:

 

(i)     provided that the relevant employees or contractors have signed or otherwise agreed to the Service Recipient’s standard third party non-disclosure and confidentiality agreement or such other undertaking or acknowledgment that may be agreed between the Parties in connection with this Agreement, give employees or contractors of the Service Recipient or any of its Affiliates access to the facilities or premises of the Service Provider or its Affiliates during Working Hours on the provision of reasonable advance written notice; and

 

(ii)    promptly provide reasonable information (including copies of documents and data) and assistance required by the Service Recipient;

 

(b)            take reasonable steps to ensure the safety of any employees or contractors of the Service Recipient or any of its Affiliates who visit the premises of the Service Provider or any of its Affiliates; and

 

(c)            not use, or attempt to access or interfere with, any systems or data used by the Service Recipient or any of its Affiliates, unless authorized to do so under this Agreement.

 

5.4           The Service Provider shall indemnify, on demand and hold harmless, the Service Recipient and any of its Affiliates against all Costs that result from a breach of Clause 5.3.

 

5.5           The Service Recipient shall, and shall procure that each other member of its Group shall, use the Services solely for the purposes of carrying on the Alcon Business or the Novartis Business (as applicable), in each case, in substantially the same manner and scope as conducted immediately before the Commencement Date.

 

5.6           The Service Recipient shall have sole responsibility for any data prepared and/or input by it or by any of its Affiliates, and the Service Provider shall not be responsible for any fault or error in that preparation and/or input.

 

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6.              DEPENDENCIES

 

6.1           Dependencies.   To assist the Service Provider in performing the Services, the Service Recipient shall use Commercially Reasonable Efforts to satisfy any dependencies required for the Service Provider to provide, or procure the provision of, any element of the Services (as specified in Exhibit 1 ( Services and Service Charges )).

 

6.2           Failure to perform a dependency.   The Service Provider shall not be obliged to provide, or procure the provision of, any Service, and the Service Provider’s liability to the Service Recipient for a failure to perform any Service shall be reduced, to the extent that:

 

(a)            the failure has been caused in whole or in part by the Service Recipient’s own failure to satisfy any specified dependencies relevant to that Service; or

 

(b)            the Service Recipient has otherwise caused or contributed to the failure (whether by act or omission).

 

6.3           Transferring assets. The Service Provider’s liability to the Service Recipient for a failure to perform any Service shall be reduced, to the extent that the failure relates to or is caused by (directly or indirectly) any asset, including any physical asset, IT System, inventory and contract, in the possession (whether the physical possession or legal ownership) of the Service Recipient, including as a result of any transfer contemplated or performed in connection with Project Moonstone.

 

6.4           Steps to mitigate impact.   If the Service Provider’s performance under this Agreement has been adversely affected under Clause 6.1 or 6.2, then it shall:

 

(a)            notify the Service Recipient of the Service Recipient’s failure to satisfy the dependency, or other act or omission, and all events or circumstances causing or contributing to the failure, act or omission, as soon as reasonably practicable after it becomes aware of them;

 

(b)            continue to perform those of its obligations under this Agreement that are unaffected by the failure to perform the Service; and

 

(c)            use reasonable efforts to minimize and mitigate the likely impact of the failure on the Service Recipient.

 

6.5           Reliance on data and information. The Service Provider and its Affiliates may, in providing the Services, rely on the provision of data and information to it by or on behalf of the Service Recipients and its Affiliates. Neither the Service Provider nor its Affiliates shall have any liability in connection with this Agreement whether in contract, tort (including negligence) or otherwise for Costs suffered or incurred by the Service Provider or its Affiliates as a result of the inaccuracy, insufficiency or incompleteness of the data or information provided by or on behalf of the Service Recipient.

 

7.              THIRD PARTY SUPPLIERS

 

7.1           Authorizations and Authorization Expenses. The Parties agree that:

 

(a)            certain Services may be provided by, or under, the Third Party Supply Agreements (including Intellectual Property Rights licenses);

 

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(b)            the use of Third Party Supply Agreements may require the Service Provider to obtain:

 

(i)     additional consents, approvals, permissions or licenses under; or

 

(ii)    changes or amendments to,

 

the Third Party Supply Agreements (collectively, Authorizations ).

 

(c)            obtaining Authorizations in accordance with Clause 7.1 may require the Service Provider to incur Costs ( Authorization Expenses );

 

(d)            the Service Provider shall notify the Service Recipient of any Authorization Expenses as soon as reasonably practicable after it becomes aware of them. If the Parties agree within ten (10) Business Days of any such notification that they do not wish to pay an Authorization Expense, neither Party shall be required to pay that Authorization Expense and the Service Provider shall not be required to obtain the relevant Authorization or to provide the Services to which the relevant Third Party Supply Agreement relates;

 

(e)            the Service Recipient shall provide, at its own cost, any assistance required by the Service Provider to procure the Authorizations; and

 

(f)             the Parties acknowledge and agree that:

 

(i)     any Authorization Expenses incurred before the Separation Date have been paid by Novartis; and

 

(ii)    any Authorisation Expenses arising after the Separation Date shall be borne equally (on a 50/50 basis and without any mark-up) by the Service Provider and the Service Recipient. The Service Recipient’s share of any such Authorisation Expense shall be invoiced and paid in accordance with the payment terms in Clause 12 ( Service Charges and Payment ).

 

7.2           Obtaining Authorizations.   The Service Provider shall use reasonable efforts:

 

(a)            to maintain in force all Third Party Supply Agreements required to provide the Services;

 

(b)            subject to Clause 7.1(d), to obtain the Authorizations necessary under any Third Party Supply Agreements to provide Services to the Service Recipient, but the Service Provider shall not be required to obtain any Authorizations where doing so would require the Service Provider to change a Third Party Supply Agreement in a manner that, in the Service Provider’s reasonable opinion, is detrimental to the Service Provider or its Affiliates;

 

(c)            to minimize the Authorization Expenses;

 

(d)            without prejudice to Clause 7.3(b), to minimize any adverse impact resulting from the failure to obtain the Authorizations, and shall work together with the Service Recipient to minimize any deterioration in the Services or impact on the Service Charges.  Any costs incurred under this Clause 7.2(d), shall be borne equally (on a 50/50 basis and without any mark-up) between the Service Provider and the Service Recipient; and

 

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(e)            to notify the Service Recipient as soon as reasonably practicable if any third party refuses to provide an Authorization necessary under a Third Party Supply Agreement and to work with the Service Recipient to agree in good faith alternative means, provided that the Service Provider has complied with its obligations under this Clause 7.2, of continuing the provision of the Service for the duration of the Service Term. Any costs incurred under this Clause 7.2(e), shall be borne equally (on a 50/50 basis and without any mark-up) between the Service Provider and the Service Recipient.

 

7.3           Refusal to grant, or loss of, an Authorization.   The Service Provider shall not be in breach of this Agreement, and its obligation to provide the Service, or part of a Service, to which the relevant Third Party Supply Agreement relates shall immediately cease if:

 

(a)            a Third Party Supplier does not grant an Authorization; or

 

(b)            an Authorization has expired or been terminated or revoked by the Third Party, or a Third Party Supply Agreement is terminated or expires during a relevant Service Term, provided that:

 

(i)     in the case of a termination or revocation, that termination or revocation was not as a result of the Service Provider’s breach of the relevant Third Party Supply Agreement; and

 

(ii)    in the case of an expiry, the Service Provider used Commercially Reasonable Efforts to extend the relevant Third Party Supply Agreement to cover the remainder of the relevant Service Term but not to the extent that doing so would require: (A) the Service Provider to incur any Cost that is, in the Service Provider’s reasonable opinion, excessive or unreasonable; or (B) the Service Provider to change the relevant Third Party Supply Agreement in a manner that, in the Service Provider’s reasonable opinion, is detrimental to the Service Provider or its Affiliates.

 

7.4           Alternative means. If any of the circumstances described in Clauses 7.3(a) to 7.3(b) (inclusive) apply, the Parties shall, (provided that the Service Provider has complied with its obligations under Clause 7.2), work together to agree in good faith alternative means for the relevant Service Recipient(s) to receive the business processes comprised in the affected Service(s).  Any costs incurred under this Clause 7.4 shall be borne equally (on a 50/50 basis and without any mark-up) between the Service Provider and the Service Recipient.

 

7.5           Compliance with Authorizations.   The Service Recipient:

 

(a)            shall comply, and shall procure that its Affiliates comply, with; and

 

(b)            shall not, and shall procure that its Affiliates shall not, cause the other Party to be in breach of,

 

the terms of the Authorizations and Third Party Supply Agreements to the extent they are relevant to the receipt of the Service, and provided that the Service Recipient has received prior written notification of the relevant terms of the Authorizations and Third Party Supply Agreement.

 

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7.6                               Indemnity for non-compliance.   The Service Recipient shall indemnify, on demand and hold harmless, the Service Provider against all Costs that result from a breach of Clause 7.5 ( Compliance with Authorizations ).

 

7.7                               Relationship with Third Party Suppliers.   The Service Provider shall manage exclusively its relationship with each Third Party Supplier. The Service Recipient shall not, and shall procure that each other member of its Group shall not, discuss with any Third Party Supplier the provision of the Services, except to the extent required to do so by Applicable Law. Without prejudice to the foregoing, the Service Recipient may discuss the Integration of the Services with a relevant Third Party Supplier provided, in each case, that: (a) the Service Provider is notified prior to, and is responsible for facilitating, the initial contact between the Service Recipient and that Third Party Supplier; and (b) except to the extent agreed otherwise by the Service Provider, the Service Recipient shall comply with the terms of Clause 23 ( Confidentiality ) in connection with its discussions with that Third Party Supplier.

 

7.8                               Costs of replacing Third Party Supply Agreements.   The Service Recipient shall be liable for the costs and expenses relating to the novation, separation, splitting, transfer or replacement of any contracts with the Third Party Suppliers for any Services it wishes to obtain for itself and its Affiliates directly from any such Third Party Supplier. The novation, separation, splitting, transfer or replacement of any such contract shall be documented in the Integration Plans and/or Integration Projects.

 

8.       SHARED PREMISES

 

8.1           Shared Premises.   From the Commencement Date, each Party shall, and shall procure that its Affiliates shall, comply with its obligations under Exhibit 3 ( Shared Premises ) in relation to the use of any shared premises.

 

9.       RECORD KEEPING

 

9.1           Record Keeping.   Subject to Clause 10 ( Compliance with Laws ) and without prejudice to the Books and Records provisions in the Separation Agreement and the Information Access Agreement (as defined in the Separation Agreement), each Party shall (and shall procure that its Affiliates shall):

 

(a)                                  maintain and keep secure accurate records and accounts relating to the performance of its obligations under this Agreement and the charges, expenses and fees charged by it under this Agreement; and

 

(b)                                  for up to six (6) years following the expiry or termination of this Agreement, on receipt of reasonable notice, provide the other with copies of these records and accounts as reasonably required to enable it, or its Affiliates, to monitor compliance with this Agreement or to comply with Applicable Law in connection with the provision and receipt of Services under this Agreement.

 

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10.     COMPLIANCE WITH LAWS

 

10.1         Compliance with Laws.   Each Party shall:

 

(a)                                  comply in all material respects with Applicable Law and, subject to Clause 3.2(c)(ii), the applicable policies of the other Party that have been notified to it in connection with this Agreement; and

 

(b)                                  obtain and maintain in force all licenses, consents, permits and approvals of Governmental Entities that are necessary in connection with this Agreement, including, in the case of the Service Provider, the provision of its Services.

 

10.2                        Notification of regulatory or compliance issues.   Subject to Clause 10.1 ( Compliance with Laws ), each Party shall notify the other of any material regulatory or compliance issue arising under this Agreement of which it becomes aware, and the Parties shall co-operate in good faith to resolve those issues. If an additional agreement is required to satisfy any regulatory or compliance issue, the Parties agree to act reasonably and in good faith in putting in place the relevant agreement.

 

10.3                        Contact by a Governmental Entity.   If a Party is contacted by a Governmental Entity in connection with this Agreement, it shall, to the extent permitted by the Governmental Entity to do so:

 

(a)                                  promptly notify the other Party and co-ordinate any interaction with the Governmental Entity; and

 

(b)                                  keep the other Party informed of all discussions and correspondence with the Governmental Entity, unless it reasonably determines that to do so would either result in a breach of Clause 10.1 ( Compliance with Laws ) or create a conflict of interest between the Parties.

 

10.4                        No requirement to breach Applicable Law.   For the avoidance of doubt, neither Party shall be required to perform any obligation under this Agreement or to allow, take or omit to take any action that it reasonably believes would result in the breach of any Applicable Law or the breach of any term of any required regulatory approval.

 

11.     INTELLECTUAL PROPERTY RIGHTS

 

11.1                        Licence grant by the Service Provider.   Subject to Clause 7 ( Third Party Suppliers ) and without prejudice to clause 11.3(b) , the Service Provider hereby grants (and agrees to procure the grant) to the Service Recipient (and any other member of the Service Recipient Group that the Service Recipient directs will receive a Service under Clause 3.1(a)) a non-exclusive, worldwide, non-sublicensable, non-transferable and royalty-free licence under the Intellectual Property Rights owned by or licensed to, the Service Provider Group during the relevant Service Term solely for, and only to the extent necessary for, the receipt of each Service in accordance with this Agreement.

 

11.2                        Licence grant by the Service Recipient.   The Service Recipient hereby grants (and agrees to procure the grant) to the Service Provider of a non-exclusive, worldwide, sublicensable (solely for the purposes of the Service Provider providing Services to the Service Recipient), non-transferable and royalty-free licence under the Intellectual Property

 

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Rights owned by or licensed to, the Service Recipient Group during the relevant Service Term solely for, and only to the extent necessary for, the provision of each Service in accordance with this Agreement.

 

11.3                        No transfer of Intellectual Property Rights.

 

(a)                                  Except as set out in Clauses 11.1 and 11.2, nothing in this Agreement shall operate to transfer, assign or otherwise grant any Party any right or interest in the other Party’s (or its Affiliates’ or licensors’) Intellectual Property Rights (including in any Party’s records maintained in accordance with Clause 9 ( Record Keeping )).

 

(b)                                  The Intellectual Property Rights in any software or other materials (including rights in relevant Third Party Software and Service Provider Proprietary Software) supplied, created or developed by, or on behalf of, the Service Provider Group after the Separation Date are, and shall remain, the exclusive property of the Service Provider or its licensors.  Subject to obtaining any relevant Authorizations and any associated costs having been borne by the Service Recipient, the Service Provider hereby grants (and agrees to procure the grant) to the Service Recipient, a non-exclusive, worldwide, perpetual, sublicensable, transferable and royalty free license under the Intellectual Property Rights in any software or other materials created as a result of providing the Services to Service Recipient (the Service Materials ), solely for and only to the extent necessary for, the receipt of each Service in accordance with this Agreement and, if and to the extent specifically provided for in any Integration Plan, the continued use of such Service Materials after the relevant Service Term.

 

11.4                        Hosted Content. The Service Recipient shall ensure that any data or material which is:

 

(a)                                  created by the Service Recipient (including any data or material of the Service Provider which is modified by the Service Recipient); and

 

(b)                                  hosted on the Service Provider’s IT Systems on behalf of the Service Recipient or any other member of its Group,

 

complies with all Applicable Laws and does not breach any rights of third parties.

 

12.     SERVICE CHARGES AND PAYMENT

 

12.1                        Service Charges.

 

(a)                                  The Service Charges, which shall be based on the cost of providing each Service plus a mark-up of five per cent (5%), shall be set forth in Exhibit 1 ( Services and Service Charges) for each Service.  The Service Charges shall reflect a best estimate of costs taking into account historical or actual costs, and shall be payable for each Service for the relevant Service Term.

 

(b)                                  If any third party costs, expenses, fees or charges associated with the provision of the Services increase or decrease (including increased or decreased charges under a Third Party Supply Contract and all costs, expenses, fees or charges arising from changes in Law or the requirements of any Governmental Entity), the Service Provider may, on prior

 

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notice to the Service Recipient, and in accordance with the governance process agreed between the parties, when needed, increase or decrease (as applicable) the Service Charges to reflect that increase or decrease.

 

(c)                                   On each anniversary of the Commencement Date the Service Charges shall be adjusted for each Service by an amount equal to such Charges multiplied by the percentage increase or decrease of the Consumer Price Index or, if applicable, with the applicable country price index (i.e. high inflation countries) during the previous twelve (12) months.

 

(d)                                  Any reasonable documented:

 

(i)             external third party costs or expenses (including any amounts payable as a result of increases in any third party costs, expenses, fees or charges associated with the provision of the Services); and/or

 

(ii)          internal costs (including any administrative costs),

 

incurred by the Service Provider or its Affiliates in connection with the provision of any Service on the basis of the respective usage and/or consumption of that Service by, or the respective benefit of that Service for, the Service Recipient (the Expenses ) shall, to the extent not already included or accounted for in the Service Charges, including the Expenses set out in Exhibit 1 ( Services and Service Charges ), be subject to a five per cent (5%) mark-up and be payable by the Service Recipient.  Any amounts paid or payable by any member of the Service Recipient Group under this Clause 12.1(d)  shall be treated, and paid for, as if they were Service Charges.

 

12.2                        Payments.

 

(a)                                  At the end of the calendar month that includes the Separation Date, and at the end of each calendar month thereafter, the Service Provider shall invoice the Service Charges in CHF to the Service Recipient for that month.

 

(b)                                  The Service Provider shall send its invoices to the Service Recipient to the address of the Service Recipient specified in Clause 26 ( Notices ).

 

(c)                                   The invoices shall set out the Service Charges and any Costs or Expenses for which the Service Recipient is liable for that month under this Agreement.

 

(d)                                  The Service Recipient shall pay the full amount invoiced to it by the Service Provider in arrears:

 

(i)             within sixty (60) days of the date on which the invoice is received; or

 

(ii)          for Services provided to or by, or invoiced to or by, entities located in the jurisdictions listed in Exhibit 9 ( Payment Provisions for Specific Jurisdictions ), in accordance with the relevant payment provisions in Exhibit 9 ( Payment Provisions for Specific Jurisdictions ).

 

(e)                                   Subject to Clause 12.3 and except as the relevant Service Recipient and Service Provider agree otherwise:

 

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(i)             any payment to be made pursuant to this Agreement by the Service Recipient shall be made in CHF to the relevant Service Provider’s Bank Account; and

 

(ii)          to the extent required, any conversion of amounts from another currency into CHF shall be calculated in accordance with the Currency Rate Conversion Table.

 

(f)                                    Payments under this Clause 12.2 shall be in immediately available funds by electronic transfer on or prior to the due date for payment.  Receipt of the amount due shall be an effective discharge of the relevant payment obligation.

 

(g)                                   If any sum due for payment in accordance with this Agreement is not paid by the due date for payment, the person in default shall pay Default Interest on that sum from but excluding the due date to, and including, the date of actual payment calculated on a daily basis.

 

(h)                                  If any amount payable under this Agreement is not paid within sixty (60) calendar days from and including the due date for payment, then, without limiting its rights under Clause 18 ( Termination ), the relevant Service Provider shall have the right to suspend all or part of any Service, including any Service in relation to which there is an outstanding amount that has not been paid by the Service Recipient. The suspending Party shall give at least five (5) Business Days’ notice of its intention to suspend the Services.

 

(i)                                      If the Service Recipient reasonably and in good faith believes that any invoice or part of an invoice issued by the Service Provider is incorrect, it shall within ten (10) Business Days of receipt of such invoice notify the Service Provider in writing stating the reasons why it believes the invoice to be incorrect.  The Service Recipient’s notice will constitute a Dispute and will be addressed in accordance with Clause 27.1 ( Dispute Resolution ).  During the existence of any such Dispute:

 

(i)             the Service Recipient shall pay the disputed invoice in full; and

 

(ii)          the Service Provider shall continue to provide the Services in accordance with this Agreement.

 

On settlement of any Dispute under this Clause 12.2(i), the Service Provider shall pay the Service Recipient any amount that was not properly due and owing under the disputed invoice, in accordance with the terms of the settlement.

 

12.3                        Service Charges payable in respect of Services provided under a Local Services Agreement shall, unless otherwise agreed by the Parties, be invoiced and paid in the currency of the country to which the Local Services Agreement applies.

 

12.4                        Unless otherwise agreed in this Agreement, all Costs incurred in connection with implementing this Agreement shall be paid by the Party (or its Affiliates) incurring the cost or expense.

 

12.5                        All income tax costs incurred by a Party with respect to the activities covered by this Agreement shall be paid by the Party (or its Affiliates) incurring the income tax costs.

 

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13.     EMPLOYEE ACCOUNTS

 

13.1                        For the purposes of this Clause 13 ( Employee Accounts ):

 

(a)                                  Employee Accounts means Employee Novartis Accounts (MKK) held by the applicable member of the Novartis Group in favour of Transferred Employees; and

 

(b)                                  Transferred Employees means members of staff employed by member(s) of the Novartis Group that have been transferred to member(s) of the Alcon Group.

 

13.2                        If and to the extent applicable, Novartis undertakes that the balance of all Employee Accounts shall be reduced to zero prior to the Commencement Date by transferring any outstanding balance to the accounts of the Transferred Employees with a bank or any other financial institution.

 

13.3                        Novartis undertakes that the Employee Accounts shall solely be used by the Novartis Group to process payroll services during the relevant Service Term by:

 

(a)                                  allocating funds received from Alcon to individual Transferred Employees based on the payroll accounting prepared by member(s) of the Novartis Group;

 

(b)                                  crediting the payment of salary and other payments in connection with the employment relationship between the Transferred Employees and Alcon to the Employee Account of the relevant Transferred Employee; and

 

(c)                                   as soon as practicable thereafter, transferring the balance of the Employee Accounts to the account of each relevant Transferred Employee with a third party bank or financial institution.

 

13.4                        Novartis undertakes that it and its Affiliates shall not offer any services in connection with the Employee Accounts and that, at any other time, the balance of the Employee Accounts shall be nil. Novartis undertakes that the Employee Accounts shall not bear interest at any time.

 

13.5                        Novartis undertakes to close all Employee Accounts upon the expiration of the relevant Service Term.

 

13.6                        In  respect  of  each  affiliate  of Alcon which  employs  Transferred  Employees following the Commencement Date (each being a Relevant Purchaser Affiliate ), the Relevant Purchaser Affiliate and Novartis shall be jointly and severally liable for any outstanding balance of the Employee Accounts owed to the Transferred Employees employed by the Relevant Purchaser Affiliate for the duration of the relevant Service Term, and each of the Parties undertakes that each of their respective Affiliates shall assume such joint and several liability as contemplated by this Clause 13.6.

 

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14.     TAX

 

14.1                        No Withholding

 

(a)                                  All sums payable under this Agreement shall be paid free and clear of all deductions, withholdings, set-offs or counterclaims whatsoever, save only as may be required by Applicable Law.

 

(b)                                  If any deductions or withholdings are required by Applicable Law in respect of any payment payable from or on behalf of the recipient of the supply (the Service Recipient) to the Service Provider under this Agreement in connection with the payment of Service Charges:

 

(i)             the Service Recipient shall not be obliged to pay any additional amount as a result of that deduction or withholding;

 

(ii)          the Service Provider shall:

 

(A)                                deduct from the Service Charges received by the Service Provider the relevant deduction or withholding required by Applicable Law,

 

(B)                                pay that sum to the relevant tax authority; and

 

(C)                                within sixty (60) days of the date on which payment to the relevant tax authority was made shall provide the Service Recipient of written evidence of such payment.

 

(c)                                   The Parties shall cooperate reasonably and in good faith, and shall take all steps reasonably required and lawfully available to them:

 

(i)             to avoid any deductions or withholdings in respect of any payment payable from or on behalf of the Service Recipient;

 

(ii)          to obtain appropriate relief for, or reduction of, any deductions or withholdings in respect of any payment payable from or on behalf of the Service Recipient,

 

and each Party shall take all reasonable steps in connection with the above, including through submitting or providing relevant certificates, forms or other information.

 

14.2                        Gross Up.

 

(a)                                  Where any payment is made under this Agreement pursuant to an indemnity, compensation or reimbursement provision, and that sum is subject to a charge to taxation in the hands of the recipient (or would be in the absence of any tax reliefs), then the sum payable shall be increased to such sum as will ensure that:

 

(i)             after payment of such taxation (including any taxation which would have been charged in the absence of any tax reliefs); and

 

(ii)          after giving credit for any tax relief available to the recipient in respect of the matter giving rise to the payment,

 

(iii)       the recipient shall be left with a sum equal to the sum that it would have received in the absence of such a charge to taxation, provided that if either Party shall have:

 

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(A)                                assigned or novated or declared a trust in respect of the benefit in whole or in part of this Agreement; or

 

(B)                                changed its tax residence or the permanent establishment to which the rights under this Agreement are allocated,

 

then the liability of the other Party under this Clause 14.2 ( Gross Up ) shall be limited to that (if any) which it would have been had no such assignment, novation, declaration of trust or change taken place.

 

(b)                                  This Clause 14.2 ( Gross Up ) shall not apply to the extent that the amount of the indemnity, compensation or reimbursement payment has already been increased to take account of the taxation that will (or would) be charged on receipt.

 

14.3                        VAT.

 

(a)                                  All amounts payable under or provided for in this Agreement shall be exclusive of any amount in respect of VAT.  If VAT is chargeable on any supply under this Agreement, then the Recipient shall pay an amount equal to VAT on that supply, provided it has first received a valid VAT invoice for the supply.

 

(b)                                  Adjustments to any amounts payable pursuant to this Agreement shall also be calculated on a VAT-exclusive basis, and the person paying the adjustment shall pay any corresponding amount due in respect of VAT on paying the adjustment or, if later, promptly following receipt of a credit or debit note, as the case may be, in a form that is valid for VAT purposes.

 

(c)                                   So far as permitted by Applicable Law, each Party shall promptly provide valid VAT invoices or credit or debit notes which are consistent with Applicable Law, addressed to the entity, entities or branches of entities requested by the Recipient.

 

15.     WARRANTY AS TO CAPACITY

 

Each Party has obtained all corporate authorisations and (other than to the extent any such consent, license or authorisation constitutes a Global Condition (as defined in the Separation Agreement)) all other governmental, statutory, regulatory or other consents, licences or authorisations required to empower it to enter into and perform its obligations under this Agreement where failure to obtain them would adversely affect to a material extent such Party’s ability to enter into or perform its obligations under this Agreement.

 

16.     LIABILITY

 

16.1         Service Provider Liability. Subject to Clause 16.3 ( Exclusions ) to Clause 16.9 ( Liability ) (inclusive), the Service Provider shall, with effect from the Commencement Date and to the fullest extent permitted by Applicable Law be liable, on a standard contractual basis, for:

 

(a)                                  any breach of the Service Provider’s (or its Affiliates’) obligations under this Agreement; or

 

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(b)                                  the Service Provider’s or its Affiliates’ gross negligence or wilful misconduct.

 

16.2         Service Recipient Liability.   Subject to Clause 16.3 ( Exclusions ) to Clause 16.9 ( Liability ) (inclusive), the Service Recipient shall, with effect from the Commencement Date and to the fullest extent permitted by Applicable Law, be liable, on a standard contractual basis, for:

 

(a)                                  any breach of the Service Recipient’s (or its Affiliates’) obligations under this Agreement; or

 

(b)                                  the Service Recipient’s or its Affiliates’ gross negligence or wilful misconduct.

 

16.3         Exclusions. Notwithstanding any other provision of this Agreement, neither Party shall be liable for:

 

(a)                                  to the maximum extent permitted by Applicable Law, any Costs arising in relation to:

 

(i)             the provision of Network-to-Network Connection;

 

(ii)          the Mobile Device Synchronisation;

 

(iii)       wiping and tattoo removal of IT Assets; and/or

 

(iv)      functionality of IT Assets,

 

including in respect of: (A) any loss or corruption; (B) any Security Incident; (C) any poor end-user experience issues;

 

(b)                                  any punitive, incidental, special or indirect damages; and/or

 

(c)                                   any consequential damages or damages for loss of future profits, revenue or income, diminution in value or loss of business reputation or opportunity.

 

16.4         Liability Caps. Subject to Clauses 16.5 ( Unlimited Liability ) and 16.6 ( Recovery from Third Parties ) other than in the case of fraud, breach of confidentiality, gross negligence or wilful misconduct, the total liability of each Party and its Affiliates under or in connection with this Agreement for all claims in each twelve (12) month period commencing on the date of this Agreement, whether in contract, tort or otherwise, shall not exceed one hundred per cent (100%) of the Service Charges associated with the provision of the Services and payable to the Service Provider in that twelve (12) month period.

 

16.5         Unlimited liability. The limitations in Clause 16.4 ( Liability Caps ) shall not apply to:

 

(a)                                  the Service Recipient’s liability to pay the Service Charges under this Agreement; or

 

(b)                                  any liability that cannot be excluded by Applicable Law.

 

16.6         Recovery from Third Parties.

 

(a)                                  The Parties intend that any Liability subject to indemnification or reimbursement pursuant to this Agreement shall be net of:

 

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(i)             Insurance Proceeds that actually reduce the amount of, or are paid to the applicable Indemnitee in respect of, such Liability; and/or

 

(ii)          Third Party Proceeds.

 

(b)                                  Accordingly, the amount that either Party (an Indemnifying Party ) is required to pay to any Person entitled to indemnification or reimbursement pursuant to this Agreement (an Indemnitee ) shall be reduced by any Insurance Proceeds or Third Party Proceeds theretofore actually recovered by or on behalf of the Indemnitee from a Third Party in respect of the related Liability.

 

(c)                                   If an Indemnitee receives a payment required by this Agreement from an Indemnifying Party in respect of any Liability (an Indemnity Payment) and subsequently receives Insurance Proceeds or Third Party Proceeds in respect of such Liability, then the Indemnitee shall pay to the Indemnifying Party an amount equal to the excess of the Indemnity Payment received over the amount of the Indemnity Payment that would have been due if such Insurance Proceeds or Third Party Proceeds had been received, realized or recovered before the Indemnity Payment was made.

 

(d)                                  An insurer that would otherwise be obligated to pay any claim shall not be relieved of the responsibility with respect thereto or have any subrogation rights with respect thereto by virtue of the indemnification provisions hereof, it being expressly understood and agreed that no insurer or any other Third Party shall be entitled to a “wind-fall” (i.e., a benefit it would not be entitled to receive in the absence of the indemnification provisions) by virtue of the indemnification provisions of this Agreement.

 

(e)                                   Each Indemnitee shall use Commercially Reasonable Efforts to seek to collect or recover any Insurance Proceeds and any Third Party Proceeds to which such Indemnitee is entitled in connection with any Liability for which such Indemnitee intends to seek indemnification; provided, however, that such Indemnitee’s inability to collect or recover any such Insurance Proceeds or Third Party Proceeds shall not limit the Indemnifying Party’s obligations hereunder.

 

16.7         Duty to mitigate. Prior to making any claim under Clause 16.1 ( Service Provider Liability ) or Clause 16.2 ( Service Recipient Liability ), each Party shall, and shall procure that each relevant member of their respective Groups shall, use Commercially Reasonable Efforts to avoid or mitigate any Liabilities for which such Person intends to seek indemnification.

 

16.8         No Double Recovery and No Double Counting. A Party shall be entitled to make more than one claim under this Agreement arising out of the same subject matter, fact, event or circumstance but shall not be entitled to recover under this Agreement or any relevant Transaction Document or otherwise more than once in respect of the same Liabilities suffered or amount for which the Party is otherwise entitled to claim (or part of such Liabilities or amount), regardless of whether more than one claim arises in respect of it. No amount (including any relief) (or part of any amount) shall be taken into account, set off or credited more than once under this Agreement or any relevant Transaction Document or otherwise, with the intent that there will be no double counting under this Agreement or any Transaction Document or otherwise.

 

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16.9         Specific Performance. In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement.  The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy.  The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived.  Any requirements for the securing or posting of any bond with such remedy are waived.

 

17.     TERM

 

17.1         Term.

 

(a)                                  This Agreement starts on the Commencement Date and, subject to earlier termination in accordance with Clause 18 ( Termination ) or to any extension under Clause 17.2 ( Extensions of Service Terms ), shall terminate automatically on the date that the last of the Service Terms ends, as specified in Exhibit 1 ( Services and Service Charges ). The Service Provider and its Affiliates shall not be obliged to provide any Service to the Service Recipient following expiry or termination.

 

(b)                                  Each Service shall:

 

(i)             be provided from the applicable Service Commencement Date; and

 

(ii)          subject to earlier termination under Clause 18.1 ( Termination of a Service ) or to any extension under Clause 17.2 ( Extensions of Service Terms ), terminate automatically at 23.59 GMT on the last day of (i) the relevant Initial Service Term; or (ii) the term of any extension agreed as per Clause 17.2 ( Extensions of Service Terms )), as specified in Exhibit 1 ( Services and Service Charges ).

 

(c)                                   Termination of a Service shall not relieve the Service Provider from its obligations to provide the remaining Services.

 

17.2         Extensions of Service Terms.

 

(a)                                  The Service Recipient shall, at least ninety (90) days (or any longer period specified for that Service in the “Extension notice period (days)” column in Exhibit 1 ( Services and Service Charges )) before the expiry of each Service Term, notify the Service Provider to confirm whether: (i) it wishes to extend a Service Term in accordance with Clause 17.2(d) or 17.2(e); or (ii) the Service will expire at the end of the Service Term.

 

(b)                                  The Service Recipient shall notify the Service Provider in writing in accordance with Clause 17.2(c) if it wishes to extend a Service Term in accordance with Clause 17.2(d) or 17.2(e).

 

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(c)                                   Notwithstanding Clause 17.2(a), any notice to extend a Service in accordance with Clause 17.2(b) shall be provided in writing by the Service Recipient to the Service Provider:

 

(i)             on at least ninety (90) days’ notice (or any longer period specified for that Service in the “Extension notice period (days)” column in Exhibit 1 ( Services and Service Charges )); or

 

(ii)          in exceptional circumstances, any shorter extension notice period as agreed between the Parties, acting reasonably and taking into account the feasibility of any shorter notice period (a Shorter Extension Notice Period ).

 

(d)                                  Notwithstanding Clause 17.2(e) and subject to Clause 17.2(f), if the Service Recipient provides notice in writing to the Service Provider to extend a Service, the Service Provider shall extend the Initial Service Term for that Service for a first extension period by a duration up to the shorter of (to be rounded to the nearest full calendar month and expiring on the final day of that calendar month):

 

(i)             the duration of the Initial Service Term; and

 

(ii)          the first extension period specified by the Service Recipient in the notice.

 

(e)                                   Notwithstanding Clause 17.2(d), and subject to Clause 17.2(f), if following any extension granted by the Service Recipient in accordance with Clause 17.2(d) and, despite having taken all steps reasonably required to cease reliance on the relevant 17.2(d) Service, the Service Recipient still reasonably and necessarily requires a further extension to the applicable Service Term, the Service Provider may consent (acting reasonably) to a second extension period for a duration to be agreed by the parties in good faith.

 

(f)                                    The Service Provider shall not be required to extend the Service Term for any Service in the following circumstances:

 

(i)             the Service Recipient is unable to demonstrate that it has reasonable grounds for making a request to extend the Service Term for that Service, provided that this shall not apply to the first request by the Service Recipient to extend the Service Term for a Service pursuant to clause 17.2(d) but shall apply to any second request to extend the Service Term for a Service pursuant to clause 17.2(e);

 

(ii)          the aggregate Service Term (as extended under this Clause 17.2 ( Extensions of Service Terms )) for that Service exceeds the Maximum Service Term; and/or

 

(iii)       where the request by the Service Recipient to extend a Service is on a Shorter Extension Notice Period and the Service Provider will incur any documented additional Costs (including one-off or incremental costs, expenses or increases in the underlying Service Charges) as a result of that Shorter Extension Notice Period, unless the Service Recipient bears the additional costs in accordance with Clause 17.3 ( Costs of Extensions ).

 

17.3         Costs of Extensions.  Any documented additional Costs (including one-off or incremental costs, expenses or increases in the underlying Service Charges) incurred, paid or payable by the

 

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Service Provider as a result of: (i) an extension under Clause 17.2 ( Extensions of Service Terms ); and/or (ii) an extension following a Shorter Extension Notice Period, shall be deemed to be Service Charges and the Service Recipient shall pay them, or procure their payment, in accordance with this Agreement.

 

18.     TERMINATION

 

18.1         Termination of a Service.

 

(a)                                  Except as expressly prohibited in Exhibit 1 ( Services and Service Charges ), or as set out in an Integration Plan, the Service Recipient may notify the Service Provider in writing in accordance with Clause 18.1(b) if it wishes to terminate a Service: (i) in whole; or (ii) in part, subject to the consent of the Service Provider, acting reasonably and, taking into account the feasibility of the termination.

 

(b)                                  Any notice to terminate a Service in accordance with Clause 18.1(a) shall be provided in writing by the Service Recipient to the Service Provider:

 

(i)             on the longer of: (A) six (6) months’ notice for IT Services or three (3) months’ notice for all other Services; and (B) the notice period specified for that Service in the “Termination notice period (days)” column in Exhibit 1 ( Services and Service Charges ); or

 

(ii)          in exceptional circumstances and subject to Clause 18.1(c), any shorter termination notice period as agreed between the Parties, acting reasonably and taking into account the feasibility of any shorter notice period (a Shorter Termination Notice Period ),

 

in each case, provided that the notice period expires on the last day of a calendar month.

 

(c)                                   Following receipt of the Service Recipient’s notice under Clause 18.1(a), the Service Provider shall provide the Service Recipient with an impact statement which outlines any:

 

(i)             Related Services that will also terminate on the same date as the relevant Service; and

 

(ii)          the impact on any other remaining Service as a result of the requested termination.

 

(d)                                  The Service Recipient shall be entitled to withdraw a requested termination by written notice to the Service Provider for a period of ten (10) Business Days following its receipt of the Service Provider’s impact statement under Clause 18.1(c).  If the Service Recipient does not withdraw the requested termination within this period it shall be deemed to have accepted the termination of any Related Service and any impact on any other remaining Services set out in the Service Provider’s impact statement.

 

(e)                                   The Service Provider shall not be required to agree to a request by the Service Recipient to terminate a Service (in whole or in part) where the request by the Service Recipient to terminate a Service (in whole or in part) is on a Shorter Termination Notice Period and the Service Provider will incur documented additional Costs (including one-off or incremental costs, expenses or increases in the underlying Service Charges) as a result of

 

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that Shorter Termination Notice Period, unless the Service Recipient bears the documented additional costs in accordance with Clause 18.2.

 

18.2         Costs of termination of a Service. Any reasonable documented additional costs (including one-off or incremental costs, expenses or increases in the underlying Service Charges) incurred, paid or payable by the Service Provider as a result of: (i) the termination in whole or in part of a Service under Clause 18.1(a) or the termination of a Related Service under Clause 18.1(d) (including any Costs in relation to the early termination of Third Party Supply Agreements); and/or (ii) a Shorter Termination Notice Period, shall be deemed to be Service Charges and the Service Recipient shall pay them, or procure their payment, in accordance with this Agreement.

 

18.3         Service Provider termination.   The Service Provider may terminate:

 

(a)                                  this Agreement or the relevant Service with immediate effect by giving written notice to the Service Recipient:

 

(i)             in the event of a breach of Clause 7.5 ( Compliance with Authorizations ) and, as a result, the relevant Third Party Supplier terminates, or serves notice to terminate, a Third Party Supply Agreement relating to that Service; or

 

(ii)          the Service Recipient divests the business (or any part of a business) in relation to which the Services are provided; and

 

(b)                                  this Agreement or the relevant Service if the Service Recipient fails to pay undisputed amounts due under this Agreement within sixty (60) calendar days of the due date for payment of that amount.

 

18.4         Termination by either Party.   Either Party may terminate this Agreement with immediate effect by giving written notice to the other Party if:

 

(a)                                  the other Party commits a material breach of any obligation under this Agreement and, in the case of a breach which is capable of remedy, fails to remedy it within thirty (30) days of receipt of written notice from the first Party of such breach and of its intention to exercise its rights under this Clause; or

 

(b)                                  an Insolvency Event occurs in relation to the other Party.

 

19.     BRAZIL

 

19.1         In respect of any Services to be provided to the Brazilian Alcon Business:

 

(a)                                  the provision of such Services shall commence from the Brazil Delayed Closing Date;

 

(b)                                  the Service Charges in respect of such Services for the Brazilian Alcon Business shall become payable from the Brazil Delayed Closing Date; and

 

(c)                                   subject to Clause 19.2, notwithstanding that such Services in Brazil commenced from the Brazil Delayed Closing Date, the Service Term in respect of such Services shall be deemed to run from the Commencement Date and shall be subject to the limitations set out in Clause 17.2.

 

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19.2         If the Brazil Delayed Closing Date takes place after the date which is the final date of the Maximum Service Term, the Parties shall discuss in good faith what Services (if any) the Service Recipient requires in connection with the Brazilian Alcon Business to meet any applicable legal, finance, tax, accounting or operational requirements of the Brazilian Alcon Business and the Service Provider shall provide the relevant Services for a reasonable period to allow the Service Recipient to procure alternative service provision.

 

20.     CONSEQUENCES OF TERMINATION

 

20.1         Consequences of termination.   On termination or expiry of a Service or this Agreement, in either case under Clauses 17.1(b) or 18 ( Termination ):

 

(a)                                  except as provided in Clauses 17.1(c) and 20.2 ( Surviving provisions ), and subject to any rights or obligations that have accrued prior to termination, neither Party shall have any further obligation to the other Party in respect of the Service or this Agreement, as appropriate;

 

(b)                                  any licenses granted under Clause 11 ( Intellectual Property Rights ) in relation to the Service, or this Agreement, as appropriate, shall terminate with immediate effect, except for any license that: (i) also relates to any remaining Services; or (ii) has been granted on a perpetual basis in relation to any Service Materials in accordance with Clause 11.3(b);

 

(c)                                   in the event of a termination of a Service or this Agreement (but not on expiry of a Service or this Agreement, in which case the standard payment terms shall apply), each Party shall immediately pay all amounts accrued for the Service Charges and other work performed before termination that have not already been paid;

 

(d)                                  subject to Clause 17.1(c), either Party shall be entitled immediately to disconnect any communications link by which the Services may be accessed; and

 

(e)                                   the provisions of Schedule 2 ( Employees ) shall apply.

 

20.2         Surviving provisions. The Surviving Provisions shall survive termination of this Agreement or a Service.

 

21.     DATA PROTECTION

 

21.1         Data protection interpretation. For the purposes of this Clause 21 ( Data Protection ), terms and expressions not defined in this Agreement shall have the meaning given in Data Protection Laws.

 

21.2         Application of Clause 21.3 . The provisions of Clause 21.3 ( Processing of Personal Data ) shall apply only to the extent:

 

(a)                                  the Service Provider is required to process Personal Data, in respect of which the Service Recipient is the controller, on behalf of the Service Recipient in providing the Services; and

 

(b)                                  required by Data Protection Laws.

 

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21.3         Processing of Personal Data. Subject to Clause 21.2 ( Application of Clause 21.3 ), the Parties acknowledge that, in respect of all Personal Data processed under this Agreement, the Service Recipient is the controller and the Service Provider is the processor and the Service Provider shall:

 

(a)                                  process Personal Data only on documented instructions from the Service Recipient, including with regard to transfers of Personal Data outside the European Economic Area, the UK or to an international organisation (unless the Service Provider is otherwise required to process Personal Data by European Union, Member State or UK law to which the Service Provider is subject, in which case the Service Provider shall inform the Service Recipient of that legal requirement unless prohibited by that law on important grounds of public interest);

 

(b)                                  prior to commencing the processing, inform the Service Recipient if, in the Service Provider’s opinion, any instruction given by the Service Recipient to the Service Provider infringes Data Protection Laws;

 

(c)                                   ensure that all Service Provider employees and subcontractors authorised to process Personal Data:

 

(i)             are subject to binding confidentiality obligations in respect of the Personal Data; and

 

(ii)          only process Personal Data in accordance with the Service Recipient’s instructions (unless otherwise required to do so by European Union, Member State or UK law);

 

(d)                                  taking into account the Service Provider’s IT Systems’ capabilities, the state of the art, the costs of implementation and the nature, scope, context and purposes of processing as well as the potential risk to data subjects in light of the nature of the Personal Data, implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk, including to the extent appropriate:

 

(i)             the pseudonymisation and encryption of Personal Data;

 

(ii)          the ability to ensure the ongoing confidentiality, integrity, availability and resilience of processing systems and services;

 

(iii)       the ability to restore the availability and access to Personal Data in a timely manner in the event of a physical or technical incident; and

 

(iv)      a process for regularly testing, assessing and evaluating the effectiveness of technical and organisational measures for ensuring the security of the processing;

 

(e)                                   only engage another processor either:

 

(i)             as permitted under Clause 27.2 ( Assignment and Subcontracting ); or

 

(ii)          with the Service Recipient’s prior specific written authorisation and the Service Recipient hereby acknowledges and authorises the engagement of any processor involved in the provision of services to the Service Recipient (or a member of the

 

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Service Recipient Group) prior to the Commencement Date to the extent that those services are substantially equivalent to the Services,

 

and in each case by entering into a legally binding written agreement that places the same data protection obligations as those set out in this Clause 21.3 ( Processing of Personal Data ) on the processor, provided that if the processor fails to fulfil its data protection obligations the Service Provider shall remain fully liable to the Service Recipient for the performance of the processor’s obligations; and

 

(f)                                    in each case at the Service Recipient’s reasonable request and at the Service Recipient’s Cost:

 

(i)             taking into account the nature of the processing, adopt appropriate technical and organisational measures to assist the Service Recipient to respond to requests from data subjects for access to or rectification, erasure or portability of Personal Data, or for restriction of processing or objections to processing of, their Personal Data, in each case under Data Protection Laws;

 

(ii)          assist the Service Recipient in ensuring compliance with the Service Recipient’s security, data breach notification, privacy impact assessment and supervisory authority consultation obligations under Data Protection Laws, taking into account the nature of processing and information available to the Service Provider;

 

(iii)       delete or return all Personal Data and existing copies to the Service Recipient at the end of the provision of the Services (unless European Union, Member State or UK law requires the Service Provider to retain the Personal Data), provided that, if the Service Recipient fails to provide instructions at the end of the provision of the Services, the Service Provider shall delete the relevant data upon expiry of the statutory retention period or periods under Data Protection Laws; and

 

(iv)      make available to the Service Recipient all information necessary, and allow for and contribute to audits and inspections conducted by the Service Recipient or its mandated auditor, to the extent required to enable the Service Recipient to demonstrate its compliance with its obligations imposed by Data Protection Laws under this Agreement.

 

21.4         Notifications and Registrations.   The Service Recipient shall ensure that it has secured all consents, registrations, notices and notifications in place, or implemented other measures required by Applicable Law, as may be required to enable lawful transfer of the Personal Data to the Service Provider for the duration and purposes of this Agreement.

 

21.5         If under Clause 21.3 ( Processing of Personal Data ) the Service Recipient requires the Service Provider to provide any assistance to the Service Recipient, implement any policies or operational changes or otherwise take any action that is not consistent with the standards of Service set out at Clause 3.2 ( Standard of Service ) or the data protection policies and practices of the Service Provider, or which otherwise results in the Service Provider incurring any Costs as a result of taking any action which the Service Provider, in the absence of this Agreement, is not itself required to incur or take under Applicable Laws, the Service Recipient shall reimburse the Service Provider for any incremental Costs incurred by the Service Provider to comply with the relevant obligations under Clause 21.3 ( Processing of Personal Data ).

 

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21.6         The Parties acknowledge that the provision set out in Exhibit 6 ( Data Processing )shall apply to the Parties’ data processing activities under this Agreement.

 

21.7         Compliance with Data Protection Laws.   Notwithstanding Clause 3.2(c), each Party shall, and shall procure that other members of its Group will, comply with all Applicable Laws in relation to the transfer, receipt, retention and use of any Personal Data provided by the other Party under this Agreement, and in particular with all Data Protection Laws.

 

22.     CHANGE MANAGEMENT

 

22.1         Change Management.   Where either Party wishes to make any:

 

(a)                                  change or addition to the scope of, and the timescale for, the Integration Plans and/or any Integration Project;

 

(b)                                  change to a Service or the Service Charges;

 

(c)                                   subject to Clause 3.4 ( In-Flight Projects ), any change in the costs to be paid by the other Party for an In-Flight Project as compared to the budgeted costs for that In-Flight Project set out in Exhibit 5 ( In-Flight Projects );

 

(d)                                  provision or receipt of a BAU Service or cost allocation for a BAU Service pursuant to Clause 3.5(b);

 

(e)                                   in the case of the Service Recipient, request for any Additional Assistance pursuant to Clause 2.3 ( Additional Assistance );

 

(f)                                    request for an Omitted Service;

 

(g)                                   change to correct a material error in the scope, content or description of the Services or Service Charges pursuant to Clause 3.6 ( Material Errors );

 

(h)                                  early termination of, or extension to, any Service; or

 

(i)                                      change to an Integration Plan or an Integration Project,

 

(each, a Change ), that Change must be submitted in accordance with the procedure set out in Exhibit 4 ( Change Management ). Unless specified otherwise in this Agreement, any other amendment to, or variation of, this Agreement must be made in accordance with Clause 27.7 ( Variations ).

 

22.2         Changes to locations, premises or Service Provider.   The Service Provider shall be entitled to change the location or premises from which any of its Services are provided, or the entity providing those Services, and this shall not be considered a Change for the purposes of this Agreement provided that such change does not have a negative impact on: (a) regulatory (e.g. GxP) compliance; or (b) the Standard Service Level.

 

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22.3         One-off costs. Any one-off costs arising as a result of agreed Changes shall be borne by the requesting party. Any Change to the applicable service charges for the changed Service shall take effect from the month following the implementation of that Change.

 

23.     CONFIDENTIALITY

 

23.1         Confidentiality Obligation. Each of the Parties shall, and shall procure that each member of their respective Groups shall, hold, and cause its Representatives to hold, in strict confidence and not release or disclose, with at least the same degree of care that each Party applies to its own confidential and proprietary Information pursuant to policies in effect immediately prior to the Separation (but no less than a reasonable degree of care), all Information concerning the Alcon Business (in respect of the obligations of the members of the Novartis Group) or the Novartis Business (in respect of the obligations of the members of the Alcon Group) that is either in its possession (including Information in its possession prior to the Separation), accessible under this Agreement or furnished by the other Group or its respective Representatives at any time pursuant to this Agreement (including under an eQuality Agreement), or the Separation Agreement or any other Ancillary Agreement, and shall not use any such Information other than for such purposes as shall be expressly permitted hereunder or thereunder, except, in each case, to the extent that such Information is:

 

(a)                                  in the public domain through no fault of any member of the Novartis Group or the Alcon Group, as applicable, or any of its respective directors, officers, employees, agents, accountants, counsel and other advisors and representatives,

 

(b)                                  lawfully acquired from other sources by any member of the Novartis Group or the Alcon Group, as applicable, or any of their respective Representatives, which sources are not themselves bound by a confidentiality obligation to the knowledge of Novartis or Alcon, as applicable;

 

(c)                                   independently generated without reference to any proprietary or confidential Information of the Novartis Group or the Alcon Group, as applicable, or

 

(d)                                  required to be disclosed by Applicable Law; provided, however, that the Person required to disclose such Information shall give the applicable Person prompt, and to the extent reasonably practicable, prior notice of such disclosure and an opportunity to contest such disclosure and shall use Commercially Reasonable Efforts to cooperate, at the expense of the requesting Person, in seeking any reasonable protective arrangements requested by such Person.

 

23.2         Exceptions to Confidentiality Obligation. Notwithstanding the foregoing, each Party (and the members of their respective Group) may release or disclose, or permit to be released or disclosed, any Information concerning the Alcon Business (in respect of the obligations of the members of the Novartis Group) or the Novartis Business (in respect of the obligations of the members of the Alcon Group):

 

(a)                                  to their respective Representatives who need to know such Information (who shall be advised of the obligations hereunder with respect to such Information); and

 

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(b)                                  to any nationally recognised statistical rating organisation as it reasonably deems necessary, solely for the purpose of obtaining a rating of securities or other debt instruments upon normal terms and conditions; provided, however, that the Party whose Information is being disclosed or released to such rating organisation is promptly notified thereof.

 

24.     FORCE MAJEURE

 

24.1                        No liability.   A Party shall not be under any liability whatsoever to the other Party for any failure or delay in the performance of any of its obligations under this Agreement where that failure or delay results from a Force Majeure.

 

24.2                        Notice of a Force Majeure.   If a Party learns of the occurrence of a Force Majeure that gives rise to a failure or delay in the performance of its obligations under this Agreement, it shall promptly notify the other Party, and the Parties shall promptly initiate good faith negotiations in order to mutually agree upon a solution, including agreeing which Party shall be responsible for approaching any third party providers to obtain replacement services for any affected Services.

 

24.3                        Mitigation. The affected Party shall, and shall procure that its Affiliates shall:

 

(a)                                  use reasonable efforts to remove the Force Majeure as soon as, and to the extent, reasonably and practically possible; and

 

(b)                                  use reasonable efforts to resume its performance of any affected obligations in accordance with this Agreement as soon as reasonably practicable after the cessation of the Force Majeure to minimize any delay.

 

24.4                        Replacement services.   If the effect of a Force Majeure on the performance of a Service cannot be resolved by the affected Service Provider or its Affiliates within a time period appropriate to the urgency of the situation, then the Service Recipient may, after consultation with the Separation Office, obtain replacement services from a third party provider.

 

24.5                        Effect of Force Majeure.   During the period of Force Majeure:

 

(a)                                  no Service Charges or associated Taxes shall be incurred in relation to any Services that are suspended or delayed as a result of the Force Majeure; and

 

(b)                                  the Service Provider’s Group shall treat Service Recipients the same as any other internal or external service recipient of the affected Services, if any.

 

24.6                        Right to terminate.   If any event of Force Majeure prevents performance by a Party for more than ninety (90) days, then the other Party shall be entitled to terminate this Agreement or the relevant Service by giving ninety (90) days’ written notice to the non-performing Party.

 

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25.             LOCAL SERVICE AGREEMENTS

 

25.1                        Requirement for local services agreements. Where:

 

(a)                                  local services agreements are required to be entered into by Applicable Laws to give effect to this Agreement; or

 

(b)                                  the Parties agree, acting reasonably and taking into account either Party’s tax, accounting and corporate governance requirements, to enter into a local services agreement,

 

each Party shall procure that a local entity of that Party shall enter into an agreement substantially in the form set out in Exhibit 8 ( Template Local Services Agreement ) (each, a Local Services Agreement ).

 

25.2                        Terms and conditions of local services agreements. The terms and conditions of:

 

(a)                                  this Agreement; and

 

(b)                                  the relevant Local Services Agreement,

 

shall govern the provision or receipt of the relevant Services by the relevant local entities. In respect of Clause 16 ( Liability ), references to a Party’s Group or a member of a Party’s Group shall be read as references to the relevant local entity of that Party, and references to Service Charges shall be read as references to the charges payable under the relevant Local Services Agreement.

 

25.3                        To the extent that any Service Charges have been paid in accordance with the provisions of a Local Services Agreement and this Agreement to a local entity in respect of Services provided under a Local Services Agreement, those amounts shall not also be payable under this Agreement.

 

25.4                        Notwithstanding any Local Services Agreements that may be entered into, each Party shall remain responsible for ensuring (and shall procure) that the performance and receipt of the Services are in accordance with the terms of this Agreement and the relevant Local Services Agreement, including by ensuring that each Party’s relevant local entity complies with the terms of this Agreement and the relevant Local Services Agreement.

 

25.5                        Each Party shall ensure, and shall procure that the relevant members of that Party’s Group ensure, that neither it nor any other member of its Group shall:

 

(a)                                  agree to any modifications to the application of this Agreement to the Local Services Agreement or the form of the template agreement set out in Exhibit 8 ( Template Local Services Agreement ) unless such modifications are strictly necessary to comply with the legal and regulatory requirements of the relevant jurisdiction; or

 

(b)                                  enter into a Local Services Agreement (or a change to a Local Services Agreement) with any member of the other Party’s Group without first providing a copy of the proposed Local Services Agreement (or the proposed change to a Local Services Agreement) to

 

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the other Party at least twenty (20) Business Days before such Local Services Agreement (or change to a Local Services Agreement) is proposed to be signed.

 

25.6                        Each Party shall ensure that any local entity that is party to a Local Services Agreement:

 

(a)                                  does not bring any claims or actions arising under or in connection with this Agreement or the relevant Local Services Agreement against any member of the other Party’s Group without that Party’s consent; and

 

(b)                                  refers each Dispute and any other issue arising in relation to this Agreement or the relevant Local Services Agreement to the other Party for resolution in accordance with Clause 27.1 ( Dispute Resolution ).

 

25.7                        Each Party shall indemnify and hold harmless the other Party and the other members of the other Party’s Group (the indemnified party ) against any losses of whatever nature incurred by the indemnified party arising out of or in connection with any claims or actions brought by Alcon or any other member of the Alcon Group which are not brought in accordance with this Clause 25 ( Local Service Agreements ).

 

25.8                        Subject to Applicable Law, where any provision of any Local Services Agreement conflicts with any provision of this Agreement (including to the extent this Agreement applies to the Local Services Agreement), the provisions of this Agreement shall prevail.

 

25.9                        Any notices served under a Local Services Agreement shall also be served to the Parties to this Agreement in accordance with Clause 26 ( Notices ).

 

26.             NOTICES

 

26.1                         Form of Notice .  Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it (in the case of notice by e-mail, a notice signed electronically or a scanned copy of a signed original notice shall suffice).  It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Novartis shall be deemed notice to all members of Novartis Group, and any notice to Alcon shall be deemed notice to all members of Alcon Group.

 

26.2                         Effectiveness of Notice .  A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

26.3                         Notice Details .  The addresses and e-mail addresses of the Parties for the purpose of Clause 26.1 ( Form of Notice ) are:

 

Novartis and each member of the Novartis Group

 

For the attention of: Head Legal M&A (Novartis International AG)

Novartis AG
Lichtstrasse 35,

 

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4056 Basel,
Switzerland

jonathan.emery@novartis.com

 

Alcon and each member of the Alcon Group

 

For the attention of: General Counsel

 

Alcon Inc
Rue Louis-d’Affry 6,
1701 Fribourg,
Switzerland

 

royce.bedward@alcon.com

 

26.4                         Change of Notice Details . Each Party shall notify the other in writing of a change to its details in Clause 26.3 ( Notice Details ) from time to time.

 

27.             MISCELLANEOUS PROVISIONS

 

27.1                        Dispute Resolution. Any dispute in relation to any aspect of, or failure to agree any matter arising in relation to, this Agreement or any document agreed or contemplated as being agreed pursuant to this Agreement shall be resolved in accordance with the escalation procedure (including as to timings) set out in Exhibit 11 ( Governance ) and the Jedi TSA Governance Model.  In the event the Parties fail to resolve the dispute in accordance with that escalation procedure (in each case, a Dispute ), the Dispute shall be resolved in accordance with clause 41 ( Dispute Resolution ) of the Separation Agreement.

 

27.2                        Assignment and Subcontracting.

 

(a)                                  Subject to Clause 27.2(c), the Service Provider may:

 

(i)             assign all or any part of its rights under this Agreement to:

 

(A)                                an Affiliate of the Service Provider, provided that before the assignee subsequently ceases to be a member of the Service Provider Group, the Service Provider shall ensure that it shall re-assign that benefit to the Service Provider or to another continuing member of the Service Provider Group; or

 

(B)                                any third party purchaser of the whole or a substantial part of the Service Provider’s business; and

 

(ii)          delegate or sub-contract any of its obligations hereunder without the prior written consent of the Service Recipient.

 

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(b)                                  Subject to Clause 27.2(c), the Service Recipient may assign all or any part of its rights under this Agreement to an Affiliate of the Service Recipient, provided that before the assignee subsequently ceases to be a member of the Service Recipient Group, the Service Recipient shall ensure that it shall re-assign that benefit to the Service Recipient or to another continuing member of the Service Recipient Group.

 

(c)                                   Neither Party may assign or otherwise transfer, including as a result of a business divestment, its right to access the other Party’s IT System without that other Party’s written consent.

 

(d)                                  If a Party assigns, delegates, subcontracts or otherwise transfers this Agreement or any obligations hereunder (including to any Third Party Supplier) in accordance with this Clause 27.2 ( Assignment and Subcontracting ):

 

(i)             the liability of the other Party under this Agreement shall not be greater than it would have been in the absence of the relevant assignment, delegation, subcontracting or transfer;

 

(ii)          any delegation or subcontracting of the performance of any obligations shall not relieve that Party from the liability for performance of that obligation, such that the Party delegating or subcontracting its obligations shall remain responsible for breaches of and compliance with this Agreement by the delegee or subcontractor; and

 

(iii)       that Party shall ensure that any delegee and subcontractors comply with confidentiality undertakings at least as protective of the other Party’s confidential Information as those set out in Clause 23 ( Confidentiality ).

 

27.3                        Further Assurances.

 

(a)                                  Subject to the express limitations in this Agreement, each of the Parties shall, at such Person’s sole expense, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or reasonably required to implement and give effect to this Agreement.

 

(b)                                  Each of Novartis and Alcon shall procure that each member of the Novartis Group and Alcon Group, respectively, complies with all obligations under this Agreement which are expressed to apply to any such member.

 

27.4                        Announcements.   The provisions of clause 29 ( Announcements ) of the Separation Agreement shall apply mutatis mutandis to this Agreement.

 

27.5                        Waivers, Rights and Remedies.   Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement or any of the Transaction Documents shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time.  No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

27.6                         Counterparts .  This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall

 

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together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

27.7                         Variations.   Unless specified otherwise in this Agreement, no amendment of this Agreement (or of any other Transaction Document) shall be valid unless it is in writing and duly executed by or on behalf of all of the Parties to it.

 

27.8                         Invalidity.   Each of the provisions of this Agreement and the other Transaction Documents is severable.  If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

27.9                         No Third Party Enforcement Rights.   A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

27.10                 Whole Agreement.

 

(a)                                  This Agreement and the other Transaction Documents together set out the whole agreement between the Parties in respect of the subject matter of this Agreement and supersedes any previous draft, agreement, arrangement or understanding, whether in writing or not, relating to its subject matter. It is agreed that:

 

(i)             no Party has relied on or shall have any claim or remedy arising under or in connection with any statement, representation, warranty or undertaking made by or on behalf of the other Party (or any of its Representatives) in relation to the subject matter of this Agreement that is not expressly set out in this Agreement and the other Transaction Documents;

 

(ii)          any terms or conditions implied by Applicable Law in any jurisdiction in relation to the subject matter of this Agreement are excluded to the fullest extent permitted by Applicable Law or, if incapable of exclusion, any rights or remedies in relation to them are irrevocably waived;

 

(iii)       the only right or remedy of a Party in relation to any provision of this Agreement shall be for breach of this Agreement; and

 

(iv)      except for any liability in respect of a breach of this Agreement, neither Party (nor any of its Representatives) shall owe any duty of care or have any liability in tort or otherwise to the other Party (or its respective Representatives in relation to the subject matter of this Agreement.

 

(b)                                  Nothing in this Clause 27.10 ( Whole Agreement ) shall limit any liability for (or remedy in respect of) fraud or fraudulent misrepresentation.

 

(c)                                   Each Party agrees to the terms of this Clause 27.10 ( Whole Agreement ) on its own behalf and as agent for each of its Representatives.

 

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28.             GOVERNING LAW

 

28.1                         Governing Law . This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

Signature Page Follows

 

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SIGNATURES

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

 

 

 

  ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ John Reding

 

 

 

 

 

Name:

David Murray

 

Name:

John Reding

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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SCHEDULE 1
 
DEFINITIONS AND INTERPRETATION

 

1.             Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Additional Assistance has the meaning given in Clause 2.3 ( Additional Assistance );

 

Affiliates has the meaning given in the Separation Agreement;

 

Agreement means this transitional services agreement;

 

Alcon Asset Transferors has the meaning given in the Separation Agreement;

 

Alcon Business has the meaning given in the Separation Agreement;

 

Alcon Group has the meaning given in the Separation Agreement;

 

Alcon Services means the Services to be provided to Novartis or any other member of the Novartis Group by Alcon or any other member of the Alcon Group, as identified with “rTSA” in the “TSA / rTSA” column in Exhibit 1 ( Services and Service Charges );

 

Ancillary Agreements has the meaning given in the Separation Agreement;

 

Applicable Law has the meaning given in the Separation Agreement;

 

Authorizations has the meaning given in Clause 7.1(b);

 

Authorization Expenses has the meaning given in Clause 7.1(c);

 

BAU Services has the meaning given in Clause 3.5(a) ( BAU Services );

 

Books and Records has the meaning given in the Separation Agreement;

 

Brazil Delayed Closing Date has the meaning given in schedule 7 ( Brazil ) to the Separation Agreement;

 

Brazilian Alcon Business has the meaning given in schedule 7 ( Brazil ) to the Separation Agreement;

 

Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

Change has the meaning given in Clause 22.1;

 

Change Representative has the meaning given in Exhibit 4 ( Change Management );

 

Change Request has the meaning given in Exhibit 4 ( Change Management );

 

Commencement Date means the date of this Agreement;

 

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Commercially Reasonable Efforts has the meaning given in the Separation Agreement;

 

Consumer Price Index means, for each country in which the Services are provided and received, the percentage increase or decrease over the last 12 months as referenced in the consumer price index published by the OECD for that country, provided that if the OECD does not report a consumer price index for the relevant country for the relevant period, the percentage increase or decrease will be the consumer price index (or equivalent) published by the central bank for the relevant country over the last 12 months, and where the relevant central bank does not publish such index, the source of the relevant index shall be as mutually agreed by the Parties;

 

Costs means losses, damages, costs (including reasonable legal costs on an indemnity basis) and expenses (including Tax), in each case of any nature whatsoever;

 

Cost Saving has the meaning given in Clause 3.2(b)(iii)(B) ( Standard of Service );

 

Currency Rates Conversion Table means the exchange rates set out in 1 ( Currency Rates Conversion Table );

 

Data Protection Laws means all laws, rules, regulations, and orders of any jurisdiction or subdivision thereof relating to the privacy, security, confidentiality and/or integrity of Personal Data that are applicable to the operations, services or products of the Service Provider and the Service Recipient, including but not limited to the US Health Insurance Portability and Accountability Act of 1996 (“HIPAA Privacy Rule”) set forth at 45 CFR 164.508(b), the applicable law indicated within the Agreement to which this exhibit is attached, and/or the General Data Protection Regulation;

 

Default Interest means: (a) for invoices in US Dollars, the prime lending rate as published in The Wall Street Journal minus two per cent (2%); and (b) for invoices in any other currency, the applicable local country one (1) month interest rate plus one per cent (1%);

 

Dispute has the meaning given in Clause 27.1;

 

eQuality Agreement has the meaning given in Clause 4.3;

 

Excluded Service means:

 

(a)                                 any service or business process that is identified as an ‘Excluded Service’ in Exhibit 1 ( Services and Service Charges );

 

(b)                                 any service, service element or asset relating to a service transferred to the Service Recipient pursuant to Project Moonstone; and

 

(c)                                  any service or business process that will be provided under the Separation Agreement or any other Transaction Document;

 

Force Majeure means, any cause or circumstance preventing, hindering or delaying either Party performing all or part of its obligations under this Agreement which arises from or is attributable to acts, events, omissions or accidents beyond the reasonable control of the Party so prevented, including any of the following:

 

(a)                                 war, threat of or preparation for war, armed conflict;

 

(b)                                 terrorist attack, civil war, civil commotion or riots;

 

(c)                                  epidemic or pandemic;

 

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(d)                                 any law or governmental order, rule, regulation or direction, or any action taken by a Governmental Entity, including but not limited to imposing an embargo, export or import restriction, quota or other restriction or prohibition, in each case, of general application or generally affecting the industries in which the Parties participate;

 

(e)                                  any flood, earthquake, hurricane or other natural disaster, weather-related conditions, explosions or fires; or

 

(f)                                   to the extent beyond the reasonable control of the relevant Party (or, as applicable, the Permitted Subcontractor), any labour dispute, including strikes, industrial action or lockouts.

 

For the purposes of this definition of Force Majeure, neither increasing costs (unless in excess of market norms due to acts, events, omissions or accidents beyond the reasonable control of the Party affected) nor a lack of funds will be interpreted as putting the event beyond the reasonable control of the Party affected;

 

General Data Protection Regulation means:

 

(a)                                 Regulation 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC; and

 

(b)                                 laws implementing Regulation 2016/679 or any successor laws arising out of the withdrawal of a member state from the European Union;

 

GFC has the meaning given in Exhibit 11 ( Governance );

 

Global Function Lead has the meaning given Clause 1.2(a) ( Governance Roles );

 

Governmental Entity has the meaning given in the Separation Agreement;

 

Group means the Service Provider Group or the Service Recipient Group, as applicable;

 

GxP means any Good Practice guidelines and wherein the “x” shall stand for any specific practice descriptor.  GxP, by way of example but not in limitation of the foregoing, includes Good Manufacturing Practice, Good Clinical Practice, and Good Laboratory Practice;

 

Identified Stranded Costs has the meaning given in Clause 2.7(b) ( Stranded Costs );

 

Indemnifying Party has the meaning given in Clause 16.6(b);

 

Indemnitee has the meaning given in Clause 16.6(b);

 

Information has the meaning given in the Separation Agreement;

 

In-Flight Projects means any and all activities, processes, projects and measures that:

 

(a)                                 are specified in Exhibit 5 ( In-Flight Projects );

 

(b)                                 will impact the Services and/or the Standard Service Levels; and

 

(c)                                  are either being implemented, or are planned for implementation, as at the Commencement Date;

 

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Initial Service Term means, for each Service, the initial period specified for the provision of that Service in the “Duration (months)” column in Exhibit 1 ( Services and Service Charges );

 

Insolvency Event in relation to a Party, means any of the following:

 

(a)                                 it is unable or admits inability to pay its debts as they fall due; suspends or threatens to suspend making payments on any of its debts; or, by reason of actual or anticipated financial difficulties, commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;

 

(b)                                 the value of its assets is less than its liabilities (taking into account contingent and prospective liabilities);

 

(c)                                  a moratorium is declared in respect of any of its indebtedness (if a moratorium occurs, the ending of the moratorium will not remedy any Insolvency Event caused by that moratorium);

 

(d)                                 any corporate action, legal proceedings or other procedure or step is taken (whether by a Party, its directors or a Third Party) in relation to:

 

(i)                           the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration (whether out of court or otherwise) or reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise);

 

(ii)                         a composition, compromise, assignment or arrangement with any creditor;

 

(iii)                      the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager or other similar officer in respect of the Party or any of its assets (in each case whether out of court or otherwise);

 

(iv)                     enforcement of any security over any assets of Novartis or Alcon (as applicable), including a creditor attaching or taking possession of, or distress, execution, sequestration or other process being levied or enforced upon or sued against all or any part of the assets of the relevant party;

 

(v)                        a meeting of the Party, its directors or its members being convened for the purpose of considering any resolution for, or to petition for, or to apply for or to file documents with a court for its winding-up, administration (whether out of court or otherwise) or dissolution, or any such resolution is passed;

 

(vi)                     any person presenting a petition, application or motion for the winding-up, administration (whether out of court or otherwise) or dissolution of the Party; or

 

(vii)                  the directors or other officers of the Party requesting the appointment of or giving notice of their intention to appoint or take any step with a view to appointing a liquidator, receiver, administrator, administrative receiver, compulsory manager, trustee in bankruptcy or other similar officer in respect of the Party (in each case whether out of court or otherwise),

 

(but paragraph (d) shall not apply to a solvent liquidation of the company or any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within fourteen (14) days of its presentation); or

 

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(e)                                  there occurs in relation to the Party or any of its assets in any country or territory in which it is incorporated or carries on business or to the jurisdiction of whose courts it or any of its assets are subject any event which corresponds in that country or territory with any of those mentioned in (a) to (d);

 

Insurance Proceeds has the meaning given in the Separation Agreement;

 

Integration has the meaning given in Clause 2.2(a) ( Integration Plans );

 

Integration Costs has the meaning given in Clause 2.6(a) ( Integration Costs );

 

Integration Plans has the meaning given in Clause 2.2(a) ( Integration Plans );

 

Integration Project Delay has the meaning given in Clause 2.6(c);

 

Integration Projects means the projects that are identified and agreed in the Integration Plans and any projects that are agreed to be undertaken in accordance with Clause 22 ( Change Management );

 

Intellectual Property Rights has the meaning given in the Separation Agreement;

 

IT Environment has the meaning given in clause 2.2(b)(i);

 

IT Service means any Service identified as “IT” in the “Function” column in Exhibit 1 ( Services and Service Charges );

 

IT Systems means information and communications technologies, including systems, applications, data centers, networks, interfaces and any other system interface or infrastructure, whether owned or licensed in by a third party;

 

Jedi TSA Governance Model has the meaning given in Exhibit 11 ( Governance );

 

Liability or Liabilities has the meaning given in the Separation Agreement;

 

Local Separation Agreement has the meaning given in the Separation Agreement;

 

Local Services Agreement has the meaning given in Clause 25.1 ( Requirement for local services agreements );

 

Managed Mobile Devices has the meaning given in Clause 4.2(a);

 

Maximum Service Term means a period of twenty-four (24) months immediately following the Commencement Date;

 

Mobile Device Systems has the meaning given in Clause 4.2(a);

 

Mobile Device Synchronization has the meaning given in Clause 4.2(b) ( Managed mobile devices );

 

Network-to-Network Connection has the meaning given in Clause 2.2(b) ( Access );

 

Novartis Business has the meaning given in the Separation Agreement;

 

50


 

Novartis Group has the meaning given in the Separation Agreement;

 

Novartis Services means the Services to be provided to Alcon or any other member of the Alcon Group by Novartis or any other member of the Novartis Group, as identified with “TSA” in the “TSA / rTSA” column in  Exhibit 1 ( Services and Service Charges );

 

Omitted Services has the meaning given in Clause 3.3(a) ( Omitted Services );

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Personal Data means any information that relates to an identified or identifiable person including without limitation electronic data and paper based files that is Processed directly or indirectly, by the Service Provider or the Service Provider’s subcontractors on behalf of and as instructed by the Service Recipient.  This may include: name or initials, home or other physical address, cell/mobile or telephone number; photograph and/or any data or information subject to Data Protection Laws. Personal Data includes Special/Sensitive Personal Data as defined below;

 

Project Moonstone means the internal restructuring project codenamed Project Moonstone, under which certain business services provided by the ‘Novartis Business Services’ business function to the Alcon Group are transferred from the Novartis Group to the Alcon Group;

 

Recipient has the meaning given in Clause 14.1(b);

 

Related Services means those other Services on which the provision of a Service is dependent, as specified in Exhibit 1 ( Services and Service Charges );

 

Representatives has the meaning given in the Separation Agreement;

 

Security Incident has the meaning given in Clause 4.1(b) ( Access );

 

Separation has the meaning given in the Separation Agreement;

 

Separation Date has the meaning given in the Separation Agreement;

 

Separation Office has the meaning given in Exhibit 11 ( Governance ) ;

 

Service means any business process (other than any Excluded Service) listed in Exhibit 1 ( Services and Service Charges ) that is selected by the Service Recipient to be provided, or procured, by the Service Provider on a transitional basis (including Alcon Services and Novartis Services as applicable and as the case may be);

 

Service Charges means the charges payable for the Services, as specified in Exhibit 1 ( Services and Service Charges );

 

Service Commencement Date means, for each of the Alcon Services or the Novartis Services, the later of: (a) the Commencement Date; and (b) in the case of the Brazilian Alcon Business, the Brazil Delayed Closing Date;

 

Service Materials has the meaning given in Clause 11.3(b);

 

Service Provider means:

 

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(a)                                 in the case of Novartis Services, Novartis and all other members of the Novartis Group who are engaged in the provision of the Novartis Services or the performance of the Service Provider’s obligations under this Agreement; and

 

(b)                                 in the case of Alcon Services, Alcon and all other members of the Alcon Group who are engaged in the provision of the Alcon Services or the performance of the Service Provider’s obligations under this Agreement;

 

Service Provider’s Bank Account means the Service Provider’s bank account as notified to the relevant Service Recipient in writing from time to time;

 

Service Provider Group means:

 

(a)                                 in the case of Novartis Services, Novartis and/or all other members of the Novartis Group; and

 

(b)                                 in the case of Alcon Services, Alcon and/or all other members of the Alcon Group;

 

Service Provider Proprietary Software means software owned by a member of the Service Provider Group and used in the provision of the Services;

 

Service Recipient means:

 

(a)                                 in the case of Alcon Services, Novartis and all other members of the of the Novartis Group who receive Alcon Services or other rights granted to the Service Recipient under this Agreement; and

 

(b)                                 in the case of Novartis Services, Alcon and all other members of the of the Alcon Group who receive Novartis Services or other rights granted to the Service Recipient under this Agreement;

 

Service Recipient Group means:

 

(a)                                 in the case of Alcon Services, the Service Recipient and all other member of the Novartis Group;

 

(b)                                 in the case of Novartis Services, the Service Recipient and all other member of the Alcon Group;

 

Service Term means, for each Service:

 

(a)                                 the Initial Service Term for that Service; and

 

(b)                                 any extension(s) in accordance with Clause 17.2 ( Extensions of Service Terms ),

 

in each case, provided that the aggregate period does not exceed the Maximum Service Term;

 

Shorter Extension Notice Period has the meaning given in Clause 17.2(c)(ii);

 

Shorter Termination Notice Period has the meaning given in Clause 18.1(b)(ii);

 

Special/Sensitive Personal Data means: (a) an individual’s physical, physiological or mental characteristics, economic status, racial or ethnic origin, political, ideological, religious opinions or philosophical beliefs, trade union membership, health or medical information including information related to payment for health services, sex life or sexual preference, genetic material

 

52


 

or information, human biological samples or cells, unique biometric data, personality profiles; or (b) an individual’s name or initials in combination with the individual’s: (i) Social Security number; (ii) alien registration number; (iii) driver’s license number; (iv) passport number, visa number or other government identifier; (v) credit card, debit card, or other financial account numbers, with or without any associated code or password that would permit access to such account; or (vi) mother’s maiden name. For the avoidance of doubt, Special/Sensitive Personal Data is a subset of Personal Data;

 

Standard Service Level means the average standard of service and performance (including as to volume, quality and content and excluding any KPIs, additional service levels or other measures in respect to any of the Services) to which service(s) equivalent to the relevant Service were provided by the Service Provider to the Service Recipient during:

 

(a)                                 to the extent a Service has been affected by an internal restructuring project (including under Project Moonstone) intended to separate the Alcon Group and the Novartis Group within the twelve (12) months immediately before the Commencement Date, the period from the completion of that restructuring project to the Commencement Date; and

 

(b)                                 otherwise, the twelve (12) months immediately before the Commencement Date;

 

Stranded Costs has the meaning given in Clause 2.7(a) ( Stranded Costs );

 

Surviving Provisions means Clause 2.4 ( Integration liability ), Clause 4.4 ( Interaction between this Agreement and eQuality Agreements ), Clause 5.2, Clause 5.4, Clause 6.2 ( Failure to perform a dependency ), 6.3 ( Transferring Assets ), Clause 6.5 ( Reliance on data and information ), Clause 7.6 ( Indemnity for non-compliance ), Clause 11.3 ( No transfer of Intellectual Property Rights ), Clause 14 ( Tax ), Clause 16 ( Liability ), Clause 20 ( Consequences of Termination ), Clause 21 ( Data Protection ), Clause 23 ( Confidentiality ), Clause 24.1 ( No Liability ), Clause 25 ( Local Service Agreements ), Clause 26 ( Notices ), Clause 27 ( Miscellaneous Provisions ), Clause 28 ( Governing Law ), Schedule 1 ( Definitions and Interpretation ) and Schedule 2 ( Employees );

 

Tax has the meaning given in the Tax Matters Agreement;

 

Tax Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement dated on or around the date of this Agreement and entered into between Novartis and Alcon;

 

Third Party means any Person other than a member of the Alcon Group or the Novartis Group;

 

Third Party Proceeds has the meaning given in the Separation Agreement;

 

Third Party Software means software owned by a Third Party that is licensed to a member of the Service Provider Group that are used by the Service Provider Group in the provision of the Services;

 

Third Party Supplier means a Third Party that supplies goods or services under a Third Party Supply Agreement;

 

Third Party Supply Agreements means the agreements entered into by members of the Service Provider Group under which Third Parties provide goods and services to the Service Provider Group that are used by the Service Provider Group in the provision of the Services;

 

Transaction Document has the meaning given in the Separation Agreement;

 

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VAT means, within the European Union, such tax, duty, assessment or similar charges as may be levied in accordance with (but subject to derogations from) Council Directive 2006/112/EC, and outside the European Union, any tax, duty, assessment or similar charges levied by reference to added value, turnover or sales, in each case including all interest, penalties and additions imposed thereon by any Tax Authority; and

 

Working Hours means 9.00am to 5.00pm in the relevant location on a Business Day.

 

2.                                       Interpretation . In this Agreement, unless the context otherwise requires:

 

(a)                                  headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

(b)                                  references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction;

 

(c)                                   references to Swiss francs or CHF are references to the lawful currency of Switzerland at the date of this Agreement;

 

(d)                                  references to US Dollars or $ are references to the lawful currency from time to time of the United States of America; and

 

(e)                                   any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as illustrative and shall not limit the sense of the words preceding those terms.

 

3.                                       Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.                                       Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

5.                                       Inconsistencies . Where there is any inconsistency between the definitions set out in this Schedule 1 ( Definitions and Interpretation ) and the definitions set out in any Clause or any Schedule or Exhibit, then, for the purposes of construing such Clause, Schedule or Exhibit, the definitions set out in such Clause, Schedule or Exhibit (as applicable) shall prevail.

 

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SCHEDULE 2

 

EMPLOYEES

 

1.               The Parties do not intend that any employee of any member of the Service Provider (the Transferor ) should transfer to the Service Recipient or any of its Affiliates or successors (in each case, the Transferee ) by operation of Applicable Law in connection with the provision of the Services (or any of them) or the termination of such provision. If the contract of employment of any such person is found or alleged to have effect at any time as if originally made with a Transferee by virtue of his or her providing or ceasing to provide any Services (such person being a Wrong Pocket Employee ), the Transferor agrees that:

 

(a)               in consultation with the relevant Transferee, the Transferor may (or it may procure that any of its Affiliates may) within ten (10) Business Days of being so requested by the relevant Transferee (as long as the request is made no later than four (4) weeks after the relevant Transferee becomes aware of the actual or alleged transfer of the Wrong Pocket Employee and, in any event, no later than three (3) months after the expiry or termination of this Agreement), make to that person an offer in writing to employ him or her under a new contract of employment subject to, and to take effect upon, the termination referred to in paragraph 2 of this Schedule 2 below; and

 

(b)               the offer to be made will be on the same terms and conditions (including as to period of continuous employment) as were provided to that Wrong Pocket Employee immediately prior to his or her actual or alleged transfer.

 

2.               After the expiry of the ten (10) Business Days referred to in paragraph 1(a) of this Schedule 2, and provided that the relevant Transferee takes such steps as are legally possible to terminate the employment of the person concerned as soon as reasonably practicable after becoming aware of the finding or allegation referred to in paragraph 1 of this Schedule 2 (either by giving notice or transferring the Wrong Pocket Employee by agreement to be concluded between the relevant Transferee, the person concerned and the relevant Affiliate of the Transferor), the Transferor shall be responsible for and shall indemnify and keep indemnified the relevant Transferee (for itself and as trustee for any of its Affiliates and/or successors) against all Losses from time to time made, suffered or incurred by the relevant Transferee as a result of:

 

(a)               the actual or alleged transfer of employment of such Wrong Pocket Employee to the relevant Transferee and (regardless of whether there has been such a transfer) any employment liabilities relating to such person;

 

(b)               employing such Wrong Pocket Employee until the effective date of termination of such person’s employment (being the date by which the Relevant Transferee can reasonably be expected to have achieved such termination in accordance with the terms of the contract of employment and Applicable Law but subject to a maximum period of six (6) months, unless prevented by the terms of the contract of employment or Applicable Law); and

 

(c)                the termination of employment of such Wrong Pocket Employee.

 

3.               The Parties agree to co-operate in good faith to minimise the Losses which are subject to the indemnity referred to in paragraph 2 of this Schedule 2.

 

55


Exhibit 99.7

 

Execution Version

 

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 


 

PATENT AND KNOW-HOW LICENSE AGREEMENT

 


 


 

CONTENTS

 

ARTICLE

 

PAGE

 

 

 

 

1.

DEFINITIONS

 

1

 

 

 

 

2.

GRANT OF LICENSES

 

1

 

 

 

 

3.

SUB-LICENSES

 

3

 

 

 

 

4.

THIRD PARTY RESTRICTIONS

 

4

 

 

 

 

5.

DURATION

 

6

 

 

 

 

6.

DISCLAIMER OF WARRANTIES

 

6

 

 

 

 

7.

OWNERSHIP AND MAINTENANCE

 

6

 

 

 

 

8.

INFRINGEMENT

 

8

 

 

 

 

9.

TERMINATION

 

9

 

 

 

 

10.

LIMITATION OF LIABILITY

 

11

 

 

 

 

11.

TAX

 

11

 

 

 

 

12.

CONFIDENTIALITY

 

11

 

 

 

 

13.

NOTICES

 

12

 

 

 

 

14.

DISPUTE RESOLUTION

 

13

 

 

 

 

15.

MISCELLANEOUS PROVISIONS

 

14

 

 

 

 

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

 

19

 

i


 

PATENT AND KNOW-HOW LICENSE AGREEMENT

 

dated  8 April 2019

 

PARTIES:

 

(1)                                 NOVARTIS AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland (the Licensor or Novartis ); and

 

(2)                                  ALCON INC. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (Alcon) (the Licensee or Alcon)

 

together, the Parties and each a Party .

 

Whereas:

 

(A)                                Novartis and Alcon have entered into a Separation and Distribution Agreement dated 8 April 2019, under which: (a) Novartis has agreed to transfer certain assets and license certain intellectual property rights to Alcon; and (b) Alcon has agreed to transfer certain assets and license certain intellectual property rights to Novartis (the Separation Agreement ).

 

(B)                                Novartis owns, or has the right to sub-license, the Licensed IP Rights.

 

(C)                                Pursuant to the Separation Agreement, Novartis now wishes to license (or procure that the relevant Affiliate of Novartis licenses) the Licensed IP Rights to Alcon on the terms of this Agreement.

 

IT IS AGREED:

 

1.                                       DEFINITIONS

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1  ( Definitions and Interpretation ).

 

2.                                       GRANT OF LICENSES

 

2.1                                Licensed Patents and Licensed Know-How

 

(a)                                  In consideration of the mutual promises and conditions set out in this Agreement and subject to the terms of this Agreement (including Clause 4 ( Third Party Restrictions )), Licensor hereby grants (or hereby procures the grant by the relevant Affiliate of Licensor) to Licensee with effect from the Effective Date:

 

(i)             a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) exclusive worldwide license under the

 

1


 

Licensed Patents and Licensed Know-How to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Alcon Existing Products in any field of use (other than the Shared Licensed Field);

 

(B)                                the Alcon Future Products in the Alcon Licensed Field; and

 

(C)                                the Alcon Optional Products in any field of use (other than the Shared Licensed Field), and

 

(ii)            a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) non-exclusive worldwide license under the Licensed Patents and Licensed Know-How to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Alcon Existing Products in the Shared Licensed Field;

 

(B)                                the Alcon Future Products in the Shared Licensed Field; and

 

(C)                                the Alcon Optional Products in the Shared Licensed Field.

 

2.2                                Licensed-In Third Party IP Rights

 

(a)                                  In consideration of the mutual promises and conditions set out in this Agreement and subject to the terms of this Agreement (including Clause 4 ( Third Party Restrictions )), Licensor hereby grants (or hereby procures the grant by the relevant Affiliate of Licensor) to Licensee with effect from the Effective Date:

 

(i)             a royalty-free, further sub-licensable (in accordance with Clause 3 ( Sub-licenses ), exclusive (subject to any other rights granted by the relevant Third Party licensor) worldwide sub-license under the Licensed-In Third Party IP Rights to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Alcon Existing Products in any field of use (other than the Shared Licensed Field);

 

(B)                                the Alcon Future Products in the Alcon Licensed Field; and

 

(C)                                the Alcon Optional Products in any field of use (other than the Shared Licensed Field), and

 

(ii)            a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) non-exclusive worldwide license under the Licensed-In Third Party IP Rights to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Alcon Existing Products in the Shared Licensed Field;

 

(B)                                the Alcon Future Products in the Shared Licensed Field; and

 

2


 

(C)                                the Alcon Optional Products in the Shared Licensed Field.

 

2.3                                Restrictions and Reservation of Rights

 

(a)                                  The licenses and sub-licenses granted under Clause 2.1(i)(B) ( Licensed Patents and Licensed Know-How — Alcon Future Products ) and Clause 2.2(i)(B) ( Licensed-In Third Party IP Rights — Alcon Future Products ) are limited solely to the Alcon Licensed Field, and shall not include any right for Licensee to make or have made the Alcon Future Products, or use or permit the use of the Licensed IP Rights, except in the Alcon Licensed Field.

 

(b)                                  Licensee acknowledges that, to the extent the licenses granted in Clause 2.2 ( Licensed-In Third Party IP Rights )  relate to territories in which Licensor or its Affiliates have not been granted a license under the terms of the Third Party licenses for the Licensed-In Third Party IP Rights, then the licenses granted in Clause 2.2 ( Licensed-In Third Party IP Rights ) shall not extend to such territories.

 

(c)                                   Licensee further acknowledges that, to the extent the licenses granted in Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) relate to territories: (a) in which Licensor or its Affiliates, or Third Party owner (in the case of Licensed-In Third Party IP Rights) have not registered the Licensed Patents; (b) where the registrations have expired or become abandoned; or (c) in which the patent applications included in the Licensed Patents are still pending and cannot be licensed under local laws, then only rights in the remaining patent registrations in the Licensed Patents and the Licensed Know-How are licensed under the terms of this Agreement; provided that once the Licensed Patents are registered in the relevant territories (and, in the case of Licensed-In Third Party IP Rights, to the extent these territories are included in the scope of such rights licensed to the Licensor) these registrations will be included in the scope of the license grant in Clause 2.1 ( Licensed Patents and Licensed Know-How ) and, to the extent permitted under the relevant Third Party licenses, Clause 2.2 ( Licensed-In Third Party IP Rights ).

 

(d)                                  Nothing in this Agreement shall be construed as conferring (whether by implication, estoppel or otherwise) upon the Licensee any right, title or interest in any Intellectual Property Rights owned or controlled by the Licensor other than those expressly granted in this Agreement. For the avoidance of doubt, the exclusivity granted to Licensee under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) apply solely to the products and fields of use specified in such clauses and do not apply (i) to other products or fields of use, or (ii) to the Licensed IP Rights other than in relation to the rights granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) for the specified products and fields of use.

 

3.                                       SUB-LICENSES

 

3.1                                Subject to Clause 4 ( Third Party Restrictions ), Licensee may sub-license or sub-contract the rights granted to it under Clause 2.1 ( Licensed Patents and Licensed

 

3


 

Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) of this Agreement, without the consent of Licensor, provided that:

 

(a)                                  the terms of the sub-license or sub-contract are consistent with the provisions of this Agreement and include provisions that:

 

(i)             prohibit further sub-licensing or sub-contracting by the sub-contractor or sub-licensee;

 

(ii)            impose obligations of confidentiality on the sub-licensee or sub-contractor which are no less onerous than those set out in Clause 12 ( Confidentiality ); and

 

(iii)           allow Licensor, its Affiliates and/or the owner of the Licensed-In Third Party IP Rights, as applicable, as third party beneficiary of the obligations of the sub-licensee of the Licensed IP Rights, to enforce any of the obligations under this Agreement directly against that sub-licensee (either: (1) without any requirement to join Licensee as a party to any proceedings; or (2) where Licensee would be a necessary party to any such proceedings, with Licensee’s express upfront agreement to be joined as a party) or to obtain any consent from Licensee, and impose a governing law that permits the enforceability of the requirements under this Clause 3.1(a)(iii);

 

(b)                                  the sub-license or sub-contract automatically terminates to the extent this Agreement is terminated;

 

(c)                                   any act of the sub-licensee or sub-contractor which would, if committed by Licensee, be a breach of this Agreement shall be treated for the purposes of this Agreement as an equivalent breach by Licensee of the terms of this Agreement; and

 

(d)                                  where a sub-license is granted to a Third Party, Licensee shall, as soon as reasonably practicable, notify Licensor of that sub-license granted under this Clause 3 and shall, on request, provide a copy of that executed sub-license to Licensor.

 

4.                                       THIRD PARTY RESTRICTIONS

 

4.1                                The licenses granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights )  shall be limited by, and subject to, any existing contractual terms as at the Effective Date, and (subject to the exclusivity granted to Licensee under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights )  as may be amended or agreed at any time after the Effective Date, between Licensor (or any Affiliate of Licensor) and a Third Party contained in any license, prior rights, settlement, co-existence or other agreement that relate to any of the Licensed IP Rights.  Licensee agrees to comply with:

 

(a)                                  the terms of any such agreement to the extent that they relate to the Licensed IP Rights, including the usage and registration of the Licensed IP Rights; and

 

4


 

(b)                                  all relevant Third Party royalty or other payment obligations in any such agreement to the extent that they relate to a Licensed IP Right in which case Licensee agrees to be responsible for any applicable royalty or other payment obligations to the relevant Third Party as if it were a party to the relevant agreement,

 

in each case, to the extent Licensee has been notified of those terms or obligations (as applicable).

 

4.2                                Consents under Third Party Licenses .

 

(a)                                  Licensee acknowledges and agrees that Licensor and its Affiliates may be required to obtain a Third Party consent, approval or permission (each, an Authorization ) to grant a sub-license of any relevant Licensed-In Third Party IP Rights to Licensee in accordance with Clause 2.2 ( Licensed-In Third Party IP Rights ) Where any Authorization is required:

 

(i)             Licensor shall (and shall procure that its Affiliates shall) use Commercially Reasonable Efforts to:

 

(A)                                obtain that Authorization as soon as reasonably practicable following the Effective Date, provided that Licensor and its Affiliates shall not be required to obtain any Authorizations where doing so would require a Third Party license to be changed or amended in a manner that, in Licensor’s reasonable opinion, is detrimental to: (1) the terms of that Third Party license or to the rights provided under it to Licensor or its Affiliates; or (2) Licensor’s or any of its Affiliate’s relationship with the relevant Third Party licensor; and

 

(B)                                minimise the Costs of obtaining that Authorization;

 

(ii)            Licensor shall keep Licensee informed of the progress in obtaining that Authorization and shall provide Licensee with a copy of each Authorization as soon as reasonably practicable after receiving it;

 

(iii)           Licensee shall cooperate, at its own cost, with Licensor and the relevant Third Party in connection with obtaining that Authorization, including by providing any information reasonably requested by Licensee or the Third Party; and

 

(iv)           Licensee shall reimburse Licensor for all reasonable documented Costs (other than any internal Costs) incurred by Licensor and its Affiliates in connection with obtaining the Authorizations, provided that Licensor shall notify Licensee of any such Costs as soon as reasonably practicable.

 

4.3                      Licensor shall not be in breach of this Agreement and its obligation under Clause 2.2 to grant a sub-license of the Licensed-In Third Party IP Rights to which the relevant Third Party license relates shall immediately cease, if:

 

5


 

(a)                                  a Third Party does not grant an Authorization, provided that Licensor has complied with Clause 4.2(a);

 

(b)                                  that Third Party license: (A) is terminated by Licensor or its Affiliates, as applicable, during the Term; and (B) does not permit the survival of the sub-license granted to Licensee under this Agreement; or

 

(c)                                   that Third Party license: (A) is terminated by the relevant Third Party licensor during the Term or expires during the Term, and (B) does not permit the survival of the sub-license granted to Licensee under his Agreement,

 

in the case of (b) above, provided that Licensor uses Commercially Reasonable Efforts and works with Licensee to agree, in good faith, alternative arrangements, if practicable, to give Licensee equivalent benefits or rights as it would have enjoyed in relation to the relevant Licensed-In Third Party IP Rights.

 

5.                                       DURATION

 

This Agreement commences on the Effective Date and, except to the extent terminated earlier in accordance with Clause 9 ( Termination ), shall continue in perpetuity

 

6.                                       DISCLAIMER OF WARRANTIES

 

ALL REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS OF ANY KIND, WHETHER EXPRESS OR IMPLIED (BY STATUTE OR OTHERWISE), REGARDING THE LICENSED IP RIGHTS OR RELATING TO THE TERMS AND CONDITIONS OR THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING ANY REPRESENTATION, WARRANTY OR UNDERTAKING OF SUITABILITY, FITNESS FOR PURPOSE OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS) ARE EXPRESSLY EXCLUDED TO THE MAXIMUM EXTENT PERMITTED BY LAW. LICENSEE IS SOLELY RESPONSIBLE FOR ITS USE, RELIANCE OR IMPLEMENTATION OF THE LICENSED IP RIGHTS, INCLUDING ANY ACTIONS OR DECISIONS TAKEN OR NOT TAKEN AS A RESULT THEREOF.

 

7.                                       OWNERSHIP AND MAINTENANCE

 

7.1                                Ownership of Licensed IP Rights

 

(a)                                  Licensee acknowledges and agrees that:

 

(i)             all Patent and Know-How Rights and other rights in the Licensed IP Rights are the exclusive property of Licensor, its Affiliates or, in the case of the Licensed-In Third Party IP Rights, its licensors; and

 

(ii)            it shall not acquire, nor claim, any right, title or interest in or to any element of the Licensed IP Rights by virtue of this Agreement or its use of the relevant Licensed IP Right, other than the rights specifically granted to it under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ).

 

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7.2                                Improvements

 

(a)                                  As between the Parties, each Party shall own all rights in any Improvement that it or any of its Affiliates makes, without further obligation to the other Party, except as expressly provided in Clause 7.2(b).

 

(b)                                  Neither Party shall be required to grant the other a license or other right in or to any Improvements made by that Party, except to the extent the manufacture, sale, offer for sale or importation of any Alcon Existing Product or Novartis Existing Product (but only in the form that product is sold by Alcon or Novartis, as applicable, as at the Effective Date) would infringe the other Party’s intellectual property rights in the Improvement. In this case only, and for no additional consideration, the Party that owns the Improvement shall grant the otherwise infringing Party a non-exclusive, sub-licensable (in accordance with Clause 3) license in the Territory in the same fields of use as set out in Clause 2.1 ( Licensed Patents and Licensed Know-How ) for so long as the otherwise infringing Party continues to manufacture, sell, offer for sale or import any Alcon Existing Product or Novartis Existing Product, in the form that product is sold by Licensor as at the Effective Date.

 

7.3                                Maintenance of Licensed Patents

 

(a)                                  Subject to Clause 7.4 ( Abandonment or Lapse of Licensed Patents ), Licensor shall:

 

(i)             pay renewal fees and take all reasonable actions to maintain the registered Licensed Patents owned by Licensor or any Affiliate of Licensor;

 

(ii)            not abandon or allow to lapse any registered Licensed Patents owned by Licensor or any Affiliate of Licensor and set out in  Exhibit 1 ( Licensed Patents ); and

 

(iii)           use Commercially Reasonable Efforts to prosecute to grant any applications for registered Licensed Patents owned by Licensor or any Affiliate of Licensor.

 

For the avoidance of doubt, as used in this Agreement, “abandon or allow to lapse” does not include actions taken by Licensor during the ordinary course of patent prosecution, for example instructions regarding claim scope or designation of territories, but does include, among other actions, non-payment of renewal fees.

 

7.4                                Abandonment or Lapse of Licensed Patents

 

(a)                                  If, during the Term, Licensor wishes to abandon or allow any registration or application for a Licensed Patent owned by Licensor or any Affiliate of Licensor and set out in Exhibit 1 ( Licensed Patents ), then Licensor shall notify Licensee of the same at least sixty (60) calendar days in advance of the expiry/abandonment date of such Licensed Patent.  Licensee shall have a period of thirty (30) calendar days from the date of receipt of the notice to confirm whether or not it is interested in maintaining the relevant Licensed Patent(s), and:

 

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(i)             if Licensee confirms in writing that it is not interested in maintaining the relevant Licensed Patent(s) or fails to notify Licensor of its decision within thirty (30) calendar days from the date of receipt of the notice, then Licensor shall be free to surrender, abandon or allow to lapse the relevant Licensed Patent(s); or

 

(ii)            if Licensee confirms in writing within thirty (30) calendar days from the date of receipt of the notice that it is interested in maintaining the relevant Licensed Patent(s), then Licensor shall assign, at Licensee’s cost, the relevant Licensed Patent(s) to Licensee and Licensee shall take over the prosecution or maintenance of the relevant Licensed Patent(s) and all associated Costs. If any Licensed Patent is assigned to Licensee under this Clause (ii), Licensee shall, with effect from the date of that assignment, grant to Licensor and Affiliates of Licensor a non-exclusive, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), royalty-free, worldwide, perpetual (subject to termination of this Agreement in accordance with Clause 9)  license under that Licensed Patent to make, use, sell, offer for sale and import products of Licensor and Affiliates of Licensor in any field of use other than the Alcon Licensed Field.

 

8.                                       INFRINGEMENT

 

8.1                                Nothing in this Agreement shall constitute any representation that the use of any Licensed IP Right does not, or will not, infringe any intellectual property rights owned by a Third Party.

 

8.2                                Licensee shall immediately notify Licensor in writing of any of the following matters that comes to its attention (giving full particulars of the matter, the identity of the Third Party and the urgency of any actions required or recommended to be taken):

 

(a)                                  any actual, suspected or threatened infringement of any element of a Licensed IP Right by a Third Party;

 

(b)                                  any allegation or complaint made by any Third Party that any element of a Licensed IP Right is invalid or that use of any element of a Licensed IP Right infringes any Third Party right; or

 

(c)                                   any other attack on or claim related to any element of a Licensed IP Right or use of such Licensed IP Right.

 

8.3                                In respect of any matter described in Clause 8.2 above:

 

(a)                                  Licensee shall not make any admissions other than to Licensor;

 

(b)                                  Subject to Clause 8.4, Licensor shall decide, in its absolute discretion whether or not to take action, and what action to take, and shall have exclusive control over any resulting claims, actions and proceedings; and

 

(c)                                   if Licensor decides to take any action  in respect of any such matter, Licensee shall (and shall procure that its Affiliates and sub-licensees shall), at Licensor’s cost, provide any assistance that Licensor reasonably requires (including bringing proceedings or joining any proceedings brought by

 

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Licensor). Subject to Clause 8.5, any award of Costs or compensation in connection with any of those matters shall be solely for the account of Licensor after reimbursement of Licensee’s reasonable costs incurred in its cooperation under this Clause 8.3(c).

 

8.4                                If either (a) Licensor notifies Licensee that Licensor does not intend to take any action in respect of any matter described in Clause 8.2 above or three (3) months have elapsed since Licensee provided notice of a matter described in Clause 8.2 without Licensor taking any action; and that matter relates to: (i) a country in the Territory in which Licensee or an Affiliate of Licensee operates; and (ii) the Licensed Alcon Field, or (b) the matter relates to or, in Licensee’s reasonable opinion, will impact a product covered under the Licensed IP Rights which the Licensee has Commercialised or intends to Commercialise within  twenty-four (24) months from the date Licensee provided notice of a matter (or such time period as otherwise agreed by the Parties on a case-by-case basis) described in Clause 8.2 then under either (a) or (b) and subject to the terms of the Licensed-In Third Party IP Rights, if applicable, Licensee may take action in its own name in respect of that matter and control any resulting claim(s), action(s) and proceeding(s), provided that, prior to taking any material action or decision with regards to that matter (including commencing any claim(s), action(s) or proceeding(s) or settling any dispute) Licensee shall consult in good faith with Licensor, shall seek Licensor’s consent for that material action or decision (such consent not to be unreasonably withheld) and shall not take any such action or decision without that consent. If Licensee (or its Representatives) takes any action or decision in respect of a matter under this Clause 8.4 that Licensor has not consented to, Licensee shall indemnify Licensor and its Representatives, against all Costs or other liabilities as a result of that action or decision. For the avoidance of doubt, the Parties acknowledge that it shall not be unreasonable for Licensor to withhold its consent under this Clause 8.4 to the extent that, in Licensor’s reasonable opinion, Licensee’s taking of the relevant material action or decision would be detrimental to the business of Licensor or any Affiliate of Licensor (including in respect of its relationship with any of its suppliers or customers).

 

8.5                                                                      Licensor shall (and shall procure that its Affiliates shall), at Licensee’s cost, provide any assistance that Licensee reasonably requires under Clause 8.4  (including bringing proceedings or joining any proceedings brought by Licensee). Any award of Costs or compensation in connection with any claim(s), action(s) or proceeding(s) brought by Licensee under Clause 8.4 shall be solely for the account of Licensee after reimbursement of Licensor (and Licensor’s Affiliates’) reasonable costs incurred in its or their cooperation under this Clause 8.5.

 

9.                                       TERMINATION

 

9.1                                Notwithstanding Clause 5 ( Duration ), Licensor may terminate this Agreement in part or in its entirety, with immediate effect, by written notice to Licensee if:

 

(a)                                  Licensee commits a breach of any material obligation under this Agreement and, in the case of a breach that is capable of remedy, fails to remedy it within ninety (90) days of receipt of a written notice from Licensor giving full particulars of the breach and requiring it to be remedied;

 

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(b)                                  Licensee or an Affiliate of Licensee challenges Licensor’s or any of its Affiliate’s’ entitlement to own, to use or to license the use of any of the Licensed IP Rights; or

 

(c)                                   an Insolvency Event occurs in relation to Licensee.

 

9.2                                For the purposes of Clause 9.1(a), a breach shall be considered capable of remedy if Licensee can comply with the provision in question in all respects other than as to time of performance.

 

9.3                                Consequences of termination .

 

On the date of termination of this Agreement for any reason (in each case, the Termination Date ),

 

(a)                                  all rights and licenses granted pursuant to this Agreement (other than any rights granted to Licensor in accordance with Clause 7.4(a)(ii) ( Grant Back License )) (shall cease with immediate effect and shall revert to Licensor;

 

(b)                                  all obligations of Licensor or its Affiliates to Licensee under this Agreement shall cease with immediate effect;

 

(c)                                   all outstanding sums payable by Licensee to Licensor shall immediately become due and payable;

 

(d)                                  Licensee shall cease, with immediate effect, to make or permit to be made any use of the Licensed IP Rights; and

 

(e)                                   Licensee shall, as soon as practicable on request by Licensor (and at Licensee’s expense):

 

(i)             return to Licensor all written documents and other materials relating to Licensor, to any Affiliate of Licensor or to this Agreement (including any Confidential Information) or in relation to which any of the Licensed IP Rights are being or have been used by Licensee, which is under Licensee or any of its Affiliate’s control, without keeping any copies thereof (other than to the extent required by Applicable Law);

 

(ii)            destroy all information or other documents derived from Confidential Information; and

 

(iii)           so far as it is practicable to do so, expunge Confidential Information of Licensor or Licensor’s Affiliates from any computer, system (including Cloud-based data systems) or other device used by or on behalf of Licensee and its Affiliates.

 

9.4                                No releases from accrued liabilities and Surviving Provisions .

 

Termination of this Agreement shall not release either Party from any liability that, at the time of termination or expiry, has already accrued to the other Party.  The Surviving Provisions, together with any other Clause reasonably intended to survive termination or expiry, shall survive termination or expiry of this Agreement.

 

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10.           LIMITATION OF LIABILITY

 

10.1                         TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR SHALL NOT BE LIABLE TO LICENSEE FOR ANY COSTS, EXPENSES, LOSSES OR DAMAGES (IN EACH CASE, WHETHER DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL OR CONSEQUENTIAL, AND WHETHER ECONOMIC OR OTHER) ARISING FROM LICENSEE’S EXERCISE OF THE RIGHTS GRANTED TO IT UNDER THIS AGREEMENT, WHETHER OR NOT LICENSEE OR ANY OF ITS AFFILIATES HAVE BEEN ADVISED OF, OR OTHERWISE MIGHT OR SHOULD HAVE ANTICIPATED, THE POSSIBILITY OR LIKELIHOOD OF SUCH COSTS, EXPENSES, LOSSES OR DAMAGES.

 

10.2                         Nothing in this Agreement shall have the effect of excluding or limiting any liability of either Party for gross negligence, wilful misconduct, death or personal injury caused by negligence or for fraud or any other liability that cannot be excluded by Applicable Law.

 

10.3                         Neither Party shall have any duty or obligation under this Agreement except as expressly set out in this Agreement.

 

11.           TAX

 

11.1                         General

 

Any sum payable by Licensee to Licensor under this Agreement is exclusive of any applicable VAT.  If any supply is treated as or deemed made by Licensor or an Affiliate of Licensor under this Agreement and Licensor or an Affiliate of Licensor is required to account for VAT in respect of that supply, Licensee shall, against receipt of a valid VAT invoice (if applicable) pay to Licensor (in addition to, and at the same time as, any other consideration for that supply) an amount equal to such VAT.

 

11.2                         Records

 

Licensee may obtain a direction from the relevant Tax Authority for the retention and preservation by it of any VAT records relating to its period of use of any Licensed IP Rights and, if such directions are obtained, Licensee agrees to preserve any such records in such a manner and for such period as may be required by Applicable Law and shall allow Licensor, upon Licensor giving reasonable notice, reasonable access and copies of such records where reasonably required by Licensor for its Tax purposes.  If no such direction is obtained and any documents are required by Applicable Law to be preserved by Licensor, Licensee shall, as soon as reasonably practicable, deliver such documents to Licensor.

 

12.           CONFIDENTIALITY

 

12.1                         Each Party shall, and shall procure that its Representatives shall, comply with the provisions of clause 28 ( Confidentiality ) of the Separation Agreement in relation to:

 

(a)                                  all Information of the other Group that is either in its possession or is furnished by the other Group or its respective Representatives in connection with this Agreement; and

 

(b)                                  information relating to the provisions and subject matter of, and negotiations leading to, this Agreement.

 

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12.2                         Notwithstanding the provisions of this Clause 12, each of the Parties may make press releases, publications or presentations regarding their research and development using the Licensed IP Rights (collectively, a Publication ) provided that:

 

(a)                                  the publishing Party shall first deliver the proposed text of the Publication to the other Party for review at least thirty (30) Business Days prior to submission of the Publication to any publisher or other third party;

 

(b)                                  the receiving Party may, within thirty (30) Business Days of such delivery, object to the Publication on the grounds that it would involve the disclosure of that Party’s Confidential Information, or because there is patentable subject matter in which that Party has an interest that needs protection; and

 

(c)                                   upon receipt of a written object within the thirty (30) Business Day period, the publishing Party shall delete any references to the Confidential Information of the other Party and/or if requested to do so by the receiving Party shall delay disclosure of the Publication for up to sixty (60) days from the initial delivery of the Publication to enable the filing of patent applications on any patentable subject matter.

 

13.           NOTICES

 

13.1                         Form of Notice . Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it. It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Licensor shall be deemed notice to all members of Licensor Group, and any notice to Licensee shall be deemed notice to all members of Licensee Group.

 

13.2                         Effectiveness of Notice . A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

13.3                         Notice Details . The addresses and e-mail addresses of the Parties for the purpose of this Clause 13 are:

 

Novartis and each member of the Novartis Group

 

For the attention of: Head Legal M&A (Novartis International AG)

 

 

 

 

 

Novartis AG

 

 

Lichtstrasse 35,

 

 

4056 Basel,

 

 

Switzerland

 

 

 

 

 

jonathan.emery@novartis.com

 

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Alcon and each member of the Alcon Group

 

For the attention of: General Counsel

 

 

 

 

 

Alcon Inc.

 

 

Rue Louis-d’Affry 6,

 

 

1701 Fribourg,

 

 

Switzerland

 

 

 

 

 

royce.bedward@alcon.com

 

13.4                         Change of Notice Details . Licensor and Licensee shall each notify the other Party in writing of a change to its details in Clause 13.3 from time to time.

 

14.           DISPUTE RESOLUTION

 

14.1                         This Clause 14 ( Dispute Resolution ) shall apply to any dispute, controversy or claim arising out of or relating to this Agreement, including a dispute, controversy or claim relating to the existence, validity or termination of this Agreement (each, a Dispute ).

 

14.2                         Before entering into any arbitration pursuant to Clauses 14.4, a Party shall give written notice of a Dispute to the other Party (a Dispute Notice ). The Dispute Notice shall:

 

(a)                                  state that it is a Dispute Notice being submitted pursuant to this Clause14 ( Dispute Resolution );

 

(b)                                  identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(c)                                   set out any steps taken by that Party or its Affiliates to resolve it.

 

14.3

 

(a)                                  Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the Resolution Period ). The time limit specified in this Clause 14.3 may be extended by the written agreement of the Parties.

 

(b)                                  Notwithstanding the foregoing, either Party may, at any time, seek interim or provisional relief, whether from an emergency arbitrator appointed and acting in accordance with the LCIA Rules, a tribunal constituted under the LCIA Rules and/or from a national court of competent jurisdiction, in advance of or in aid of the arbitration proceedings contemplated by Clause 14.4.

 

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14.4                         If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(a)                                  the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the LCIA Rules );

 

(b)                                  the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(c)                                   the seat of arbitration shall be London;

 

(d)                                  the written and spoken language to be used in the arbitral proceedings shall be English; and

 

(e)                                   the award of the arbitral tribunal shall be final and binding upon the parties and judgment may be entered on an award in any court of competent jurisdiction.

 

14.5                         Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Ancillary Agreement, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with Clause 14.4.

 

14.6                         The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this Clause 14.6 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

15.           MISCELLANEOUS PROVISIONS

 

15.1                         Assignment by Licensor

 

(a)                                  Licensor may assign its rights and obligations under this Agreement, or any of the Licensed IP Rights, to an Affiliate of Licensor or to a Third Party.

 

(b)                                  If Licensor transfers its rights in any Licensed IP Right to an Affiliate or to a Third Party, it shall be entitled to assign any element of this Agreement that relates to the Licensed IP Right to that Affiliate or Third Party.

 

15.2                         Assignment by Licensee

 

(a)                                  Subject to any prohibition or restriction of assignments or transfers pursuant to Clause 4 ( Third Party Restrictions ), Licensee may assign or transfer this Agreement and/or any of the rights granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights )  of this Agreement to any:

 

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(i)                                      Affiliate of Licensee; or

 

(ii)                                   Third Party in connection with the disposal to that Third Party of: (A) any Alcon Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensee’s business to which this Agreement relates.

 

(b)                                  If Licensee assigns or transfers any of its rights and/or obligations under this Agreement to an Affiliate or a Third Party, it shall notify Licensor as soon as practicable after such assignment or transfer together with particulars of the assignee or transferee.

 

15.3                     Permitted Assignees . Any permitted assignee or transferee under Clause 15.1 ( Assignment by Licensor ) or Clause 15.2 ( Assignment by Licensee ) will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and will inure to the benefit of the Parties and their respective successors and assigns.

 

15.4                     Waivers, Rights and Remedies . Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time.  No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

15.5                     Announcements . The provisions of clause 29 (Announcements) of the Separation Agreement shall apply to this Agreement.

 

15.6                         Further Assurances

 

(a)                                  Further Acts and Documents. Subject to the express limitations in this Agreement, each of the Parties shall, at the request (and expense) of the other Party, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or reasonably required to implement and give effect to this Agreement including, at the request of Licensee, the Licensor’s provision of, or access to,  Licensed Know-How in its possession or control that it is legally entitled to disclose to Licensee and which is reasonably necessary to enable the Licensee to exercise its rights under this Agreement, and provided that Licensee shall not be required to:

 

(i)                                      supply the Licensee with the Licensed Know-How in any language other than the original language of the document in the possession or control of the licensor or an Affiliate of the Licensor as at the Effective Date;

 

(ii)                                   create, generate, record or reduce to writing any Licensed Know-How;

 

(iii)                                provide any Licensed Know-How not yet created or developed at the Effective Date;

 

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(iv)                               perform any conversion of electronic files or any translation of documentation or materials; or

 

(v)                                  transfer any prototypes or physical product samples.

 

(b)                                  Obligations of Agreement on Affiliates . Each of Licensor and Licensee shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

15.7                     No Third Party Enforcement Rights . A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

15.8                     Counterparts. This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

15.9                     Variations. No amendment of this Agreement shall be valid unless it is in writing and duly executed by or on behalf of all of the Parties to it.

 

15.10                  Invalidity . Each of the provisions of this Agreement is severable. If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the Parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

15.11                  Method of Payment and Set-Off . Any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or as otherwise agreed).  Any payments pursuant to this Agreement shall be effected by crediting for same day value the account specified by Licensor or Licensee (as the case may be) on behalf of the Person entitled to payment on or before the due date for payment.  Payment of a sum in accordance with this Clause 15.11 shall constitute a payment in full of the sum payable and shall be a valid discharge to the payer (and those on whose behalf such payment is made) of the payer’s obligation to make such payment and the payer (and those on whose behalf such payment is being made) shall not be obligated to see to the application of the payment as between those on whose behalf payment is received.

 

15.12                  Costs . Except as otherwise provided in this Agreement or as otherwise agreed in writing between the Parties, Licensor and Licensee shall each be responsible for its own costs, charges and other expenses (including those of members of their respective Groups) incurred in connection with this Agreement.

 

15.13                  Whole Agreement . This Agreement and the other Transaction Documents contain the entire agreement and understanding between the Parties with respect to the subject matter hereof and supersede all prior agreements and understandings (whether oral or written) relating to such subject matter.  None of the Parties shall be liable or bound to any other Party in any manner by any representations, warranties or covenants relating to such subject matter except as specifically set forth herein or therein.

 

15.14                  Governing Law . This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in

 

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accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

15.15                  Specific Performance . In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement.  The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy.  The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived.  Any requirements for the securing or posting of any bond with such remedy are waived.

 

[Signature Page Follows]

 

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SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

 

 

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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SCHEDULE 1
DEFINITIONS AND INTERPRETATION

 

1.              Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Affiliate has the meaning given to it in the Separation Agreement;

 

Agreement means this patent and know-how license agreement;

 

Alcon Existing Products means:

 

(a)                                  any contact lens or contact lens care product, including those products listed under part 1 ( Vision Care ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  any ophthalmic surgical products, including those products listed under part 2 ( Surgical (incl. Diagnostics) ) of the “Alcon” tab of the Products List and  any product having substantially the same formula as any of them;

 

(c)                                   any other products listed under part 3 ( Dry Eye & Ocular Health ), Part 4 ( Viscoelastics ) or Part 5 ( R&D and Clinical Trials ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(d)                                  any other ophthalmic or vision care product that is, as of the date of this Agreement or at any time prior, lawfully Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates, and any product having substantially the same formula as any of them and that is or has been Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates (in which case, such product shall constitute an Alcon Existing Product in all jurisdictions);

 

in each case other than any product included within paragraphs (a), (b) or (c) of the definition of Novartis Existing Products.

 

Alcon Future Products means any products owned or controlled by Alcon or its Affiliates after the Effective Date, excluding the Alcon Existing Products;

 

Alcon Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields );

 

Alcon Optional Products has the meaning given in  Exhibit 3 ( Alcon Optional Products );

 

Alcon Products means: (i) the Alcon Existing Products; (ii) the Alcon Future Products; and (iii) the Alcon Optional Products;

 

Applicable Law has the meaning given to it in the Separation Agreement;

 

Authorization has the meaning set forth in Clause 4.2(a);

 

Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

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Commercialise has the meaning given to it in the Separation Agreement;

 

Commercially Reasonable Efforts has the meaning given to it in the Separation Agreement;

 

Confidential Information has the meaning given in Clause 12;

 

Costs means losses, damages, costs (including reasonable legal costs on an indemnity basis) and expenses (including Tax), in each case of any nature whatsoever;

 

Development means, with respect to any Product, any research, pre-clinical or non-clinical testing, clinical studies, chemistry manufacturing controls (CMC), quality, statistical analysis or report writing, and related development and regulatory activities associated therewith, and Develop and Developed shall be construed accordingly;

 

Dispute has the meaning set forth on Clause 14.1;

 

Dispute Notice has the meaning set forth in Clause 14.2;

 

Effective Date means the date of this Agreement;

 

Governmental Entity has the meaning given to it in the Separation Agreement;

 

Group has the meaning given to it in the Separation Agreement;

 

Improvement means any improvement, refinement, enhancement, modification, adaptation or development of any of the Licensed IP Rights;

 

Insolvency Event means, in relation to a Party, any of the following:

 

(a)                                  it is unable or admits inability to pay its debts as they fall due; suspends or threatens to suspend making payments on any of its debts; or, by reason of actual or anticipated financial difficulties, commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;

 

(b)                                  the value of its assets is less than its liabilities (taking into account contingent and prospective liabilities);

 

(c)                                   a moratorium is declared in respect of any of its indebtedness (if a moratorium occurs, the ending of the moratorium will not remedy any Insolvency Event caused by that moratorium);

 

(d)                                  any corporate action, legal proceedings or other procedure or step is taken   (whether by a Party, its directors or a Third Party) in relation to:

 

(i)                                      the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration (whether out of court or otherwise) or reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise);

 

(ii)                                   a composition, compromise, assignment or arrangement with any creditor;

 

(iii)                                the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager or other similar officer in respect of the Party or any of its assets (in each case whether out of court or otherwise);

 

20


 

(iv)                               enforcement of any security over any assets of Licensor or Licensee (as applicable), including a creditor attaching or taking possession of, or distress, execution, sequestration or other process being levied or enforced upon or sued against all or any part of the assets of the relevant party;

 

(v)                                  a meeting of the Party, its directors or its members being convened for the purpose of considering any resolution for, or to petition for, or to apply for or to file documents with a court for its winding-up, administration (whether out of court or otherwise) or dissolution, or any such resolution is passed;

 

(vi)                               any person presenting a petition, application or motion for the winding-up, administration (whether out of court or otherwise) or dissolution of the Party; or

 

(vii)                            the directors or other officers of the Party requesting the appointment of or giving notice of their intention to appoint or take any step with a view to appointing a liquidator, receiver, administrator, administrative receiver, compulsory manager, trustee in bankruptcy or other similar officer in respect of the Party (in each case whether out of court or otherwise),

 

(but paragraph (d) shall not apply to a solvent liquidation of the company or any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within fourteen (14) days of its presentation); or

 

(e)                                   there occurs in relation to the Party or any of its assets in any country or territory in which it is incorporated or carries on business or to the jurisdiction of whose courts it or any of its assets are subject any event which corresponds in that country or territory with any of those mentioned in (a) to (d);

 

Know-How means all existing and available technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data;

 

LCIA Rules  has the meaning given to it in Clause 14.4;

 

Licensed-In Third Party IP Rights means the patent rights and Know-How rights that are used by Licensor, or any Affiliate of Licensor, under license from a Third Party in the manufacture, distribution, promotion or sale of an Alcon Existing Product;

 

Licensed IP Rights means the Licensed Patents, Licensed Know-How and the Licensed-In Third Party IP Rights;

 

Licensed Know-How means the Know-How owned or controlled by Novartis or any Affiliate of Novartis as of the Effective Date that (i) is in the possession or control of Alcon as of the Effective Date, or  (ii) has been used in the design, manufacture or application of any Alcon Existing Product;

 

21


 

Licensed Patents means the: (i) patents and patent applications listed in Exhibit 1 ( Licensed Patents ); (ii) all patents and patent applications owned or controlled by Novartis or any Affiliate of Novartis immediately following the Effective Date that, but for the licenses granted in this Agreement, would be infringed by the making, using, selling, offering for sale or importation of the Alcon Products; (iii) all equivalent, divisional and continuation applications (whether existing or made in the future) of those patents and patent applications, (iv) all patents that may be granted pursuant to any of those patent applications, and (v) any reissues, re-examinations and extensions of those patents, in the case of each of (i)-(v), in any jurisdiction;

 

Manufacture means, as applicable, the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality release, sample retention and stability testing of products, including the active ingredients of such products, and Manufacturing or Manufactured shall be construed accordingly;

 

Novartis Existing Products means

 

(a)                                  the products listed under Part 1 ( Pharmaceuticals ) or Part 6 ( R&D and Clinical Trials ) of the “Novartis” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  the products listed under the “Emerging Markets Brands” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)                                   the Sandoz Products; and

 

(d)                                  any other product as at the Effective Date that is not an Alcon Existing Product.

 

Novartis Future Products means any products owned or controlled by Novartis or its Affiliates, including Sandoz, after the Effective Date, excluding the Novartis Existing Products;

 

Novartis Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields );

 

Novartis Optional Products has the meaning given in Exhibit 4 ( Novartis Optional Products );

 

Novartis Products means: (i) the Novartis Existing Products; (ii) the Novartis Future Products; and (iii) the Novartis Optional Products;

 

Over-the-counter Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription;

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Product List has the meaning given to it in the Separation Agreement;

 

Publication has the meaning given to it in Clause 12.2;

 

Representatives has the meaning given to it in the Separation Agreement;

 

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Sandoz means Sandoz AG and any of its Subsidiaries;

 

Sandoz Products means any products which, as at the date of this Agreement, are researched, Developed, Manufactured, or Commercialised by Sandoz, or Commercialised as a generic or biosimilar product of the Sandoz division, provided, that if at the date of this Agreement, any product is Commercialised by both (i) Sandoz; and (ii) a member of the Alcon Group, pursuant to a Marketing Authorisation held solely by the Alcon Group, such product shall constitute an “Alcon Existing Product” when and to the extent Commercialised by a member of the Alcon Group and a “Sandoz Product” (and therefore a “Novartis Existing Product”) when and to the extent Commercialised by Sandoz.

 

Separation Agreement has the meaning given in the Recitals;

 

Separation Date has the meaning given in the Separation Agreement;

 

Shared Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields ).

 

Surviving Provisions means Clause 7 ( Ownership and Maintenance ), Clause 7.4(a)(ii) ( Grant Back License ), Clause 9.3 ( Consequences of Termination ), Clause 10 ( Limitation of liability ), Clause 12 ( Confidentiality ) and Clause 13 ( Miscellaneous Provisions );

 

Tax has the meaning given in the Tax Matters Agreement;

 

Taxing Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement dated on or around the date of this Agreement and entered into between Novartis and Alcon;

 

Term means the period commencing on the Effective Date and terminating on the Termination Date;

 

Termination Date has the meaning given in Clause 9.3 ( Consequences of Termination );

 

Territory means worldwide;

 

Third Party means any Person other than the Licensor, the Licensee or their Affiliates from time to time; and

 

VAT means, within the European Union, such tax, duty, assessment or similar charges as may be levied in accordance with (but subject to derogations from) Council Directive 2006/112/EC, and outside the European Union, any tax, duty, assessment or similar charges levied by reference to added value, turnover or sales, in each case including all interest, penalties and additions imposed thereon by any Tax Authority; and

 

Working Hours means 9.00 am to 5.00 pm in the relevant location on a Business Day.

 

2.              Interpretation . In this Agreement, unless the context otherwise requires:

 

(a)                                  headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

(b)                                  references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction; and

 

23


 

(c)                                   any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as without limitation and illustrative and shall not limit the sense of the words preceding those terms.

 

3.              Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.              Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

5.              Inconsistencies. Where there is any inconsistency between the definitions set out in Schedule 1 ( Definitions ) and the definitions set out in any Clause or any other Schedule or Exhibit, then, for the purposes of construing such Clause or Schedule or Exhibit, the definitions set out in such Clause, or Schedule or Exhibit (as applicable) shall prevail.

 

24


Exhibit 99.8

 

Execution Version

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 


 

PATENT AND KNOW-HOW LICENSE AGREEMENT

 


 


 

CONTENTS

 

ARTICLE

 

PAGE

 

 

 

 

1.

DEFINITIONS

 

1

 

 

 

 

2.

GRANT OF LICENSES

 

1

 

 

 

 

3.

SUB-LICENSES

 

4

 

 

 

 

4.

THIRD PARTY RESTRICTIONS

 

5

 

 

 

 

5.

DURATION

 

6

 

 

 

 

6.

DISCLAIMER OF WARRANTIES

 

6

 

 

 

 

7.

OWNERSHIP AND MAINTENANCE

 

7

 

 

 

 

8.

INFRINGEMENT

 

8

 

 

 

 

9.

TERMINATION

 

10

 

 

 

 

10.

LIMITATION OF LIABILITY

 

11

 

 

 

 

11.

TAX

 

11

 

 

 

 

12.

CONFIDENTIALITY

 

12

 

 

 

 

13.

NOTICES

 

12

 

 

 

 

14.

DISPUTE RESOLUTION

 

13

 

 

 

 

15.

MISCELLANEOUS PROVISIONS

 

15

 

 

 

 

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

 

19

 

i


 

PATENT AND KNOW-HOW LICENSE AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

(1)                                 ALCON INC. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification n                umber (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (the Licensor or Alcon ); and

 

(2)                                  NOVARTIS AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland (the Licensee or Novartis )

 

together, the Parties and each a Party .

 

Whereas:

 

(A)                                Novartis and Alcon have entered into a Separation and Distribution Agreement dated 8 April 2019, under which: (a) Novartis has agreed to transfer certain assets and license certain intellectual property rights to Alcon; and (b) Alcon has agreed to transfer certain assets and license certain intellectual property rights to Novartis (the Separation Agreement ).

 

(B)                                Alcon owns, or has the right to sub-license, the Licensed IP Rights.

 

(C)                                Pursuant to the Separation Agreement, Alcon now wishes to license (or procure that the relevant Affiliate of Alcon licenses) the Licensed IP Rights to Novartis on the terms of this Agreement.

 

IT IS AGREED:

 

1.                                       DEFINITIONS

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

2.                                       GRANT OF LICENSES

 

2.1                                Licensed Patents and Licensed Know-How

 

(a)                                  In consideration of the mutual promises and conditions set out in this Agreement and subject to the terms of this Agreement (including Clause 4 ( Third Party Restrictions )), Licensor hereby grants (or hereby procures the grant by the relevant Affiliate of Licensor) to Licensee with effect from the Effective Date:

 

(i)             a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) exclusive worldwide license under the

 

1


 

Licensed Patents and Licensed Know-How to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Novartis Existing Products in any field of use (other than the Shared Licensed Field);

 

(B)                                the Novartis Future Products in the Novartis Licensed Field; and

 

(C)                                the Novartis Optional Products in any field of use (other than the Shared Licensed Field), and

 

(ii)            a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) non-exclusive worldwide license under the Licensed Patents and Licensed Know-How to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Novartis Existing Products in the Shared Licensed Field;

 

(B)                                the Novartis Future Products in the Shared Licensed Field; and

 

(C)                                the Novartis Optional Products in the Shared Licensed Field.

 

2.2                                Licensed-In Third Party IP Rights

 

(a)                                  In consideration of the mutual promises and conditions set out in this Agreement and subject to the terms of this Agreement (including Clause 4 ( Third Party Restrictions )), Licensor hereby grants (or hereby procures the grant by the relevant Affiliate of Licensor) to Licensee with effect from the Effective Date:

 

(i)             a royalty-free, further sub-licensable (in accordance with Clause 3 ( Sub-licenses ), exclusive (subject to any other rights granted by the relevant Third Party licensor) worldwide sub-license under the Licensed-In Third Party IP Rights to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Novartis Existing Products in any field of use (other than the Shared Licensed Field);

 

(B)                                the Novartis Future Products in the Novartis Licensed Field; and

 

(C)                                the Novartis Optional Products in any field of use (other than the Shared Licensed Field), and

 

(ii)            a royalty-free, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), perpetual (subject to termination of this Agreement in accordance with Clause 9) non-exclusive worldwide license under the Licensed-In Third Party IP Rights to make, use, sell, offer for sale, import and otherwise Commercialise:

 

(A)                                the Novartis Existing Products in the Shared Licensed Field;

 

2


 

(B)                                the Novartis Future Products in the Shared Licensed Field; and

 

(C)                                the Novartis Optional Products in the Shared Licensed Field.

 

2.3                                Sandoz Products

 

(a)                                  For the avoidance of doubt: Sandoz Products are covered by the licenses granted by Alcon to Novartis under Clause 2.1(a)(i)(A) and Clause 2.1(a)(ii)(A) ( Grant of Rights under Licensed Patents and Licensed Know-How for Novartis Existing Products ), and 2.2(a)(i)(A) and 2.2(a)(ii)(A) ( Grant of Rights under Licensed-In Third Party IP Rights for Novartis Existing Products ) as Novartis Existing Products are defined to include Sandoz Products; and

 

(b)                                  Future Sandoz products are covered by the licenses granted by Alcon to Novartis under Clause 2.1(a)(i)(B) and Clause 2.1(a)(ii)(B) ( Grant of Rights under Licensed Patents and Licensed Know-How for Novartis Future Products ), and Clause 2.2(a)(i)(B) and Clause 2.2(a)(ii)(B) ( Grant of Rights under Licensed-In Third Party IP Rights for Novartis Future Products) , as Novartis Future Products include products of Novartis’s Affiliates (including Sandoz).

 

2.4                                Restrictions and Reservation of Rights

 

(a)                                  The licenses and sub-licenses granted under Clause 2.1(i)(B) ( Licensed Patents and Licensed Know-How — Novartis Future Products ) and Clause 2.2(i)(B) ( Licensed-In Third Party IP Rights — Novartis Future Products ) are limited solely to the Novartis Licensed Field, and shall not include any right for Licensee to make or have made the Novartis Future Products, or use or permit the use of the Licensed IP Rights, except in the Novartis Licensed Field.

 

(b)                                  Licensee acknowledges that, to the extent the licenses granted in Clause 2.2 ( Licensed-In Third Party IP Rights ) relate to territories in which Licensor or its Affiliates have not been granted a license under the terms of the Third Party licenses for the Licensed-In Third Party IP Rights, then the licenses granted in Clause 2.2 ( Licensed-In Third Party IP Rights ) shall not extend to such territories.

 

(c)                                   Licensee further acknowledges that, to the extent the licenses granted in Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) relate to territories: (a) in which Licensor or its Affiliates, or Third Party owner (in the case of Licensed-In Third Party IP Rights) have not registered the Licensed Patents; (b) where the registrations have expired or become abandoned; or (c) in which the patent applications included in the Licensed Patents are still pending and cannot be licensed under local laws, then only rights in the remaining patent registrations in the Licensed Patents and the Licensed Know-How are licensed under the terms of this Agreement; provided that once the Licensed Patents are registered in the relevant territories (and, in the case of Licensed-In Third Party IP Rights, to the extent these territories are included in the

 

3


 

scope of such rights licensed to the Licensor) these registrations will be included in the scope of the license grant in Clause 2.1 ( Licensed Patents and Licensed Know-How ) and, to the extent permitted under the relevant Third Party licenses, Clause 2.2 ( Licensed-In Third Party IP Rights ).

 

(d)                                  Nothing in this Agreement shall be construed as conferring (whether by implication, estoppel or otherwise) upon the Licensee any right, title or interest in any Intellectual Property Rights owned or controlled by the Licensor other than those expressly granted in this Agreement. For the avoidance of doubt, the exclusivity granted to Licensee under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) apply solely to the products and fields of use specified in such clauses and do not apply (i) to other products or fields of use, or (ii) to the Licensed IP Rights other than in relation to the rights granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) for the specified products and fields of use.

 

3.                                       SUB-LICENSES

 

3.1                                Subject to Clause 4 ( Third Party Restrictions ), Licensee may sub-license or sub-contract the rights granted to it under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ) of this Agreement, without the consent of Licensor, provided that:

 

(a)                                  the terms of the sub-license or sub-contract are consistent with the provisions of this Agreement and include provisions that:

 

(i)                                      prohibit further sub-licensing or sub-contracting by the sub-contractor or sub-licensee;

 

(ii)            impose obligations of confidentiality on the sub-licensee or sub-contractor which are no less onerous than those set out in Clause 12 ( Confidentiality ); and

 

(iii)           allow Licensor, its Affiliates and/or the owner of the Licensed-In Third Party IP Rights, as applicable, as third party beneficiary of the obligations of the sub-licensee of the Licensed IP Rights, to enforce any of the obligations under this Agreement directly against that sub-licensee (either: (1) without any requirement to join Licensee as a party to any proceedings; or (2) where Licensee would be a necessary party to any such proceedings, with Licensee’s express upfront agreement to be joined as a party) or to obtain any consent from Licensee, and impose a governing law that permits the enforceability of the requirements under this Clause 3.1(a)(iii);

 

(b)                                  the sub-license or sub-contract automatically terminates to the extent this Agreement is terminated;

 

(c)                                   any act of the sub-licensee or sub-contractor which would, if committed by Licensee, be a breach of this Agreement shall be treated for the purposes of

 

4


 

this Agreement as an equivalent breach by Licensee of the terms of this Agreement; and

 

(d)                                  where a sub-license is granted to a Third Party, Licensee shall, as soon as reasonably practicable, notify Licensor of that sub-license granted under this Clause 3 and shall, on request, provide a copy of that executed sub-license to Licensor.

 

4.                                       THIRD PARTY RESTRICTIONS

 

4.1                                The licenses granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights )  shall be limited by, and subject to, any existing contractual terms as at the Effective Date, and (subject to the exclusivity granted to Licensee under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ))  as may be amended or agreed at any time after the Effective Date, between Licensor (or any Affiliate of Licensor) and a Third Party contained in any license, prior rights, settlement, co-existence or other agreement that relate to any of the Licensed IP Rights.  Licensee agrees to comply with:

 

(a)                                  the terms of any such agreement to the extent that they relate to the Licensed IP Rights, including the usage and registration of the Licensed IP Rights; and

 

(b)                                  all relevant Third Party royalty or other payment obligations in any such agreement to the extent that they relate to a Licensed IP Right in which case Licensee agrees to be responsible for any applicable royalty or other payment obligations to the relevant Third Party as if it were a party to the relevant agreement,

 

in each case, to the extent Licensee has been notified of those terms or obligations (as applicable).

 

4.2                                Consents under Third Party Licenses .

 

(a)                                  Licensee acknowledges and agrees that Licensor and its Affiliates may be required to obtain a Third Party consent, approval or permission (each, an Authorization ) to grant a sub-license of any relevant Licensed-In Third Party IP Rights to Licensee in accordance with Clause 2.2 ( Licensed-In Third Party IP Rights ) Where any Authorization is required:

 

(i)                                      Licensor shall (and shall procure that its Affiliates shall) use Commercially Reasonable Efforts to:

 

(A)           obtain that Authorization as soon as reasonably practicable following the Effective Date, provided that Licensor and its Affiliates shall not be required to obtain any Authorizations where doing so would require a Third Party license to be changed or amended in a manner that, in Licensor’s reasonable opinion, is detrimental to: (1) the terms of that Third Party license or to the rights provided under it to Licensor or its Affiliates; or (2) Licensor’s or any of its Affiliate’s relationship with the relevant Third Party licensor; and

 

5


 

(B)                                minimise the Costs of obtaining that Authorization;

 

(ii)            Licensor shall keep Licensee informed of the progress in obtaining that Authorization and shall provide Licensee with a copy of each Authorization as soon as reasonably practicable after receiving it;

 

(iii)           Licensee shall cooperate, at its own cost, with Licensor and the relevant Third Party in connection with obtaining that Authorization, including by providing any information reasonably requested by Licensee or the Third Party; and

 

(iv)                               Licensee shall reimburse Licensor for all reasonable documented Costs (other than any internal Costs) incurred by Licensor and its Affiliates in connection with obtaining the Authorizations, provided that Licensor shall notify Licensee of any such Costs as soon as reasonably practicable.

 

4.3                                Licensor shall not be in breach of this Agreement and its obligation under Clause 2.2 to grant a sub-license of the Licensed-In Third Party IP Rights to which the relevant Third Party license relates shall immediately cease, if:

 

(a)                                  a Third Party does not grant an Authorization, provided that Licensor has complied with Clause 4.2(a);

 

(b)                                  that Third Party license: (A) is terminated by Licensor or its Affiliates, as applicable, during the Term; and (B) does not permit the survival of the sub-license granted to Licensee under this Agreement; or

 

(c)                                   that Third Party license: (A) is terminated by the relevant Third Party licensor during the Term or expires during the Term, and (B) does not permit the survival of the sub-license granted to Licensee under his Agreement,

 

in the case of (b) above, provided that Licensor uses Commercially Reasonable Efforts and works with Licensee to agree, in good faith, alternative arrangements, if practicable, to give Licensee equivalent benefits or rights as it would have enjoyed in relation to the relevant Licensed-In Third Party IP Rights.

 

5.                                       DURATION

 

This Agreement commences on the Effective Date and, except to the extent terminated earlier in accordance with Clause 9 ( Termination ), shall continue in perpetuity

 

6.                                       DISCLAIMER OF WARRANTIES

 

ALL REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS OF ANY KIND, WHETHER EXPRESS OR IMPLIED (BY STATUTE OR OTHERWISE), REGARDING THE LICENSED IP RIGHTS OR RELATING TO THE TERMS AND CONDITIONS OR THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING ANY REPRESENTATION, WARRANTY OR UNDERTAKING OF SUITABILITY, FITNESS FOR PURPOSE OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS) ARE EXPRESSLY EXCLUDED TO THE MAXIMUM EXTENT PERMITTED BY LAW.

 

6


 

LICENSEE IS SOLELY RESPONSIBLE FOR ITS USE, RELIANCE OR IMPLEMENTATION OF THE LICENSED IP RIGHTS, INCLUDING ANY ACTIONS OR DECISIONS TAKEN OR NOT TAKEN AS A RESULT THEREOF.

 

7.                                       OWNERSHIP AND MAINTENANCE

 

7.1                                Ownership of Licensed IP Rights

 

(a)                                  Licensee acknowledges and agrees that:

 

(i)             all Patent and Know-How Rights and other rights in the Licensed IP Rights are the exclusive property of Licensor, its Affiliates or, in the case of the Licensed-In Third Party IP Rights, its licensors; and

 

(ii)            it shall not acquire, nor claim, any right, title or interest in or to any element of the Licensed IP Right by virtue of this Agreement or its use of the relevant Licensed IP Rights, other than the rights specifically granted to it under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights ).

 

7.2                                Improvements

 

(a)                                  As between the Parties, each Party shall own all rights in any Improvement that it or any of its Affiliates makes, without further obligation to the other Party, except as expressly provided in Clause 7.2(b).

 

(b)                                  Neither Party shall be required to grant the other a license or other right in or to any Improvements made by that Party, except to the extent the manufacture, sale, offer for sale or importation of any Alcon Existing Product or Novartis Existing Product (but only in the form that product is sold by Alcon or Novartis, as applicable, as at the Effective Date) would infringe the other Party’s intellectual property rights in the Improvement. In this case only, and for no additional consideration, the Party that owns the Improvement shall grant the otherwise infringing Party a non-exclusive, sub-licensable (in accordance with Clause 3) license in the Territory in the same fields of use as set out in Clause 2.1 ( Licensed Patents and Licensed Know-How ) for so long as the otherwise infringing Party continues to manufacture, sell, offer for sale or import any Alcon Existing Product or Novartis Existing Product, in the form that product is sold by Licensor as at the Effective Date.

 

7.3                                Maintenance of Licensed Patents

 

(a)                                  Subject to Clause 7.4 ( Abandonment or Lapse of Licensed Patents ), Licensor shall:

 

(i)             pay renewal fees and take all reasonable actions to maintain the registered Licensed Patents owned by Licensor or any Affiliate of Licensor;

 

(ii)            not abandon or allow to lapse any registered Licensed Patents owned by Licensor or any Affiliate of Licensor and set out in  Exhibit 1 ( Licensed Patents ); and

 

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(iii)           use Commercially Reasonable Efforts to prosecute to grant any applications for registered Licensed Patents owned by Licensor or any Affiliate of Licensor.

 

For the avoidance of doubt, as used in this Agreement, “abandon or allow to lapse” does not include actions taken by Licensor during the ordinary course of patent prosecution, for example instructions regarding claim scope or designation of territories, but does include, among other actions, non-payment of renewal fees.

 

7.4                                Abandonment or Lapse of Licensed Patents

 

(a)                                  If, during the Term, Licensor wishes to abandon or allow any registration or application for a Licensed Patent owned by Licensor or any Affiliate of Licensor and set out in Exhibit 1 ( Licensed Patents ), then Licensor shall notify Licensee of the same at least sixty (60) calendar days in advance of the expiry/abandonment date of such Licensed Patent.  Licensee shall have a period of thirty (30) calendar days from the date of receipt of the notice to confirm whether or not it is interested in maintaining the relevant Licensed Patent(s), and:

 

(i)             if Licensee confirms in writing that it is not interested in maintaining the relevant Licensed Patent(s) or fails to notify Licensor of its decision within thirty (30) calendar days from the date of receipt of the notice, then Licensor shall be free to surrender, abandon or allow to lapse the relevant Licensed Patent(s); or

 

(ii)            if Licensee confirms in writing within thirty (30) calendar days from the date of receipt of the notice that it is interested in maintaining the relevant Licensed Patent(s), then Licensor shall assign, at Licensee’s cost, the relevant Licensed Patent(s) to Licensee and Licensee shall take over the prosecution or maintenance of the relevant Licensed Patent(s) and all associated Costs. If any Licensed Patent is assigned to Licensee under this Clause (ii), Licensee shall, with effect from the date of that assignment, grant to Licensor and Affiliates of Licensor a non-exclusive, sub-licensable (in accordance with Clause 3 ( Sub-licenses )), royalty-free, worldwide, perpetual (subject to termination of this Agreement in accordance with Clause 9) license under that Licensed Patent to make, use, sell, offer for sale and import products of Licensor and Affiliates of Licensor in any field of use other than the Novartis Licensed Field.

 

8.                                       INFRINGEMENT

 

8.1                                Nothing in this Agreement shall constitute any representation that the use of any Licensed IP Right does not, or will not, infringe any intellectual property rights owned by a Third Party.

 

8.2                                Licensee shall immediately notify Licensor in writing of any of the following matters that comes to its attention (giving full particulars of the matter, the identity of the Third Party and the urgency of any actions required or recommended to be taken):

 

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(a)                                  any actual, suspected or threatened infringement of any element of a Licensed IP Right by a Third Party;

 

(b)                                  any allegation or complaint made by any Third Party that any element of a Licensed IP Right is invalid or that use of any element of a Licensed IP Right infringes any Third Party right; or

 

(c)                                   any other attack on or claim related to any element of a Licensed IP Right or use of such Licensed IP Right.

 

8.3                                In respect of any matter described in Clause 8.2 above:

 

(a)                                  Licensee shall not make any admissions other than to Licensor;

 

(b)                                  Subject to Clause 8.4, Licensor shall decide, in its absolute discretion whether or not to take action, and what action to take, and shall have exclusive control over any resulting claims, actions and proceedings; and

 

(c)                                   if Licensor decides to take any action  in respect of any such matter, Licensee shall (and shall procure that its Affiliates and sub-licensees shall), at Licensor’s cost, provide any assistance that Licensor reasonably requires (including bringing proceedings or joining any proceedings brought by Licensor). Subject to Clause 8.5, any award of Costs or compensation in connection with any of those matters shall be solely for the account of Licensor after reimbursement of Licensee’s reasonable costs incurred in its cooperation under this Clause 8.3(c).

 

8.4                                If either (a) Licensor notifies Licensee that Licensor does not intend to take any action in respect of any matter described in Clause 8.2 above or three (3) months have elapsed since Licensee provided notice of a matter described in Clause 8.2 without Licensor taking any action; and that matter relates to: (i) a country in the Territory in which Licensee or an Affiliate of Licensee operates; and (ii) the Licensed Novartis Field, or (b) the matter relates to or, in Licensee’s reasonable opinion, will impact a product covered under the Licensed IP Rights which the Licensee has Commercialised or intends to Commercialise within  twenty-four (24) months from the date Licensee provided notice of a matter (or such time period as otherwise agreed by the Parties on a case-by-case basis) described in Clause 8.2 then under either (a) or (b) and subject to the terms of the Licensed-In Third Party IP Rights, if applicable, Licensee may take action in its own name in respect of that matter and control any resulting claim(s), action(s) and proceeding(s), provided that, prior to taking any material action or decision with regards to that matter (including commencing any claim(s), action(s) or proceeding(s) or settling any dispute) Licensee shall consult in good faith with Licensor, shall seek Licensor’s consent for that material action or decision (such consent not to be unreasonably withheld) and shall not take any such action or decision without that consent. If Licensee (or its Representatives) takes any action or decision in respect of a matter under this Clause 8.4 that Licensor has not consented to, Licensee shall indemnify Licensor and its Representatives, against all Costs or other liabilities as a result of that action or decision. For the avoidance of doubt, the Parties acknowledge that it shall not be unreasonable for Licensor to withhold its consent under this Clause 8.4 to the extent that, in Licensor’s reasonable opinion, Licensee’s taking of the relevant material action or decision would be

 

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detrimental to the business of Licensor or any Affiliate of Licensor (including in respect of its relationship with any of its suppliers or customers).

 

8.5                       Licensor shall (and shall procure that its Affiliates shall), at Licensee’s cost, provide any assistance that Licensee reasonably requires under Clause 8.4  (including bringing proceedings or joining any proceedings brought by Licensee). Any award of Costs or compensation in connection with any claim(s), action(s) or proceeding(s) brought by Licensee under Clause 8.4 shall be solely for the account of Licensee after reimbursement of Licensor (and Licensor’s Affiliates’) reasonable costs incurred in its or their cooperation under this Clause 8.5.

 

9.              TERMINATION

 

9.1                                Notwithstanding Clause 5 ( Duration ), Licensor may terminate this Agreement in part or in its entirety, with immediate effect, by written notice to Licensee if:

 

(a)                                  Licensee commits a breach of any material obligation under this Agreement and, in the case of a breach that is capable of remedy, fails to remedy it within ninety (90) days of receipt of a written notice from Licensor giving full particulars of the breach and requiring it to be remedied;

 

(b)                                  Licensee or an Affiliate of Licensee challenges Licensor’s or any of its Affiliate’s’ entitlement to own, to use or to license the use of any of the Licensed IP Rights; or

 

(c)                                   an Insolvency Event occurs in relation to Licensee.

 

9.2                                For the purposes of Clause 9.1(a), a breach shall be considered capable of remedy if Licensee can comply with the provision in question in all respects other than as to time of performance.

 

9.3                                Consequences of termination .

 

On the date of termination of this Agreement for any reason (in each case, the Termination Date ),

 

(a)                                  all rights and licenses granted pursuant to this Agreement (other than any rights granted to Licensor in accordance with Clause 7.4(a)(ii) ( Grant Back License )) (shall cease with immediate effect and shall revert to Licensor;

 

(b)                                  all obligations of Licensor or its Affiliates to Licensee under this Agreement shall cease with immediate effect;

 

(c)                                   all outstanding sums payable by Licensee to Licensor shall immediately become due and payable;

 

(d)                                  Licensee shall cease, with immediate effect, to make or permit to be made any use of the Licensed IP Rights; and

 

(e)                                   Licensee shall, as soon as practicable on request by Licensor (and at Licensee’s expense):

 

(i)                                      return to Licensor all written documents and other materials relating to Licensor, to any Affiliate of Licensor or to this Agreement

 

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(including any Confidential Information) or in relation to which any of the Licensed IP Rights are being or have been used by Licensee, which is under Licensee or any of its Affiliate’s control, without keeping any copies thereof (other than to the extent required by Applicable Law);

 

(ii)                                   destroy all information or other documents derived from Confidential Information; and

 

(iii)           so far as it is practicable to do so, expunge Confidential Information of Licensor or Licensor’s Affiliates from any computer, system (including Cloud-based data systems) or other device used by or on behalf of Licensee and its Affiliates.

 

9.4                                No releases from accrued liabilities and Surviving Provisions .

 

Termination of this Agreement shall not release either Party from any liability that, at the time of termination or expiry, has already accrued to the other Party.  The Surviving Provisions, together with any other Clause reasonably intended to survive termination or expiry, shall survive termination or expiry of this Agreement.

 

10.           LIMITATION OF LIABILITY

 

10.1                         TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR SHALL NOT BE LIABLE TO LICENSEE FOR ANY COSTS, EXPENSES, LOSSES OR DAMAGES (IN EACH CASE, WHETHER DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL OR CONSEQUENTIAL, AND WHETHER ECONOMIC OR OTHER) ARISING FROM LICENSEE’S EXERCISE OF THE RIGHTS GRANTED TO IT UNDER THIS AGREEMENT, WHETHER OR NOT LICENSEE OR ANY OF ITS AFFILIATES HAVE BEEN ADVISED OF, OR OTHERWISE MIGHT OR SHOULD HAVE ANTICIPATED, THE POSSIBILITY OR LIKELIHOOD OF SUCH COSTS, EXPENSES, LOSSES OR DAMAGES.

 

10.2                         Nothing in this Agreement shall have the effect of excluding or limiting any liability of either Party for gross negligence, wilful misconduct, death or personal injury caused by negligence or for fraud or any other liability that cannot be excluded by Applicable Law.

 

10.3                         Neither Party shall have any duty or obligation under this Agreement except as expressly set out in this Agreement.

 

11.           TAX

 

11.1                         General

 

Any sum payable by Licensee to Licensor under this Agreement is exclusive of any applicable VAT.  If any supply is treated as or deemed made by Licensor or an Affiliate of Licensor under this Agreement and Licensor or an Affiliate of Licensor is required to account for VAT in respect of that supply, Licensee shall, against receipt of a valid VAT invoice (if applicable) pay to Licensor (in addition to, and at the same time as, any other consideration for that supply) an amount equal to such VAT.

 

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11.2                         Records

 

Licensee may obtain a direction from the relevant Tax Authority for the retention and preservation by it of any VAT records relating to its period of use of any Licensed IP Rights and, if such directions are obtained, Licensee agrees to preserve any such records in such a manner and for such period as may be required by Applicable Law and shall allow Licensor, upon Licensor giving reasonable notice, reasonable access and copies of such records where reasonably required by Licensor for its Tax purposes.  If no such direction is obtained and any documents are required by Applicable Law to be preserved by Licensor, Licensee shall, as soon as reasonably practicable, deliver such documents to Licensor.

 

12.           CONFIDENTIALITY

 

12.1                         Each Party shall, and shall procure that its Representatives shall, comply with the provisions of clause 28 ( Confidentiality ) of the Separation Agreement in relation to:

 

(a)                                  all Information of the other Group that is either in its possession or is furnished by the other Group or its respective Representatives in connection with this Agreement; and

 

(b)                                  information relating to the provisions and subject matter of, and negotiations leading to, this Agreement.

 

12.2                         Notwithstanding the provisions of this Clause 12, each of the Parties may make press releases, publications or presentations regarding their research and development using the Licensed IP Rights (collectively, a Publication ) provided that:

 

(a)                                  the publishing Party shall first deliver the proposed text of the Publication to the other Party for review at least thirty (30) Business Days prior to submission of the Publication to any publisher or other third party;

 

(b)                                  the receiving Party may, within thirty (30) Business Days of such delivery, object to the Publication on the grounds that it would involve the disclosure of that Party’s Confidential Information, or because there is patentable subject matter in which that Party has an interest that needs protection; and

 

(c)                                   upon receipt of a written object within the thirty (30) Business Day period, the publishing Party shall delete any references to the Confidential Information of the other Party and/or if requested to do so by the receiving Party shall delay disclosure of the Publication for up to sixty (60) days from the initial delivery of the Publication to enable the filing of patent applications on any patentable subject matter.

 

13.           NOTICES

 

13.1                         Form of Notice . Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it. It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Licensor shall be deemed notice to all members of Licensor Group, and any notice to Licensee shall be deemed notice to all members of Licensee Group.

 

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13.2                         Effectiveness of Notice . A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

13.3                         Notice Details . The addresses and e-mail addresses of the Parties for the purpose of this Clause 13 are:

 

Alcon and each member of the Alcon Group

For the attention of: General Counsel

 

Alcon Inc.

Rue Louis-d’Affry 6,

1701 Fribourg,

Switzerland

 

royce.bedward@alcon.com

 

 

Novartis and each member of the Novartis Group

For the attention of: Head Legal M&A

(Novartis International AG)

 

Novartis AG

Lichtstrasse 35,

4056 Basel,

Switzerland

 

jonathan.emery@novartis.com

 

13.4                         Change of Notice Details . Licensor and Licensee shall each notify the other Party in writing of a change to its details in Clause 13.3 from time to time.

 

14.           DISPUTE RESOLUTION

 

14.1                         This Clause 14 ( Dispute Resolution ) shall apply to any dispute, controversy or claim arising out of or relating to this Agreement, including a dispute, controversy or claim relating to the existence, validity or termination of this Agreement (each, a Dispute ).

 

14.2                         Before entering into any arbitration pursuant to Clauses 14.4, a Party shall give written notice of a Dispute to the other Party (a Dispute Notice ). The Dispute Notice shall:

 

(a)                                  state that it is a Dispute Notice being submitted pursuant to this Clause14 ( Dispute Resolution );

 

(b)                                  identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(c)                                   set out any steps taken by that Party or its Affiliates to resolve it.

 

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14.3

 

(a)                                  Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the Resolution Period ). The time limit specified in this Clause 14.3 may be extended by the written agreement of the Parties.

 

(b)                                  Notwithstanding the foregoing, either Party may, at any time, seek interim or provisional relief, whether from an emergency arbitrator appointed and acting in accordance with the LCIA Rules, a tribunal constituted under the LCIA Rules and/or from a national court of competent jurisdiction, in advance of or in aid of the arbitration proceedings contemplated by Clause 14.4.

 

14.4                         If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(a)                                  the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the LCIA Rules );

 

(b)                                  the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(c)                                   the seat of arbitration shall be London;

 

(d)                                  the written and spoken language to be used in the arbitral proceedings shall be English; and

 

(e)                                   the award of the arbitral tribunal shall be final and binding upon the parties and judgment may be entered on an award in any court of competent jurisdiction.

 

14.5                         Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Ancillary Agreement, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with Clause 14.4.

 

14.6                         The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this Clause 14.6 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

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15.           MISCELLANEOUS PROVISIONS

 

15.1                         Assignment by Licensor

 

(a)                                  Licensor may assign its rights and obligations under this Agreement, or any of the Licensed IP Rights, to an Affiliate of Licensor or to a Third Party.

 

(b)                                  If Licensor transfers its rights in any Licensed IP Right to an Affiliate or to a Third Party, it shall be entitled to assign any element of this Agreement that relates to the Licensed IP Right to that Affiliate or Third Party.

 

15.2                         Assignment by Licensee

 

(a)                                  Subject to any prohibition or restriction of assignments or transfers pursuant to Clause 4 ( Third Party Restrictions ), Licensee may assign or transfer this Agreement and/or any of the rights granted under Clause 2.1 ( Licensed Patents and Licensed Know-How ) and Clause 2.2 ( Licensed-In Third Party IP Rights )  of this Agreement to any:

 

(i)                                      Affiliate of Licensee; or

 

(ii)            Third Party in connection with the disposal to that Third Party of: (A) any Novartis Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensee’s business to which this Agreement relates.

 

(b)                                  If Licensee assigns or transfers any of its rights and/or obligations under this Agreement to an Affiliate or a Third Party, it shall notify Licensor as soon as practicable after such assignment or transfer together with particulars of the assignee or transferee.

 

15.3                     Permitted Assignees . Any permitted assignee or transferee under Clause 15.1 ( Assignment by Licensor ) or Clause 15.2 ( Assignment by Licensee ) will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and will inure to the benefit of the Parties and their respective successors and assigns.

 

15.4                     Waivers, Rights and Remedies . Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time.  No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

15.5                     Announcements . The provisions of clause 29 (Announcements) of the Separation Agreement shall apply to this Agreement.

 

15.6                         Further Assurances

 

(a)                                  Further Acts and Documents. Subject to the express limitations in this Agreement, each of the Parties shall, at the request (and expense) of the other Party, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or

 

15


 

reasonably required to implement and give effect to this Agreement including, at the request of Licensee, the Licensor’s provision of, or access to,  Licensed Know-How in its possession or control that it is legally entitled to disclose to Licensee and which is reasonably necessary to enable the Licensee to exercise its rights under this Agreement, and provided that Licensee shall not be required to:

 

(i)                                      supply the Licensee with the Licensed Know-How in any language other than the original language of the document in the possession or control of the licensor or an Affiliate of the Licensor as at the Effective Date;

 

(ii)            create, generate, record or reduce to writing any Licensed Know-How;

 

(iii)           provide any Licensed Know-How not yet created or developed at the Effective Date;

 

(iv)                               perform any conversion of electronic files or any translation of documentation or materials; or

 

(v)                                  transfer any prototypes or physical product samples.

 

(b)                                  Obligations of Agreement on Affiliates . Each of Licensor and Licensee shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

15.7                     No Third Party Enforcement Rights . A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

15.8                     Counterparts. This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

15.9                     Variations. No amendment of this Agreement shall be valid unless it is in writing and duly executed by or on behalf of all of the Parties to it.

 

15.10                  Invalidity . Each of the provisions of this Agreement is severable. If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the Parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

15.11                  Method of Payment and Set-Off . Any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or as otherwise agreed).  Any payments pursuant to this Agreement shall be effected by crediting for same day value the account specified by Licensor or Licensee (as the case may be) on behalf of the Person entitled to payment on or before the due date for payment.  Payment of a sum in accordance with this Clause 15.11 shall constitute a payment in full of the sum payable and shall be a valid discharge to the payer (and those on whose behalf such payment is made) of

 

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the payer’s obligation to make such payment and the payer (and those on whose behalf such payment is being made) shall not be obligated to see to the application of the payment as between those on whose behalf payment is received.

 

15.12                  Costs . Except as otherwise provided in this Agreement or as otherwise agreed in writing between the Parties, Licensor and Licensee shall each be responsible for its own costs, charges and other expenses (including those of members of their respective Groups) incurred in connection with this Agreement.

 

15.13                  Whole Agreement . This Agreement and the other Transaction Documents contain the entire agreement and understanding between the Parties with respect to the subject matter hereof and supersede all prior agreements and understandings (whether oral or written) relating to such subject matter.  None of the Parties shall be liable or bound to any other Party in any manner by any representations, warranties or covenants relating to such subject matter except as specifically set forth herein or therein.

 

15.14                  Governing Law . This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

15.15                  Specific Performance . In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement.  The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy.  The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived.  Any requirements for the securing or posting of any bond with such remedy are waived.

 

[Signature Page Follows]

 

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SIGNATURE

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

 

 

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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SCHEDULE 1
DEFINITIONS AND INTERPRETATION

 

1.             Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Affiliate has the meaning given to it in the Separation Agreement;

 

Agreement means this patent and know-how license agreement;

 

Alcon Existing Products means:

 

(a)                                  any contact lens or contact lens care product, including those products listed under part 1 ( Vision Care ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  any ophthalmic surgical products, including those products listed under part 2 ( Surgical (incl. Diagnostics) ) of the “Alcon” tab of the Products List and  any product having substantially the same formula as any of them;

 

(c)                                   any other products listed under part 3 ( Dry Eye & Ocular Health ), Part 4 ( Viscoelastics ) or Part 5 ( R&D and Clinical Trials ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(d)                                  any other ophthalmic or vision care product that is, as of the date of this Agreement or at any time prior, lawfully Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates, and any product having substantially the same formula as any of them and that is or has been Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates (in which case, such product shall constitute an Alcon Existing Product in all jurisdictions);

 

in each case other than any product included within paragraphs (a), (b) or (c) of the definition of Novartis Existing Products.

 

Alcon Future Products means any products owned or controlled by Alcon or its Affiliates after the Effective Date, excluding the Alcon Existing Products;

 

Alcon Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields );

 

Alcon Optional Products has the meaning given in Exhibit 3 ( Alcon Optional Products );

 

Alcon Products means: (i) the Alcon Existing Products; (ii) the Alcon Future Products; and (iii) the Alcon Optional Products;

 

Applicable Law has the meaning given to it in the Separation Agreement;

 

Authorization has the meaning set forth in Clause 4.2(a);

 

Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

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Commercialise has the meaning given to it in the Separation Agreement;

 

Commercially Reasonable Efforts has the meaning given to it in the Separation Agreement;

 

Confidential Information has the meaning given in Clause 12;

 

Costs means losses, damages, costs (including reasonable legal costs on an indemnity basis) and expenses (including Tax), in each case of any nature whatsoever;

 

Development means, with respect to any Product, any research, pre-clinical or non-clinical testing, clinical studies, chemistry manufacturing controls (CMC), quality, statistical analysis or report writing, and related development and regulatory activities associated therewith, and Develop and Developed shall be construed accordingly;

 

Dispute has the meaning set forth on Clause 14.1;

 

Dispute Notice has the meaning set forth in Clause 14.2;

 

Effective Date means the date of this Agreement;

 

Governmental Entity has the meaning given to it in the Separation Agreement;

 

Group has the meaning given to it in the Separation Agreement;

 

Improvement means any improvement, refinement, enhancement, modification, adaptation or development of any of the Licensed IP Rights;

 

Insolvency Event means, in relation to a Party, any of the following:

 

(a)                                  it is unable or admits inability to pay its debts as they fall due; suspends or threatens to suspend making payments on any of its debts; or, by reason of actual or anticipated financial difficulties, commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;

 

(b)                                  the value of its assets is less than its liabilities (taking into account contingent and prospective liabilities);

 

(c)                                   a moratorium is declared in respect of any of its indebtedness (if a moratorium occurs, the ending of the moratorium will not remedy any Insolvency Event caused by that moratorium);

 

(d)                                  any corporate action, legal proceedings or other procedure or step is taken   (whether by a Party, its directors or a Third Party) in relation to:

 

(i)                                      the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration (whether out of court or otherwise) or reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise);

 

(ii)         a composition, compromise, assignment or arrangement with any creditor;

 

(iii)        the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager or other similar officer in respect of the Party or any of its assets (in each case whether out of court or otherwise);

 

20


 

(iv)           enforcement of any security over any assets of Licensor or Licensee (as applicable), including a creditor attaching or taking possession of, or distress, execution, sequestration or other process being levied or enforced upon or sued against all or any part of the assets of the relevant party;

 

(v)            a meeting of the Party, its directors or its members being convened for the purpose of considering any resolution for, or to petition for, or to apply for or to file documents with a court for its winding-up, administration (whether out of court or otherwise) or dissolution, or any such resolution is passed;

 

(vi)           any person presenting a petition, application or motion for the winding-up, administration (whether out of court or otherwise) or dissolution of the Party; or

 

(vii)          the directors or other officers of the Party requesting the appointment of or giving notice of their intention to appoint or take any step with a view to appointing a liquidator, receiver, administrator, administrative receiver, compulsory manager, trustee in bankruptcy or other similar officer in respect of the Party (in each case whether out of court or otherwise),

 

(but paragraph (d) shall not apply to a solvent liquidation of the company or any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within fourteen (14) days of its presentation); or

 

(e)                                   there occurs in relation to the Party or any of its assets in any country or territory in which it is incorporated or carries on business or to the jurisdiction of whose courts it or any of its assets are subject any event which corresponds in that country or territory with any of those mentioned in (a) to (d);

 

Know-How means all existing and available technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data;

 

LCIA Rules  has the meaning given to it in Clause 14.4;

 

Licensed-In Third Party IP Rights means the patent rights and Know-How rights that are used by Licensor, or any Affiliate of Licensor, under license from a Third Party in the manufacture, distribution, promotion or sale of a Novartis Existing Product;

 

Licensed IP Rights means the Licensed Patents, Licensed Know-How and the Licensed-In Third Party IP Rights;

 

Licensed Know-How the Know-How owned or controlled by Alcon  as of the Effective Date that (i) is in the possession or control of Novartis as of the Effective Date, or  (ii) has been used in the design, manufacture or application of any Novartis Existing Product;

 

21


 

Licensed Patents means the: (i) patents and patent applications listed in  Exhibit 1  ( Licensed Patents ); (ii) all patents and patent applications owned or controlled by Alcon immediately following the Effective Date that, but for the license granted in this Agreement, would be infringed by the making, using, selling, offering for sale or importation of the Novartis Products; (iii) all equivalent, divisional and continuation applications (whether existing or made in the future) of those patents and patent applications, (iv) all patents that may be granted pursuant to any of those patent applications, and (v) any reissues, re-examinations and extensions of those patents, each of (i)-(v) in any jurisdiction;

 

Manufacture means, as applicable, the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality release, sample retention and stability testing of products, including the active ingredients of such products, and Manufacturing or Manufactured shall be construed accordingly;

 

Novartis Existing Products means

 

(a)                                  the products listed under Part 1 ( Pharmaceuticals ) or Part 6 ( R&D and Clinical Trials ) of the “Novartis” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  the products listed under the “Emerging Markets Brands” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)                                   the Sandoz Products; and

 

(d)                                  any other product as at the Effective Date that is not an Alcon Existing Product.

 

Novartis Future Products means any products owned or controlled by Novartis or its Affiliates, including Sandoz, after the Effective Date, excluding the Novartis Existing Products;

 

Novartis Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields );

 

Novartis Optional Products has the meaning given in Exhibit 4 ( Novartis Optional Products );

 

Novartis Products means: (i) the Novartis Existing Products; (ii) the Novartis Future Products; and (iii) the Novartis Optional Products;

 

Over-the-counter Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription;

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Product List has the meaning given to it in the Separation Agreement;

 

Publication has the meaning given to it in Clause 12.2;

 

Representatives has the meaning given to it in the Separation Agreement;

 

Sandoz means Sandoz AG and any of its Subsidiaries;

 

22


 

Sandoz Products means any products which, as at the date of this Agreement, are researched, Developed, Manufactured, or Commercialised by Sandoz, or Commercialised as a generic or biosimilar product of the Sandoz division, provided, that if at the date of this Agreement, any product is Commercialised by both (i) Sandoz; and (ii) a member of the Alcon Group, pursuant to a Marketing Authorisation held solely by the Alcon Group, such product shall constitute an “Alcon Existing Product” when and to the extent Commercialised by a member of the Alcon Group and a “Sandoz Product” (and therefore a “Novartis Existing Product”) when and to the extent Commercialised by Sandoz.

 

Separation Agreement has the meaning given in the Recitals;

 

Separation Date has the meaning given in the Separation Agreement;

 

Shared Licensed Field has the meaning given in Exhibit 2 ( Licensed Fields ).

 

Surviving Provisions means Clause 7 ( Ownership and Maintenance ), Clause 7.4(a)(ii) ( Grant Back License ), Clause 9.3 ( Consequences of Termination ), Clause 10 ( Limitation of liability ), Clause 12 ( Confidentiality ) and Clause 13 ( Miscellaneous Provisions );

 

Tax has the meaning given in the Tax Matters Agreement;

 

Taxing Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement dated on or around the date of this Agreement and entered into between Novartis and Alcon;

 

Term means the period commencing on the Effective Date and terminating on the Termination Date;

 

Termination Date has the meaning given in Clause 9.3 ( Consequences of Termination );

 

Territory means worldwide;

 

Third Party means any Person other than the Licensor, the Licensee or their Affiliates from time to time; and

 

VAT means, within the European Union, such tax, duty, assessment or similar charges as may be levied in accordance with (but subject to derogations from) Council Directive 2006/112/EC, and outside the European Union, any tax, duty, assessment or similar charges levied by reference to added value, turnover or sales, in each case including all interest, penalties and additions imposed thereon by any Tax Authority; and

 

Working Hours means 9.00 am to 5.00 pm in the relevant location on a Business Day.

 

2.             Interpretation . In this Agreement, unless the context otherwise requires:

 

(a)                                  headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

(b)                                  references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction; and

 

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(c)                                   any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as without limitation and illustrative and shall not limit the sense of the words preceding those terms.

 

3.             Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.             Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

5.             Inconsistencies. Where there is any inconsistency between the definitions set out in Schedule 1 ( Definitions ) and the definitions set out in any Clause or any other Schedule or Exhibit, then, for the purposes of construing such Clause or Schedule or Exhibit, the definitions set out in such Clause, or Schedule or Exhibit (as applicable) shall prevail.

 

24


Exhibit 99.9

 

Execution Version

 

8 APRIL 2019

 

NOVARTIS AG

 

ALCON INC.

 


 

BRAND LICENSE AGREEMENT

 


 


 

CONTENTS

 

CLAUSE

 

PAGE

 

 

 

 

1.

GRANT OF LICENSE

 

1

 

 

 

 

2.

SUBLICENSES

 

2

 

 

 

 

3.

DURATION

 

3

 

 

 

 

4.

CONDITIONS OF USE OF LICENSED IP RIGHTS

 

3

 

 

 

 

5.

CONDITIONS OF USE OF TRANSITIONALLY LICENSED IP RIGHTS

 

5

 

 

 

 

6.

MAINTENANCE OF LICENSED TMS

 

7

 

 

 

 

7.

APPROVAL AND INSPECTION

 

8

 

 

 

 

8.

OWNERSHIP OF LICENSED IP RIGHTS

 

8

 

 

 

 

9.

INFRINGEMENT

 

8

 

 

 

 

10.

TERMINATION

 

10

 

 

 

 

11.

LIMITATION OF LIABILITY

 

11

 

 

 

 

12.

TAX

 

11

 

 

 

 

13.

CONFIDENTIALITY

 

12

 

 

 

 

14.

NOTICES

 

12

 

 

 

 

15.

MISCELLANEOUS PROVISIONS

 

13

 

 

 

 

16.

DISPUTE RESOLUTION

 

15

 

 

 

 

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

 

18

 

i


 

BRAND LICENSE AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

(1)                                  NOVARTIS AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland (the Licensor or Novartis ); and

 

(2)                                  ALCON INC. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (the Licensee or Alcon ),

 

together, the Parties , and each a Party .

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

Whereas:

 

(A)                                Novartis and Alcon have entered into a Separation and Distribution Agreement dated 8 April 2019, under which: (a) Novartis has agreed to transfer certain assets and license certain intellectual property rights to Alcon; and (b) Alcon has agreed to transfer certain assets and license certain intellectual property rights to Novartis (the Separation Agreement ).

 

(B)                                Novartis is the owner of certain trademark rights, including the Licensed TMs.

 

(C)                                Pursuant to the Separation Agreement, Novartis now wishes to license (or procure that the relevant Affiliate of Novartis licenses) the Licensed IP Rights to Alcon on the terms of this Agreement.

 

IT IS AGREED:

 

1.       GRANT OF LICENSE

 

1.1          In consideration of the mutual promises and conditions set out in this Agreement, and subject to the terms of this Agreement, Licensor hereby grants, or hereby procures the grant by the relevant Affiliate of Licensor, to Licensee, with effect from the Effective Date, a royalty-free, assignable (in  accordance with Clause 15.2 ( Assignment by Licensee )), sub-licensable (in accordance with Clause 2 ( Sub-licenses ))

 

(a)                                  and, subject to Clause 1.3, exclusive license during the Transitional License Term (subject to earlier termination of this Agreement in accordance with Clause 10 ( Termination )) to use the Transitionally Licensed IP Rights (other than the Licensed Corporate Names) for the Transitional License Purpose;

 

(b)                                  and Non-exclusive license during the Transitional License Term (subject to earlier termination of this Agreement in accordance with Clause 10 ( Terminatio n)) to use the Licensed Corporate Names for the Transitional License Purpose; and

 

(c)                                   subject to Clause 1.3, exclusive and perpetual license (subject to termination of this Agreement in accordance with Clause 10 ( Termination )) to use the Perpetually Licensed IP Rights for the Perpetual License Purpose,

 

1


 

provided that, for (c), Alcon acknowledges that the license granted in this Clause 1.1 is exclusive other than with respect to Novartis’ and its Affiliates’ continued right to use the Perpetually Licensed IP Rights in connection with the making, using, selling, offering for sale, importing and otherwise Commercialising the Novartis Products in the Shared Licensed Field.

 

1.2          Licensee acknowledges that to the extent the licenses granted under Clause 1.1 includes jurisdictions in the Territory in which Licensor has not registered any of the Licensed IP Rights, Licensor licenses only its unregistered right, title and interest in the Licensed IP Rights (if any).

 

1.3          The licenses granted to Licensee under Clause 1.1 shall be subject to any rights granted by Licensor and its Affiliates to any Third Party in relation to the Transitionally Licensed IP Rights and the Perpetually Licensed IP Rights before the Effective Date.

 

1.4          Subject to Clause 1.5, any Party (and any relevant Affiliate of any Party, including, in the case of Licensee, any Affiliate of Licensee that is granted a sub-license in accordance with Clause 2 ( Sub-licenses )) may, at its own cost, take all steps required for the recordal of any license granted under Clause 1.1 at any relevant intellectual property registry in the Territory, provided that, it shall, unless otherwise agreed, use a short-form license confirming the key terms of this Agreement applicable to the relevant license(s) in a form mutually agreed by Licensor and Licensee. If requested, each Party shall, at the requesting Party’s cost, provide any reasonable assistance in connection with a recordal under this Clause 1.4 at an intellectual property registry in the Territory. Licensee shall (unless Licensor has assisted with that recordal) promptly inform Licensor of any recordal of a license granted under Clause 1.1 that is made by Licensee (or any Affiliate of Licensee) at any intellectual property registry in the Territory.

 

1.5          Licensee hereby grants, and agrees, as applicable, to cause its Affiliates to grant, to Licensor an irrevocable power of attorney, on behalf of Licensee or such applicable Affiliate, for the sole purpose of executing the cancellation of any recordal of a license granted under Clause 1.1 in any relevant intellectual property registry in the Territory upon termination of this Agreement.

 

1.6          The Parties acknowledge and agree that certain rights, including with respect to certain Licensed IP Rights, have been granted by the Licensor to the Licensee pursuant to Exhibit 9 ( Shared Moulds ) of the Manufacturing and Supply Agreement in connection with the use of Shared Moulds, and the relevant rights and obligations set out in that Exhibit shall govern the use of Shared Moulds.

 

2.       SUBLICENSES

 

2.1          Licensee may sub-license or sub-contract any of its rights under this Agreement, without the consent of Licensor,  to any:

 

(a)                                  Third Party or Affiliate of Licensee in the ordinary course of business or in relation to any part of its supply chain; and

 

(b)                                  Third Party in connection with the disposal to that Third Party of: (A) any Licensed  Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensor’s business,

 

in each case for the purpose of any of the activities set out in Clause 1.1, provided that:

 

(i)                          the terms of the sub-license or sub-contract are consistent with the provisions of this Agreement;

 

2


 

(ii)         the sub-license prohibits further sub-licensing or sub-contracting by the sub-contractor or sub-licensee (other than in the ordinary course of business for the purpose of any of the activities set out in Clause 1.1) without the prior written consent of Licensor;

 

(iii)                    the sub-license imposes obligations of confidentiality on the sub-licensee or sub-contractor which are no less onerous than those set out in Clause 13 ( Confidentiality );

 

(iv)     the sub-license automatically terminates if this Agreement expires or is terminated in respect of the relevant Licensed IP Rights;

 

(v)                      any act of the sub-licensee or sub-contractor which would, if committed by Licensee, be a breach of this Agreement shall be treated for the purposes of this Agreement as an equivalent breach by Licensee of the terms of this Agreement; and

 

(vi)                   where a sub-license is granted to a Third Party, Licensee shall, as soon as reasonably practicable, notify Licensor of that sub-license granted under this Clause 2 ( Sublicenses ) and shall, on request, provide a copy of that executed sub-license to Licensor.

 

2.2          Any sub-license of the Licensed IP Rights in accordance with this Agreement shall allow Licensor and/or its Affiliates, as applicable, as third party beneficiary of the obligations of the sub-licensee of the Licensed IP Rights, to enforce any of the obligations under this Agreement directly against that sub-licensee (either: (i) without any requirement to join Licensee as a party to any proceedings; or (ii) where Licensee would be a necessary party to any such proceedings, with Licensee’s express upfront agreement to be joined as a party) or to obtain any consent from Licensee, and shall impose a governing law that permits the enforceability of the requirements under this Clause 2.2.

 

3.       DURATION

 

This Agreement commences on the Effective Date and shall, except to the extent terminated earlier in accordance with Clause 10 ( Termination ):

 

(a)                                  in relation to the Perpetually Licensed IP Rights continue in perpetuity; and

 

(b)                                  in relation to the Transitionally Licensed IP Rights continue in force until midnight GMT of the last date of the relevant Transitional License Term,

 

(the Term ).

 

4.       CONDITIONS OF USE OF LICENSED IP RIGHTS

 

4.1          Licensee shall not use, or permit any of its Affiliates or any Third Party to use, the Licensed IP Rights for any purpose other than for the exercise or performance of its rights and obligations under this Agreement.

 

4.2          Licensee shall ensure that each Alcon Product is manufactured, distributed, promoted, marketed and sold in all material respects in accordance with Applicable Law, in each case, to the extent that any of those activities involves any use of the Licensed IP Rights, and complies with applicable industry requirements and standards in force in the jurisdiction in which that product is manufactured, distributed or sold.

 

3


 

4.3          In relation to any product manufactured, distributed or sold by, or on behalf of, Licensee that incorporates or is marketed by reference to a Formulation Mark, Licensee shall ensure that the product complies with the specification for that Formulation Mark as described in Exhibit 4 ( Formulation Marks ).

 

4.4          In respect of the Licensed IP Rights, Licensee shall (and shall procure that each of its sublicensees permitted in accordance with this Agreement shall):

 

(a)                                  use the Licensed TMs that are either word marks, stylized word marks, logos or other device marks (excluding marks for trade dress which cover the packaging or appearance of the products as a whole rather than an element of it) solely in the form in which they are registered, as set out in Exhibit 1 ( Licensed TMs );

 

(b)                                  comply with the relevant Brand Guidelines in its use of the Licensed TMs;

 

(c)                                   not do anything that could, in Licensor’s reasonable opinion, bring a Licensed TM, Licensor or any Affiliate of Licensor into disrepute or that could otherwise damage the goodwill attaching to the Licensed TMs or any other trademarks or trade names of Licensor or any Affiliate of Licensor;

 

(d)                                  not use the Licensed TMs in a manner that could, in Licensor’s reasonable opinion, result in any of them becoming generic or in Licensor’s rights in any of them becoming diluted, or that could otherwise prejudice or invalidate a registration or application for registration of any of the Licensed TMs;

 

(e)                                   not use any Licensed IP Rights in a particular jurisdiction in relation to any type of business that is unlawful in that jurisdiction;

 

(f)                                    unless approved by Licensor prior to such use, not use the Licensed TMs in combination with any other mark, name, device, symbol or logo other than:

 

(i)                                      as permitted under the Brand Guidelines; or

 

(ii)            Licensee’s company name and logo;

 

(g)                                   following the Separation Date and with effect from the date on which Licensee first changes any of its packaging, advertising or promotional materials, on any of those materials on which any Licensed TM or other trademark of Licensor or any Affiliate of Licensor appears, Licensee shall comply with its internal branding policies and practices in connection with the usage of licensed third party trade marks (including, to the extent applicable, the inclusion of any accompanying statement of ownership or usage under license from a third party, and the usage of the ® or ™ symbols in proximity to the Licensed TM or trademark).

 

(h)                                  unless otherwise agreed by Licensor, not register or attempt to register any new trademarks, company, business or trading names or domain names following the Separation Date that are identical or similar to (or that incorporate) any element of the Licensed IP Rights, any aspect of them, or any other trademarks or trade names of Licensor and any Affiliate of Licensor.

 

(i)                                      ALL REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS OF ANY KIND, WHETHER EXPRESS OR IMPLIED (BY STATUTE OR OTHERWISE), REGARDING THE LICENSED IP RIGHTS OR RELATING TO THE TERMS

 

4


 

AND CONDITIONS OR THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING ANY REPRESENTATION, WARRANTY OR UNDERTAKING OF SUITABILITY, FITNESS FOR PURPOSE OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS) ARE EXPRESSLY EXCLUDED TO THE MAXIMUM EXTENT PERMITTED BY LAW. LICENSEE IS SOLELY RESPONSIBLE FOR ITS USE, RELIANCE OR IMPLEMENTATION OF THE LICENSED IP RIGHTS, INCLUDING ANY ACTIONS OR DECISIONS TAKEN OR NOT TAKEN AS A RESULT THEREOF.

 

5.       CONDITIONS OF USE OF TRANSITIONALLY LICENSED IP RIGHTS

 

5.1          Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) ensure that, in each case, any use of a Transitionally Licensed IP Right is limited to the use made of that Transitionally Licensed IP Right (including as regards form, manner and extent (including with respect to the jurisdictions in which that Transitionally Licensed IP Right is used)) in connection with the Alcon Existing Products as at the Effective Date.

 

5.2          Subject to Clauses 5.5 and 5.8, Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) use Commercially Reasonable Efforts to cease use of the Transitionally Licensed IP Rights as quickly as practicable after the Effective Date, and in any event by the end of the relevant Transitional License Term, including by promptly seeking labelling approval (or equivalent) from any Governmental Entity with competent jurisdiction for each Alcon Existing Product to change each such Alcon Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Alcon Existing Product.

 

5.3          Subject to Clause 5.2, Licensee shall, in complying with its obligations under Clause 5.1, prioritize the removal of any Transitionally Licensed IP Rights from the packaging of the Alcon Existing Products.

 

5.4          Subject to Clause 5.8, if by the date which is thirty (30) months after the Effective Date Licensee, having complied with its obligations under Clause 5.1, is prevented by Applicable Law from changing any label for a Alcon Existing Product so that it no longer displays any Transitionally Licensed IP Rights on any marketing materials, packaging or labels of that Alcon Existing Product, Licensee shall notify Licensor of the relevant Alcon Existing Product and the steps that have been taken by Licensee to comply with its obligations under Clause 5.1. Provided Licensee has, in the reasonable opinion of Licensor, complied with its obligations under Clause 5.1, and its other obligations under this Agreement, Licensor shall permit Licensee to continue to use the relevant Transitionally Licensed IP Rights on the relevant Alcon Existing Product for the remaining duration of the Transitional License Term solely to the extent required in order to comply with Applicable Law, provided that Licensee complies with (and continues to comply with) its obligations under Clause 5.1 ( Conditions of use of Transitionally Licensed IP Rights ), including to cease use of those Transitionally Licensed IP Rights by the end of the applicable Transitional License Term, and takes all reasonable steps to obtain all relevant regulatory approvals.

 

5.5          To the extent that Licensee is required by Applicable Law to display the name of Licensor or an Affiliate of Licensor which is the manufacturer or distributor of a Alcon Existing Product, Licensee shall be entitled for as long as Licensor or an Affiliate of Licensor is the manufacturer of that Alcon Existing Product during the Transitional License Term, to use the corporate name of Licensor or an Affiliate of Licensor, as relevant, provided that:

 

(a)                                  any such use is limited to descriptive use only;

 

5


 

(b)                                  the name of Licensor or relevant Licensor Affiliate is reproduced in plain text in a non-prominent manner and in the same form as other information that is required to be disclosed under Applicable Law for the Alcon Existing Product; and

 

(c)                                   any change to the corporate name of Licensor or an Affiliate of Licensor that manufactures the Alcon Existing Product shall be reflected, as soon as reasonably practicable following such change, in any material in which Licensee is entitled to use Transitionally Licensed IP Rights.

 

5.6          On written request from Licensor, Licensee shall promptly notify Licensor of:

 

(a)                                  any approval granted by a Governmental Entity to change a Alcon Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Alcon Existing Product; and

 

(b)                                  the rebranding of any Alcon Existing Product so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Alcon Existing Product.

 

5.7          Except for the rights granted in Clause 5.5, which shall continue in accordance with the terms of Clause 5.5, the grant of rights under Clauses 1.1(a) and 1.1(b) shall terminate, on a country-by-country and Product-by-Product basis, on, subject to Clause 5.8, the earlier of:

 

(a)                                  the date on which Licensee rebrands the relevant Alcon Existing Product so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Alcon Existing Product;

 

(b)                                  the date which is six (6) months after the date on which approval is granted by a Governmental Entity to change a Alcon Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Alcon Existing Product; and

 

(c)                                   the end of the relevant Transitional License Term.

 

5.8          The Parties may agree to extend the period of the license for any of the rights granted under Clause 1.1, on a country-by-country and Alcon Existing Product-by-Alcon Existing Product basis, in order to align the termination of that license (and the related rebranding of any Alcon Existing Product) with the date of the transfer of the relevant Marketing Authorization for that Alcon Existing Product from Licensor (or an Affiliate of Licensor) to Licensee (or an Affiliate of Licensee) in accordance with the Separation Agreement.

 

5.9          Prior to or promptly after the termination of all rights in relation to Transitionally Licensed IP Rights in accordance with Clause 5.7 (and subject to Clause 10.6 ( Run-off License )), Licensee shall:

 

(a)                                  deliver, at Licensee’s cost, to Licensor (or to any Person nominated by Licensor) all Alcon Existing Products or materials in its possession or under its control which reproduce or display any Transitionally Licensed IP Rights, or at the election of Licensor, destroy such Alcon Existing Products and other materials and provide Licensor with satisfactory evidence of their destruction; and

 

(b)                                  make no further use of the Transitionally Licensed IP Rights without the prior written consent of Licensor.

 

6


 

6.       MAINTENANCE OF LICENSED TMS

 

6.1          Maintenance of existing registrations and applications. Unless the Parties otherwise agree, Licensor shall, at its own cost, take all reasonable steps to: (i) maintain the registrations for; and (ii) prosecute applications for registration through to registration of, the Licensed TMs listed in Exhibit 1 ( Licensed TMs ), provided that Licensee promptly provides, or procures the provision from any permitted sublicensee of Licensee of, all reasonable assistance required by Licensor in connection with doing so.

 

6.2          Applications for, and maintenance of, new registrations. Without prejudice to Clause 6.1 ( Maintenance of existing registrations and applications ), Licensee shall notify Licensor if it believes that a new application for a Licensed TM that is a Perpetually Licensed IP Right is necessary in relation to the import, export, manufacture, packaging, promotion, distribution, marketing or sale of any Alcon Product in any Territory. Upon receipt of that notice, Licensor shall, unless it reasonably determines that the new application would be detrimental to the business of Licensor and its Affiliates, make that application in its own name and shall take all reasonable steps to prosecute that application through to registration. In respect of any application made by Licensor under this Clause 6.2, Licensee shall:

 

(a)                                  at Licensee’s cost, promptly provide, or procure the provision from any permitted sublicensee of Licensee of, all reasonable assistance (including preparing evidence of any applicable use of the relevant Licensed TM) required by Licensor to enable Licensor to prepare, file and prosecute that application; and

 

(b)                                  upon receipt of an undisputed invoice from Licensor, promptly reimburse Licensor for half of any costs reasonably incurred by Licensor in connection with making that application, or subsequently maintaining any new registration, for a Licensed TM requested by Licensee under this Clause 6.2.

 

6.3          New applications by Licensor. If Licensor believes that a new application for a Licensed TM is necessary in relation to any Territory, Licensor may, at its own cost, make that application in its own name and take all reasonable steps to prosecute that application through to registration, and Licensee shall, at Licensor’s cost, promptly provide, or procure the provision from any permitted sublicensee of Licensee of, all reasonable assistance (including preparing evidence of any applicable use of the relevant Licensed TM) required by Licensor to enable Licensor to prepare, file and prosecute that application.

 

6.4          Restrictions on transfers of the Licensed IP Rights. Licensor shall (and shall procure that any Affiliate of Licensor shall) not assign or transfer any of its right, title or interest in or to any of the Licensed IP Rights unless the relevant assignee or transferee:

 

(a)                                  joins as a party to this Agreement by entering into a deed of adherence with the Parties in respect of those Licensed IP Rights; or

 

(b)                                  enters into an assignment with Licensor pursuant to Clause 15.1 for any element of this Agreement that relates to those Licensed IP Rights,

 

in each case, on terms that are acceptable to Licensee (acting reasonably).

 

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7.       APPROVAL AND INSPECTION

 

7.1          Licensee shall:

 

(a)                                  on written request from Licensor, provide Licensor with a reasonable number of samples of all products and materials (including any advertising, marketing or promotional materials) on which the Licensed IP Rights are used; and

 

(b)                                  once per calendar year, on reasonable prior notice from Licensor, permit Licensor (or its nominated representative) to enter Licensee’s premises during Working Hours solely for the purposes of verifying that Licensee is complying with its obligations under this Agreement.

 

7.2          If Licensor believes, on reasonable grounds, that Licensee is failing to comply with any of its obligations under Clause 4 ( Conditions of use of Licensed IP Rights ) or Clause 5 ( Conditions of use of Transitionally Licensed IP Rights ):

 

(a)                                  Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) take any steps (at its own cost) that Licensor reasonably determines are necessary to ensure compliance; and

 

(b)                                  Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) not sell, distribute or otherwise dispose of any materials or products that Licensor determines do not comply with Licensee’s obligations under Clause 4 (Conditions of use of Licensed IP Rights) or Clause 5 ( Conditions of use of Transitionally Licensed IP Rights ) without the prior written consent of Licensor.

 

8.       OWNERSHIP OF LICENSED IP RIGHTS

 

Licensee acknowledges and agrees that:

 

(a)                                  all Intellectual Property Rights and other rights in the Licensed IP Rights are the exclusive property of Licensor or its Affiliates;

 

(b)                                  it shall not acquire, nor claim, any right, title or interest in or to any element of the Licensed IP Right or the goodwill attaching to any Licensed TM by virtue of this Agreement or its use of the relevant Licensed IP Right, other than the rights specifically granted to it under Clause 1.1;

 

(c)                                   all goodwill arising from use of the Licensed TMs by Licensee before, during or after the term of this Agreement shall accrue and belong to Licensor, and Licensee shall, at Licensor’s request and cost, promptly execute all documents required by Licensor to confirm this; and

 

(d)                                  all use of the Licensed TMs by Licensee shall be deemed to be use by Licensor for the purpose of satisfying any applicable trademark laws that require the use of the mark, or entitle Licensor to rights in relation to use (including any distinctiveness acquired through use).

 

9.       INFRINGEMENT

 

9.1          Nothing in this Agreement shall constitute any representation that any use of any Licensed IP Right does not, or will not, infringe any Intellectual Property Rights owned by a Third Party.

 

9.2          Each Party shall immediately notify the other in writing of any of the following matters that comes to its attention (giving full particulars of the matter, the identity of the Third Party and the urgency of any actions required or recommended to be taken):

 

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(a)                                  any actual, suspected or threatened infringement of any element of a Licensed IP Right by a Third Party;

 

(b)                                  any allegation or complaint made by any Third Party that any element of a Licensed IP Right is invalid, that use of any element of a Licensed IP Right infringes any Third Party right, or that use of any element of a Licensed IP Right may deceive or confuse the public; or

 

(c)                                   any other attack on or claim to any element of a Licensed IP Right.

 

9.3          In respect of any matter described in Clause 9.2 above:

 

(a)                                  Licensee shall not make any admissions other than to Licensor;

 

(b)                                  Subject to Clause 9.4, Licensor shall decide, in its absolute discretion, whether or not to take action, and what action to take, and shall have exclusive control over any resulting claims, actions and proceedings. Except as set out in Clause 9.4 and Clause 9.5, the provisions of section 43(a) of the U.S. Trademark (Lanham) Act with respect to any purported licensee rights to maintain an action under section 43(a), and any similar provisions under the laws of any other jurisdiction, are expressly excluded; and

 

(c)                                   if Licensor decides to take any action  in respect of any such matter, Licensee shall (and shall procure that its Affiliates and sub-licensees shall), at Licensor’s cost, provide any assistance that Licensor reasonably requires (including bringing proceedings or lending its name to any proceedings brought by Licensor). Subject to Clause 9.5, any award of Costs or compensation in connection with any of those matters shall be solely for the account of Licensor.

 

9.4          Licensee’s enforcement rights

 

If (a) Licensor notifies Licensee that Licensor does not intend to take any action in respect of any matter described in Clause 9.2 above or three (3) months have elapsed since notice of a matter described in Clause 9.2 was provided by one Party to the other without Licensor taking any action and that matter relates to: (i) a Perpetually Licensed IP Right; and (ii) a country in the Territory in which Licensee or an Affiliate of Licensee operates; or (b) the matter relates to or, in Licensee’s reasonable opinion, will impact a Alcon Product which the Licensee has Commercialised or intends to Commercialise within twenty-four (24) months from the date Licensee provided notice of the matter (or such time as otherwise agreed by the Parties on a case-by-case basis) described in Clause 9.2, then under either (a) or (b) Licensee may take action in its own name in respect of that matter and control any resulting claim(s), action(s) and proceeding(s), provided that, prior to taking any material action or decision with regards to that matter (including commencing any claim(s), action(s) or proceeding(s) or settling any dispute) Licensee shall consult in good faith with Licensor, shall seek Licensor’s consent for that material action or decision (such consent not to be unreasonably withheld) and shall not take any such action or decision without that consent. If Licensee (or its Representatives) takes any action or decision in respect of a matter under this Clause 9.4 that Licensor has not consented to, Licensee shall indemnify Licensor and its Representatives against all Costs or other liabilities as a result of that action or decision. For the avoidance of doubt, the Parties acknowledge that it shall not be unreasonable for Licensor to withhold its consent under this Clause 9.4 to the extent that Licensee’s taking of the relevant material action or decision

 

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would be detrimental to the business of Licensor or any Affiliate of Licensor (including in respect of its relationship with any of its suppliers or customers).

 

9.5          Licensor shall (and shall procure that its Affiliates shall), at Licensee’s cost, provide any assistance that Licensee reasonably requires under Clause 9.4 (including bringing proceedings or lending its name to any proceedings brought by Licensee). Any award of Costs or compensation in connection with any claim(s), action(s) or proceeding(s) brought by Licensee under Clause 9.4 shall be solely for the account of Licensee.

 

10.     TERMINATION

 

10.1        Termination of Agreement. Notwithstanding Clause 3 ( Duration ), Licensor may terminate this Agreement in part or in its entirety, with immediate effect, by written notice to Licensee if:

 

(a)                                  Licensee commits a breach of any material obligation under this Agreement and, in the case of a breach that is capable of remedy, fails to remedy it within ninety (90) days of receipt of a written notice from Licensor giving full particulars of the breach and requiring it to be remedied;

 

(b)                                  Licensee or an Affiliate of Licensee challenges Licensor’s entitlement to own, to use or to license the use of any of the Licensed IP Rights; or

 

(c)                                   an Insolvency Event occurs in relation to Licensee.

 

10.2        For the purposes of Clause 10.1, a breach shall be considered capable of remedy if Licensee can comply with the provision in question in all respects other than as to time of performance.

 

10.3        Termination in relation to Perpetually Licensed IP Rights. Notwithstanding Clause 2(a), Licensor may terminate this Agreement in respect of a Licensed TM that is a Perpetually Licensed IP Right if:

 

(a)                                  Licensee, and its sublicensees, cease use of that Licensed TM for a continuous period of thirty-six (36) months; or

 

(b)                                  where that Licensed TM is not in use as at the Effective Date, Licensee, and its sublicensees, fail to use that Licensed TM within a period of five (5) years from the Effective Date.

 

10.4        Consequences of termination. On the date of expiry or termination of this Agreement, in part or in its entirety, for any reason (in each case the Termination Date ):

 

(a)                                  subject to Clause 10.6, the rights and licenses granted pursuant to this Agreement that are affected by that expiry or termination shall cease with immediate effect;

 

(b)                                  all relevant obligations of Licensor to Licensee under this Agreement shall cease with immediate effect;

 

(c)                                   all relevant outstanding sums payable by one Party to the other shall immediately become due and payable;

 

(d)                                  subject to Clause 10.6, Licensee shall cease, within thirty (30) days from the date of that termination or expiry, to make any use of the affected Licensed IP Rights; and

 

(e)                                   subject to Clause 10.6, Licensee shall (at its own expense) on request by Licensor, as soon as practicable:

 

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(i)                                      deliver to Licensor, or to any person nominated by Licensor, representative samples of all materials, in electronic or hard copy form, under its control on, or in relation to which, any of the affected Licensed IP Rights are being used by Licensee or any Affiliate of Licensee; or

 

(ii)                                   following the period described in Clause 10.6, destroy such products and materials (except to the extent that Licensee or any Affiliate of Licensee is required to retain any of them in order to comply with Applicable Law) and certify in writing to Licensor that this has been done.

 

10.5        No releases from accrued liabilities and Surviving Provisions . Termination of this Agreement shall not release either Party from any liability that at the time of termination or expiry had already accrued to the other Party.  The Surviving Provisions, together with any other Clause reasonably intended to survive termination or expiry, shall survive termination or expiry of this Agreement.

 

10.6        Run-off license for inventory. In relation to affected Alcon Products that are either in stock or under the control of Licensee or any Affiliate of Licensee at the time of that termination or expiry, Licensee and its Affiliates may continue to sell those Alcon Products for a maximum period of six (6) months from the date of termination or expiry (as applicable), or any longer period that the Parties agree.

 

11.     LIMITATION OF LIABILITY

 

11.1        TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR SHALL NOT BE LIABLE TO LICENSEE FOR ANY COSTS EXPENSES, LOSSES OR DAMAGES (IN EACH CASE, WHETHER DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL OR CONSEQUENTIAL, AND WHETHER ECONOMIC OR OTHER) ARISING FROM LICENSEE’S EXERCISE OF THE RIGHTS GRANTED TO IT UNDER THIS AGREEMENT, WHETHER OR NOT LICENSEE OR ANY OF ITS AFFILIATES HAVE BEEN ADVISED OF, OR OTHERWISE MIGHT OR SHOULD HAVE ANTICIPATED, THE POSSIBILITY OR LIKELIHOOD OF SUCH COSTS, EXPENSES, LOSSES OR DAMAGES.

 

11.2        Nothing in this Agreement shall have the effect of excluding or limiting any liability for gross negligence, wilful misconduct, death or personal injury caused by negligence or for fraud or any other liability that cannot be excluded by Applicable Law.

 

11.3        Neither Party shall have any duty or obligation under this Agreement except as expressly set out in this Agreement.

 

12.     TAX

 

12.1        General. Any sum payable by Licensee to Licensor under this Agreement is exclusive of any applicable VAT.  If any supply is treated as or deemed made by Licensor or an Affiliate of Licensor under this Agreement and Licensor or an Affiliate of Licensor is required to account for VAT in respect of that supply, Licensee shall, against receipt of a valid VAT invoice (if applicable) pay to Licensor (in addition to, and at the same time as, any other consideration for that supply) an amount equal to such VAT.

 

12.2        Records . Licensee may obtain a direction from the relevant Tax Authority for the retention and preservation by it of any VAT records relating to its period of use of any Licensed IP Rights and, if such directions are obtained, Licensee agrees to preserve any such records in such a manner and for such period as may be required by Applicable Law and shall allow Licensor, upon Licensor giving reasonable notice, reasonable access and copies of such records where reasonably required by Licensor for its Tax purposes.  If no such direction is obtained and any documents are required by

 

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Applicable Law to be preserved by Licensor, Licensee shall, as soon as reasonably practicable, deliver such documents to Licensor.

 

13.     CONFIDENTIALITY

 

Each Party shall, and shall procure that its Representatives shall, comply with the provisions of clause 28 ( Confidentiality ) of the Separation Agreement in relation to:

 

(a)                                  all Information of the other Group that is either in its possession or is furnished by the other Group or its respective Representatives in connection with this Agreement; and

 

(b)                                  information relating to the provisions and subject matter of, and negotiations leading to, this Agreement.

 

14.     NOTICES

 

14.1        Form of notice.   Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it (in the case of notice by e-mail, a notice signed electronically or a scanned copy of a signed original notice shall suffice). It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Licensee shall be deemed notice to all members of Licensee Group, and any notice to Licensor shall be deemed notice to all members of Licensor Group.

 

14.2        Effectiveness of notice.   A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

14.3        Notice details.   The addresses and e-mail addresses of the Parties for the purpose of Clause 14.1 ( Form of notice ) are:

 

Licensee and each member of the Licensee Group

 

For the attention of: General Counsel

Alcon Inc.
Rue Louis-d’Affry 6,
1701 Fribourg,
Switzerland

royce.bedward@alcon.com

 

 

 

Licensor and each member of the Licensor Group

 

For the attention of: Head of Legal M&A (Novartis International AG)

Novartis AG
Lichtstrasse 35,
4056 Basel,
Switzerland

jonathan.emery@novartis.com

 

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14.4        Change of notice details. Licensee and Licensor shall each notify the other Party in writing of a change to its details in Clause 14.1 ( Form of notice ) from time to time.

 

15.     MISCELLANEOUS PROVISIONS

 

15.1        Assignment by Licensor. Subject to Clause 6.4 ( Restrictions on transfers of the Licensed IP Rights ):

 

(a)                                  Licensor may assign its rights and obligations under this Agreement, or any of the Licensed IP Rights, to an Affiliate of Licensor or to a Third Party.

 

(b)                                  If Licensor transfers its rights in any Licensed IP Right to an Affiliate or to a Third Party, it shall be entitled to assign any element of this Agreement that relates to the Licensed IP Right to that Affiliate or Third Party.

 

15.2        Assignment by Licensee.

 

(a)                                  Licensee may assign or transfer this Agreement and/or any of the rights granted under Clause 1.1 of this Agreement to any:

 

(i)                                      Affiliate of Licensee; and

 

(ii)                                   Third Party in connection with the disposal to that Third Party of: (A) any Alcon Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensor’s business to which this Agreement relates.

 

(b)                                  If Licensee assigns or transfers any of its rights and/or obligations under this Agreement to an Affiliate or a Third Party, it shall notify Licensor as soon as practicable after such assignment or transfer together with particulars of the assignee or transferee.

 

15.3        Any permitted assignee or transferee under Clause 15.1 ( Assignment by Licensor ) or Clause 15.2 ( Assignment by Licensee ) will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and will inure to the benefit of the Parties and their respective successors and assigns.

 

15.4        Waivers, Rights and Remedies. Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time.  No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

15.5        Announcements. The provisions of clause 29 ( Announcements ) of the Separation Agreement shall apply to this Agreement.

 

15.6        Further Assurances.

 

(a)                                  Further Acts and Documents. Subject to the express limitations in this Agreement, each of the Parties shall, at the request (and expense) of the other Party, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution

 

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and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or reasonably required to implement and give effect to this Agreement.

 

(b)                                  Obligations of Agreement on Affiliates. Each of Licensee and Licensor shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

15.7        No Third Party Enforcement Rights. A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

15.8        Counterparts. This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

15.9        Variations. No amendment of this Agreement shall be valid unless it is in writing and duly executed by or on behalf of all of the Parties to it.

 

15.10      Invalidity. Each of the provisions of this Agreement is severable.  If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the Parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

15.11      Method of Payment and Set-Off. Any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or as otherwise agreed).  Any payments pursuant to this Agreement shall be effected by crediting for same day value the account specified by Licensee or Licensor (as the case may be) on behalf of the Person entitled to payment on or before the due date for payment.  Payment of a sum in accordance with this Clause 15.11 shall constitute a payment in full of the sum payable and shall be a valid discharge to the payer (and those on whose behalf such payment is made) of the payer’s obligation to make such payment and the payer (and those on whose behalf such payment is being made) shall not be obligated to see to the application of the payment as between those on whose behalf payment is received.

 

15.12      Costs. Except as otherwise provided in this Agreement or as otherwise agreed in writing between the Parties, Licensee and Licensor shall each be responsible for its own costs, charges and other expenses (including those of members of their respective Groups) incurred in connection with this Agreement.

 

15.13      Whole Agreement.

 

(a)                                  This Agreement and the other Transaction Documents together set out the whole agreement between the Parties in respect of the subject matter of this Agreement and supersedes any previous draft, agreement, arrangement or understanding, whether in writing or not, relating to its subject matter. It is agreed that:

 

(i)                                      no Party has relied on or shall have any claim or remedy arising under or in connection with any statement, representation, warranty or undertaking made by or on behalf of the other Party (or any of its Representatives) in relation to the subject matter of this Agreement that is not expressly set out in this Agreement and the other Transaction Documents;

 

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(ii)                                   any terms or conditions implied by Applicable Law in any jurisdiction in relation to the subject matter of this Agreement are excluded to the fullest extent permitted by Applicable Law or, if incapable of exclusion, any rights or remedies in relation to them are irrevocably waived;

 

(iii)                                the only right or remedy of a Party in relation to any provision of this Agreement shall be for breach of this Agreement; and

 

(iv)                               except for any liability in respect of a breach of this Agreement, neither Party (nor any of its Representatives) shall owe any duty of care or have any liability in tort or otherwise to the other Party (or its respective Representatives in relation to the subject matter of this Agreement.

 

(b)                                  Nothing in this Clause 15.13 ( Whole Agreement ) shall limit any liability for (or remedy in respect of) fraud or fraudulent misrepresentation.

 

(c)                                   Each Party agrees to the terms of this Clause 15.13 ( Whole Agreement ) on its own behalf and as agent for each of its Representatives.

 

15.14      Governing Law. This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

15.15      Specific Performance. In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement.  The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy.  The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived.  Any requirements for the securing or posting of any bond with such remedy are waived.

 

16.     DISPUTE RESOLUTION

 

16.1        This Clause 16 ( Dispute Resolution ) shall apply to any dispute, controversy or claim arising out of or relating to this Agreement, including a dispute, controversy or claim relating to the existence, validity or termination of this Agreement (each, a Dispute ).

 

16.2        Before entering into any arbitration pursuant to Clauses 16.4 or 16.4(a), a Party shall give written notice of a Dispute to the other Party (a Dispute Notice ). The Dispute Notice shall:

 

(a)                                  state that it is a Dispute Notice being submitted pursuant to this Clause 16 ( Dispute Resolution );

 

(b)                                  identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(c)                                   set out any steps taken by that Party or its Affiliates to resolve it.

 

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16.3

 

(a)                                  Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the Resolution Period ). The time limit specified in this Clause 16.3 may be extended by the written agreement of the Parties.

 

(b)                                  Notwithstanding the foregoing, either Party may, at any time, seek interim or provisional relief, whether from an emergency arbitrator appointed and acting in accordance with the LCIA Rules, a tribunal constituted under the LCIA Rules and/or from a national court of competent jurisdiction, in advance of or in aid of the arbitration proceedings contemplated by Clause 16.4.

 

16.4        If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(a)                                  the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the LCIA Rules );

 

(b)                                  the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(c)                                   the seat of arbitration shall be London;

 

(d)                                  the written and spoken language to be used in the arbitral proceedings shall be English; and

 

(e)                                   the award of the arbitral tribunal shall be final and binding upon the parties and judgment may be entered on an award in any court of competent jurisdiction.

 

16.5        Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Ancillary Agreement, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with Clause 16.4.

 

16.6        The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this Clause 16.6 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

[ Signature Page Follows ]

 

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SIGNATURES

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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SCHEDULE 1
DEFINITIONS AND INTERPRETATION

 

1.             Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Affiliate has the meaning given in the Separation Agreement;

 

Agreement means this brand license agreement;

 

Alcon Existing Products means:

 

(a)                                 any contact lens or contact lens care product, including those products listed under part 1 ( Vision Care ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                 any ophthalmic surgical products, including those products listed under part 2 ( Surgical (incl. Diagnostics) ) of the “Alcon” tab of the Products List and  any product having substantially the same formula as any of them;

 

(c)                                  any other products listed under part 3 ( Dry Eye & Ocular Health ), Part 4 ( Viscoelastics ) or Part 5 ( R&D and Clinical Trials ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them; and

 

(d)                                 any other ophthalmic or vision care product that is, as of the date of this Agreement or at any time prior, lawfully Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates, and any product having substantially the same formula as any of them and that is or has been Commercialised by either Party or any of their respective current or historic Affiliates as an Over-the-counter Product in the United States of America (in which case, such product shall constitute an Alcon Existing Product in all jurisdictions),

 

in each case other than any product included within paragraphs (a), (b) or (c) of the definition of Novartis Existing Products.

 

Alcon Future Products means means any products owned or controlled by Alcon or its Affiliates after the Effective Date, excluding the Alcon Existing Products;

 

Alcon Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Alcon Optional Products has the meaning given in Exhibit 6 ( Alcon Optional Products );

 

Alcon Products means: (i) the Alcon Existing Products; (ii) the Alcon Future Products; and (iii) the Alcon Optional Products;

 

Applicable Law has the meaning given in the Separation Agreement;

 

Brand Guidelines means the brand guidelines at Exhibit 2 ( Brand Guidelines ), as updated from time to time by Licensor;

 

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Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

 

Commercially Reasonable Efforts has the meaning given in the Separation Agreement;

 

Confidential Material has the meaning given in Clause 16(h);

 

Costs means losses, damages, costs (including reasonable legal costs on an indemnity basis) and expenses (including Tax), in each case of any nature whatsoever;

 

Development means, with respect to any product, any research, pre-clinical or non-clinical testing, clinical studies, chemistry manufacturing controls (CMC), quality, statistical analysis or report writing, and related development and regulatory activities associated therewith, and Develop and Developed shall be construed accordingly;

 

Dispute has the meaning given in Clause 16.1;

 

Dispute Notice has the meaning given in Clause 16.2;

 

Effective Date means the date of this Agreement;

 

Formulation Mark means any Licensed TM that comprises or incorporates the trademarks identified in Exhibit 4 ( Formulation Marks );

 

Governmental Entity has the meaning given in the Separation Agreement;

 

Group has the meaning given in the Separation Agreement;

 

Information has the meaning given in the Separation Agreement;

 

Insolvency Event means, in relation to a Party, any of the following:

 

(a)                                  it is unable or admits inability to pay its debts as they fall due; suspends or threatens to suspend making payments on any of its debts; or, by reason of actual or anticipated financial difficulties, commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;

 

(b)                                  the value of its assets is less than its liabilities (taking into account contingent and prospective liabilities);

 

(c)                                   a moratorium is declared in respect of any of its indebtedness (if a moratorium occurs, the ending of the moratorium will not remedy any Insolvency Event caused by that moratorium);

 

(d)                                  any corporate action, legal proceedings or other procedure or step is taken   (whether by a Party, its directors or a Third Party) in relation to:

 

(i)                                      the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration (whether out of court or otherwise) or reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise);

 

19


 

(ii)                                   a composition, compromise, assignment or arrangement with any creditor;

 

(iii)                                the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager or other similar officer in respect of the Party or any of its assets (in each case whether out of court or otherwise);

 

(iv)                               enforcement of any security over any assets of Licensee or Licensor (as applicable), including a creditor attaching or taking possession of, or distress, execution, sequestration or other process being levied or enforced upon or sued against all or any part of the assets of the relevant party;

 

(v)                                  a meeting of the Party, its directors or its members being convened for the purpose of considering any resolution for, or to petition for, or to apply for or to file documents with a court for its winding-up, administration (whether out of court or otherwise) or dissolution, or any such resolution is passed;

 

(vi)                               any person presenting a petition, application or motion for the winding-up, administration (whether out of court or otherwise) or dissolution of the Party; or

 

(vii)                            the directors or other officers of the Party requesting the appointment of or giving notice of their intention to appoint or take any step with a view to appointing a liquidator, receiver, administrator, administrative receiver, compulsory manager, trustee in bankruptcy or other similar officer in respect of the Party (in each case whether out of court or otherwise),

 

(but paragraph (d) shall not apply to a solvent liquidation of the company or any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within fourteen (14) days of its presentation); or

 

(e)                                   there occurs in relation to the Party or any of its assets in any country or territory in which it is incorporated or carries on business or to the jurisdiction of whose courts it or any of its assets are subject any event which corresponds in that country or territory with any of those mentioned in (a) to (d);

 

Intellectual Property Rights means all: (i) Patents; (ii) Know-How; (iii) Trademarks; (iv) Internet domain names; and (v) works of authorship, copyrights, database rights, mask work rights and registrations and applications therefor;

 

Know-How means all existing and available technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data;

 

LCIA Rules  has the meaning given in Clause 16.4(a);

 

Licensed Corporate Names means the corporate names listed in Exhibit 7 ( Licensed Corporate Names );

 

20


 

Licensed IP Rights means the Transitionally Licensed IP Rights and the Perpetually Licensed IP Rights;

 

Licensed TMs means all of the trademarks listed in Exhibit 1 ( Licensed TMs ), and any new Trademarks registered pursuant to Clause 6.2 ( Applications for, and maintenance of, new registrations ) (and Licensed TM means any one of them);

 

Manufacture means, as applicable, the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality release, sample retention and stability testing of products, including the active ingredients of such products, and Manufacturing or Manufactured shall be construed accordingly;

 

Manufacturing and Supply Agreement means the manufacturing and supply agreement entered into between Alcon and Novartis Pharma AG on or about the date of this Agreement;

 

Marketing Authorization has the meaning given in the Separation Agreement;

 

Non-exclusive means the right to use Intellectual Property Rights, without precluding Licensor using the Intellectual Property Rights itself or from granting the same rights to Third Parties;

 

Novartis Existing Products means:

 

(a)                                  the products listed under part 1 ( Pharmaceuticals ) or Part 6 ( R&D and Clinical Trials ) of the “Novartis” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  the products listed under the “Emerging Markets Brands” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)                                   the Sandoz Products; and

 

(d)                                  any other product as at the Effective Date that is not an Alcon Existing Product.

 

Novartis Future Products means any products owned or controlled by Novartis or its Affiliates, including Sandoz, after the Effective Date, excluding the Novartis Existing Products;

 

Novartis Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Novartis Optional Products has the meaning given in Exhibit 8 ( Novartis Optional Products );

 

Novartis Products means: (i) the Novartis Existing Products; (ii) the Novartis Future Products; and (iii) the Novartis Optional Products;

 

Over-the-counter Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription;

 

Patents means, whether domestic or foreign, any patent applications and issued patents;

 

21


 

Perpetual License Purpose means use in the Territory on or in connection with the import, export, manufacture, packaging, promotion, distribution, marketing and sale (or conducting, or having conducted on its behalf, any of these activities) of: (i) the Alcon Existing Products in any field of use; (ii) the Alcon Future Products in the Alcon Licensed Field; and (iii) the Alcon Optional Products in the Alcon Licensed Field;

 

Perpetually Licensed IP Rights means the Licensed TMs that are identified as being Perpetually Licensed IP Rights in Exhibit 1 ( Licensed TMs );

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Products List has the meaning given in the Separation Agreement;

 

Representatives has the meaning given in the Separation Agreement;

 

Resolution Period has the meaning given in Clause 16.3;

 

Sandoz means Sandoz AG and any of its Subsidiaries;

 

Sandoz Products means any products which, as at the date of this Agreement, are researched, Developed, Manufactured, or Commercialised by Sandoz, or Commercialised as a generic or biosimilar product of the Sandoz division, provided, that if at the date of this Agreement, any product is Commercialised by both (i) Sandoz; and (ii) a member of the Alcon Group, pursuant to a Marketing Authorisation held solely by the Alcon Group, such product shall constitute an “Alcon Existing Product” when and to the extent Commercialised by a member of the Alcon Group and a “Sandoz Product” (and therefore a “Novartis Existing Product”) when and to the extent Commercialised by Sandoz;

 

Separation Agreement has the meaning given in the Recitals;

 

Separation Date has the meaning given in the Separation Agreement;

 

Shared Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Shared Moulds has the meaning given in the Manufacturing and Supply Agreement;

 

Subsidiary has the meaning given in the Separation Agreement;

 

Surviving Provisions means Clause 8 ( Ownership of Licensed IP Rights ), Clause 10.4 ( Consequences of termination), Clause 11 ( Limitation of liability ), Clause 13 ( Confidentiality ), Clause 15 ( Miscellaneous Provisions ) and Schedule 1 ( Definitions and Interpretation );

 

Tax has the meaning given in the Tax Matters Agreement;

 

Tax Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement dated on or around the date of this Agreement and entered into between Novartis and Alcon;

 

Term means the period commencing on the Effective Date and terminating on the Termination Date;

 

22


 

Termination Date has the meaning given in Clause 10.4 ( Consequences of termination );

 

Territory means worldwide (except to the extent indicated otherwise in Exhibit 5 ( Alcon Existing Products with Limited Territory ) in relation to any Alcon Existing Product;

 

Third Party means a person other than Licensee, Licensor or their respective Affiliates from time to time;

 

Trademarks means trademarks, service marks, trade names, certification marks, service names, industrial designs, brand names, brand marks, trade dress rights, identifying symbols, logos, emblems, and signs or insignia, and any applications for the foregoing;

 

Transaction Document has the meaning given in the Separation Agreement;

 

Transitional License Purpose means use on or in connection with the import, export, manufacture, packaging, promotion, distribution, marketing and sale (or conducting, or having conducted on its behalf, any of these activities) of the Alcon Existing Products in the Territory in any field of use;

 

Transitional License Term means:

 

(a)                                  in respect of any Licensed Corporate Names that are used in order to indicate the manufacturer or distributor of an Alcon Product pursuant to Clause 5.5, a period of four years from and including the Effective Date; and

 

(b)                                  otherwise, a period of three years from and including the Effective Date.

 

Transitionally Licensed IP Rights means:

 

(a)                                  the Licensed TMs that are identified as being Transitionally Licensed IP Rights in Exhibit 1 ( Licensed TMs );

 

(b)                                  the Licensed Corporate Names; and

 

(c)                                   any other corporate marks, trademarks, housemarks, trade names and trade dress (whether registered or unregistered) owned by Licensor or any Affiliate of Licensor which include the name “NOVARTIS” or “SANDOZ”, and any associated device marks and logos, or any variants of any of the foregoing, in each case as used on any Alcon Existing Products at the Effective Date;

 

VAT means, within the European Union, such tax, duty, assessment or similar charges as may be levied in accordance with (but subject to derogations from) Council Directive 2006/112/EC, and outside the European Union, any tax, duty, assessment or similar charges levied by reference to added value, turnover or sales, in each case including all interest, penalties and additions imposed thereon by any Tax Authority; and

 

Working Hours means 9.00am to 5.00pm in the relevant location on a Business Day.

 

2.             Definitions . In this Agreement, unless the context otherwise requires:

 

(a)                                 headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

23


 

(b)                                 references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction; and

 

(c)                                  any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as without limitation and illustrative and shall not limit the sense of the words preceding those terms.

 

3.             Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.             Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

5.             Inconsistencies. Where there is any inconsistency between the definitions set out in Schedule 1 ( Definitions and Interpretation ) and the definitions set out in any Clause or any other Schedule or Exhibit, then, for the purposes of construing such Clause or Schedule or Exhibit, the definitions set out in such Clause, or Schedule or Exhibit (as applicable) shall prevail.

 

24


Exhibit 99.10

 

8 APRIL 2019

 

ALCON INC.

 

NOVARTIS AG

 


 

BRAND LICENSE AGREEMENT

 


 


 

CONTENTS

 

CLAUSE

 

PAGE

 

 

 

 

1.

GRANT OF LICENSE

 

1

 

 

 

 

2.

SUBLICENSES

 

2

 

 

 

 

3.

DURATION

 

3

 

 

 

 

4.

CONDITIONS OF USE OF LICENSED IP RIGHTS

 

3

 

 

 

 

5.

CONDITIONS OF USE OF TRANSITIONALLY LICENSED IP RIGHTS

 

5

 

 

 

 

6.

MAINTENANCE OF LICENSED TMS

 

6

 

 

 

 

7.

APPROVAL AND INSPECTION

 

7

 

 

 

 

8.

OWNERSHIP OF LICENSED IP RIGHTS

 

8

 

 

 

 

9.

INFRINGEMENT

 

8

 

 

 

 

10.

TERMINATION

 

10

 

 

 

 

11.

LIMITATION OF LIABILITY

 

11

 

 

 

 

12.

TAX

 

11

 

 

 

 

13.

CONFIDENTIALITY

 

12

 

 

 

 

14.

NOTICES

 

12

 

 

 

 

15.

MISCELLANEOUS PROVISIONS

 

13

 

 

 

 

16.

DISPUTE RESOLUTION

 

15

 

 

 

 

SCHEDULE 1 DEFINITIONS AND INTERPRETATION

18

 

i


 

BRAND LICENSE AGREEMENT

 

dated 8 April 2019

 

PARTIES:

 

(1)                                  ALCON INC. , a corporation (Aktiengesellschaft) incorporated in the Canton of Fribourg, Switzerland with enterprise identification number (UID) CHE-234.781.164 and its registered office at Rue Louis-d’Affry 6, 1701 Fribourg, Switzerland (the Licensor or Alcon ); and

 

(2)                                  NOVARTIS AG , a corporation (Aktiengesellschaft) incorporated in the Canton of Baselstadt, Switzerland with enterprise identification number (UID) CHE-103.867.266 and its registered office at Lichtstrasse 35, 4056 Basel, Switzerland (the Licensee or Novartis ),

 

together, the Parties , and each a Party .

 

Words and expressions used in this Agreement shall be interpreted in accordance with Schedule 1 ( Definitions and Interpretation ).

 

Whereas:

 

(A)                                Novartis and Alcon have entered into a Separation and Distribution Agreement dated 8 April 2019, under which: (a) Novartis has agreed to transfer certain assets and license certain intellectual property rights to Alcon; and (b) Alcon has agreed to transfer certain assets and license certain intellectual property rights to Novartis (the Separation Agreement ).

 

(B)                                Alcon is the owner of certain trademark rights, including the Licensed TMs.

 

(C)                                Pursuant to the Separation Agreement, Alcon now wishes to license (or procure that the relevant Affiliate of Alcon licenses) the Licensed IP Rights to Novartis on the terms of this Agreement.

 

IT IS AGREED:

 

1.                    GRANT OF LICENSE

 

1.1                                In consideration of the mutual promises and conditions set out in this Agreement, and subject to the terms of this Agreement, Licensor hereby grants, or hereby procures the grant by the relevant Affiliate of Licensor, to Licensee, with effect from the Effective Date, a royalty-free, assignable (in  accordance with Clause 15.2 ( Assignment by Licensee )), sub-licensable (in accordance with Clause 2 ( Sub-licenses ))

 

(a)                                  and, subject to Clause 1.3, exclusive license during the Transitional License Term (subject to earlier termination of this Agreement in accordance with Clause 10 ( Termination )) to use the Transitionally Licensed IP Rights (other than the Licensed Corporate Names) for the Transitional License Purpose;

 

(b)                                  and Non-exclusive license during the Transitional License Term (subject to earlier termination of this Agreement in accordance with Clause 10 ( Terminatio n)) to use the Licensed Corporate Names for the Transitional License Purpose; and

 

(c)                                   subject to Clause 1.3, exclusive and perpetual license (subject to termination of this Agreement in accordance with Clause 10 ( Termination )) to use the Perpetually Licensed IP Rights for the Perpetual License Purpose,

 

1


 

provided that, for (c), Novartis acknowledges that the license granted in this Clause 1.1 is exclusive other than with respect to Alcon’s and its Affiliates’ continued right to use the Perpetually Licensed IP Rights in connection with the making, using, selling, offering for sale, importing and otherwise Commercialising the Alcon Products in the Shared Licensed Field.

 

1.2                                Licensee acknowledges that to the extent the licenses granted under Clause 1.1 includes jurisdictions in the Territory in which Licensor has not registered any of the Licensed IP Rights, Licensor licenses only its unregistered right, title and interest in the Licensed IP Rights (if any).

 

1.3                                The licenses granted to Licensee under Clause 1.1 shall be subject to any rights granted by Licensor and its Affiliates to any Third Party in relation to the Transitionally Licensed IP Rights and the Perpetually Licensed IP Rights before the Effective Date.

 

1.4                                Subject to Clause 1.5, any Party (and any relevant Affiliate of any Party, including, in the case of Licensee, any Affiliate of Licensee that is granted a sub-license in accordance with Clause 2 ( Sub-licenses )) may, at its own cost, take all steps required for the recordal of any license granted under Clause 1.1 at any relevant intellectual property registry in the Territory, provided that, it shall, unless otherwise agreed, use a short-form license confirming the key terms of this Agreement applicable to the relevant license(s) in a form mutually agreed by Licensor and Licensee. If requested, each Party shall, at the requesting Party’s cost, provide any reasonable assistance in connection with a recordal under this Clause 1.3 at an intellectual property registry in the Territory. Licensee shall (unless Licensor has assisted with that recordal) promptly inform Licensor of any recordal of a license granted under Clause 1.1 that is made by Licensee (or any Affiliate of Licensee) at any intellectual property registry in the Territory.

 

1.5                                Licensee hereby grants, and agrees, as applicable, to cause its Affiliates to grant, to Licensor an irrevocable power of attorney, on behalf of Licensee or such applicable Affiliate, for the sole purpose of executing the cancellation of any recordal of a license granted under Clause 1.1 in any relevant intellectual property registry in the Territory upon termination of this Agreement.

 

1.6                                The Parties acknowledge and agree that certain rights, including with respect to certain Licensed IP Rights, have been granted by the Licensor to the Licensee pursuant to Exhibit 9 ( Shared Moulds ) of the Manufacturing and Supply Agreement in connection with the use of Shared Moulds, and the relevant rights and obligations set out in that Exhibit shall govern the use of Shared Moulds.

 

2.                    SUBLICENSES

 

2.1                                Licensee may sub-license or sub-contract any of its rights under this Agreement, without the consent of Licensor,  to any:

 

(a)                                  Third Party or Affiliate of Licensee in the ordinary course of business or in relation to any part of its supply chain; and

 

(b)                                  Third Party in connection with the disposal to that Third Party of: (A) any Licensed  Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensor’s business,

 

in each case for the purpose of any of the activities set out in Clause 1.1, provided that:

 

(i)                   the terms of the sub-license or sub-contract are consistent with the provisions of this Agreement;

 

(ii)                the sub-license prohibits further sub-licensing or sub-contracting by the sub-contractor or sub-licensee (other than in the ordinary course of business for the

 

2


 

purpose of any of the activities set out in Clause 1.1) without the prior written consent of Licensor;

 

(iii)           the sub-license imposes obligations of confidentiality on the sub-licensee or sub-contractor which are no less onerous than those set out in Clause 13 ( Confidentiality );

 

(iv)            the sub-license automatically terminates if this Agreement expires or is terminated in respect of the relevant Licensed IP Rights;

 

(v)               any act of the sub-licensee or sub-contractor which would, if committed by Licensee, be a breach of this Agreement shall be treated for the purposes of this Agreement as an equivalent breach by Licensee of the terms of this Agreement; and

 

(vi)            where a sub-license is granted to a Third Party, Licensee shall, as soon as reasonably practicable, notify Licensor of that sub-license granted under this Clause 2 ( Sublicenses ) and shall, on request, provide a copy of that executed sub-license to Licensor.

 

2.2                                Any sub-license of the Licensed IP Rights in accordance with this Agreement shall allow Licensor and/or its Affiliates, as applicable, as third party beneficiary of the obligations of the sub-licensee of the Licensed IP Rights, to enforce any of the obligations under this Agreement directly against that sub-licensee (either: (i) without any requirement to join Licensee as a party to any proceedings; or (ii) where Licensee would be a necessary party to any such proceedings, with Licensee’s express upfront agreement to be joined as a party) or to obtain any consent from Licensee, and shall impose a governing law that permits the enforceability of the requirements under this Clause 2.2.

 

3.                    DURATION

 

3.1                                This Agreement commences on the Effective Date and shall, except to the extent terminated earlier in accordance with Clause 10 ( Termination ):

 

(a)                                  in relation to the Perpetually Licensed IP Rights continue in perpetuity; and

 

(b)                                  in relation to the Transitionally Licensed IP Rights continue in force until midnight GMT of the last date of the relevant Transitional License Term,

 

(the Term ).

 

4.                    CONDITIONS OF USE OF LICENSED IP RIGHTS

 

4.1                                Licensee shall not use, or permit any of its Affiliates or any Third Party to use, the Licensed IP Rights for any purpose other than for the exercise or performance of its rights and obligations under this Agreement.

 

4.2                                Licensee shall ensure that each Novartis Product is manufactured, distributed, promoted, marketed and sold in all material respects in accordance with Applicable Law, in each case, to the extent that any of those activities involves any use of the Licensed IP Rights, and complies with applicable industry requirements and standards in force in the jurisdiction in which that product is manufactured, distributed or sold.

 

4.3                                In relation to any product manufactured, distributed or sold by, or on behalf of, Licensee that incorporates or is marketed by reference to a Formulation Mark, Licensee shall ensure that the product

 

3


 

complies with the specification for that Formulation Mark as described in Exhibit 4 ( Formulation Marks ).

 

4.4                                In respect of the Licensed IP Rights, Licensee shall (and shall procure that each of its sublicensees permitted in accordance with this Agreement shall):

 

(a)                                  use the Licensed TMs that are either word marks, stylized word marks, logos or other device marks (excluding marks for trade dress which cover the packaging or appearance of the products as a whole rather than an element of it) solely in the form in which they are registered, as set out in Exhibit 1 ( Licensed TMs );

 

(b)                                  comply with the relevant Brand Guidelines in its use of the Licensed TMs;

 

(c)                                   not do anything that could, in Licensor’s reasonable opinion, bring a Licensed TM, Licensor or any Affiliate of Licensor into disrepute or that could otherwise damage the goodwill attaching to the Licensed TMs or any other trademarks or trade names of Licensor or any Affiliate of Licensor;

 

(d)                                  not use the Licensed TMs in a manner that could, in Licensor’s reasonable opinion, result in any of them becoming generic or in Licensor’s rights in any of them becoming diluted, or that could otherwise prejudice or invalidate a registration or application for registration of any of the Licensed TMs;

 

(e)                                   not use any Licensed IP Rights in a particular jurisdiction in relation to any type of business that is unlawful in that jurisdiction;

 

(f)                                    unless approved by Licensor prior to such use, not use the Licensed TMs in combination with any other mark, name, device, symbol or logo other than:

 

(i)                                      as permitted under the Brand Guidelines; or

 

(ii)                                   Licensee’s company name and logo;

 

(g)                                   following the Separation Date and with effect from the date on which Licensee first changes any of its packaging, advertising or promotional materials, on any of those materials on which any Licensed TM or other trademark of Licensor or any Affiliate of Licensor appears, Licensee shall comply with its internal branding policies and practices in connection with the usage of licensed third party trade marks (including, to the extent applicable, the inclusion of any accompanying statement of ownership or usage under license from a third party, and the usage of the ® or ™ symbols in proximity to the Licensed TM or trademark).

 

(h)                                  unless otherwise agreed by Licensor, not register or attempt to register any new trademarks, company, business or trading names or domain names following the Separation Date that are identical or similar to (or that incorporate) any element of the Licensed IP Rights, any aspect of them, or any other trademarks or trade names of Licensor and any Affiliate of Licensor.

 

(i)                                      ALL REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS OF ANY KIND, WHETHER EXPRESS OR IMPLIED (BY STATUTE OR OTHERWISE), REGARDING THE LICENSED IP RIGHTS OR RELATING TO THE TERMS AND CONDITIONS OR THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING ANY REPRESENTATION, WARRANTY OR UNDERTAKING OF

 

4


 

 

SUITABILITY, FITNESS FOR PURPOSE OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS) ARE EXPRESSLY EXCLUDED TO THE MAXIMUM EXTENT PERMITTED BY LAW. LICENSEE IS SOLELY RESPONSIBLE FOR ITS USE, RELIANCE OR IMPLEMENTATION OF THE LICENSED IP RIGHTS, INCLUDING ANY ACTIONS OR DECISIONS TAKEN OR NOT TAKEN AS A RESULT THEREOF.

 

5.                    CONDITIONS OF USE OF TRANSITIONALLY LICENSED IP RIGHTS

 

5.1                                Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) ensure that, in each case, any use of a Transitionally Licensed IP Right is limited to the use made of that Transitionally Licensed IP Right (including as regards form, manner and extent (including with respect to the jurisdictions in which that Transitionally Licensed IP Right is used)) in connection with the Novartis Existing Products as at the Effective Date.

 

5.2                                Subject to Clauses 5.5 and 5.8, Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) use Commercially Reasonable Efforts to cease use of the Transitionally Licensed IP Rights as quickly as practicable after the Effective Date, and in any event by the end of the relevant Transitional License Term, including by promptly seeking labelling approval (or equivalent) from any Governmental Entity with competent jurisdiction for each Novartis Existing Product to change each such Novartis Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Novartis Existing Product.

 

5.3                                Subject to Clause 5.2, Licensee shall, in complying with its obligations under Clause 5.1, prioritize the removal of any Transitionally Licensed IP Rights from the packaging of the Novartis Existing Products.

 

5.4                                Subject to Clause 5.8, if by the date which is thirty (30) months after the Effective Date Licensee, having complied with its obligations under Clause 5.1, is prevented by Applicable Law from changing any label for a Novartis Existing Product so that it no longer displays any Transitionally Licensed IP Rights on any marketing materials, packaging or labels of that Novartis Existing Product, Licensee shall notify Licensor of the relevant Novartis Existing Product and the steps that have been taken by Licensee to comply with its obligations under Clause 5.1. Provided Licensee has, in the reasonable opinion of Licensor, complied with its obligations under Clause 5.1, and its other obligations under this Agreement, Licensor shall permit Licensee to continue to use the relevant Transitionally Licensed IP Rights on the relevant Novartis Existing Product for the remaining duration of the Transitional License Term solely to the extent required in order to comply with Applicable Law, provided that Licensee complies with (and continues to comply with) its obligations under Clause 5.1 ( Conditions of use of Transitionally Licensed IP Rights ), including to cease use of those Transitionally Licensed IP Rights by the end of the applicable Transitional License Term, and takes all reasonable steps to obtain all relevant regulatory approvals.

 

5.5                                To the extent that Licensee is required by Applicable Law to display the name of Licensor or an Affiliate of Licensor which is the manufacturer or distributor of a Novartis Existing Product, Licensee shall be entitled for as long as Licensor or an Affiliate of Licensor is the manufacturer of that Novartis Existing Product during the Transitional License Term, to use the corporate name of Licensor or an Affiliate of Licensor, as relevant, provided that:

 

(a)                                  any such use is limited to descriptive use only;

 

(b)                                  the name of Licensor or relevant Licensor Affiliate is reproduced in plain text in a non-prominent manner and in the same form as other information that is required to be disclosed under Applicable Law for the Novartis Existing Product; and

 

5


 

(c)                                   any change to the corporate name of Licensor or an Affiliate of Licensor that manufactures the Novartis Existing Product shall be reflected, as soon as reasonably practicable following such change, in any material in which Licensee is entitled to use Transitionally Licensed IP Rights.

 

5.6                                On written request from Licensor, Licensee shall promptly notify Licensor of:

 

(a)                                  any approval granted by a Governmental Entity to change a Novartis Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Novartis Existing Product; and

 

(b)                                  the rebranding of any Novartis Existing Product so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Novartis Existing Product.

 

5.7                                Except for the rights granted in Clause 5.5, which shall continue in accordance with the terms of Clause 5.5, the grant of rights under Clauses 1.1(a) and 1.1(b) shall terminate, on a country-by-country and Product-by-Product basis, on, subject to Clause 5.8, the earlier of:

 

(a)                                  the date on which Licensee rebrands the relevant Novartis Existing Product so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Novartis Existing Product;

 

(b)                                  the date which is six (6) months after the date on which approval is granted by a Governmental Entity to change a Novartis Existing Product’s label so that it no longer displays any Transitionally Licensed IP Rights on marketing materials, packaging or labels of that Novartis Existing Product; and

 

(c)                                   the end of the relevant Transitional License Term.

 

5.8                                The Parties may agree to extend the period of the license for any of the rights granted under Clause 1.1, on a country-by-country and Novartis Existing Product-by-Novartis Existing Product basis, in order to align the termination of that license (and the related rebranding of any Novartis Existing Product) with the date of the transfer of the relevant Marketing Authorization for that Novartis Existing Product from Licensor (or an Affiliate of Licensor) to Licensee (or an Affiliate of Licensee) in accordance with the Separation Agreement.

 

5.9                                Prior to or promptly after the termination of all rights in relation to Transitionally Licensed IP Rights in accordance with Clause 5.7 (and subject to Clause 10.6 ( Run-off License )), Licensee shall:

 

(a)                                  deliver, at Licensee’s cost, to Licensor (or to any Person nominated by Licensor) all Novartis Existing Products or materials in its possession or under its control which reproduce or display any Transitionally Licensed IP Rights, or at the election of Licensor, destroy such Novartis Existing Products and other materials and provide Licensor with satisfactory evidence of their destruction; and

 

(b)                                  make no further use of the Transitionally Licensed IP Rights without the prior written consent of Licensor.

 

6.                    MAINTENANCE OF LICENSED TMS

 

6.1                                Maintenance of existing registrations and applications. Unless the Parties otherwise agree, Licensor shall, at its own cost, take all reasonable steps to: (i) maintain the registrations for; and (ii) prosecute applications for registration through to registration of, the Licensed TMs listed in Exhibit 1

 

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( Licensed TMs ), provided that Licensee promptly provides, or procures the provision from any permitted sublicensee of Licensee of, all reasonable assistance required by Licensor in connection with doing so.

 

6.2                                Applications for, and maintenance of, new registrations. Without prejudice to Clause 6.1 ( Maintenance of existing registrations and applications ), Licensee shall notify Licensor if it believes that a new application for a Licensed TM that is a Perpetually Licensed IP Right is necessary in relation to the import, export, manufacture, packaging, promotion, distribution, marketing or sale of any Novartis Product in any Territory. Upon receipt of that notice, Licensor shall, unless it reasonably determines that the new application would be detrimental to the business of Licensor and its Affiliates, make that application in its own name and shall take all reasonable steps to prosecute that application through to registration. In respect of any application made by Licensor under this Clause 6.2, Licensee shall:

 

(a)                                  at Licensee’s cost, promptly provide, or procure the provision from any permitted sublicensee of Licensee of, all reasonable assistance (including preparing evidence of any applicable use of the relevant Licensed TM) required by Licensor to enable Licensor to prepare, file and prosecute that application; and

 

(b)                                  upon receipt of an undisputed invoice from Licensor, promptly reimburse Licensor for half of any costs reasonably incurred by Licensor in connection with making that application, or subsequently maintaining any new registration, for a Licensed TM requested by Licensee under this Clause 6.2.

 

6.3                                New applications by Licensor. If Licensor believes that a new application for a Licensed TM is necessary in relation to any Territory, Licensor may, at its own cost, make that application in its own name and take all reasonable steps to prosecute that application through to registration, and Licensee shall, at Licensor’s cost, promptly provide, or procure the provision from any permitted sublicensee of Licensee of, all reasonable assistance (including preparing evidence of any applicable use of the relevant Licensed TM) required by Licensor to enable Licensor to prepare, file and prosecute that application.

 

6.4                                Restrictions on transfers of the Licensed IP Rights. Licensor shall (and shall procure that any Affiliate of Licensor shall) not assign or transfer any of its right, title or interest in or to any of the Licensed IP Rights unless the relevant assignee or transferee:

 

(a)                                  joins as a party to this Agreement by entering into a deed of adherence with the Parties in respect of those Licensed IP Rights; or

 

(b)                                  enters into an assignment with Licensor pursuant to Clause 15.1 for any element of this Agreement that relates to those Licensed IP Rights,

 

in each case, on terms that are acceptable to Licensee (acting reasonably).

 

7.                    APPROVAL AND INSPECTION

 

7.1                                Licensee shall:

 

(a)                                  on written request from Licensor, provide Licensor with a reasonable number of samples of all products and materials (including any advertising, marketing or promotional materials) on which the Licensed IP Rights are used; and

 

(b)                                  once per calendar year, on reasonable prior notice from Licensor, permit Licensor (or its nominated representative) to enter Licensee’s premises during Working Hours

 

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solely for the purposes of verifying that Licensee is complying with its obligations under this Agreement.

 

7.2                                If Licensor believes, on reasonable grounds, that Licensee is failing to comply with any of its obligations under Clause 4 ( Conditions of use of Licensed IP Rights ) or Clause 5 ( Conditions of use of Transitionally Licensed IP Rights ):

 

(a)                                  Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) take any steps (at its own cost) that Licensor reasonably determines are necessary to ensure compliance; and

 

(b)                                  Licensee shall (and shall procure that its sublicensees permitted in accordance with this Agreement shall) not sell, distribute or otherwise dispose of any materials or products that Licensor determines do not comply with Licensee’s obligations under Clause 4 (Conditions of use of Licensed IP Rights) or Clause 5 ( Conditions of use of Transitionally Licensed IP Rights ) without the prior written consent of Licensor.

 

8.                    OWNERSHIP OF LICENSED IP RIGHTS

 

Licensee acknowledges and agrees that:

 

(a)                                  all Intellectual Property Rights and other rights in the Licensed IP Rights are the exclusive property of Licensor or its Affiliates;

 

(b)                                  it shall not acquire, nor claim, any right, title or interest in or to any element of the Licensed IP Right or the goodwill attaching to any Licensed TM by virtue of this Agreement or its use of the relevant Licensed IP Right, other than the rights specifically granted to it under Clause 1.1;

 

(c)                                   all goodwill arising from use of the Licensed TMs by Licensee before, during or after the term of this Agreement shall accrue and belong to Licensor, and Licensee shall, at Licensor’s request and cost, promptly execute all documents required by Licensor to confirm this; and

 

(d)                                  all use of the Licensed TMs by Licensee shall be deemed to be use by Licensor for the purpose of satisfying any applicable trademark laws that require the use of the mark, or entitle Licensor to rights in relation to use (including any distinctiveness acquired through use).

 

9.                    INFRINGEMENT

 

9.1                                Nothing in this Agreement shall constitute any representation that any use of any Licensed IP Right does not, or will not, infringe any Intellectual Property Rights owned by a Third Party.

 

9.2                                Each Party shall immediately notify the other in writing of any of the following matters that comes to its attention (giving full particulars of the matter, the identity of the Third Party and the urgency of any actions required or recommended to be taken):

 

(a)                                  any actual, suspected or threatened infringement of any element of a Licensed IP Right by a Third Party;

 

(b)                                  any allegation or complaint made by any Third Party that any element of a Licensed IP Right is invalid, that use of any element of a Licensed IP Right infringes any Third

 

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Party right, or that use of any element of a Licensed IP Right may deceive or confuse the public; or

 

(c)                                   any other attack on or claim to any element of a Licensed IP Right.

 

9.3                                In respect of any matter described in Clause 9.2 above:

 

(a)                                  Licensee shall not make any admissions other than to Licensor;

 

(b)                                  Subject to Clause 9.4, Licensor shall decide, in its absolute discretion, whether or not to take action, and what action to take, and shall have exclusive control over any resulting claims, actions and proceedings. Except as set out in Clause 9.4 and Clause 9.5, the provisions of section 43(a) of the U.S. Trademark (Lanham) Act with respect to any purported licensee rights to maintain an action under section 43(a), and any similar provisions under the laws of any other jurisdiction, are expressly excluded; and

 

(c)                                   if Licensor decides to take any action  in respect of any such matter, Licensee shall (and shall procure that its Affiliates and sub-licensees shall), at Licensor’s cost, provide any assistance that Licensor reasonably requires (including bringing proceedings or lending its name to any proceedings brought by Licensor). Subject to Clause 9.5, any award of Costs or compensation in connection with any of those matters shall be solely for the account of Licensor.

 

9.4                                Licensee’s enforcement rights

 

If (a) Licensor notifies Licensee that Licensor does not intend to take any action in respect of any matter described in Clause 9.2 above or three (3) months have elapsed since notice of a matter described in Clause 9.2 was provided by one Party to the other without Licensor taking any action and that matter relates to: (i) a Perpetually Licensed IP Right; and (ii) a country in the Territory in which Licensee or an Affiliate of Licensee operates; or (b) the matter relates to or, in Licensee’s reasonable opinion, will impact a Novartis Product which the Licensee has Commercialised or intends to Commercialise within twenty-four (24) months from the date Licensee provided notice of the matter (or such time as otherwise agreed by the Parties on a case-by-case basis) described in Clause 9.2, then under either (a) or (b) Licensee may take action in its own name in respect of that matter and control any resulting claim(s), action(s) and proceeding(s), provided that, prior to taking any material action or decision with regards to that matter (including commencing any claim(s), action(s) or proceeding(s) or settling any dispute) Licensee shall consult in good faith with Licensor, shall seek Licensor’s consent for that material action or decision (such consent not to be unreasonably withheld) and shall not take any such action or decision without that consent. If Licensee (or its Representatives) takes any action or decision in respect of a matter under this Clause 9.4 that Licensor has not consented to, Licensee shall indemnify Licensor and its Representatives against all Costs or other liabilities as a result of that action or decision. For the avoidance of doubt, the Parties acknowledge that it shall not be unreasonable for Licensor to withhold its consent under this Clause 9.4 to the extent that Licensee’s taking of the relevant material action or decision would be detrimental to the business of Licensor or any Affiliate of Licensor (including in respect of its relationship with any of its suppliers or customers).

 

9.5                                Licensor shall (and shall procure that its Affiliates shall), at Licensee’s cost, provide any assistance that Licensee reasonably requires under Clause 9.4 (including bringing proceedings or lending its name to any proceedings brought by Licensee). Any award of Costs or compensation in

 

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connection with any claim(s), action(s) or proceeding(s) brought by Licensee under Clause 9.4 shall be solely for the account of Licensee.

 

10.             TERMINATION

 

10.1                         Termination of Agreement. Notwithstanding Clause 3 ( Duration ), Licensor may terminate this Agreement in part or in its entirety, with immediate effect, by written notice to Licensee if:

 

(a)                                  Licensee commits a breach of any material obligation under this Agreement and, in the case of a breach that is capable of remedy, fails to remedy it within ninety (90) days of receipt of a written notice from Licensor giving full particulars of the breach and requiring it to be remedied;

 

(b)                                  Licensee or an Affiliate of Licensee challenges Licensor’s entitlement to own, to use or to license the use of any of the Licensed IP Rights; or

 

(c)                                   an Insolvency Event occurs in relation to Licensee.

 

10.2                         For the purposes of Clause 10.1, a breach shall be considered capable of remedy if Licensee can comply with the provision in question in all respects other than as to time of performance.

 

10.3                         Termination in relation to Perpetually Licensed IP Rights. Notwithstanding Clause 2(a), Licensor may terminate this Agreement in respect of a Licensed TM that is a Perpetually Licensed IP Right if:

 

(a)                                  Licensee, and its sublicensees, cease use of that Licensed TM for a continuous period of thirty-six (36) months; or

 

(b)                                  where that Licensed TM is not in use as at the Effective Date, Licensee, and its sublicensees, fail to use that Licensed TM within a period of five (5) years from the Effective Date.

 

10.4                         Consequences of termination. On the date of expiry or termination of this Agreement, in part or in its entirety, for any reason (in each case the Termination Date ):

 

(a)                                  subject to Clause 10.6, the rights and licenses granted pursuant to this Agreement that are affected by that expiry or termination shall cease with immediate effect;

 

(b)                                  all relevant obligations of Licensor to Licensee under this Agreement shall cease with immediate effect;

 

(c)                                   all relevant outstanding sums payable by one Party to the other shall immediately become due and payable;

 

(d)                                  subject to Clause 10.6, Licensee shall cease, within thirty (30) days from the date of that termination or expiry, to make any use of the affected Licensed IP Rights; and

 

(e)                                   subject to Clause 10.6, Licensee shall (at its own expense) on request by Licensor, as soon as practicable:

 

(i)                                      deliver to Licensor, or to any person nominated by Licensor, representative samples of all materials, in electronic or hard copy form, under its control on, or in relation to which, any of the affected Licensed IP Rights are being used by Licensee or any Affiliate of Licensee; or

 

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(ii)                                   following the period described in Clause 10.6, destroy such products and materials (except to the extent that Licensee or any Affiliate of Licensee is required to retain any of them in order to comply with Applicable Law) and certify in writing to Licensor that this has been done.

 

10.5                         No releases from accrued liabilities and Surviving Provisions . Termination of this Agreement shall not release either Party from any liability that at the time of termination or expiry had already accrued to the other Party.  The Surviving Provisions, together with any other Clause reasonably intended to survive termination or expiry, shall survive termination or expiry of this Agreement.

 

10.6                         Run-off license for inventory. In relation to affected Novartis Products that are either in stock or under the control of Licensee or any Affiliate of Licensee at the time of that termination or expiry, Licensee and its Affiliates may continue to sell those Novartis Products for a maximum period of six (6) months from the date of termination or expiry (as applicable), or any longer period that the Parties agree.

 

11.             LIMITATION OF LIABILITY

 

11.1                         TO THE FULLEST EXTENT PERMITTED BY LAW, LICENSOR SHALL NOT BE LIABLE TO LICENSEE FOR ANY COSTS EXPENSES, LOSSES OR DAMAGES (IN EACH CASE, WHETHER DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL OR CONSEQUENTIAL, AND WHETHER ECONOMIC OR OTHER) ARISING FROM LICENSEE’S EXERCISE OF THE RIGHTS GRANTED TO IT UNDER THIS AGREEMENT, WHETHER OR NOT LICENSEE OR ANY OF ITS AFFILIATES HAVE BEEN ADVISED OF, OR OTHERWISE MIGHT OR SHOULD HAVE ANTICIPATED, THE POSSIBILITY OR LIKELIHOOD OF SUCH COSTS, EXPENSES, LOSSES OR DAMAGES.

 

11.2                         Nothing in this Agreement shall have the effect of excluding or limiting any liability for gross negligence, wilful misconduct, death or personal injury caused by negligence or for fraud or any other liability that cannot be excluded by Applicable Law.

 

11.3                         Neither Party shall have any duty or obligation under this Agreement except as expressly set out in this Agreement.

 

12.             TAX

 

12.1                         General. Any sum payable by Licensee to Licensor under this Agreement is exclusive of any applicable VAT.  If any supply is treated as or deemed made by Licensor or an Affiliate of Licensor under this Agreement and Licensor or an Affiliate of Licensor is required to account for VAT in respect of that supply, Licensee shall, against receipt of a valid VAT invoice (if applicable) pay to Licensor (in addition to, and at the same time as, any other consideration for that supply) an amount equal to such VAT.

 

12.2                         Records . Licensee may obtain a direction from the relevant Tax Authority for the retention and preservation by it of any VAT records relating to its period of use of any Licensed IP Rights and, if such directions are obtained, Licensee agrees to preserve any such records in such a manner and for such period as may be required by Applicable Law and shall allow Licensor, upon Licensor giving reasonable notice, reasonable access and copies of such records where reasonably required by Licensor for its Tax purposes.  If no such direction is obtained and any documents are required by Applicable Law to be preserved by Licensor, Licensee shall, as soon as reasonably practicable, deliver such documents to Licensor.

 

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13.             CONFIDENTIALITY

 

Each Party shall, and shall procure that its Representatives shall, comply with the provisions of clause 28 ( Confidentiality ) of the Separation Agreement in relation to:

 

(a)                                  all Information of the other Group that is either in its possession or is furnished by the other Group or its respective Representatives in connection with this Agreement; and

 

(b)                                  information relating to the provisions and subject matter of, and negotiations leading to, this Agreement.

 

14.             NOTICES

 

14.1                         Form of notice.   Any notice to be given in connection with this Agreement shall be in writing in English and signed by or on behalf of the Party giving it (in the case of notice by e-mail, a notice signed electronically or a scanned copy of a signed original notice shall suffice). It shall be delivered by hand, registered post, e-mail or courier using an internationally recognised courier company. Any notice to Licensee shall be deemed notice to all members of Licensee Group, and any notice to Licensor shall be deemed notice to all members of Licensor Group.

 

14.2                         Effectiveness of notice.   A notice shall be effective upon receipt and shall be deemed to have been received at the time of delivery, if delivered by hand, registered post or courier, or at the time of transmission if delivered by e-mail (subject to confirmation or evidence of receipt). Where delivery occurs outside Working Hours, notice shall be deemed to have been received at the start of Working Hours on the next following Business Day.

 

14.3                         Notice details.   The addresses and e-mail addresses of the Parties for the purpose of Clause 14.1 ( Form of notice ) are:

 

Licensee and each member of the Licensee Group

 

For the attention of: Head of Legal M&A (Novartis International AG)

 

Novartis AG
Lichtstrasse 35,
4056 Basel,
Switzerland

 

jonathan.emery@novartis.com

 

 

 

Licensor and each member of the Licensor Group

 

For the attention of: General Counsel

 

Alcon Inc.
Rue Louis-d’Affry 6,
1701 Fribourg,
Switzerland

 

royce.bedward@alcon.com

 

14.4                         Change of notice details. Licensee and Licensor shall each notify the other Party in writing of a change to its details in Clause 14.1 ( Form of notice ) from time to time.

 

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15.             MISCELLANEOUS PROVISIONS

 

15.1                         Assignment by Licensor. Subject to Clause 6.4 ( Restrictions on transfers of the Licensed IP Rights ):

 

(a)                                  Licensor may assign its rights and obligations under this Agreement, or any of the Licensed IP Rights, to an Affiliate of Licensor or to a Third Party.

 

(b)                                  If Licensor transfers its rights in any Licensed IP Right to an Affiliate or to a Third Party, it shall be entitled to assign any element of this Agreement that relates to the Licensed IP Right to that Affiliate or Third Party.

 

15.2                         Assignment by Licensee.

 

(a)                                  Licensee may assign or transfer this Agreement and/or any of the rights granted under Clause 1.1 of this Agreement to any:

 

(i)                   Affiliate of Licensee; and

 

(ii)                Third Party in connection with the disposal to that Third Party of: (A) any Novartis Product that uses any element of the Licensed IP Rights as at the date of that disposal; or (B) all or substantially all of the Licensor’s business to which this Agreement relates.

 

(b)                                  If Licensee assigns or transfers any of its rights and/or obligations under this Agreement to an Affiliate or a Third Party, it shall notify Licensor as soon as practicable after such assignment or transfer together with particulars of the assignee or transferee.

 

15.3                         Any permitted assignee or transferee under Clause 15.1 ( Assignment by Licensor ) or Clause 15.2 ( Assignment by Licensee ) will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and will inure to the benefit of the Parties and their respective successors and assigns.

 

15.4                         Waivers, Rights and Remedies. Except as expressly provided in this Agreement, no failure or delay by any Party in exercising any right or remedy relating to this Agreement shall affect or operate as a waiver or variation of that right or remedy or preclude its exercise at any subsequent time.  No single or partial exercise of any such right or remedy shall preclude any further exercise of it or the exercise of any other remedy.

 

15.5                         Announcements. The provisions of clause 29 ( Announcements ) of the Separation Agreement shall apply to this Agreement.

 

15.6                         Further Assurances.

 

(a)                                  Further Acts and Documents. Subject to the express limitations in this Agreement, each of the Parties shall, at the request (and expense) of the other Party, perform (or procure the performance of) all further acts and things and execute and deliver (or procure the execution and delivery of) such further documents, as may be required by Applicable Law or as may be necessary or reasonably required to implement and give effect to this Agreement.

 

(b)                                  Obligations of Agreement on Affiliates. Each of Licensee and Licensor shall procure that each member of its respective Group complies with all obligations under this Agreement which are expressed to apply to any such member.

 

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15.7                         No Third Party Enforcement Rights. A Person who is not a Party to this Agreement shall have no right under any statutory provision to enforce any of its terms.

 

15.8                         Counterparts. This Agreement may be executed in any number of counterparts, and by each Party on separate counterparts. Each counterpart is an original, but all counterparts shall together constitute one and the same instrument. Delivery of a counterpart of this Agreement by e-mail attachment shall be an effective mode of delivery.

 

15.9                         Variations. No amendment of this Agreement shall be valid unless it is in writing and duly executed by or on behalf of all of the Parties to it.

 

15.10                  Invalidity. Each of the provisions of this Agreement is severable.  If any such provision is held to be or becomes invalid or unenforceable in any respect under the law of any jurisdiction, it shall have no effect in that respect and the Parties shall use Commercially Reasonable Efforts to replace it in that respect with a valid and enforceable substitute provision the effect of which is as close to its intended effect as possible.

 

15.11                  Method of Payment and Set-Off. Any payments pursuant to this Agreement shall be made in full, without any set-off, counterclaim, restriction or condition and without any deduction or withholding (save as may be required by Applicable Law or as otherwise agreed).  Any payments pursuant to this Agreement shall be effected by crediting for same day value the account specified by Licensee or Licensor (as the case may be) on behalf of the Person entitled to payment on or before the due date for payment.  Payment of a sum in accordance with this Clause 15.11 shall constitute a payment in full of the sum payable and shall be a valid discharge to the payer (and those on whose behalf such payment is made) of the payer’s obligation to make such payment and the payer (and those on whose behalf such payment is being made) shall not be obligated to see to the application of the payment as between those on whose behalf payment is received.

 

15.12                  Costs. Except as otherwise provided in this Agreement or as otherwise agreed in writing between the Parties, Licensee and Licensor shall each be responsible for its own costs, charges and other expenses (including those of members of their respective Groups) incurred in connection with this Agreement.

 

15.13                  Whole Agreement.

 

(a)                                  This Agreement and the other Transaction Documents together set out the whole agreement between the Parties in respect of the subject matter of this Agreement and supersedes any previous draft, agreement, arrangement or understanding, whether in writing or not, relating to its subject matter. It is agreed that:

 

(i)                   no Party has relied on or shall have any claim or remedy arising under or in connection with any statement, representation, warranty or undertaking made by or on behalf of the other Party (or any of its Representatives) in relation to the subject matter of this Agreement that is not expressly set out in this Agreement and the other Transaction Documents;

 

(ii)                any terms or conditions implied by Applicable Law in any jurisdiction in relation to the subject matter of this Agreement are excluded to the fullest extent permitted by Applicable Law or, if incapable of exclusion, any rights or remedies in relation to them are irrevocably waived;

 

(iii)             the only right or remedy of a Party in relation to any provision of this Agreement shall be for breach of this Agreement; and

 

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(iv)            except for any liability in respect of a breach of this Agreement, neither Party (nor any of its Representatives) shall owe any duty of care or have any liability in tort or otherwise to the other Party (or its respective Representatives in relation to the subject matter of this Agreement.

 

(b)                                  Nothing in this Clause 15.13 ( Whole Agreement ) shall limit any liability for (or remedy in respect of) fraud or fraudulent misrepresentation.

 

(c)                                   Each Party agrees to the terms of this Clause 15.13 ( Whole Agreement ) on its own behalf and as agent for each of its Representatives.

 

15.14                  Governing Law. This Agreement and any non-contractual obligations arising out of or in connection with this Agreement shall be governed by, and interpreted in accordance with, the substantive laws of Switzerland (excluding its rules on conflict of laws and excluding the UN Convention on Contracts for the International Sale of Goods).

 

15.15                  Specific Performance. In the event of any actual or threatened default in, or breach of, any of the terms, conditions and provisions of this Agreement, the affected Party shall have the right to specific performance and injunctive or other similar relief of its rights under this Agreement to prevent breaches of this Agreement and to enforce specific performance of the terms and provisions of this Agreement, in addition to any other remedy to which the affected Party is entitled pursuant to this Agreement.  The other Party shall not oppose the granting of such relief on the basis that money damages are an adequate remedy.  The Parties agree that the remedies under Applicable Law for any breach or threatened breach hereof, including monetary damages, are inadequate compensation for any loss and that any defence in any action for specific performance that a remedy under Applicable Law would be adequate is waived.  Any requirements for the securing or posting of any bond with such remedy are waived.

 

16.             DISPUTE RESOLUTION

 

16.1                         This Clause 16 ( Dispute Resolution ) shall apply to any dispute, controversy or claim arising out of or relating to this Agreement, including a dispute, controversy or claim relating to the existence, validity or termination of this Agreement (each, a Dispute ).

 

16.2                         Before entering into any arbitration pursuant to Clauses 16.4 or 16.4(a), a Party shall give written notice of a Dispute to the other Party (a Dispute Notice ). The Dispute Notice shall:

 

(a)                                  state that it is a Dispute Notice being submitted pursuant to this Clause 16 ( Dispute Resolution );

 

(b)                                  identify the Dispute in sufficient detail to allow the Party receiving the Dispute Notice to understand reasonably the nature of the Dispute; and

 

(c)                                   set out any steps taken by that Party or its Affiliates to resolve it.

 

16.3

 

(a)                                  Upon receipt of a Dispute Notice, each Party shall refer the Dispute to its Group General Counsel (or, if they are not reasonably available during the relevant period, their appointed alternate, who shall be of sufficient seniority within the relevant Party and have authority to be able to reach a resolution of the Dispute) and the two Group General Counsel shall attempt in good faith to settle the Dispute by means of an appropriate written agreement setting out the terms on which the Dispute is resolved within twenty (20) Business Days of the date of receipt of the Dispute Notice (the Resolution Period ). The time limit specified in this Clause 16.3 may be extended by the written agreement of the Parties.

 

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(b)                                  Notwithstanding the foregoing, either Party may, at any time, seek interim or provisional relief, whether from an emergency arbitrator appointed and acting in accordance with the LCIA Rules, a tribunal constituted under the LCIA Rules and/or from a national court of competent jurisdiction, in advance of or in aid of the arbitration proceedings contemplated by Clause 16.4.

 

16.4                         If the Parties do not conclude a binding written agreement settling the Dispute within the Resolution Period, either Party shall be entitled to refer the Dispute to be finally resolved by arbitration. In those circumstances, the Parties agree that:

 

(a)                                  the arbitration shall be conducted in accordance with the LCIA Arbitration Rules in effect at the date of this Agreement (the LCIA Rules );

 

(b)                                  the tribunal shall comprise three arbitrators, with one arbitrator selected by each Party and the chairperson selected by the LCIA Court. The chairperson shall not be of Swiss or American nationality;

 

(c)                                   the seat of arbitration shall be London;

 

(d)                                  the written and spoken language to be used in the arbitral proceedings shall be English; and

 

(e)                                   the award of the arbitral tribunal shall be final and binding upon the parties and judgment may be entered on an award in any court of competent jurisdiction.

 

16.5                         Where the Dispute relates to or is in any way connected with any dispute referred to arbitration under any other Ancillary Agreement, either Party may apply to the LCIA Court at any time before the tribunal is fully constituted in either arbitration requesting that the two arbitrations be consolidated and the Parties hereby agree that in such circumstances the arbitrations are to be consolidated by the LCIA Court. In the event of consolidation, the Parties agree that the consolidated arbitration shall be conducted under the LCIA Rules in accordance with Clause 16.4.

 

16.6                         The Parties agree that any settlement discussions and communications or negotiations in connection with the proposed resolution of a Dispute are without prejudice to the Parties’ positions, are to be kept confidential, and shall not be used or submitted in any arbitration or other legal proceeding between the Parties for any purpose. For the avoidance of doubt, this Clause 16.6 shall not affect a Party’s right to submit and rely on any correspondence marked “without prejudice save as to costs” for the purpose of the tribunal’s determination on costs.

 

[ Signature Page Follows ]

 

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SIGNATURES

 

This Agreement is signed by duly authorised representatives of the Parties:

 

NOVARTIS AG

 

 

 

 

 

 

 

 

/s/ Christian Diehl

 

/s/ Michael Stewart

 

 

 

Name:

Christian Diehl

 

Name:

Michael Stewart

 

 

 

 

 

Title:

As Attorney

 

Title:

As Attorney

 

 

 

 

 

 

ALCON INC.

 

 

 

 

 

 

 

 

/s/ David Murray

 

/s/ Tom Hudnall

 

 

 

Name:

David Murray

 

Name:

Tom Hudnall

 

 

 

 

 

Title:

Authorized Signatory

 

Title:

Attorney in Fact

 

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SCHEDULE 1
DEFINITIONS AND INTERPRETATION

 

1.                                       Definitions . In this Agreement, the following words and expressions shall have the following meanings:

 

Affiliate has the meaning given in the Separation Agreement;

 

Agreement means this brand license agreement;

 

Alcon Existing Products means:

 

(a)                                 any contact lens or contact lens care product, including those products listed under part 1 ( Vision Care ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                 any ophthalmic surgical products, including those products listed under part 2 ( Surgical (incl. Diagnostics) ) of the “Alcon” tab of the Products List and  any product having substantially the same formula as any of them;

 

(c)                                  any other products listed under part 3 ( Dry Eye & Ocular Health ), Part 4 ( Viscoelastics ) or Part 5 ( R&D and Clinical Trials ) of the “Alcon” tab of the Products List and any product having substantially the same formula as any of them; and

 

(d)                                 any other ophthalmic or vision care product that is, as of the date of this Agreement or at any time prior, lawfully Commercialised as an Over-the-counter Product in the United States of America by either Party or any of their respective current or historic Affiliates, and any product having substantially the same formula as any of them and that is or has been Commercialised by either Party or any of their respective current or historic Affiliates as an Over-the-counter Product in the United States of America (in which case, such product shall constitute an Alcon Existing Product in all jurisdictions),

 

in each case other than any product included within paragraphs (a), (b) or (c) of the definition of Novartis Existing Products.

 

Alcon Future Products means means any products owned or controlled by Alcon or its Affiliates after the Effective Date, excluding the Alcon Existing Products;

 

Alcon Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Alcon Optional Products has the meaning given in Exhibit 6 ( Alcon Optional Products );

 

Alcon Products means (i) the Alcon Existing Products; (ii) the Alcon Future Products; and (iii) the Alcon Optional Products;

 

Applicable Law has the meaning given in the Separation Agreement;

 

Brand Guidelines means the brand guidelines at Exhibit 2 ( Brand Guidelines ), as updated from time to time by Licensor;

 

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Business Day means a day, other than a Saturday or Sunday or public holiday in Switzerland or the United States, on which banks are open in Basel, Fribourg, Geneva, Zurich and New York City for general commercial business;

 

Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

 

Commercially Reasonable Efforts has the meaning given in the Separation Agreement;

 

Confidential Material has the meaning given in Clause 16(h);

 

Costs means losses, damages, costs (including reasonable legal costs on an indemnity basis) and expenses (including Tax), in each case of any nature whatsoever;

 

Development means, with respect to any product, any research, pre-clinical or non-clinical testing, clinical studies, chemistry manufacturing controls (CMC), quality, statistical analysis or report writing, and related development and regulatory activities associated therewith, and Develop and Developed shall be construed accordingly;

 

Dispute has the meaning given in Clause 16.1;

 

Dispute Notice has the meaning given in Clause 16.2;

 

Effective Date means the date of this Agreement;

 

Formulation Mark means any Licensed TM that comprises or incorporates the trademarks identified in Exhibit 4 ( Formulation Marks );

 

Governmental Entity has the meaning given in the Separation Agreement;

 

Group has the meaning given in the Separation Agreement;

 

Information has the meaning given in the Separation Agreement;

 

Insolvency Event means, in relation to a Party, any of the following:

 

(a)                                 it is unable or admits inability to pay its debts as they fall due; suspends or threatens to suspend making payments on any of its debts; or, by reason of actual or anticipated financial difficulties, commences negotiations with one or more of its creditors with a view to rescheduling any of its indebtedness;

 

(b)                                 the value of its assets is less than its liabilities (taking into account contingent and prospective liabilities);

 

(c)                                  a moratorium is declared in respect of any of its indebtedness (if a moratorium occurs, the ending of the moratorium will not remedy any Insolvency Event caused by that moratorium);

 

(d)                                 any corporate action, legal proceedings or other procedure or step is taken (whether by a Party, its directors or a Third Party) in relation to:

 

(i)                                    the suspension of payments, a moratorium of any indebtedness, winding-up, dissolution, administration (whether out of court or otherwise) or reorganization (by way of voluntary arrangement, scheme of arrangement or otherwise);

 

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(ii)                                 a composition, compromise, assignment or arrangement with any creditor;

 

(iii)                               the appointment of a liquidator, receiver, administrator, administrative receiver, compulsory manager or other similar officer in respect of the Party or any of its assets (in each case whether out of court or otherwise);

 

(iv)                              enforcement of any security over any assets of Licensee or Licensor (as applicable), including a creditor attaching or taking possession of, or distress, execution, sequestration or other process being levied or enforced upon or sued against all or any part of the assets of the relevant party;

 

(v)                                a meeting of the Party, its directors or its members being convened for the purpose of considering any resolution for, or to petition for, or to apply for or to file documents with a court for its winding-up, administration (whether out of court or otherwise) or dissolution, or any such resolution is passed;

 

(vi)                             any person presenting a petition, application or motion for the winding-up, administration (whether out of court or otherwise) or dissolution of the Party; or

 

(vii)                          the directors or other officers of the Party requesting the appointment of or giving notice of their intention to appoint or take any step with a view to appointing a liquidator, receiver, administrator, administrative receiver, compulsory manager, trustee in bankruptcy or other similar officer in respect of the Party (in each case whether out of court or otherwise),

 

(but paragraph (d) shall not apply to a solvent liquidation of the company or any winding-up petition which is frivolous or vexatious and is discharged, stayed or dismissed within fourteen (14) days of its presentation); or

 

(e)                                  there occurs in relation to the Party or any of its assets in any country or territory in which it is incorporated or carries on business or to the jurisdiction of whose courts it or any of its assets are subject any event which corresponds in that country or territory with any of those mentioned in (a) to (d);

 

Intellectual Property Rights means all: (i) Patents; (ii) Know-How; (iii) Trademarks; (iv) Internet domain names; and (v) works of authorship, copyrights, database rights, mask work rights and registrations and applications therefor;

 

Know-How means all existing and available technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data;

 

LCIA Rules  has the meaning given in Clause 16.4(a);

 

Licensed Corporate Names means the corporate names listed in Exhibit 7 ( Licensed Corporate Names );

 

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Licensed IP Rights means the Transitionally Licensed IP Rights and the Perpetually Licensed IP Rights;

 

Licensed TMs means all of the trademarks listed in Exhibit 1 ( Licensed TMs ), and any new Trademarks registered pursuant to Clause 6.2 ( Applications for, and maintenance of, new registrations ) (and Licensed TM means any one of them);

 

Manufacture means, as applicable, the planning, purchasing of materials for, production, processing, compounding, storage, filling, packaging, labelling, leafleting, warehousing, quality control testing, waste disposal, quality release, sample retention and stability testing of products, including the active ingredients of such products, and Manufacturing or Manufactured shall be construed accordingly;

 

Manufacturing and Supply Agreement means the manufacturing and supply agreement entered into between Alcon and Novartis Pharma AG on or about the date of this Agreement;

 

Marketing Authorization has the meaning given in the Separation Agreement;

 

Non-exclusive means the right to use Intellectual Property Rights, without precluding Licensor using the Intellectual Property Rights itself or from granting the same rights to Third Parties;

 

Novartis Existing Products means:

 

(a)                                  the products listed under part 1 ( Pharmaceuticals ) or Part 6 ( R&D and Clinical Trials ) of the “Novartis” tab of the Products List and any product having substantially the same formula as any of them;

 

(b)                                  the products listed under the “Emerging Markets Brands” tab of the Products List and any product having substantially the same formula as any of them;

 

(c)                                   the Sandoz Products; and

 

(d)                                  any other product as at the Effective Date that is not an Alcon Existing Product.

 

Novartis Future Products means any products owned or controlled by Novartis or its Affiliates, including Sandoz, after the Effective Date, excluding the Novartis Existing Products;

 

Novartis Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Novartis Optional Products has the meaning given in Exhibit 8 ( Novartis Optional Products );

 

Novartis Products means: (i) the Novartis Existing Products; (ii) the Novartis Future Products; and (iii) the Novartis Optional Products;

 

Over-the-counter Product means, in respect of any jurisdiction, a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription;

 

Patents means, whether domestic or foreign, any patent applications and issued patents;

 

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Perpetual License Purpose means use in the Territory on or in connection with the import, export, manufacture, packaging, promotion, distribution, marketing and sale (or conducting, or having conducted on its behalf, any of these activities) of: (i) the Novartis Existing Products in any field of use; (ii) the Novartis Future Products in the Novartis Licensed Field; and (iii) the Novartis Optional Products in the Novartis Licensed Field;

 

Perpetually Licensed IP Rights means the Licensed TMs that are identified as being Perpetually Licensed IP Rights in Exhibit 1 ( Licensed TMs );

 

Person means any individual, corporation, partnership, limited liability company, firm, joint venture, association, joint-stock company, trust, unincorporated organisation, Governmental Entity or other entity;

 

Products List has the meaning given in the Separation Agreement;

 

Representatives has the meaning given in the Separation Agreement;

 

Resolution Period has the meaning given in Clause 16.3;

 

Sandoz means Sandoz AG and any of its Subsidiaries;

 

Sandoz Products means any products which, as at the date of this Agreement, are researched, Developed, Manufactured, or Commercialised by Sandoz, or Commercialised as a generic or biosimilar product of the Sandoz division, provided, that if at the date of this Agreement, any product is Commercialised by both (i) Sandoz; and (ii) a member of the Alcon Group, pursuant to a Marketing Authorisation held solely by the Alcon Group, such product shall constitute an “Alcon Existing Product” when and to the extent Commercialised by a member of the Alcon Group and a “Sandoz Product” (and therefore a “Novartis Existing Product”) when and to the extent Commercialised by Sandoz;

 

Separation Agreement has the meaning given in the Recitals;

 

Separation Date has the meaning given in the Separation Agreement;

 

Shared Licensed Field has the meaning given in Exhibit 3 ( Licensed Fields );

 

Shared Moulds has the meaning given in the Manufacturing and Supply Agreement;

 

Subsidiary has the meaning given in the Separation Agreement;

 

Surviving Provisions means Clause 8 ( Ownership of Licensed IP Rights ), Clause 10.4 ( Consequences of termination), Clause 11 ( Limitation of liability ), Clause 13 ( Confidentiality ), Clause 15 ( Miscellaneous Provisions ) and Schedule 1 ( Definitions and Interpretation );

 

Tax has the meaning given in the Tax Matters Agreement;

 

Tax Authority has the meaning given in the Tax Matters Agreement;

 

Tax Matters Agreement means the tax matters agreement dated on or around the date of this Agreement and entered into between Novartis and Alcon;

 

Term means the period commencing on the Effective Date and terminating on the Termination Date;

 

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Termination Date has the meaning given in Clause 10.4 ( Consequences of termination );

 

Territory means worldwide (except to the extent indicated otherwise in Exhibit 5 ( Novartis Existing Products with Limited Territory ) in relation to any Novartis Existing Product;

 

Third Party means a person other than Licensee, Licensor or their respective Affiliates from time to time;

 

Trademarks means trademarks, service marks, trade names, certification marks, service names, industrial designs, brand names, brand marks, trade dress rights, identifying symbols, logos, emblems, and signs or insignia, and any applications for the foregoing;

 

Transaction Document has the meaning given in the Separation Agreement;

 

Transitional License Purpose means use on or in connection with the import, export, manufacture, packaging, promotion, distribution, marketing and sale (or conducting, or having conducted on its behalf, any of these activities) of the Novartis Existing Products in the Territory in any field of use;

 

Transitional License Term means:

 

(a)                                 in respect of any Licensed Corporate Names that are used in order to indicate the manufacturer or distributor of a Novartis Product pursuant to Clause 5.5, a period of four years from and including the Effective Date; and

 

(b)                                 otherwise, a period of three years from and including the Effective Date.

 

Transitionally Licensed IP Rights means:

 

(a)                                 the Licensed TMs that are identified as being Transitionally Licensed IP Rights in Exhibit 1 ( Licensed TMs );

 

(b)                                 the Licensed Corporate Names; and

 

(c)                                  any other corporate marks, trademarks, housemarks, trade names and trade dress (whether registered or unregistered) owned by Licensor or any Affiliate of Licensor which include the name “ALCON”, and any associated device marks and logos, or any variants of any of the foregoing, in each case as used on any Novartis Existing Products at the Effective Date;

 

VAT means, within the European Union, such tax, duty, assessment or similar charges as may be levied in accordance with (but subject to derogations from) Council Directive 2006/112/EC, and outside the European Union, any tax, duty, assessment or similar charges levied by reference to added value, turnover or sales, in each case including all interest, penalties and additions imposed thereon by any Tax Authority; and

 

Working Hours means 9.00am to 5.00pm in the relevant location on a Business Day.

 

2.                                       Definitions . In this Agreement, unless the context otherwise requires:

 

(a)                                  headings do not affect the interpretation of this Agreement; the singular shall include the plural and vice versa; and references to one gender include all genders;

 

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(b)                                  references to any English legal term or concept shall, in respect of any jurisdiction other than England, be construed as references to the term or concept which most nearly corresponds to it in that jurisdiction; and

 

(c)                                   any phrase introduced by the terms including , include , in particular or any similar expression shall be construed as without limitation and illustrative and shall not limit the sense of the words preceding those terms.

 

3.                                       Enactments . Except as otherwise expressly provided in this Agreement, any express reference to an enactment (which includes any legislation in any jurisdiction) includes references to (i) that enactment as amended, consolidated or re-enacted by or under any other enactment before or after the date of this Agreement; (ii) any enactment which that enactment re-enacts (with or without modification); and (iii) any subordinate legislation (including regulations) made (before or after the date of this Agreement) under that enactment, as amended, consolidated or re-enacted as described in (i) or (ii) above, except to the extent that any of the matters referred to in (i) to (iii) occurs after the date of this Agreement and increases or alters the liability of Novartis or Alcon (or any Person on whose behalf it is acting as agent pursuant to this Agreement) under this Agreement.

 

4.                                       Schedules and Exhibits . The Schedules and Exhibits comprise schedules and exhibits to this Agreement and form part of this Agreement.

 

5.                                       Inconsistencies. Where there is any inconsistency between the definitions set out in Schedule 1 ( Definitions and Interpretation ) and the definitions set out in any Clause or any other Schedule or Exhibit, then, for the purposes of construing such Clause or Schedule or Exhibit, the definitions set out in such Clause, or Schedule or Exhibit (as applicable) shall prevail.

 

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