Exhibit 10.1


 


EXECUTION
COPY


 


AMENDMENT
NO. 4


TO


TRANSACTION
AGREEMENT


 


THIS
AMENDMENT NO. 4 TO TRANSACTION AGREEMENT (this “Amendment 4”), dated as
of April 5, 2006, between BOSTON SCIENTIFIC CORPORATION, a Delaware corporation
(“Boston Scientific”), and ABBOTT LABORATORIES, an Illinois corporation
(“Abbott”).


 


WHEREAS, Boston
Scientific and Abbott are parties to that certain Transaction Agreement dated
as of January 8, 2006 and amended by Amendment Nos. 1 and 2 thereto dated as of
January 16, 2006, and by Amendment No. 3 thereto dated as of February 22, 2006,
pursuant to which Abbott agreed to acquire certain assets and businesses and
assume certain liabilities of Guidant contingent upon Boston Scientific’s
acquisition of Guidant (the “Agreement”); and


 


WHEREAS, Boston
Scientific and Abbott desire to further amend the Agreement as provided in this
Amendment 4 in accordance with Section 12.07 of the Agreement.


 


NOW, THEREFORE, in consideration of the foregoing and the promises and
mutual agreements contained in this Amendment 4, and for other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, and intending to be legally bound, the parties hereto agree as
follows:


 


SECTION 1. Amendments to the Agreement. (a)  The definition of “Definitive Agreements” in
Section 1.01 of the Agreement is hereby amended and restated to read as
follows:


 


““Definitive Agreements” means the
Purchase Agreement, the Transition Services Agreement, the Note, the
Subscription and Stockholder Agreement, the release and/or settlement agreement
in respect of Actions between Boston Scientific and/or its Affiliates and
Guidant and/or its Affiliates relating to the Business to the extent
contemplated herein and such other agreements as may be mutually agreed between
the parties.”


 


(b)           The
reference in Section 2.01(b)(ii) of the Agreement to Section 5.08(h) is hereby
amended and restated to be a reference to Section 5.08(i).


 


(c)           Section
5.07(a) of the Agreement is hereby amended and restated to read as follows:


 


“(a)         Following
the Closing, Abbott will supply Boston Scientific, on a private label basis, at
the pricing and on the terms provided in this Section 5.07 and on other terms
and conditions customary for similar supply arrangements, with DES Stents in
the following territories: United States, Japan, the European Economic Area and
Rest of


 

















 


World (each, a “Territory”). ”


 


(d)           Section
5.07(c) of the Agreement is hereby amended and restated to read as follows:


 


“(c)         (i)  Abbott’s obligation to supply DES Stents to Boston
Scientific in the United States and Japan shall terminate on the later of (A)
December 31, 2010, or (B) the date that is one year following the last date on
which Boston Scientific has received all requisite approvals from applicable Governmental
Authorities to sell an everolimus eluting stent on a Boston Scientific stent
platform in the applicable Territory; provided, however, that
such obligation shall terminate on a date that is not later than June 30, 2012.


 


(ii)           Abbott’s
obligation to supply DES Stents to Boston Scientific in the European Economic
Area shall terminate on the earliest of:


 


(A) 90 days after issuance of the European
Commision design examination certificate (pursuant to which the CE mark may be
affixed) with respect to an Everolimus (as defined below) eluting stent on a
Boston Scientific platform;


 


(B) three years following the date on which
Boston Scientific receives from Abbott its first commercial shipment of DES
Stents for marketing and sale by Boston Scientific in the European Economic
Area, unless prior to the end of such three years either (1) the European
Commission has determined that Boston Scientific has submitted a design
dossier, pursuant to Council Directive 93/42/EC of June 14, 1993, Annex II,
point 4.1, in relation to an Everolimus eluting stent on a Boston Scientific
platform that is deemed satisfactory by a body designated in accordance with
the requirements of Council Directive 93/42/EC of June 14, 1993, Annex XI with
responsibility for carrying out conformity assessments of medical devices in
accordance with that Directive in support of CE marking, and Boston Scientific
has not yet received the European Commission design examination certificate, or
(2) the European Commission shall have approved an extension of such three-year
term on the ground that such extension is compatible with European Commission
competition rules; and


 


(C) June 30, 2012.


 


(iii)          Abbott’s
obligation to supply DES Stents to Boston Scientific in the Rest of World shall
terminate on December 31, 2010.


 


(iv)          For
purposes of this Agreement, “Everolimus” means the agent having the
chemical name 40-O-(2-hydroxyethyl)-rapamycin, an example of which is set forth
in the attached Schedule. For avoidance of doubt, Everolimus does not mean (A) any unknown prodrugs or
metabolites of Everolimus as of the date that Abbott grants a license,
sublicense, covenant not to sue or other rights with respect to the DES
Intellectual Property, (B) any derivatives or analogues of Everolimus, (C) any


 


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intermediates in the manufacturing process of
Everolimus, (D) the agents known as Zotarolimus, Biolimus, Sirolimus,
Tacrolimus and Pimecrolimus, or (E) any of (A), (B), (C) or (D) that contain
residual or impurity levels of Everolimus. For purposes of this Section
5.08(c)(iv), “unknown” means that for the period of time up to
and including the earlier of the last to expire, be held invalid or otherwise
become unenforceable U.S. patent that is the subject of the Novartis Agreement
or December 31, 2013, the agent is not
generally known within the industry at the time of Abbott granting rights in
the DES Intellectual Property to a third party through (1) written peer
publications, (2) written industry presentations, (3) written prior public
admissions of Abbott, or (4) prior public (other than to Abbott) admissions of
the third party recipient of the rights to the DES Intellectual Property as a
prodrug or metabolite of Everolimus.”


 


(e)           Section
5.08(a) of the Agreement is hereby deleted and replaced with the following:


 


“(a)         (i) 
Abbott, on behalf of itself and its Affiliates, grants to Boston
Scientific, effective as of the Closing, to the fullest extent permitted by Law
and subject to the agreements included in the Assets, a perpetual (except as
set forth in Section 5.10(a) of this Agreement), worldwide, royalty-free (other
than as set forth in Section 5.08(a)(iii) of this Agreement) right and license,
without the right to grant sublicenses (except the right to “have made” solely
on behalf of Boston Scientific and its Affiliates) and without the right
to grant covenants not to sue, to use the DES Intellectual Property
(except for trademarks and related rights, other than as set forth in Section
5.07 of this Agreement or as otherwise agreed by the parties). The foregoing
license is non-exclusive, which means that Abbott and its Affiliates, as of the
Closing, have the right to grant licenses, sublicenses or covenants not to sue
or other rights with respect to the DES Intellectual Property, except that the
license granted to Boston Scientific to DES Intellectual Property is
co-exclusive as to Everolimus eluting stent systems, which means that any
rights to DES Intellectual Property granted by Abbott to a third party shall not
extend to such third party’s drug eluting stent system if the drug used in such
drug eluting stent system is Everolimus.  Notwithstanding the preceding
sentence, Abbott and its Affiliates, as of the Closing, have the right to grant
licenses, sublicenses or covenants not to sue or other rights with respect to
the DES Intellectual Property in the countries of the European Economic Area
within the field of use for medical devices designed for the minimally invasive
treatment of peripheral vascular (or endovascular) diseases.


 


(ii)           The
license granted pursuant to this Section 5.08(a) is assignable by Boston
Scientific to Guidant or any controlled Affiliate of Guidant or Boston
Scientific, and is not otherwise assignable by Guidant, Boston Scientific or
any Affiliate of Guidant or Boston Scientific except in connection with a
merger, change of control, or sale of all or substantially all of Guidant’s and
its Affiliates’ vascular intervention business.


 


(iii)          Boston
Scientific shall be responsible for all royalties payable by it and its Affiliates
with respect to products sold by Boston Scientific and its Affiliates 


 


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using the DES Intellectual Property licensed
to Boston Scientific and its Affiliates pursuant to this Section 5.08.


 


(iv)          Subject to the other
provisions of this Section 5.08, the parties hereby acknowledge that the spirit
of this Section 5.08 is that Boston Scientific and its Affiliates will have
access to the DES Intellectual Property as if they were co-owners thereof,
including with respect to Boston Scientific’s ability to supplement Abbott’s
PMA for DES Stents.”


 


(f)            Section
5.08(d) of the Agreement is hereby amended to add the following to the end of
such section:


 


“Abbott
has the sole right, but not the obligation, in its sole discretion to commence
and prosecute any Action against a third party involving the Intellectual
Property included in the Assets (including the DES Intellectual Property) and,
also in its sole discretion, to settle or otherwise resolve such Action by
seeking and/or obtaining injunctive relief and past damages, and/or granting
licenses, sublicenses or covenants not to sue under any terms, including, but
not limited to, in exchange for future royalties, licenses or sublicenses,
payments, covenants not to sue or any other consideration; provided that, with
respect to the DES Intellectual Property, Abbott may not grant a license,
sublicense or covenant not to sue to a third party that could not otherwise be
granted pursuant to the second sentence of Section 5.08(a)(i) of this
Agreement.”


 


(g)           Section
5.08(i) of the Agreement is hereby amended and restated as follows:


 


“(i)          Boston Scientific, on behalf of itself
and its Affiliates, grants to Abbott and its Affiliates, effective as of the
Closing, a perpetual, non-exclusive, royalty-free, worldwide right and license
in and to all Intellectual Property (except for trademarks and related rights
unless otherwise agreed by the parties) owned or, to the extent permitted by
the applicable agreement, licensed to (with the right to sublicense) or
otherwise controlled by, Guidant or any of its Affiliates immediately prior to
the consummation of the Merger that is used in the Business but is not included
in the Assets. The license granted pursuant to this Section 5.08(i) is not
assignable by Abbott or any of its Affiliates except in connection with a
merger, change of control, or sale of all or substantially all of Abbott’s
vascular intervention business and is sublicensable by Abbott and its Affiliates
to all suppliers, licensees, distributors and customers of Abbott and its
Affiliates that are not Restricted Persons; provided, however,
that Abbott and its Affiliates have the exclusive (subject to the second
proviso of this sentence) right to sublicense the Intellectual Property
licensed under this Section 5.08(i) to any Person for any and all purposes in
the vascular intervention or endovascular solutions fields; and provided,
further, that neither Boston Scientific nor any of its Affiliates has
the right to license or sublicense (except the right to “have made” solely
on behalf of Boston Scientific and its Affiliates) the Intellectual
Property licensed under this Section 5.08(i) to any Person (other than Abbott
and its Affiliates) for any purpose in the vascular intervention or
endovascular solutions fields.


 


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(h)           The following new Section 5.16 is
hereby added to the Agreement:


 


“SECTION 5.16. Abbott
and Boston Scientific hereby agree and acknowledge that, (a) notwithstanding
the second sentence of Section 5.07(a) of the Agreement, the second sentence of
Section 5.08(a) of the Agreement or any other provision in the Agreement or any
other Definitive Agreement to the contrary, on the Closing Abbott and Boston
Scientific shall not be entering into the Supply Agreements or the License and
Technology Transfer Agreement and consequently all references in this Agreement
to the Supply Agreements or the License and Technology and Transfer Agreement
are hereby deleted, and such references are deemed replaced with references to
Section 5.07 or 5.08, as applicable, and (b) following the Closing, the parties
may, but subject to Section 5.13 shall not have any obligation to, enter into
agreements covering certain matters related to the supply of DES Stents by
Abbott to Boston Scientific and/or the licenses granted herein.”


 


(i)            Section 12.11 of the Agreement is
hereby amended to add the following as the first two sentences of such section:


 


“As between the
parties, the terms of this Agreement and the Definitive Agreements shall govern
without regard to the provisions of the Federal Trade Commission’s Decision and
Order In the Matter of Boston Scientific Corporation and Guidant Corporation. Each
party agrees not to use the provisions of the Decision and Order In the Matter
of Boston Scientific Corporation and Guidant Corporation to construe or
interpret the provisions of this Agreement or any Definitive Agreement.”


 


SECTION 2. Public Announcement. The provisions contained in
Section 12.03 of the Agreement are incorporated by reference in this Amendment
4 as though they were expressly set forth herein.


 


SECTION 3. Representations and Warranties. (a) Boston Scientific
represents and warrants to Abbott as follows: 
Boston Scientific is a corporation duly incorporated, validly existing
and in good standing under the Laws of the State of Delaware and has all
necessary corporate power and authority to enter into, execute and deliver this
Amendment 4, to carry out its obligations hereunder and to consummate the
transactions contemplated hereby. The execution and delivery of this Amendment
4 by Boston Scientific, the performance by Boston Scientific of its obligations
hereunder and the consummation by Boston Scientific of the transactions
contemplated hereby have been duly authorized by all requisite corporate action
on the part of Boston Scientific. This Amendment 4 has been duly executed and
delivered by Boston Scientific, and, assuming due authorization, execution and
delivery by Abbott, this Amendment 4 is a legal, valid and binding obligation
of Boston Scientific, enforceable against it in accordance with its terms.


 


(b)           Abbott represents and warrants to
Boston Scientific as follows:  Abbott is a
corporation duly incorporated, validly existing and in good standing under the
laws of the State of Illinois and has all necessary corporate power and
authority to enter into, execute and deliver this Amendment 4, to carry out its
obligations hereunder and to consummate the transactions contemplated hereby. The
execution and delivery of this Amendment 4 by Abbott, the


 


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performance by Abbott
of its obligations hereunder and the consummation by Abbott of the transactions contemplated hereby have
been duly authorized by all requisite corporate action on the part of Abbott. This
Amendment 4 has been duly executed and delivered by Abbott, and, assuming due authorization, execution
and delivery by Boston Scientific, this Amendment 4 is a legal, valid and
binding obligation of Abbott
enforceable against it in accordance with its terms.


 


SECTION 4. Ratification of Agreement. Except as expressly
provided in this Amendment 4, all of the terms, covenants, and other provisions
of the Agreement are hereby ratified and confirmed and shall continue to be in
full force and effect in accordance with their respective terms. From and after
the date hereof, all references to the Agreement shall refer to the Agreement
as amended by this Amendment 4. Capitalized terms used but not defined in this
Amendment 4 shall have the meanings assigned to them in the Agreement.


 


SECTION 5. Governing Law. This Amendment 4 shall be governed by,
and construed in accordance with, the laws of the State of New York. All
Actions arising out of or relating to this Amendment 4 shall be heard and
determined exclusively in any New York federal court sitting in the Borough of
Manhattan of The City of New York.


 


SECTION 6. Counterparts. This Amendment 4 may be executed and
delivered (including by facsimile transmission) in one or more counterparts,
and by the different parties hereto in separate counterparts, each of which
when executed shall be deemed to be an original, but all of which taken
together shall constitute one and the same agreement.


 


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IN WITNESS WHEREOF,
Boston Scientific and Abbott have caused this Amendment 4 to be executed as of
the date first written above by their respective officers thereunto duly
authorized.


 


 


	
   

  	
  BOSTON
  SCIENTIFIC CORPORATION

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Lawrence J. Knopf

  	
   

  
	
   

  	
   

  	
  Name:

  	
  Lawrence
  J. Knopf

  	
   

  
	
   

  	
   

  	
  Title:

  	
  Vice
  President and Assistant

  General Counsel

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  ABBOTT
  LABORATORIES

  
	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  By:

  	
  /s/ Richard A. Gonzalez

  	
   

  
	
   

  	
   

  	
  Name:

  	
  Richard
  A. Gonzalez

  	
   

  
	
   

  	
   

  	
  Title:

  	
  President
  and Chief Operating

  Officer

  	
   

  
							



 

















 


EVEROLIMUS SCHEDULE