Exhibit 10.4

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

This LICENSE AGREEMENT (“Agreement”), dated as of June 2, 2005 (the “Effective
Date”), is by and between 3F Therapeutics, Inc., a Delaware corporation (“3F”),
on the one hand, and Edwards Lifesciences PVT, Inc., a Delaware corporation
(“Edwards PVT”), on the other hand.  Each of 3F and Edwards PVT may be referred
to herein individually as a “Party” or collectively as the “Parties.”

 

RECITALS

 

WHEREAS 3F is the owner of certain patents, patent applications, and know-how
relating to heart valves and catheter-delivered heart valves;

 

WHEREAS Edwards desires to obtain a non-exclusive license to such patents,
patent applications, and know-how; and

 

WHEREAS 3F is willing to grant such license under the following terms and
conditions.

 

AGREEMENT

 

NOW, THEREFORE, in consideration of the covenants and agreements set forth
herein, which constitutes good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1.                                                                                      
DEFINITIONS.  THE FOLLOWING DEFINITIONS SHALL APPLY TO THE FOLLOWING TERMS:

 

1.1                                 “3F” SHALL HAVE THE MEANING SET FORTH IN THE
PREAMBLE.

 

1.2                                 “AFFILIATE” SHALL MEAN, WITH RESPECT TO ANY
SPECIFIED PERSON, A PERSON THAT DIRECTLY, OR INDIRECTLY THROUGH ONE OR MORE
INTERMEDIARIES, CONTROLS, OR IS CONTROLLED BY, OR IS UNDER COMMON CONTROL WITH,
THE PERSON SPECIFIED.

 

1.3                                 “AGREEMENT” SHALL HAVE THE MEANING SET FORTH
IN THE PREAMBLE.

 

1.4                                 “EDWARDS PVT” SHALL HAVE THE MEANING SET
FORTH IN THE PREAMBLE.

 

1.5                                 “EDWARDS” SHALL MEAN EDWARDS PVT AND ITS
AFFILIATES.

 

1.6                                 “EFFECTIVE DATE” SHALL HAVE THE MEANING SET
FORTH IN THE PREAMBLE.

 

1.7                                 “EXCLUDED 3F IP” SHALL MEAN THE PATENTS AND
PATENT APPLICATIONS LISTED ON EXHIBIT A HERETO.

 

1.8                                 “FIELDS OF USE” SHALL MEAN THE SURGICAL
FIELD OF USE AND THE PERCUTANEOUS FIELD OF USE.

 

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1.9                                 “PVT PRODUCT” SHALL MEAN THE THE
CRIBIER-EDWARDS PERCUTANEOUS HEART VALVE, EXISTING AS OF THE EFFECTIVE DATE,
INCLUDING (I) ANY MODIFICATIONS OR ALTERATIONS TO SUCH VALVE THAT ARE MADE PRIOR
TO THE FIRST APPROVAL BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (“FDA”)
OF A PREMARKET APPROVAL (“PMA”) APPLICATION SUBMITTED ON SUCH VALVE IN THE
PERCUTANEOUS FIELD OF USE, (II) ANY MODIFICATIONS OR ALTERATIONS THAT ARE MADE
TO SUCH VALVE TO ADAPT IT FOR USE IN THE SURGICAL FIELD OF USE PRIOR TO THE
FIRST APPROVAL BY THE FDA OF A PMA APPLICATION SUBMITTED ON SUCH VALVE IN THE
SURGICAL FIELD OF USE, AND (III) ANY MODIFICATIONS OR ALTERATIONS THAT ARE MADE
TO THE FDA APPROVED VALVES DESCRIBED IN (I) AND (II) THAT DO NOT REQUIRE
SUBMISSION OF A NEW PMA APPLICATION.

 

1.10                           “LASER PATENTS” SHALL MEAN THE PATENTS AND PATENT
APPLICATIONS LISTED ON EXHIBIT B HERETO, AND ANY CONTINUATIONS, DIVISIONALS,
REEXAMINATIONS, REISSUES, EXTENSIONS AND FOREIGN COUNTERPARTS THEREOF.

 

1.11                           “LICENSED PATENTS” SHALL MEAN THE LASER PATENTS
AND THE PATENTS AND PATENT APPLICATIONS OWNED OR LICENSED BY 3F AS OF THE
EFFECTIVE DATE THAT RELATE TO THE FIELDS OF USE, AND ANY CONTINUATIONS,
DIVISIONALS, REEXAMINATIONS, REISSUES, EXTENSIONS AND FOREIGN COUNTERPARTS
THEREOF; PROVIDED, HOWEVER, THAT THE LICENSED PATENTS SHALL NOT INCLUDE THE
EXCLUDED 3F IP.

 

1.12                           “LICENSED PRODUCT” SHALL MEAN A PRODUCT IN THE
FIELDS OF USE UTILIZING THE TISSUE VALVE KNOW-HOW OR COVERED BY ANY VALID CLAIM
OF THE LICENSED PATENTS.

 

1.13                           “LITIGATION” SHALL HAVE THE MEANING SET FORTH IN
SECTION 4.2.

 

1.14                           “PARTY” SHALL HAVE THE MEANING SET FORTH IN THE
PREAMBLE.

 

1.15                           “PARTIES” SHALL HAVE THE MEANING SET FORTH IN THE
PREAMBLE.

 

1.16                           “PERCUTANEOUS FIELD OF USE” SHALL MEAN THE
PERCUTANEOUS INSERTION OF A STENTED, TISSUE HEART VALVE THROUGH ANY VESSEL USING
A CATHETER DELIVERY SYSTEM.

 

1.17                           “PERSON” SHALL MEAN ANY INDIVIDUAL, PARTNERSHIP,
FIRM, CORPORATION, ASSOCIATION, TRUST, UNINCORPORATED ORGANIZATION OR OTHER
ENTITY, AS WELL AS ANY SYNDICATE OR GROUP THAT WOULD BE DEEMED TO BE A PERSON
UNDER SECTION 13(D)(3) OF THE EXCHANGE ACT.

 

1.18                           “SUPPLY AND TRAINING AGREEMENT” SHALL MEAN THE
SUPPLY AND TRAINING AGREEMENT, DATED JUNE 2, 2005, BY AND BETWEEN THE PARTIES
HERETO.

 

1.19                           “SURGICAL FIELD OF USE” SHALL MEAN THE SURGICAL
INSERTION THROUGH THE CHEST CAVITY OF A STENTED, TISSUE HEART VALVE USING A
CATHETER DELIVERY SYSTEM OF NO GREATER THAN 50 CENTIMETERS IN USABLE LENGTH
(I.E., THE LENGTH THAT CAN BE INSERTED INTO THE HUMAN BODY); PROVIDED, HOWEVER,
THAT SUCH SURGICAL FIELD OF USE DOES NOT INCLUDE THE DELIVERY OF A STENTED,
TISSUE HEART VALVE TO THE HEART BY WAY OF ANY VESSEL OTHER THAN SOLELY THROUGH
THE THORACIC AORTA.

 

1.20                           “THIRD PARTY” SHALL MEAN ANY PERSON OTHER THAN
3F, EDWARDS, OR AN AFFILIATE OF EITHER.

 

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1.21                           “TISSUE VALVE KNOW-HOW” SHALL MEAN (I) ANY
INFORMATION OWNED OR LICENSED BY 3F OR ITS AFFILIATES EXISTING AS OF THE
TERMINATION OF THE SUPPLY AND TRAINING AGREEMENT WHICH RELATE TO THE FIELDS OF
USE AND WHICH IS LISTED ON EXHIBIT C; AND (II) ANY INFORMATION RELATED TO VALVE
LEAFLETS, VALVE SUBASSEMBLIES, AND FINISHED PRODUCTS FROM VALVE LEAFLETS AND
VALVE SUBASSEMBLIES, AND THE PROCESSING AND MANUFACTURE OF VALVE LEAFLETS, VALVE
SUBASSEMBLIES, AND FINISHED PRODUCTS FROM VALVE LEAFLETS AND VALVE SUBASSEMBLIES
WHICH IS USED BY 3F OR NEEDED BY EDWARDS TO PROCESS AND MANUFACTURE VALVE
LEAFLETS, VALVE SUBASSEMBLIES, AND FINISHED PRODUCTS FROM VALVE LEAFLETS AND
VALVE SUBASSEMBLIES THAT WERE BEING MADE BY 3F FOR EDWARDS UNDER THE SUPPLY AND
TRAINING AGREEMENT AND WHICH IS IN THE POSSESSION OF 3F OR ITS AFFILIATES AT ANY
TIME PRIOR TO THE TERMINATION OF THE SUPPLY AND TRAINING AGREEMENT.

 

1.22                           “VALID CLAIM” SHALL MEAN A CLAIM OF AN ISSUED AND
UNEXPIRED PATENT INCLUDED IN THE LICENSED PATENTS WHICH HAS NOT BEEN REVOKED OR
HELD UNENFORCEABLE OR INVALID BY A DECISION OF A COURT OR OTHER GOVERNMENTAL
AGENCY OF COMPETENT JURISDICTION, UNAPPEALABLE OR UNAPPEALED WITHIN THE TIME
ALLOWED FOR APPEAL, AND WHICH HAS NOT BEEN DISCLAIMED, DENIED, OR ADMITTED TO BE
INVALID OR OTHERWISE UNENFORCEABLE THROUGH REISSUE, REEXAMINATION, DISCLAIMER,
OR OTHERWISE.

 

2.                                                                                      
LICENSE GRANTS.

 

2.1                                 3F HEREBY GRANTS TO EDWARDS A WORLDWIDE,
NON-TRANSFERABLE (EXCEPT AS SET FORTH IN SECTION 10.2.1 BELOW), ROYALTY FREE,
NON-EXCLUSIVE LICENSE UNDER THE LICENSED PATENTS, EXCEPT FOR THE LASER PATENTS,
WITHOUT THE RIGHT TO SUBLICENSE, TO MANUFACTURE, HAVE MANUFACTURED, USE, IMPORT,
OFFER FOR SALE, AND SELL LICENSED PRODUCTS ONLY IN THE SURGICAL FIELD OF USE
AND/OR THE PERCUTANEOUS FIELD OF USE.

 

2.2                                 3F HEREBY GRANTS TO EDWARDS A WORLDWIDE,
NON-TRANSFERABLE (EXCEPT AS SET FORTH IN SECTION 10.2.1 BELOW), ROYALTY FREE,
NON-EXCLUSIVE LICENSE UNDER THE LASER PATENTS, WITHOUT THE RIGHT TO SUBLICENSE,
TO MANUFACTURE, HAVE MANUFACTURED, USE, IMPORT, OFFER FOR SALE, AND SELL PVT
PRODUCTS ONLY IN THE SURGICAL FIELD OF USE AND/OR THE PERCUTANEOUS FIELD OF USE.

 

2.3                                 3F HEREBY GRANTS TO EDWARDS A WORLDWIDE,
NON-TRANSFERABLE (EXCEPT AS SET FORTH IN SECTION 10.2.1 BELOW), ROYALTY FREE,
NON-EXCLUSIVE LICENSE TO THE TISSUE VALVE KNOW-HOW, WITHOUT THE RIGHT TO
SUBLICENSE, TO MANUFACTURE, HAVE MANUFACTURED, USE, IMPORT, OFFER FOR SALE, AND
SELL LICENSED PRODUCTS ONLY IN THE FIELDS OF USE.

 

2.4                                 EDWARDS AGREES AND ACKNOWLEDGES THAT THE
LIMITED SCOPE OF THE FIELDS OF USE SET FORTH IN THIS AGREEMENT ARE A MATERIAL
AND ESSENTIAL PART OF THIS AGREEMENT.  AS SUCH, THE LICENSES SET FORTH IN THIS
SECTION 2 INCLUDE A COVENANT BY EDWARDS TO REFRAIN FROM TAKING ANY ACTIONS THAT
WOULD PERMIT, ENCOURAGE, PROMOTE, MARKET, FUND, SPONSOR, OR FACILITATE, DIRECTLY
OR INDIRECTLY, ANY OFF LABEL USE OR ANY OTHER USE OF ANY LICENSED PRODUCT
OUTSIDE THE FIELDS OF USE, AND TO USE ITS BEST EFFORTS TO PREVENT ANY SUCH OFF
LABEL USE OR ANY OTHER USE OUTSIDE THE FIELDS OF USE.  ANY BREACH BY EDWARDS OF
THIS COVENANT SHALL BE DEEMED A MATERIAL BREACH OF THIS AGREEMENT.

 

2.5                                 NO IMPLIED PATENT OR OTHER INTELLECTUAL
PROPERTY RIGHTS OR LICENSES ARE GRANTED BY 3F HEREUNDER OR IN CONNECTION
HEREWITH OTHER THAN THOSE LICENSES EXPRESSLY GRANTED IN THIS AGREEMENT.

 

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2.6                                 NOTHING IN THIS AGREEMENT SHALL LIMIT OR
PRECLUDE EDWARDS USE OF, IN ANY MANNER OR IN ANY FIELD, THE TISSUE VALVE
KNOW-HOW, THAT (I) IS OR BECOMES PUBLICLY KNOWN (THROUGH NO WRONGFUL ACT,
OMISSION, OR BREACH OF THIS AGREEMENT BY EDWARDS); (II) IS ALREADY KNOWN TO
EDWARDS OR ITS AFFILIATES AT THE TIME THAT SUCH TISSUE VALVE KNOW-HOW IS
TRANSFERRED TO EDWARDS; (III) IS INDEPENDENTLY DEVELOPED BY EDWARDS OR ITS
AFFILIATES WITHOUT THE BENEFIT OF THE TISSUE VALVE KNOW-HOW; OR (IV) IS
RIGHTFULLY RECEIVED OR OBTAINED BY EDWARDS OR ITS AFFILIATES INDEPENDENT OF THE
TRANSFER OF THE TISSUE VALVE KNOW-HOW BY 3F.

 

3.                                                                                      
PRODUCT LABELING.

 

3.1                                 UPON WRITTEN NOTICE FROM 3F OF A SPECIFIC
LICENSED PATENT THAT APPLIES TO A SPECIFIC LICENSED PRODUCT, EACH LICENSED
PRODUCT SOLD BY EDWARDS SHALL BE MARKED IN COMPLIANCE WITH 35 U.S.C. § 287, OR
THE RELEVANT CORRESPONDING STATUTE UNDER THE LAW OF THE COUNTRY IN WHICH SUCH
LICENSED PRODUCT IS SOLD.

 

3.2                                 EACH LICENSED PRODUCT MANUFACTURED BY OR FOR
EDWARDS SHALL BE LABELED FOR USE ONLY IN THE FIELDS OF USE.

 

4.                                                                                      
INFRINGEMENT AND ENFORCEMENT.

 

4.1                                 IF AT ANY TIME DURING THE TERM OF THIS
AGREEMENT, EDWARDS LEARNS OR BELIEVES THAT ANY THIRD PARTY IS INFRINGING ANY OF
THE LICENSED PATENTS OR USING TISSUE VALVE KNOW-HOW WITHOUT A LICENSE IN THE
FIELDS OF USE, EDWARDS SHALL NOTIFY 3F IN WRITING OF THE EXISTENCE OF SUCH
ALLEGED INFRINGEMENT OR UNLICENSED USE.

 

4.2                                 3F MAY, BUT HAS NO OBLIGATION TO, TAKE ANY
AND ALL ACTIONS TO ENFORCE THE LICENSED PATENTS (INCLUDING WITHOUT LIMITATION
INSTITUTING LITIGATION) AGAINST ANY INFRINGEMENT IN THE FIELDS OF USE OR TO
PREVENT ANY UNLICENSED USE OF THE TISSUE VALVE KNOW-HOW (“LITIGATION”).  3F
SHALL BEAR ALL THE EXPENSES AND COSTS WITH RESPECT TO ANY SUCH LITIGATION AND 3F
SHALL BE ENTITLED TO ALL DAMAGES RECOVERED IN SUCH LITIGATION.

 

4.3                                 AT 3F’S REQUEST, EDWARDS AGREES TO COOPERATE
IN ANY SUCH LITIGATION, INCLUDING BUT NOT LIMITED TO PARTICIPATING IN SUCH
LITIGATION AS A NAMED PARTY.  3F AGREES TO PAY EDWARD’S REASONABLE COSTS AND
EXPENSES IN CONNECTION WITH SUCH LITIGATION.  IN THE EVENT THAT EDWARDS DESIRES
TO RETAIN SEPARATE COUNSEL IN CONNECTION WITH SUCH LITIGATION, HOWEVER, EDWARDS
SHALL BEAR ITS OWN COSTS AND EXPENSES CONCERNING THE LITIGATION, INCLUDING
WITHOUT LIMITATION THE COSTS AND EXPENSES OF SUCH SEPARATE COUNSEL. 
NOTWITHSTANDING EDWARD’S PARTICIPATION IN SUCH LITIGATION, 3F SHALL RETAIN THE
FULL RIGHT TO CONTROL SUCH LITIGATION, INCLUDING WITHOUT LIMITATION ANY
SETTLEMENT OF SUCH LITIGATION.  3F SHALL HAVE THE RIGHT, IN ITS SOLE AND
ABSOLUTE DISCRETION, TO SETTLE ANY LITIGATION ON SUCH TERMS AND CONDITIONS THAT
3F DEEMS TO BE APPROPRIATE.

 

5.                                                                                      
REPRESENTATIONS AND WARRANTIES.

 

5.1                                 3F HEREBY REPRESENTS AND WARRANTS TO EDWARDS
THAT

 

(i) it has all of the requisite power and authority to enter into this Agreement
and to perform its obligations hereunder and that this Agreement has been duly
and validly authorized, executed, and delivered by 3F;

 

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(ii)                                  it is the owner of, or has the exclusive
license to, the Tissue Valve Know-How, such Tissue Valve Know-How, to the best
of 3F’s knowledge, does not infringe or misappropriate the intellectual property
of any Third Party, and that 3F has the entire right to enter these licenses;
and

 

(iii)                               it is the owner of, or has the exclusive
license to, the Licensed Patents and that it has the entire right to enter into
these licenses.

 

5.2                                 EXCEPT AS EXPRESSLY SET FORTH IN SECTION 5.1
AND TO THE EXTENT THAT 3F PROVIDES NOTICE IN ACCORDANCE WITH SECTION 3.1, 3F
DOES NOT MAKE, AND THERE ARE NO, WARRANTIES, REPRESENTATIONS, OR CONDITIONS,
EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE RELATING TO THE LICENSED PATENTS OR
TISSUE VALVE KNOW-HOW, INCLUDING WITHOUT LIMITATION ANY REPRESENTATIONS OR
WARRANTIES OF VALIDITY, ENFORCEABILITY, NON-INFRINGEMENT, OR FITNESS FOR ANY
PARTICULAR PURPOSE.

 

5.3                                 EDWARDS HEREBY REPRESENTS AND WARRANTS TO 3F
THAT IT HAS ALL OF THE REQUISITE POWER AND AUTHORITY TO ENTER INTO THIS
AGREEMENT AND THAT THIS AGREEMENT HAS BEEN DULY AND VALIDLY AUTHORIZED,
EXECUTED, AND DELIVERED BY EDWARDS.

 

6.                                                                                      
TERM AND TERMINATION.

 

6.1                                 THE TERM OF THIS AGREEMENT SHALL COMMENCE ON
THE EFFECTIVE DATE AND, SUBJECT TO EARLIER TERMINATION AS PROVIDED HEREIN, SHALL
CONTINUE UNTIL THE LATER OF: (I) THE DATE OF EXPIRATION OF THE LAST TO EXPIRE OF
ANY LICENSED PATENT COVERING A LICENSED PRODUCT; OR (II) THE DATE ON WHICH
EDWARDS NO LONGER INTENDS TO UTILIZE THE TISSUE VALVE KNOW-HOW.  EDWARDS SHALL
PROMPTLY NOTIFY 3F AT SUCH TIME THAT EDWARDS NO LONGER INTENDS TO UTILIZE THE
TISSUE VALVE KNOW-HOW.

 

6.2                                 EITHER PARTY MAY TERMINATE THIS AGREEMENT
FOR A MATERIAL BREACH BY THE OTHER PARTY THAT REMAINS UNCURED FOR NINETY (90)
DAYS FOLLOWING NOTICE TO THE BREACHING PARTY.

 

6.3                                 THIS AGREEMENT, INCLUDING ALL LICENSES
HEREIN, SHALL AUTOMATICALLY AND IMMEDIATELY TERMINATE, WITHOUT ANY FURTHER
ACTION OR NOTICE BY 3F, IN THE EVENT THAT EDWARDS IS OR BECOMES INSOLVENT.  FOR
PURPOSES OF THIS AGREEMENT, EDWARDS SHALL BE DEEMED “INSOLVENT” IF IT IS UNABLE
TO PAY ITS DEBTS AND OBLIGATIONS AS AND WHEN THEY COME DUE.

 

7.                                                                                      
NOTICES.

 

Any notice which is required or permitted to be given to a Party pursuant to
this Agreement shall be deemed to have been given only if such notice is reduced
to writing and (i) delivered personally, (ii) sent by reputable overnight
courier service for next business day delivery to the person in question at the
address given below, or (iii) sent by facsimile machine (with proof transmission
capability) to the fax number set forth below, with a hard copy to be sent by
first class mail to the person at the address given below:

 

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If to 3F:

 

If to Edwards:

 

 

 

3F Therapeutics, Inc.
20412 James Bay Circle
Lake Forest, CA 92630
Facsimile No.: (949) 380-9399
Attn: Walter A. Cuevas

 

Edwards Lifesciences PVT, Inc.
One Edwards Way
Irvine, CA 92614
Facsimile No.: (949) 250-6868
Attn: General Counsel

 

 

 

with a copy to (which copy shall not
constitute notice):

 

with a copy to (which copy shall not
constitute notice):

 

 

 

Reed Smith, LLP
1901 Avenue of the Stars, Suite 700
Los Angeles, CA 90067
Facsimile No.: (310) 734-5299
Attn: Michael Sanders

 

Gibson, Dunn & Crutcher LLP
Jamboree Center
4 Park Plaza
Irvine, CA 92614
Facsimile No.: (949) 475-4673
Attn: John M. Williams

 

or to such other address or facsimile number as either Party shall have
specified by notice in writing to the other Party.

 

If delivered personally or by facsimile during normal business hours on a
business day, a notice shall be deemed delivered when actually received at the
address specified above.  In any other case, notice shall be deemed delivered on
the next business day following the date on which it was sent.

 

8.                                                                                      
INDEMNIFICATION.

 

8.1                                 EDWARDS SHALL INDEMNIFY, DEFEND, AND HOLD 3F
HARMLESS AGAINST ANY AND ALL LOSSES ARISING OUT OF A THIRD PARTY CLAIM TO THE
EXTENT SUCH CLAIM ARISES FROM THE NEGLIGENCE, WILLFUL MISCONDUCT, BREACH OF
CONTRACT, OR VIOLATIONS OF LAW BY EDWARDS, ITS EMPLOYEES, AGENTS,
SUBCONTRACTORS, OR ASSIGNS IN THE PERFORMANCE OF THIS AGREEMENT.  THE LOSSES
COVERED BY THIS SECTION 8.1 INCLUDE, BUT ARE NOT LIMITED TO, SETTLEMENTS,
JUDGMENTS (COURT COSTS, ATTORNEYS’ FEES, EXPERT FEES, AND OTHER LITIGATION
EXPENSES), FINES AND PENALTIES ARISING OUT OF ACTUAL OR ALLEGED (I) INJURY TO OR
DEATH OF ANY PERSON; (II) LOSS OF OR DAMAGE TO TANGIBLE OR INTANGIBLE PROPERTY;
(III) PATENT MISMARKING; AND (IV) BREACH OF CONTRACT.

 

8.2                                 3F SHALL INDEMNIFY, DEFEND, AND HOLD EDWARDS
HARMLESS AGAINST ANY AND ALL LOSSES ARISING OUT OF A THIRD PARTY CLAIM TO THE
EXTENT SUCH CLAIM ARISES FROM THE NEGLIGENCE, WILLFUL MISCONDUCT, BREACH OF
CONTRACT, OR VIOLATIONS OF LAW BY 3F, ITS EMPLOYEES, AGENTS, SUBCONTRACTORS, OR
ASSIGNS IN THE PERFORMANCE OF THIS AGREEMENT.  THE LOSSES COVERED BY THIS
SECTION 8.2 INCLUDE, BUT ARE NOT LIMITED TO, SETTLEMENTS, JUDGMENTS (COURT
COSTS, ATTORNEYS’ FEES, EXPERT FEES, AND OTHER LITIGATION EXPENSES), FINES AND
PENALTIES ARISING OUT OF ACTUAL OR ALLEGED (I) LOSS OF OR DAMAGE TO INTANGIBLE
PROPERTY; (II) PATENT MISMARKING TO THE EXTENT THAT 3F PROVIDES NOTICE PURSUANT
TO SECTION 3.1; AND (III) BREACH OF CONTRACT.

 

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9.                                                                                      
LIMITATION OF LIABILITY OR DAMAGES.

 

9.1                                 EXCEPT WITH RESPECT TO EACH PARTY’S
RESPECTIVE INDEMNITY OBLIGATIONS PURSUANT TO SECTION 8, IN NO EVENT SHALL EITHER
PARTY, ITS AGENTS, OR EMPLOYEES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT,
SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, OR ANY PUNITIVE DAMAGES,
INCLUDING WITHOUT LIMITATION LOST PROFITS, IN CONNECTION WITH THIS AGREEMENT,
THE LICENSED PATENTS, OR TISSUE VALVE KNOW-HOW, HOWEVER SO CAUSED, WHETHER
ARISING IN CONTRACT (INCLUDING BREACH), TORT (INCLUDING NEGLIGENCE), OR
OTHERWISE.  THE PARTIES ACKNOWLEDGE AND AGREE THAT THE EXCLUSION OF LIABILITY
HEREIN IS REASONABLE AND APPROPRIATE IN THE CIRCUMSTANCES AND WAS A MATERIAL
FACTOR IN DETERMINING THE TERMS OF THIS AGREEMENT.

 

9.2                                 WITHOUT LIMITING THE GENERALITY OF
SECTION 9.1 AND EXCEPT AS 3F PROVIDES NOTICE IN ACCORDANCE WITH SECTION 3.1,
NOTHING CONTAINED IN THIS AGREEMENT SHALL BE CONSTRUED AS:

 

(i)                                     requiring the enforcement of any patent
or patent application, including any obligation by 3F to institute any suit or
action for infringement of any of the Licensed Patents;

 

(ii)                                  reflecting a determination by 3F of the
applicability of any of the Licensed Patents to the Fields of Use or any
Licensed Product of Edwards;

 

(iii)                               a warranty or representation by 3F as to the
validity or scope of any Licensed Patents; or

 

(iv)                              any obligation by 3F to furnish any assistance
under this Agreement; provided, however, that this subsection (iv) shall not
limit any of 3F’s obligations pursuant to the Supply and Training Agreement.

 

10.                                                                                
MISCELLANEOUS.

 

10.1                           RELATIONSHIP OF THE PARTIES.  NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED TO CREATE A PARTNERSHIP, JOINT VENTURE, EMPLOYMENT
OR AGENCY RELATIONSHIP, OR ANY OTHER FORM OF LEGAL ASSOCIATION BETWEEN 3F AND
EDWARDS.  EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY SHALL
CONDUCT BUSINESS IN ITS OWN NAME AND SHALL BE SOLELY RESPONSIBLE FOR THE ACTS
AND CONDUCT OF ITS EMPLOYEES AND AGENTS.

 

10.2                           ASSIGNABILITY.

 

10.2.1                  THIS AGREEMENT IS NOT ASSIGNABLE OR TRANSFERABLE BY
EDWARDS, IN WHOLE OR IN PART, EXCEPT (I) WITH THE PRIOR WRITTEN CONSENT OF 3F;
(II) AN ASSIGNMENT IN CONNECTION WITH THE SALE OF ALL OR SUBSTANTIALLY ALL OF
EDWARDS’ BUSINESS; (III) AN ASSIGNMENT BY EDWARDS TO A PURCHASER OF ALL OR
SUBSTANTIALLY ALL OF THE ASSETS OF THE BUSINESS RELATING TO THE TISSUE VALVE
KNOW-HOW; OR (IV) THE LICENSES SET FORTH IN SECTION 2 CAN BE SEPARATELY ASSIGNED
BY EDWARDS TO A PURCHASER OF ALL OR SUBSTANTIALLY ALL OF THE ASSETS OF THE
BUSINESS RELATING TO ANY OF THE FIELDS OF USE, AS APPLICABLE; PROVIDED, HOWEVER,
THAT IN THE EVENT OF ANY ASSIGNMENT PURSUANT TO THIS

 

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SECTION, SUCH ASSIGNEE SHALL AGREE TO BE BOUND AND COMPLY WITH ALL OF THE
APPLICABLE OBLIGATIONS OF THIS AGREEMENT.  BY WAY OF EXAMPLE, IN CONNECTION WITH
SUBSECTION (IV) OF THIS SECTION, IF EDWARDS SELLS ALL OR SUBSTANTIALLY ALL OF
ITS BUSINESS RELATING TO THE SURGICAL FIELD OF USE, THE LICENSES SET FORTH IN
SECTIONS 2.1, 2.2 AND 2.3 RELATING TO THE SURGICAL FIELD OF USE MAY BE ASSIGNED
TO THE PURCHASER OF SUCH BUSINESS, PROVIDED SUCH ASSIGNEE AGREES TO BE BOUND AND
COMPLY WITH ALL OF THE OBLIGATIONS OF THIS AGREEMENT RELATED TO SUCH ASSIGNED
LICENSES, INCLUDING WITHOUT LIMITATION, FOR EXAMPLE, SECTIONS 2.4, 3, 4, 8.1, 9,
AND 10.

 

10.2.2                                          3F MAY ASSIGN OR TRANSFER THIS
AGREEMENT, IN WHOLE OR IN PART; PROVIDED, HOWEVER, THAT 3F PROVIDE WRITTEN
NOTICE TO EDWARDS AND THAT SUCH ASSIGNEE AGREES TO BE BOUND AND COMPLY WITH ALL
APPLICABLE OBLIGATIONS OF THIS AGREEMENT.

 

10.3                           GOVERNING LAW.  THIS AGREEMENT SHALL BE GOVERNED
BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF
CALIFORNIA, WITHOUT GIVING EFFECT TO THE CHOICE OF LAW RULES THEREOF.  EACH OF
THE PARTIES HERETO IRREVOCABLY CONSENTS TO THE JURISDICTION OF THE STATE AND
FEDERAL COURTS LOCATED WITHIN ORANGE COUNTY, STATE OF CALIFORNIA, AND
IRREVOCABLY AGREES THAT ALL ACTIONS OR PROCEEDINGS RELATING TO THIS AGREEMENT,
THE LICENSED PATENTS, OR THE TISSUE VALVE KNOW-HOW SHALL BE LITIGATED IN SUCH
COURTS, AND EACH OF THE PARTIES EXPRESSLY WAIVES ANY OBJECTION OR DEFENSES THAT
IT MAY HAVE BASED ON LACK OF PERSONAL JURISDICTION, IMPROPER VENUE, OR FORUM NON
CONVENIENS WITH RESPECT TO SUCH COURTS.  THE PARTIES’ CONSENT AND WAIVER SET
FORTH IN THIS SECTION 10.3 EXPRESSLY SHALL APPLY IN THE EVENT THAT ANY SUCH
ACTION IS TRANSFERRED BY THE UNITED STATES DISTRICT COURT SITTING IN ORANGE
COUNTY, ON ITS OWN MOTION OR UPON FILING, TO ANY OTHER DIVISION OF THE UNITED
STATES DISTRICT COURT FOR THE CENTRAL DISTRICT OF CALIFORNIA.

 

10.4                           ATTORNEYS’ FEES.  IF ANY PARTY TO THIS AGREEMENT
SHALL BRING ANY ACTION, SUIT, ARBITRATION, MEDIATION, COUNTERCLAIM OR APPEAL FOR
ANY RELIEF AGAINST ANY OTHER PARTY, DECLARATORY OR OTHERWISE, TO ENFORCE THE
TERMS HEREOF OR TO DECLARE RIGHTS HEREUNDER, THE PREVAILING PARTY IN SUCH ACTION
SHALL BE ENTITLED TO RECOVER AS RECOVERABLE COSTS IN ANY SUCH ACTION ITS
ATTORNEYS’ FEES AND COSTS (INCLUDING REASONABLE FEES AND COSTS FOR IN-HOUSE
COUNSEL), ALL EXPERT FEES AND COSTS, ALL COURT AND/OR ARBITRATION EXPENSES, AND
ANY OTHER COSTS REASONABLY AND PROPERLY INCURRED, INCLUDING ANY FEES AND COSTS
INCURRED IN BRINGING AND PROSECUTING SUCH ACTION AND/OR ENFORCING ANY ORDER,
JUDGMENT, RULING, OR AWARD GRANTED AS PART OF SUCH ACTION.  AS USED IN THIS
SECTION, “PREVAILING PARTY” SHALL INCLUDE, WITHOUT LIMITATION, A PARTY WHO
AGREES TO DISMISS AN ACTION OR WHO OBTAINS SUBSTANTIALLY THE RELIEF SOUGHT BY
IT.

 

10.5                           COUNTERPARTS.  THIS AGREEMENT MAY BE EXECUTED IN
TWO OR MORE COUNTERPARTS (INCLUDING BY MEANS OF FACSIMILE), EACH OF WHICH SHALL
BE DEEMED AN ORIGINAL, BUT ALL OF WHICH TOGETHER SHALL CONSTITUTE ONE AND THE
SAME INSTRUMENT.

 

10.6                           SEVERABILITY.  SHOULD ANY PART OR PROVISION OF
THIS AGREEMENT BE RENDERED OR DECLARED INVALID BY REASON OF ANY LAW OR BY DECREE
OF A COURT OF COMPETENT JURISDICTION, THE VALIDITY OF ANY OTHER TERM, CLAUSE, OR
PROVISION SHALL NOT BE AFFECTED PROVIDED THAT SUCH INVALID OR UNENFORCEABLE
PROVISION IS AND CAN BE REPLACED WITH AN ENFORCEABLE CLAUSE WHICH MOST CLOSELY
ACHIEVES THE RESULT INTENDED BY SUCH INVALID CLAUSE.

 

10.7                           SURVIVABILITY.  THE PROVISIONS OF SECTIONS 1, 4,
5, 8, 9, AND 10 SHALL SURVIVE ANY TERMINATION OR EXPIRATION OF THIS AGREEMENT.

 

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10.8                           HEADINGS.  THE HEADINGS USED IN THIS AGREEMENT
ARE FOR PURPOSE OF REFERENCE ONLY AND SHALL NOT AFFECT THE MEANING OR
INTERPRETATION OF ANY PROVISION OF THIS AGREEMENT.

 

10.9                           DRAFTING.  EACH PARTY HAS HAD THE OPPORTUNITY TO
CONSULT WITH COMPETENT, INDEPENDENT COUNSEL IN CONNECTION WITH THIS AGREEMENT
AND HAS PARTICIPATED IN THE DRAFTING OF THIS AGREEMENT.  ACCORDINGLY, THIS
AGREEMENT SHALL NOT BE CONSTRUED AGAINST EITHER PARTY AS THE DRAFTER.

 

10.10                     WAIVER.  NO WAIVER OR DELAY BY EITHER PARTY OF ANY
BREACH OF THE COVENANTS CONTAINED HEREIN TO BE PERFORMED BY THE OTHER PARTY
SHALL BE CONSTRUED AS A WAIVER OF ANY SUCCEEDING BREACH OF THE SAME OR ANY OTHER
COVENANTS OR CONDITIONS HEREOF.

 

10.11                     ENTIRETY OF AGREEMENT.  THIS AGREEMENT SUPERSEDES ANY
PRIOR UNDERSTANDINGS OR AGREEMENTS, WHETHER WRITTEN OR ORAL, AND ANY
CONTEMPORANEOUS ORAL AGREEMENTS, BETWEEN THE PARTIES HERETO IN REGARD TO THE
SUBJECT MATTER HEREOF AND, TOGETHER WITH THE MASTER AGREEMENT AND OTHER RELATED
AGREEMENTS (AS DEFINED IN THE MASTER AGREEMENT), CONTAIN THE ENTIRE AGREEMENT
BETWEEN THE PARTIES IN REGARD TO THE SUBJECT MATTER HEREOF.  THIS AGREEMENT MAY
NOT BE CHANGED OR MODIFIED ORALLY, BUT ONLY BY AN AGREEMENT, IN WRITING, SIGNED
BY ALL PARTIES HERETO.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed and
delivered by their duly authorized representations, effective as of the
Effective Date set forth above.

 

3F THERAPEUTICS, INC.

 

EDWARDS LIFESCIENCES PVT, INC.

 

 

 

 

 

 

By:

 /s/ Walter Cuevas

 

 

By:

 /s/ Jay P. Wertheim

 

Name:

 Walter Cuevas

 

 

Name: Jay P. Wertheim

Title:

President and Chief Executive Officer

 

 

Title: Vice President, Associate General

 

 

Counsel and Secretary

 

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