Document:

Exhibit 10.2

 

EXECUTION COPY

 

SUPPLY
AND TRAINING AGREEMENT

 

This SUPPLY AND TRAINING AGREEMENT (this “Agreement”)
is made and entered into as of this 2nd day of June, 2005 (the “Effective
Date”), by and between Edwards Lifesciences PVT, Inc., a Delaware corporation
(“Edwards”), and 3F Therapeutics, Inc., a Delaware corporation (“3F
Therapeutics” and, together with Edwards, are each referred to herein as a “Party”
and collectively as the “Parties”).

 

RECITALS

 

WHEREAS, Edwards (as successor in
interest to Percutaneous Valve Technologies, Inc. (“PVT”)) and 3F
Therapeutics are parties to that certain Development and Supply Agreement,
dated as of June 13, 2002, as amended by the First Amendment to
Development and Supply Agreement, dated as of October 31, 2002, and the
Second Amendment to Development and Supply Agreement, dated as of May 27,
2003 (as so amended, the “3F Development and Supply Agreement”), by and
between PVT and 3F Therapeutics, which provides for, among other things, the
supply of certain products by 3F Therapeutics to Edwards;

 

WHEREAS, the Parties have entered into
that certain Master Agreement, dated as of May        ,
2005 (the “Master Agreement”), pursuant to which the Parties have agreed
to, among other things, terminate the 3F Development and Supply Agreement and
release each other from certain obligations thereunder, upon the terms and
subject to the conditions contained therein;

 

WHEREAS, the Parties have agreed to enter into this
Agreement in conjunction with the Master Agreement in order to provide for the (i) supply
of certain products by 3F Therapeutics to Edwards and (ii) delivery of the
Know-How Documentation (as defined below) and provision of certain training
services by 3F Therapeutics to Edwards with respect to such products.

 

NOW, THEREFORE, in consideration of the
premises and the mutual covenants and agreements hereinafter set forth, the
Parties agree as follows:

 

1.             DEFINITIONS.  The following definitions shall apply to the
following terms:

 

1.1          “3F
Development and Supply Agreement” shall have the meaning set forth in the
first recital.

 

1.2          “3F
License Agreement” shall mean that certain license agreement, dated as of
the Effective Date, between Edwards and 3F Therapeutics, pursuant to which 3F
will grant to Edwards a license to produce and sell products incorporating the
Tissue Valve Know-How.

 

1.3          “3F
Therapeutics” shall have the meaning set forth in the preamble.

 

1.4          “3F-PVT
SA” shall mean a Cribier Edwards PHV aortic bio-prosthesis.

 

1.5          “3F-PVT
SA Supply Term” shall mean the period of twelve (12) months beginning from
the Effective Date, unless earlier terminated in accordance with Section 5.2
or 5.3.

 

 

1.6          “AAA” shall mean the American Arbitration
Association.

 

1.7          “Act”
shall have the meaning set forth in Section 4.2.

 

1.8          “Agreement”
shall have the meaning set forth in the preamble.

 

1.9          “Arbitration
Act” shall mean the United States Arbitration Act, 9 U.S.C.  §§1, et seq., as amended from time to time.

 

1.10        “Change
of Control” shall mean (i) the consummation of a merger or
consolidation of 3F Therapeutics with another entity, other than a merger or
consolidation which would result in the voting securities of 3F Therapeutics
outstanding immediately prior thereto continuing to represent (either by
remaining outstanding or by being converted into voting securities of the
surviving entity) more than fifty percent (50%) of the total voting power
represented by the voting securities of 3F Therapeutics or such surviving
entity outstanding immediately after such merger or consolidation, (ii) the
consummation of the sale or disposition by 3F Therapeutics of substantially all
of its assets, (iii) at any time, any Edwards Competitor (together with
its affiliates), holds more than fifty percent (50%) of the total voting power
represented by the then-outstanding voting securities of 3F Therapeutics or (iv) at
any time, any Edwards Competitor (together with its affiliates) holds the
right, by contract, security holdings or otherwise, to nominate, elect or
appoint more than fifty percent (50%) of the number of directors on 3F
Therapeutics’ then-current board of directors.

 

1.11        “Edwards”
shall have the meaning set forth in the preamble.

 

1.12        “Edwards
Competitor” shall mean any entity that is engaged in the business of
developing, marketing and/or selling cardiovascular devices and/or products.

 

1.13        “Edwards
Components” shall mean the components provided to 3F Therapeutics by
Edwards for use by 3F Therapeutics in connection with its manufacture and
packaging of the Products.  Such components
shall include, but not be limited to, those items identified on Exhibit A
hereto, as the same may be modified from time-to-time upon the mutual agreement
of Edwards and 3F Therapeutics.

 

1.14        “Edwards
Product” shall mean any product sold by Edwards that contains a Product.

 

1.15        “Edwards
Specifications” shall mean the specifications for the manufacture and
testing of the Products as set forth on Exhibit B hereto.

 

1.16        “Effective
Date” shall have the meaning set forth in the preamble.

 

1.17        “Holdback
Amount” shall have the meaning set forth in the Master Agreement.

 

1.18        “Indemnified
Party” shall have the meaning set forth in Section 6.1.

 

1.19        “Indemnifying
Party” shall have the meaning set forth in Section 6.1.

 

2

 

1.20        “Know-How Documentation” shall mean any and
all documentation and information related to the Tissue Valve Know-How that was
developed by 3F Therapeutics prior to the expiration of the Term (including
prior to the Effective Date), including without limitation, such documentation
and information as set forth on Exhibit C hereto.

 

1.21        “Losses”
shall have the meaning set forth in Section 6.1.

 

1.22        “Master
Agreement” shall have the meaning set forth in the second recital.

 

1.23        “Obsolete” shall mean raw materials used by
3F Therapeutics to manufacture Products, which raw materials have a shelf life
that has expired or will expire within three (3) months of the expiration
of the Term, or are damaged.

 

1.24        “Party”
or “Parties” shall have the meaning set forth in the preamble.

 

1.25        “Prevailing
Party” shall have the meaning set forth in Section 7.7

 

1.26        “Product”
shall mean a 3F-PVT SA or a valve leaflet.

 

1.27        “PVT”
shall have the meaning set forth in the first recital.

 

1.28        “Quality
System Regulation” shall have the meaning set forth in Section 2.3(a).

 

1.29        “Supply
Term” shall mean the longer of the 3F-PVT SA Supply Term or the Valve
Leaflet Supply Term, as either may expire or be earlier terminated in
accordance with the terms of this Agreement.

 

1.30        “Technology
Transfer Plan” shall have the meaning set forth in Section 3.2.

 

1.31        “Term”
shall mean the shorter of (i) the Transfer Plan Term or (ii) the
Supply Term.

 

1.32        “Tissue
Valve Know-How” shall have the meaning set forth in the 3F License
Agreement.

 

1.33        “Training
Services” shall have the meaning set forth in Section 3.1.

 

1.34        “Transfer
Plan Term” shall mean the period from the Effective Date to the date set
forth in a statement or acknowledgement, jointly executed by the Parties pursuant
to the Technology Transfer Plan, providing that as of such date, 3F
Therapeutics has fully performed all of its obligations under the Technology
Transfer Plan to Edwards’ satisfaction and all elements of such Technology
Transfer Plan have been satisfied.

 

1.35        “Valve
Leaflet Supply Term” shall mean the period of eighteen (18) months
beginning from the Effective Date, unless earlier terminated in accordance with
Section 5.2 or 5.3.

 

3

 

2.             SUPPLY
OF PRODUCTS.

 

2.1          Manufacture of Products.  3F Therapeutics agrees to manufacture and
sell the Products exclusively to Edwards (provided,
however, that notwithstanding Section 5.7
hereof and the proviso contained in Section 2.2(b) of the Master
Agreement, an inadvertent sale of any Product by 3F Therapeutics to any party
other than Edwards shall not constitute a failure of the condition to Edwards’
obligation to pay the Holdback Amount to 3F Therapeutics under Section 2.2(b) of
the Master Agreement), and Edwards agrees to purchase the Products upon the
following terms:

 

(a)           Within
thirty (30) days after the Effective Date, Edwards shall provide 3F
Therapeutics with a good faith, non-binding forecast of its purchase
requirements for (i) 3F-PVT SAs covering the 3F-PVT SA Supply Term and (ii) valve
leaflets covering the Valve Leaflet Supply Term, updated on a quarterly
basis.  The initial forecast will be
accompanied by a firm purchase order for the first three (3) months, and a
projection of orders for (x) 3F-PVT SAs for the remaining 3F-PVT SA Supply Term
and (y) valve leaflets for the remaining Valve Leaflet Supply Term.  Thereafter, firm purchase orders shall be
furnished on a monthly basis for Products to be delivered in the third full
calendar month following the month in which 3F Therapeutics receives such
purchase order.

 

(b)           Projections
of orders provided pursuant to Section 2.1(a) shall be for the
Parties’ planning purposes only, and shall not constitute binding commitments
upon Edwards.  In addition, Edwards may modify
any firm purchase order furnished pursuant to Section 2.1(a) up to
sixty (60) days prior to the beginning of the month covered by such purchase
order.

 

(c)           3F
Therapeutics shall acknowledge promptly each Edwards purchase order in writing
and confirm delivery dates to destinations specified by Edwards.

 

(d)           All
sales of Products shall be subject to the terms and conditions of this
Agreement and, to the extent they specify quantities, destinations and delivery
dates, to Edwards’ purchase orders.  If
there is any conflict or difference in interpretation between any Edwards
purchase order and this Agreement, the terms and conditions of this Agreement
shall supersede those of such purchase order.

 

2.2          Product/Process Changes.  3F Therapeutics
shall notify Edwards in advance and in writing of all proposed changes in the
following aspects of the Products or their components (provided, however,
that notwithstanding Section 5.7 hereof and the proviso contained in Section 2.2(b) of
the Master Agreement, if 3F Therapeutics is using commercially reasonable best
efforts but fails to provide advance notice as required by this Section 2.2,
such failure shall not constitute a failure of the condition to Edwards’
obligation to pay the Holdback Amount to 3F Therapeutics under Section 2.2(b) of
the Master Agreement): (i) composition or source of any raw material, (ii) method
of producing, processing or testing, (iii) change in subcontractors for
producing, processing or testing, (iv) site of manufacture and (v) labeling.  No such change shall be made without Edwards’
prior written consent.

 

2.3          Quality Control.  3F Therapeutics
shall perform incoming inspection and testing on all materials it receives from
any source for inclusion in any of the Products and shall advise Edwards if any
such materials fail to conform to the specifications mutually agreed to by

 

4

 

Edwards and 3F Therapeutics (provided, however,
that notwithstanding Section 5.7 hereof and the proviso contained in Section 2.2(b) of
the Master Agreement, if 3F Therapeutics is using commercially reasonable best
efforts but fails to perform incoming inspection and testing as required by
this Section 2.3, such failure shall not constitute a failure of the
condition to Edwards’ obligation to pay the Holdback Amount to 3F Therapeutics
under Section 2.2(b) of the Master Agreement).  In no case shall non-conforming materials
from any source be used in the manufacture of the Products.

 

(a)           All
Products shall be manufactured in accordance with Quality System Regulation
promulgated by the United States Food and Drug Administration (the “Quality
System Regulation”) (provided,
however, that notwithstanding Section 5.7
hereof and the proviso contained in Section 2.2(b) of the Master
Agreement, if 3F Therapeutics is using commercially reasonable best efforts but
fails to comply with this Section 2.3(a), such failure shall not
constitute a failure of the condition to Edwards’ obligation to pay the
Holdback Amount to 3F Therapeutics under Section 2.2(b) of the Master
Agreement).

 

(b)           All
Products shall meet the Edwards Specifications and shall be subjected to
quality control inspection by 3F Therapeutics in accordance with Edwards’
quality control standards and system (provided,
however, that notwithstanding Section 5.7
hereof and the proviso contained in Section 2.2(b) of the Master
Agreement, if 3F Therapeutics is using commercially reasonable best efforts but
fails to meet the Edwards Specifications as required by this Section 2.3(b),
such failure shall not constitute a failure of the condition to Edwards’
obligation to pay the Holdback Amount to 3F Therapeutics under Section 2.2(b) of
the Master Agreement).  3F Therapeutics
shall permit Edwards to review periodically 3F Therapeutics’ production and
quality control procedures and records and to visit 3F Therapeutics’ facilities
at reasonable times with a representative of 3F Therapeutics present.  Edwards’ review shall not be deemed an
approval of 3F Therapeutics’ quality control, inspection processes or
standards.

 

(c)           Edwards
may inspect or audit the Products for integrity and adherence to the Edwards
Specifications at any time upon reasonable notice to 3F Therapeutics.  Edwards shall inspect all finished Products
at 3F Therapeutics’ facility for integrity and adherence to Edwards
Specifications prior to such finished products being shipped.  If any of the Products fail to meet 3F
Therapeutics’ warranties or to conform to the Edwards Specifications, Edwards
may elect not to accept such Products and require 3F Therapeutics, at its
expense, to repair or replace such Products. 
If any customer of Edwards rejects or returns any Edwards Product to
Edwards as a result of a performance problem attributable to (i) 3F
Therapeutics’ negligence or willful misconduct, (ii) the rejected or
returned Product’s failure to meet the Edwards Specifications, (iii) 3F
Therapeutics’ failure to comply with the Quality System Regulation or (iv) any
other breach of this Agreement by 3F Therapeutics, Edwards shall notify 3F
Therapeutics in writing within sixty (60) days. 
At 3F Therapeutics’ option, 3F Therapeutics shall repair or replace such
Products or credit Edwards for the purchase price of such Products (provided, however, that notwithstanding Section 5.7 hereof
and the proviso contained in Section 2.2(b) of the Master Agreement, if 3F
Therapeutics is using commercially reasonable best efforts but fails to repair
or replace such Products or credit Edwards for the purchase price thereof as
required by this Section 2.3(c), such failure shall not constitute a failure of
the condition to Edwards’ obligation to pay the Holdback Amount to 3F
Therapeutics under Section 2.2(b) of the Master Agreement).  If 3F Therapeutics so requests, Edwards will
return any such Products to 3F Therapeutics at 3F Therapeutics’ expense.  Notwithstanding the foregoing, in the event
Edwards has supplied components to 3F Therapeutics for such Products, Edwards
may retain the Products if 3F Therapeutics elects to replace the Products or
credit Edwards for the purchase price.

 

(d)           3F
Therapeutics will notify Edwards immediately of any Quality System Regulation
audit of 3F Therapeutics by the United Stated Food and Drug Administration or
other

 

5

 

inspection of 3F Therapeutics’ records or its
facilities by any federal, state or local regulatory agency as well as the
results of such audit or inspection (provided,
however, that notwithstanding Section 5.7
hereof and the proviso contained in Section 2.2(b) of the Master
Agreement, if 3F Therapeutics is using commercially reasonable best efforts but
fails to “immediately” notify Edwards as required by this Section 2.3(d),
such failure shall not constitute a failure of the condition to Edwards’
obligation to pay the Holdback Amount to 3F Therapeutics under Section 2.2(b) of
the Master Agreement).

 

(e)           3F
Therapeutics hereby agrees to provide Edwards with all information in 3F
Therapeutics’ possession with respect to the Products and 3F Therapeutics’
operations which is required by the United States Food and Drug Administration
or any other notified body to be filed by Edwards (provided,
however, that notwithstanding Section 5.7 hereof and the proviso
contained in Section 2.2(b) of the Master Agreement, if 3F Therapeutics is
using commercially reasonable best efforts but fails to provide Edwards with
the information with respect to the Products and 3F Therapeutics’ operations as
required by this Section 2.3(e), such failure shall not constitute a failure of
the condition to Edwards’ obligation to pay the Holdback Amount to 3F
Therapeutics under Section 2.2(b) of the Master Agreement).

 

2.4          Product Recall.  In the event
that any Edwards Product is recalled by Edwards or any Product is recalled by
3F Therapeutics as the result of (i) 3F Therapeutics’ negligence or
willful misconduct, (ii) the recalled Product’s failure to meet the
Edwards Specifications due to an error or omission by 3F Therapeutics, (iii) 3F
Therapeutics’ failure to comply with the Quality System Regulation or (iv) any
other breach of this Agreement by 3F Therapeutics, 3F Therapeutics shall bear
all costs and expenses of such recall, including, without limitation, the cost
of notifying customers, shipping costs and any obligations to third parties
arising from such recall.  The Parties
will cooperate fully with each other in effecting any recall of any Product or
Edwards Product and communicating with purchasers, users and the media (provided, however, that notwithstanding Section 5.7 hereof
and the proviso contained in Section 2.2(b) of the Master Agreement, if 3F
Therapeutics is using commercially reasonable best efforts but fails to
cooperate with Edwards in connection with any product recall as required by
this Section 2.4, such failure shall not constitute a failure of the condition
to Edwards’ obligation to pay the Holdback Amount to 3F Therapeutics under
Section 2.2(b) of the Master Agreement).

 

2.5          Capacity and Supply of Products.  3F Therapeutics shall use commercially
reasonable best efforts to (i) provide sufficient available manufacturing
capacity of Products in contemplation of commercialization of Edwards Products
in accordance with Edwards’ forecasts of its Product requirements pursuant to Section 2.1(a) and
(ii) meet Edwards’ orders for Products hereunder.

 

2.6          Supply of Edwards Components.  Edwards shall provide all Edwards Components
to 3F Therapeutics free of charge and in a time frame that will allow 3F
Therapeutics to meet Edwards’ orders for Products hereunder.

 

2.7          Pricing.  Subject to the terms and conditions of this
Agreement, Edwards shall pay to 3F Therapeutics $600.00 for each 3F-PVT SA
assembled by Edwards’ operators at 3F Therapeutics’ facility, $800.00 for each
3F-PVT SA assembled by 3F Therapeutics’ operators and $150.00 for each valve
leaflet sold separately and delivered by 3F Therapeutics and purchased and
accepted by Edwards under this Agreement. 
These prices shall remain fixed during the Term.

 

2.8          Payment Terms.  Terms of payment are net sixty (60) days from
receipt of Product.  3F Therapeutics
shall ship the Products F.O.B. destinations specified by Edwards in purchase
orders provided in accordance with Section 2.1(a) via mutually agreed
upon carriers.  3F Therapeutics shall pay
all normal freight charges (provided, however,
that notwithstanding Section 5.7 hereof and the proviso contained in Section
2.2(b) of the Master Agreement, if 3F Therapeutics is using commercially
reasonable best efforts but fails to comply with the shipping terms as set
forth in this Section 2.8, such failure shall not constitute a failure of the
condition to Edwards’ obligation to pay the Holdback Amount to 3F Therapeutics
under Section 2.2(b) of the Master Agreement).

 

2.9          Certain Agreements by 3F Therapeutics.  3F Therapeutics hereby agrees that it shall
take the actions set forth in Exhibit D.

 

6

 

3.             DELIVERY OF KNOW-HOW DOCUMENTATION AND
PROVISION OF TRAINING SERVICES.

 

3.1          Delivery of Know-How Documentation and
Provision of Training Services.  3F Therapeutics hereby agrees that it shall (i) deliver
to Edwards the Know-How Documentation and (ii) during the Term, provide
training to Edwards with respect to the Tissue Valve Know-How.  3F Therapeutics agrees to work closely with
employees of Edwards and to use commercially reasonable best efforts to ensure
that based on such training Edwards is fully capable of manufacturing 3F-PVT
SAs, valve leaflets and finished products from valve leaflets to the same
quality standards, specifications and workmanship that 3F Therapeutics is
currently manufacturing 3F-PVT SAs and valve leaflets (such services, the “Training
Services”).

 

3.2          Written Plan for Delivery of Know-How
Documentation and Provision of Training Services.  Edwards and 3F Therapeutics have developed a
written technology transfer plan, attached hereto as Exhibit E (the
“Technology Transfer Plan”), which sets forth, among other things, the
timetable and procedures pursuant to which 3F Therapeutics will deliver the
Know-How Documentation and provide the training provided for herein (i.e., a schedule as
to when training will be provided, the individuals to be trained, the tasks and
procedures with respect to which training will be provided, the scope and the
level of the training to be provided). 
3F Therapeutics shall use commercially reasonable best efforts to
perform its obligations under the Technology Transfer Plan.  Subject to Section 2.9, the Technology
Transfer Plan may be modified from time to time upon mutual agreement of
Edwards and 3F Therapeutics.

 

3.3          Compensation for Delivery of Know-How
Documentation and Provision of Training Services.  3F Therapeutics hereby agrees that the
consideration payable to it by Edwards in connection with 3F Therapeutics’
manufacture and supply of the Products pursuant to the terms of this Agreement
shall constitute consideration in full in exchange for the (i) delivery of
the Know-How Documentation and (ii) provision by 3F Therapeutics of the
Training Services to Edwards, in each case pursuant to Section 3.1.

 

3.4          Independent Contractor.  Nothing in this Agreement is intended to
create, or shall be construed as creating, an employment relationship, joint
venture, partnership, agency, or taxable entity between the Parties, it being
understood that 3F Therapeutics is an independent contractor of Edwards with
respect to the provision of the Training Services to Edwards.  Except as expressly provided to the contrary
in this Agreement, Edwards shall have no right or power to bind or obligate 3F
Therapeutics in any manner whatsoever.

 

4.             REPRESENTATIONS
AND GUARANTEE AND WARRANTY.

 

4.1          Representations by the Parties.  The Parties hereby represent and warrant that
(i) each has full right, power and authority to enter into and be bound by
all of the terms and conditions of this Agreement, and to carry out all of its
obligations under this Agreement, without the approval or consent of any other
person or entity; (ii) each has duly executed and delivered this
Agreement; (iii) the entering into of this Agreement, and the carrying out
of that Party’s obligations under this Agreement is not prohibited, restricted
or otherwise limited by any contract, agreement or understanding entered into
by that Party, or by which that party is bound, with any other person or any
governmental authority or entity; (iv) there is no contract, agreement,
understanding or judgment entered into by a Party, or by which that Party is
bound,

 

7

 

which if enforced, terminated or modified, would
be in derogation of, contrary to, or adversely affect any of the rights
acquired or to be acquired hereunder by either Party; and (v) there is no
action, suit, proceeding or investigation pending or currently threatened
against either Party which, if adversely determined, would restrict or limit
that Party’s right to enter into and be bound by this Agreement.

 

4.2          Representation
and Guarantee by 3F Therapeutics.  3F Therapeutics represents and warrants that to its knowledge
the Products supplied to Edwards under this Agreement and the sale of the
Products as contained in the Edwards Products by Edwards will not infringe any
patent, copyright or other intellectual property of any third party.  All Products sold to Edwards pursuant
to this Agreement are hereby guaranteed by 3F Therapeutics, as of the date of
shipment or delivery, to be, on such date, not adulterated or misbranded within
the meaning of the United States Federal Food, Drug and Cosmetics Act (the “Act”),
and all amendments and successor laws and regulations thereto, whether federal,
state or local, and is not otherwise an article which may not, under the
terms of the Act, be introduced into interstate commerce (provided,
however, that notwithstanding Section 5.7 hereof and the proviso
contained in Section 2.2(b) of the Master Agreement, if 3F Therapeutics is
using commercially reasonable best efforts but breaches its representation or
guarantee as set forth in this Section 4.2, such breach shall not constitute a
failure of the condition to Edwards’ obligation to pay the Holdback Amount to
3F Therapeutics under Section 2.2(b) of the Master Agreement).

 

4.3          Warranty.  3F THERAPEUTICS WARRANTS THAT (I) ALL 3F-PVT
SAs ASSEMBLED BY ITS PERSONNEL AND SOLD TO EDWARDS UNDER THIS AGREEMENT AND
(II) ALL VALVE LEAFLETS SOLD TO EDWARDS UNDER THIS AGREEMENT ARE FREE FROM
DEFECTS IN WORKMANSHIP AND MATERIALS AND ARE IN COMPLIANCE WITH THE EDWARDS
SPECIFICATIONS.  3F THERAPEUTICS FURTHER
WARRANTS THAT THE PRODUCTS ARE MANUFACTURED IN ACCORDANCE WITH THE QUALITY
SYSTEM REGULATION AND 3F THERAPEUTICS’ QUALITY CONTROL PROCESSES AND STANDARDS,
WHICH PROCESSES AND STANDARDS MEET ALL LEGAL AND REGULATORY REQUIREMENTS
APPLICABLE TO THE PRODUCTS (provided, however,
that notwithstanding Section 5.7 hereof and the proviso contained in Section
2.2(b) of the Master Agreement, if 3F Therapeutics is using commercially
reasonable best efforts but breaches its warranty as set forth in this Section
4.3, such breach shall not constitute a failure of the condition to Edwards’
obligation to pay the Holdback Amount to 3F Therapeutics under Section 2.2(b)
of the Master Agreement).

 

4.4          Disclaimer of Other Warranties.  EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, THE MASTER AGREEMENT, THE EDWARDS LICENSE AGREEMENT (AS SUCH TERM IS
DEFINED IN THE MASTER AGREEMENT) AND THE 3F LICENSE AGREEMENT (AS SUCH TERM IS
DEFINED IN THE MASTER AGREEMENT), NEITHER PARTY MAKES ANY REPRESENTATION OR
WARRANTY TO THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE.

 

4.5          No Liability with Respect to Edwards
Components.  3F Therapeutics will have no liability of any
nature whatsoever with respect to any claims or liabilities attributable to
Edwards Components.  3F Therapeutics is
not making any warranties of any nature whatsoever with respect to the Edwards
Components.

 

5.             TERM AND TERMINATION; BREACH BY 3F
THERAPEUTICS; HOLDBACK AMOUNT.

 

5.1          Term.  This Agreement shall be effective as of the
Effective Date, continue in effect for the duration of the Term and expire upon
the expiration of the Term.

 

8

 

5.2          Termination of the 3F-PVT SA Supply Term or
Valve Leaflet Supply Term by Edwards.  Edwards may terminate the 3F-PVT SA Supply
Term and/or the Valve Leaflet Supply Term in its sole discretion, for any
reason or no reason, by giving at least seven (7) days’ prior written
notice to 3F Therapeutics.

 

5.3          Termination of the 3F-PVT SA Supply Term or
Valve Leaflet Supply Term by 3F Therapeutics. 
3F Therapeutics may terminate the 3F-PVT
SA Supply Term and/or the Valve Leaflet Supply Term by giving at least thirty
(30) days’ prior written notice to Edwards only if Edwards materially breaches
this Agreement.  The 3F-PVT SA Supply
Term and/or the Valve Leaflet Supply Term, as applicable, shall automatically
terminate at the end of such notice period unless such material breach is
cured.  Failure to terminate the 3F-PVT
SA Supply Term or the Valve Leaflet Supply Term for any material breach shall
not constitute a waiver by 3F Therapeutics of its right to terminate for such
breach at a later time if such breach remains uncured and for any other
material breach.  If 3F Therapeutics believes
Edwards has not complied in any material aspect with this Agreement, it shall
give Edwards notice, specifying the acts or omissions constituting such
non-compliance.  Edwards’ non-compliance
with any provision of this Agreement shall not be considered to be a breach of
this Agreement provided that Edwards cures the non-compliance within the thirty
(30) day notice period first set forth above. 
Material breach shall be deemed to include but not be limited to Edwards’
failure to make any payments when due to 3F Therapeutics under this Agreement.

 

5.4          Effect of Expiration or Termination.  Expiration or earlier termination of either
the 3F-PVT SA Supply Term or the Valve Leaflet Supply Term shall not affect the
duration of, or the terms and conditions with respect to, the other under this
Agreement.  All rights and obligations of
the parties that have accrued or are intended to survive the expiration of the
Term shall survive such expiration as provided in Section 7.1.

 

5.5          Purchase of Materials by Edwards Upon
Termination.  At 3F Therapeutics’ election, upon expiration
of the Term, Edwards will purchase from 3F Therapeutics, at
3F Therapeutics’ cost, all usable inventory of raw materials purchased by
3F Therapeutics to manufacture Products for Edwards pursuant to the terms
hereof, provided, however, that (i) 3F
Therapeutics shall first return to its vendors as much of such raw materials as
it is able to obtain a full refund therefor, (ii) Edwards shall not be
required to purchase any raw materials that are Obsolete and (iii) the
level of inventory of raw materials is consistent with the forecasts delivered
pursuant to Section 2.1(a) hereof.

 

5.6          Breach by 3F Therapeutics.  If Edwards believes 3F Therapeutics has not
complied with any provision of this Agreement, it shall give 3F Therapeutics
notice, specifying the acts or omissions constituting such non-compliance.  3F Therapeutics’ non-compliance with any
provision of this Agreement shall be considered a breach of this Agreement
unless 3F Therapeutics cures or Edwards waives such non-compliance within
thirty (30) days from the date of 3F Therapeutics’ receipt (as determined in
accordance with Section 7.5) of the notice provided by Edwards pursuant to
the immediately preceding sentence.

 

5.7          Holdback Amount.  3F
Therapeutics hereby agrees and acknowledges that under the terms of the Master
Agreement, Edwards shall not be obligated to pay, and 3F Therapeutics shall not
be entitled to receive, any portion of the Holdback Amount if there shall have
been any breach by 3F Therapeutics of any provision of this Agreement as
provided in Section 5.6 above at any time during the Term.

 

9

 

6.             INDEMNIFICATION AND INSURANCE.

 

6.1          Indemnity.  Each Party (the “Indemnifying Party”)
hereby agrees to indemnify, defend and hold the other Party (the “Indemnified
Party”), its permitted successors, affiliates, and permitted assigns
harmless from and against all claims, demands, liabilities, damages, losses and
expenses suffered or incurred by the Indemnified Party (“Losses”) only
to the extent arising out of or in connection with (i) any breach of any
representation or warranty of the Indemnifying Party set forth in this
Agreement and (ii) any breach of any agreement, covenant or obligation of
the Indemnifying Party set forth in this Agreement.

 

6.2          Indemnification Procedures.  If an Indemnified Party intends
to seek indemnification pursuant to this Section 6, such Indemnified Party
shall promptly notify the Indemnifying Party in writing of such claim.  The Indemnified Party will provide the
Indemnifying Party with prompt written notice of any third party claim in
respect of which indemnification is sought. 
The failure to provide either such notice will not affect any rights
hereunder except to the extent the Indemnifying Party is materially prejudiced
thereby.  Any such notice shall set forth
in reasonable detail the available facts, circumstances and basis of the claim.
If such claim involves a claim by a third party against the Indemnified Party,
the Indemnifying Party may, after acknowledging in writing liability hereunder,
assume, through counsel of its own choosing (so long as reasonably acceptable
to the Indemnified Party) and at its own expense, the defense thereby and the
Indemnified Party shall cooperate with it in connection therewith (including by
furnishing such information as the Indemnifying Party may reasonably request),
provided, that the Indemnified Party may participate in such defense through
counsel chosen by it, at its own expense. 
So long as the Indemnifying Party is contesting any such claim in good
faith, the Indemnified Party shall not pay or settle, or admit any liability
with respect to, any such claim which it continues to seek indemnification for
without the Indemnifying Party’s consent. 
The Indemnifying Party will not without the Indemnified Party’s prior
written consent settle or compromise any claim or consent to entry of any
judgment which does not include as an unconditional term thereof the giving by
the claimant or the plaintiff to the Indemnified Party of a release from all
liability in respect of such claim. The Indemnifying Party shall not, without
the prior written consent of the Indemnified Party (which consent shall not be
unreasonably withheld), take any measure or step in connection with any
settlement or compromise that imposes a material burden or encumbrance upon the
operation or conduct of the Indemnified Party’s business. If the Indemnifying
Party is not contesting such claim in good faith, then the Indemnified Party
may, upon at least ten (10) days’ notice to the Indemnifying Party (unless
the Indemnifying Party shall assume such settlement or defense within such ten (10) day
period), conduct and control, through counsel of its own choosing and at the
expense of the Indemnifying Party, the settlement or defense thereof, and the
Indemnifying Party shall cooperate with it in connection therewith.  The failure of the Indemnified Party to
participate in, conduct or control such defense shall not relieve the
Indemnifying Party of any obligation it may have hereunder.

 

6.3          Insurance.  3F Therapeutics shall obtain and keep in
force at all times during the Term the following insurance policies, covering
3F Therapeutics and its employees under this Agreement:

 

10

 

(a)           Worldwide comprehensive general liability, in
an amount not less than $3,000,000 each occurrence for bodily injury and
property damage for:

 

(i)            premises-operations;

 

(ii)           products/completed operations;

 

(iii)          blanket contractual liability; and

 

(iv)          personal injury.

 

(b)           Workers’ compensation, occupational disease
and disability, in accordance with applicable statutory requirements.

 

(c)           Employer’s liability, in an amount of not
less than $1,000,000.

 

During
the Term and for a period of five (5) years following the expiration of
the Term in accordance with Section 5.1, each insurance policy shall
evidence Edwards as an additional insured and shall provide for written
notification to Edwards by the insurer not less than thirty (30) days prior to
cancellation, expiration or modification. 
A certificate of insurance evidencing compliance with this Section 6.3
shall be furnished to Edwards by 3F Therapeutics within thirty (30) days after
the Effective Date.

 

6.4          Limitation of Liability or Damages.  IN NO EVENT SHALL EITHER PARTY,
ITS AGENTS OR EMPLOYEES, BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL,
PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST PROFITS,
IN CONNECTION WITH THIS AGREEMENT, THE MANUFACTURE OF PRODUCTS OR THE PROVISION
OF TRAINING SERVICES, HOWEVER SO CAUSED, WHETHER ARISING IN CONTRACT (INCLUDING
BREACH), TORT (INCLUDING NEGLIGENCE), OR OTHERWISE.  3F THERAPEUTICS HEREBY ACKNOWLEDGES AND
AGREES THAT NOTWITHSTANDING THE FOREGOING, 3F THERAPEUTICS, ITS SUCCESSORS AND
ASSIGNS AND THEIR RESPECTIVE AFFILIATES SHALL BE LIABLE TO EDWARDS (PROVIDED,
HOWEVER THAT IN THE EVENT THAT THIS AGREEMENT IS ASSIGNED BY 3F THERAPEUTICS
PURSUANT TO SECTION 7.3, SUCH SUCCESSORS AND ASSIGNS AND THEIR RESPECTIVE
AFFILIATES SHALL BE LIABLE BUT 3F THERAPEUTICS SHALL NOT BE LIABLE) FOR ANY AND
ALL OF EDWARDS’ INDIRECT,
SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT
LIMITATION LOST PROFITS, IN CONNECTION WITH THIS AGREEMENT, THE MANUFACTURE OF
PRODUCTS OR THE PROVISION OF TRAINING SERVICES, WHETHER ARISING IN CONTRACT
(INCLUDING BREACH), TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, IF (I) A CHANGE
OF CONTROL (AS DEFINED IN SECTION 1.10 ABOVE) HAS OCCURRED AND (II) SUCH
LIABILITY OR DAMAGE WAS CAUSED BY A WILLFUL BREACH OF ANY PROVISION OF THIS
AGREEMENT BY ANY OF 3F THERAPEUTICS, ITS SUCCESSORS OR ASSIGNS OR ANY OF THEIR
RESPECTIVE AFFILIATES.  THE PARTIES
HEREBY FURTHER ACKNOWLEDGE AND AGREE THAT THE PROVISIONS OF THIS SECTION 6.4
ARE REASONABLE AND APPROPRIATE IN THE

 

11

 

CIRCUMSTANCES
AND WERE MATERIAL FACTORS IN DETERMINING THE TERMS OF THIS AGREEMENT.

 

7.             GENERAL.

 

7.1          Survival.  The
provisions of Section 2.4, each of the representations, guarantee and
warranty made by the Parties in Section 4, the indemnification provisions
contained in Sections 6.1 and 6.2, the insurance provisions contained in Section 6.3
(for such period as set forth in such Section) and the general provisions in
Sections 7.1 through 7.10, shall survive the expiration of this Agreement in
accordance with Section 5.1.

 

7.2          Entire Agreement.  This
Agreement (including the documents referred to herein) constitutes the entire
agreement between the Parties concerning its subject matter and supersedes any
prior understandings, agreements, or representations by or between the Parties,
written or oral, to the extent they relate in any way to the subject matter
hereof.

 

7.3          Succession
and Assignment.  3F Therapeutics may not assign either this Agreement or any of its
rights, interests, or obligations hereunder except (i) with the prior
written approval of Edwards, (ii) in connection with the sale of all or
substantially all of 3F Therapeutics’ business or (iii) in connection with
the sale by 3F Therapeutics of all or substantially all of the assets of the
business relating to the Surgical Field of Use (as such term is defined in the
3F License Agreement).  This Agreement
shall be binding upon and inure to the benefit of the Parties named herein and
their respective successors and permitted assigns.

 

7.4          Counterparts.  This
Agreement may be executed in one or more counterparts, (including by means of
facsimile), each of which shall be deemed an original but all of which together
will constitute one and the same instrument.

 

7.5          Notices
and Demands.  Any notice or demand which is required or provided to be given under
this Agreement shall be deemed to have been sufficiently given and received for
all purposes when delivered by hand, telecopy, telex or other method of
facsimile, or five days after being sent by certified or registered mail,
postage and charges prepaid, return receipt requested, or two days after being
sent by overnight delivery providing receipt of delivery, to the following
addresses:

 

	
  If to Edwards:

  

  Edwards Lifesciences PVT, Inc.

  One Edwards Way

  Irvine, CA 92614

  Facsimile No.: (949) 250-6868

  Attn: General Counsel

  

  

  If to 3F Therapeutics:

  	
  Copy to (which copy shall not constitute notice):

  

  Gibson, Dunn & Crutcher LLP

  Jamboree Center

  4 Park Plaza

  Irvine, CA 92614

  Facsimile No.: (949) 475-4673

  Attn:  John M. Williams

  

  Copy to (which copy shall not constitute notice):

  

 

	
  3F Therapeutics, Inc.

  20412 James Bay Circle

  Lake Forest, CA  92630

  Facsimile No.: (949) 380-9399

  Attn: Walter A. Cuevas

  	
  Reed Smith LLP

  1901 Avenue of the Stars

  Suite 700

  Los Angeles, CA 90067

  Facsimile No.: (310) 734-5299

  Attention:  Michael Sanders

  

 

 

12

 

7.6          Governing
Law.  This
Agreement shall be governed by and construed in accordance with the domestic
laws of the State of California without giving effect to any choice or conflict
of law provision or rule (whether of the State of California or any other
jurisdiction) that would cause the application of the laws of any jurisdiction
other than the State of California.

 

7.7          Arbitration;
Resolution of Certain Disputes.

 

(a)           Subject to Section 7.7(c) below,
all disputes between Edwards and 3F Therapeutics arising out of or in
connection with the execution, interpretation and performance of this Agreement
(including the validity, scope and enforceability of this arbitration
provision) shall be solely and finally settled by arbitration in accordance
with the Arbitration Act, the rules of practice and procedure for the
arbitration of commercial disputes of the AAA and the “special rules” set forth
in this Section 7.7(a).  In the
event of any inconsistency, the “special rules” set forth herein shall
control.  The following shall constitute
the “special rules” applicable to any arbitration commenced under this Section 7.7(a):
(i) the arbitration shall be conducted in the County of Orange,
California, and administered by the AAA, who will appoint an arbitrator that is
either a lawyer from a national firm or a judge with at least 15 years of experience,
in each case experienced in the industry of the Parties’ business and (ii) all
arbitration hearings will be commenced within sixty (60) days of the demand for
arbitration, provided that, the arbitrator shall, upon a showing of cause, be
permitted to extend the commencement of such hearing for up to an additional
sixty (60) days.

 

(b)           To the extent permissible under applicable
law, Edwards and 3F Therapeutics agree that the award of the arbitrator shall
be final and shall not be subject to judicial review.  Judgment on the arbitration award may be
entered and enforced in any court having jurisdiction over the parties or their
assets.  It is the intent of the parties
that the arbitration provisions hereof be enforced to the fullest extent
permitted by applicable law.

 

(c)           During the course of 3F Therapeutics’ sale to
Edwards of Products pursuant to Section 1 of Exhibit D, if Edwards
shall reject any such Products and 3F shall dispute the basis for such
rejection, the following dispute resolution mechanisms shall apply if the
Parties are unable to resolve such dispute within a reasonable period of time:

 

(i)            each Party shall appoint an expert with
significant knowledge and experience in the industry, and the two experts so
appointed shall together appoint a third expert with significant knowledge and
experience in the industry;

 

(ii)           the three experts appointed pursuant to Section 7.7(c)(i) shall
determine, by majority vote, the resolution of the subject dispute; and

 

13

 

(iii)          each Party hereby agrees that the resolution
reached by the three experts in accordance with Section 7.7(c)(ii) with
respect to any dispute submitted for decision under Section 7.7(c) shall
be final and binding on such Party.

 

7.8          Amendments
and Waivers.  No amendment of any provision of this Agreement shall be valid unless
the same shall be in writing and signed by all Parties.  No waiver by any Party of any provision of
this Agreement or any default, misrepresentation, or breach of warranty or
covenant hereunder, whether intentional or not, shall be valid unless the same
shall be in writing and signed by the Party making such waiver nor shall such
waiver be deemed to extend to any prior or subsequent default,
misrepresentation, or breach of warranty or covenant hereunder or affect in any
way any rights arising by virtue of any such prior or subsequent default,
misrepresentation, or breach of warranty or covenant.

 

7.9          Severability.  Any term or
provision of this Agreement that is invalid or unenforceable in any situation
in any jurisdiction shall not affect the validity or enforceability of the
remaining terms and provisions hereof or the validity or enforceability of the
offending term or provision in any other situation or in any other
jurisdiction.

 

7.10        Expenses.  Unless
otherwise set forth in this Agreement, each of the Parties will bear its own
costs and expenses (including legal fees and expenses) incurred in connection
with this Agreement and the transactions contemplated hereby.

 

7.11        Administration.  Each of the Parties shall designate one
individual within their respective organizations to act as a point of contact
for day-to-day administration of and communications concerning the supply of
Products and provision of training under this Agreement.

 

7.12        Force Majeure. 
Neither Party hereto shall be liable to the extent that its ability to
fulfill any provision of this Agreement is delayed, hindered or prevented by
any cause beyond its reasonable control, including, without limitation, war
(declared or undeclared), riots, acts of terror, insurrection, fire, flood,
interruption of transportation, embargo, accident, explosion, strikes, lockouts
or other labor disputes. Any such event shall excuse the affected party from
performance only for the period of time during which such event continues and
only to the extent performance is directly affected thereby and the time for
performance shall accordingly be extended for the period of the delay and for a
reasonable period thereafter.

 

14

 

IN WITNESS WHEREOF, the Parties have caused this
Agreement to be duly executed and delivered by their proper and duly authorized
officers as of the day and year first above written.

 

 

	
   

  	
  EDWARDS LIFESCIENCES PVT,
  INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Jay P. Wertheim

  	
   

  
	
   

  	
   

  	
  Name:

  	
  Jay P. Wertheim

  
	
   

  	
   

  	
  Title:

  	
  Vice President, Associate
  Counsel

  and Secretary

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  3F THERAPEUTICS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Walter Cuevas

  	
   

  
	
   

  	
   

  	
  Name:

  	
  Walter Cuevas

  
	
   

  	
   

  	
  Title:

  	
  President and Chief
  Executive Officer

  
					

 

15Exhibit 10.3

 

CO-EXCLUSIVE LICENSE AGREEMENT

 

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

 

RECITALS

 

WHEREAS
Edwards is the owner or has the right to sublicense certain patents and patent
applications relating to catheter-delivered heart valves and venous valves;

 

WHEREAS 3F
desires to obtain a co-exclusive license to such patents and patent
applications in the Fields of Use defined below; and

 

WHEREAS
Edwards is willing to grant such license to 3F 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         “Additional
License” shall mean either a Compelled License
or a Granted License.

 

1.3         “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.

 

1.4         “Agreement” shall have the meaning set forth in the preamble.

 

1.5         “Calendar
Quarter” shall mean each three-month-period
beginning January 1, April 1, July 1, and October 1 of each calendar year.

 

1.6   “Combination
Price” shall be calculated by multiplying the
gross invoice price charged and the value of any other consideration owed for
such combined Licensed Product or Unauthorized Product and other product(s)
that are not Licensed Products or Unauthorized Products by the fraction where A is the gross selling price of the
Licensed Product or Unauthorized Product sold separately and B is the gross selling price of the other
product(s) sold separately. 
Notwithstanding any of the foregoing, in no event shall the fraction  used in the calculation of the Combination
Price be less than one-half (1/2).

 

1

 

1.7                                 “Compelled
License” shall have the meaning set forth in
Section 7.5.

 

1.8                                 “Edwards” shall have the
meaning set forth in the preamble.

 

1.9                                 “Effective
Date” shall have the meaning set forth in the
preamble.

 

1.10                           “Field-Restricted
Royalty” shall have the meaning set forth in
Section 4.1.

 

1.11                           “Fields
of Use” shall mean the Surgical Field of Use
and the Venous Field of Use.

 

1.12                           “Granted
License” shall have the meaning set forth in
Section 7.5.

 

1.13                           “Heartport
License” shall mean the license agreement,
dated December 21, 2000, by and between Heartport, Inc., together with its
predecessor Stanford Surgical Technologies, and Edwards’
predecessor-in-interest Percutaneous Valve Technologies, Inc., attached hereto
as Exhibit D.

 

1.14                           “Licensed
Patents” shall mean the Surgical Licensed
Patents and the Venous Licensed Patents.

 

1.15                           “Licensed
Products” shall mean the Surgical Licensed
Products and the Venous Licensed Products.

 

1.16                           “Litigation”
shall have the meaning set forth in Section 7.2.

 

1.17                           “Litigation
Expenses” shall mean all attorneys’ fees and
costs (including reasonable fees and costs attributable for work performed by
in-house counsel), all expert fees and costs, all court and/or arbitration
expenses, and any other fees and costs properly incurred, including any fees
and costs incurred in bringing and prosecuting the Litigation and/or enforcing
any order, judgment, ruling, or award granted as part of such Litigation.

 

1.18                           “Net
Invoice Price” means (a) the gross invoice
price charged and the value of any other consideration owed for a Licensed
Product or Unauthorized Product, or (b) in those instances where the Licensed
Product or Unauthorized Product is sold in combination with one or more other
products that are not Licensed Products or Unauthorized Products, the
Combination Price, less the following items, but only to the extent that they
actually pertain to the disposition of such Licensed Product or Unauthorized
Product and are identified separately on a bill or invoice:

 

i)                                         allowances
actually granted to customers for rejections, returns, or prompt payment and
volume discounts;

 

ii)                                      freight,
transport packing, and insurance charges associated with transportation; and

 

iii)                                   rebates
or discounts paid or credited pursuant to applicable law.

 

2

 

Notwithstanding
the foregoing, for purposes of this Section and this Agreement, in no event
shall the Combination Price be used if such other product(s) are essential for
the use or delivery of the Licensed Product or Unauthorized Product.  By way of example, the Net Invoice Price of a
stented, tissue heart valve combined with a catheter delivery system shall be
the gross invoice price charged and the value of any other consideration owed
for both the stented, tissue heart valve and catheter delivery system, and not
the Combination Price.

 

1.19                           “Net
Sales” shall mean the Net Invoice Price
charged by 3F or its Affiliates to a Third Party.

 

1.20                           “Outside-Field
Royalty” shall have the meaning set forth in
Section 4.2.

 

1.21                           “Party” shall have the meaning set forth in the
preamble.

 

1.22                           “Parties” shall have the meaning set forth in the
preamble.

 

1.23                           “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.

 

1.24                           “Royalty”
or “Royalties” shall mean the Field-Restricted Royalty and/or Outside-Field Royalty,
as appropriate.

 

1.25                           “Royalty
Report” shall have the meaning set forth in
Section 5.1.

 

1.26                           “Sublicensed
Patents” shall mean (i) the patents and patent
applications listed on Exhibit A attached hereto and (ii) any continuations,
divisionals, reexaminations, reissues, extensions and foreign counterparts
thereof, if and only to the extent that such rights are possessed by Edwards.

 

1.27                           “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.

 

1.28                           “Surgical
Licensed Patents” shall mean the patents and
patent applications listed on Exhibit B attached hereto, and any continuations,
divisionals, reexaminations, reissues, extensions and foreign counterparts
thereof.

 

1.29                           “Surgical
Licensed Product” shall mean a product in the
Surgical Field of Use covered by any Valid Claim of the Surgical Licensed
Patents or Sublicensed Patents.

 

3

 

1.30                           “Third
Party” shall mean any Person other than
Edwards, 3F, or an Affiliate of either.

 

1.31                           “Unauthorized
Product” shall mean a product sold by 3F that
would be a Licensed Product under this Agreement if such product was used in
the Surgical Field of Use or Venous Field of Use, as applicable, but which is
actually used, with or without the direct involvement or prior knowledge of 3F,
outside such applicable Field of Use.

 

1.32                           “Valid
Claim” shall mean a claim of an issued and
unexpired patent included in the Licensed Patents or Sublicensed 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.

 

1.33                           “Venous
Field of Use” shall mean the treatment and
repair outside of the heart of venous valves with venous insufficiency;
provided, however, that such Venous Field of Use shall also include venous
valves placed in the superior or inferior vena cava for treatment of the
tricuspid valve.

 

1.34                           “Venous
Licensed Patents” shall mean the patents and
patent applications listed on Exhibit C attached hereto, and any continuations,
divisionals, reexaminations, reissues, extensions and foreign counterparts
thereof.

 

1.35                           “Venous
Licensed Product” shall mean a product in the
Venous Field of Use covered by any Valid Claim of the Venous Licensed Patents
or Sublicensed Patents.

 

2.               License
Grants.

 

2.1         Edwards hereby grants to
3F a worldwide, non-transferable (except as set forth in Section 13.2.1 below),
royalty-bearing, co-exclusive license under the Surgical Licensed Patents,
without the right to sublicense, to manufacture, have manufactured, use,
import, offer for sale, and sell Surgical Licensed Products solely in the
Surgical Field of Use.

 

2.2         Edwards hereby further grants to 3F a worldwide,
non-transferable (except as set forth in Section 13.2.1 below),
royalty-bearing, co-exclusive license under the Venous Licensed Patents,
without the right to sublicense, to manufacture, have manufactured, use, import,
offer for sale,  and sell Venous Licensed
Products solely in the Venous Field of Use.

 

2.3         Edwards also hereby further grants to 3F a
worldwide, non-transferable (except as set forth in Section 13.2.1 below),
royalty-bearing co-exclusive sublicense under the Sublicensed Patents, without
the right to further sublicense, to manufacture, have manufactured, use,
import, offer for sale, and sell Licensed Products solely in the Fields of Use.

 

2.4         3F 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
and sublicenses set forth in this Section 2 include a covenant by 3F to refrain
from taking any actions that would permit, encourage, promote, market, fund,
sponsor, or facilitate, directly or indirectly,

 

4

 

any off label use or any other use of any Licensed Product outside the
Surgical Field of Use or Venous Field of Use, as applicable, and to use its
best efforts to prevent any such off label use or any other use outside such
applicable Field of Use.  Any breach by
3F of this covenant shall be deemed a material breach of this Agreement.

 

2.5         The co-exclusive licenses and sublicense set forth
in this Section 2 shall be co-exclusive with Edwards, its Affiliates,
successors, and/or assigns. During the term of this Agreement, Edwards shall
have no right to grant to any third party any license under the Surgical
Licensed Patents in the Surgical Field of Use or Venous Licensed Patents in the
Venous Field of Use or sublicense under the Sublicensed Patents in the Surgical
Field of Use or the Venous Field of Use, except as provided in Section 7.5
hereof.

 

2.6         No implied patent or other intellectual property
rights or licenses are granted by Edwards hereunder or in connection herewith
other than those licenses and the sublicense expressly granted in this
Agreement.

 

2.7         3F, as a sublicensee to the Sublicensed Patents,
hereby agrees to comply with all terms and conditions applicable to a
sublicensee under the Heartport License.

 

3.               Product
Labeling.

 

3.1         Upon written notice from Edwards of a specific
Licensed Patent that applies to a specific Licensed Product, each Licensed
Product sold by 3F shall be marked in compliance with 35 U.S.C. § 287, or the
relevant corresponding statute under the law of the country in which the
Licensed Product is sold.

 

3.2         Each Licensed Product manufactured by or for 3F shall be labeled for
use solely in the Surgical Field of Use or Venous Field of Use, as applicable.

 

4.               Royalties.

 

4.1         In consideration of the grant of rights under the
Licensed Patents and Sublicensed Patents in this Agreement, and except as
provided by Section 4.2 below, 3F shall pay Edwards a royalty (the “Field-Restricted
Royalty”) of four percent (4%) of the Net
Sales of any Licensed Product sold by 3F. 
The Field-Restricted Royalty accrues and shall be deemed payable at the
time that each Licensed Product is sold.

 

4.2         In light of the essential nature of the limited
scope of the Fields of Use, 3F shall pay Edwards a royalty (the “Outside-Field
Royalty”) of twenty-five percent (25%) of the
Net Sales of all Unauthorized Products above the first fifty (50) Unauthorized
Products sold by 3F in any year during the term hereof.  3F agrees and acknowledges that the
Outside-Field Royalty represents a fair and reasonable Royalty for such
Unauthorized Products and shall not be considered a penalty or fine.

 

5.               Payments.

 

5.1         Within thirty (30) days of the last day of each Calendar
Quarter, 3F shall pay Edwards all Royalties accrued during such Calendar
Quarter, along with a written report (the

 

5

 

“Royalty Report”) detailing for each country, for the Calendar
Quarter covered, the calculation of any Royalties along with (i) the number of
Surgical and Venous Licensed Products sold by 3F; (ii) the Net Sales charged
for each such Licensed Product; (iii) the number of any Unauthorized Products;
and (iv) the Net Sales charged for each such Unauthorized Product.

 

5.2         No Royalties accrued under this Agreement shall be
reduced by any taxes, fees, or other charges imposed by the government of such
country on the remittance of such Royalties. 
3F shall further be responsible for all bank charges associated with
remittance of any Royalties.

 

5.3         All Royalties accrued pursuant to this Agreement
shall be paid in United States dollars. 
When Licensed or Unauthorized Products are sold for monies other than
United States dollars, the Royalties will be first determined in such foreign
currency and then converted into equivalent United States dollars based on the
exchange rate quoted in The Wall Street
Journal on the last business day of the applicable Calendar Quarter.

 

5.4         Any amount payable to Edwards pursuant to this
Agreement and which is not paid when due shall bear interest at the lesser of
(i) one percent (1.0%) per month or (ii) the maximum amount allowable by law.

 

5.5         Within five (5) days of becoming insolvent, as
defined in Section 9.3, 3F shall give written notice to Edwards of such
insolvency.

 

6.               Right
to Audit.

 

6.1         3F shall keep, and maintain, complete and accurate
records concerning the sale of Licensed or Unauthorized Products by 3F at its
principal executive offices in California or such other locations as the
Parties shall agree.  On fourteen (14)
days prior written notice by Edwards, 3F shall permit said records to be
inspected at Edward’s expense, at any time, by an independent auditor appointed
by Edwards and reasonably accepted by 3F for this purpose.  In the event of an underpayment by 3F, 3F
shall immediately pay Edwards for any such underpayment plus applicable
interest.  In the event that the audit reveals
an underpayment of Royalties by 3F of more than five percent (5%), 3F shall
reimburse Edwards for all such reasonable costs of such audit.

 

7.               Infringement
and Enforcement.

 

7.1         If any time during the term of this Agreement, 3F
learns or believes that any Third Party is infringing any of the Licensed
Patents or Sublicensed Patents hereunder in the Fields of Use, 3F shall notify
Edwards in writing of the existence of such alleged infringement.

 

7.2         Edwards may, but has no obligation to, take any and
all actions to enforce the Licensed Patents or Sublicensed Patents (including without
limitation instituting litigation) against any infringement in the Fields of
Use (“Litigation”); provided, however,
that Edwards agrees that, upon notice from 3F pursuant to Section 7.1, Edwards
will make a good faith evaluation as to whether and when to institute any such
Litigation, in light of the factors that Edwards believes are relevant,
including without limitation the potential costs and risks associated with such
Litigation.  Edwards shall bear all the
expenses and costs with respect to

 

6

 

any such Litigation and, except as expressly set forth herein, Edwards
shall be entitled to all damages recovered in such Litigation.

 

7.3         At Edwards’ request, 3F agrees to cooperate in any such Litigation, including
but not limited to participating in such Litigation as a named party.  Edwards agrees to pay 3F’s reasonable costs
and expenses in connection with such Litigation.  In the event that 3F desires to retain
separate counsel in connection with such Litigation, however, 3F shall bear its
own costs and expenses concerning the Litigation, including without limitation
the costs and expenses of such separate counsel.  Notwithstanding 3F’s participation in such
Litigation, Edwards shall retain the full right to control such Litigation,
including without limitation any settlement of such Litigation.  Edwards shall have the right, in its sole and
absolute discretion, to settle any Litigation on such terms and conditions that
Edwards deems to be appropriate.

 

7.4         With respect to any monetary award received by Edwards in the
Litigation, or amounts received by Edwards in settlement of the Litigation:

 

(i)                                     Attributable
to infringement of the Sublicensed Patents in the Fields of Use, and after
deducting all Litigation Expenses, 3F shall be entitled to receive twenty-four
percent (24%) of such award or settlement; or

 

(ii)                                  Attributable
to infringement of the Licensed Patents in the Fields of Use, and after
deducting all Litigation Expenses, 3F shall be entitled to receive forty-eight
percent (48%) of such award or settlement.

 

7.5         To the extent not governed by Section 7.4 above, in the event that, in
connection with any settlement of the Litigation, Edwards grants a license
within the Fields of Use and receives on-going royalty payments for such
license in the Fields of Use (“Granted License”) or, in the event that an injunction against future infringement is
not granted and a party is permitted to continue to practice either the
Licensed Patents or the Sublicensed Patents within the Fields of Use and
Edwards receives on-going royalty payments for such practice in the Fields of
Use (“Compelled License”), then:

 

(i)                                     With
respect to such royalty payments received for such Additional License for the
Sublicensed Patents, and after deducting all Litigation Expenses to the extent
such Litigation Expenses have not been reimbursed pursuant to Section 7.4, 3F
shall be entitled to receive twenty-four percent (24%) of such payments; or

 

(ii)                                  With
respect to such royalty payments received for such Additional License for the
Licensed Patents, and after deducting all Litigation Expenses to the extent
such Litigation Expenses have not been reimbursed pursuant to Section 7.4, 3F
shall be entitled to receive forty-eight percent (48%) of such payments.

 

7.6         Nothing in this
Agreement shall require Edwards to provide 3F with any compensation or portion
of any recovery in connection with any litigation initiated by Heartport, Inc.,
or its successor or assignee, in accordance with Section 5.4 of the Heartport
License.

 

7

 

7.7         In no event shall any amounts pursuant to Sections 7.4
and/or 7.5 be payable by Edwards to 3F before thirty (30) days after Edwards
actually receives payment of such amounts from the Third Party.

 

8.               Representations
and Warranties.

 

8.1         Edwards hereby represents and warrants to 3F 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 Edwards; and

 

(ii)                                  it
is the owner of, or has the exclusive license to, the patents and patent
applications subject to the Agreement and that it has the entire right to enter
into these licenses.

 

8.2         EXCEPT AS EXPRESSLY SET
FORTH IN SECTION 8.1 AND TO THE EXTENT THAT EDWARDS PROVIDES NOTICE IN
ACCORDANCE WITH SECTION 3.1, EDWARDS DOES NOT MAKE, AND THERE ARE NO,
WARRANTIES, REPRESENTATIONS, OR CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR
OTHERWISE RELATING TO THE LICENSED PATENTS OR SUBLICENSED PATENTS, INCLUDING
WITHOUT LIMITATION ANY REPRESENTATIONS OR WARRANTIES OF VALIDITY,
ENFORCEABILITY, NON-INFRINGEMENT, OR FITNESS FOR ANY PARTICULAR PURPOSE.

 

8.3         3F hereby represents and warrants to Edwards 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 3F.

 

9.               Term
and Termination.

 

9.1         The term of this Agreement shall commence on the
Effective Date and, subject to earlier termination as provided herein, shall
continue to the date of expiration of the last to expire of any Licensed Patent
or Sublicensed Patent covering any Licensed Product.

 

9.2         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 except for non-payment of Royalties for
which 3F shall have forty-five (45) days to cure such nonpayment breach.

 

9.3         This Agreement, including all licenses and
sublicenses herein, shall automatically and immediately terminate, without any
further action or notice by Edwards, in the event that 3F is or becomes
insolvent.  For purposes of this
Agreement, the term “insolvent” shall mean 3F shall be deemed “insolvent” if it
is unable to pay its debts and obligations as and when they come due..

 

8

 

10.         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 a 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:

 

	
  If to Edwards:

  	
   

  	
  If to 3F:

  
	
   

  	
   

  	
   

  
	
  Edwards Lifesciences PVT, Inc.

  One Edwards Way

  Irvine, CA 92614

  Facsimile No.: (949) 250-6868

  Attn: General Counsel

  	
   

  	
  3F Therapeutics, Inc.

  20412 James Bay Circle

  Lake Forest, CA 92630

  Facsimile No.: (949) 380-9399

  Attn: Walter A. Cuevas

  
	
   

  	
   

  	
   

  
	
  with a copy to (which copy shall not constitute

  notice):

  	
   

  	
  with a copy to (which copy shall not

  constitute notice): 

  
	
   

  	
   

  	
   

  
	
  Gibson, Dunn & Crutcher LLP

  Jamboree Center

  4 Park Plaza

  Irvine, CA 92614

  Facsimile No.: (949) 475-4673

  Attn: John M. Williams

  	
   

  	
  Reed Smith, LLP

  1901 Avenue of the Stars, Suite 700

  Los Angeles, CA 90067

  Facsimile No.: (310) 734-5299

  Attn: Michael Sanders

  

 

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.

 

11.         Indemnification.

 

11.1                           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 11 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.

 

11.2                           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,

 

9

 

subcontractors, or assigns in the performance of this Agreement.  The losses covered by this Section 11
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 Edwards provides notice pursuant to
Section 3.1; and (iii) breach of contract.

 

12.         Limitation
of Liability or Damages.

 

12.1                           EXCEPT
WITH RESPECT TO EDWARDS’ INDEMNITY OBLIGATIONS PURSUANT TO SECTION 11, IN NO
EVENT SHALL EDWARDS, ITS AGENTS OR EMPLOYEES, BE LIABLE 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 THE SUBLICENSED PATENTS, 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.

 

12.2                           Without limiting the generality of Section 12.1,
nothing contained in this Agreement shall be construed as:

 

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

 

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

 

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

 

(iv)                              any
promise, obligation, or duty by or imposed on Edwards to obtain any
clarification, declaration, or other determination, listing, or identification
of any patents, patent applications, or rights licensed or possessed by Edwards
under the Heartport License or, correspondingly, sublicensed to 3F as part of
the Sublicensed Patents; or

 

(v)                                 any
obligation by Edwards to furnish any assistance under this Agreement.

 

13.         Miscellaneous.

 

13.1                           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 Edwards and 3F. 
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

 

13.2                           Assignability.

 

13.2.1                  This Agreement is not assignable or transferable by
3F, in whole or in part, except (i) with the prior written consent of Edwards;
(ii) an assignment in connection with the sale of all or substantially all of
3F’s business; or (iii) the licenses and sublicense set forth in Section 2 can
be separately assigned by 3F to a purchaser of all or substantially all of the
assets of the business relating to the Surgical Field of Use or Venous Field of
Use, as applicable; provided, however, that in the event of any assignment
pursuant to this 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 (iii) of this Section, if 3F sells all or substantially all of its
business relating to the Surgical Field of Use, the license set forth in
Section 2.1 and the sublicense relating to the Surgical Field of Use set forth
in Section 2.3 may be assigned to the purchaser of such business, provided that
such assignee agrees to be bound and comply with all of the obligations of this
Agreement related to such assigned license and sublicense, including without
limitation, for example, Sections 2.4, 2.7, 3, 4, 5, 6, 7, 11.1, 12, and 13.

 

13.2.2                  Edwards may assign or transfer this Agreement, in
whole or in part; provided, however, that Edwards provide written notice to 3F
and that such assignee agrees to be bound and comply with all of the applicable
obligations of this Agreement.

 

13.3                           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 Sublicensed Patents shall be litigated in such courts, and each of the
Parties expressly waive 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 13.3 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.

 

13.4                           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.

 

13.5                           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.

 

11

 

13.6                           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.

 

13.7                           Survivability.  The
provisions of Sections 1, 4, 5, 6, 7, 8, 11, 12, and 13 shall survive any
termination or expiration of this Agreement.

 

13.8                           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.

 

13.9                           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.

 

13.10                     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.

 

13.11                     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.

 

	
  EDWARDS LIFESCIENCES PVT, INC.

  	
   

  	
  3F THERAPEUTICS, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Jay P. Wertheim

  	
   

  	
   

  	
  By:

  	
  /s/ Walter Cuevas

  	
   

  
	
  Name:  Jay P. Wertheim

  	
   

  	
   

  	
  Name:

  	
  Walter Cuevas

  	
   

  
	
  Title: Vice President, Associate General

  	
   

  	
  Title:

  	
  President and Chief Executive Officer

  	
   

  
	
  Counsel and Secretary

  	
   

  	
   

  	
   

  	
   

  
								

 

12

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