IN THE UNITED STATES PATENT AND TRADEMARK OFFICERECEIVED
`
`Confirmation No.: 142 1
`Art Unit: 3738
`OFilCE OF PETITIONS
`Examiner: PELLEGRINO, Brian E.
`,Am. Docket: P0039854(1737.4040000)
`
`In re application of:
`BERGHEIM et al.
`Appl. No.: 10183 1,770
`Filed: April 23, 2004
`For: Delivery System for a Stentless
`Cardiac Valve
`
`12/38/2810 DCILLEW
`00600022 012525
`323l.BB DCI +,
`01 FC:1595
`c-7 --.
`Payment of Fees Under 37 C.F.R. 5 1.28(~)(2)
`C -3
`0
`rrl
`t3
`
`10031770
`.
`
`. .
`
`Commissioner for Patents
`PO Box 1450
`Alexandria, VA 223 13-1450
`
`Sir:
`
`Small entity status was established in the above-captioned application in good
`
`faith, and small entity fees were paid in good faith. However, it has recently been
`
`discovered that small entity status may have been maintained in error but in good faith,
`
`and that small entity fees therefore may have been paid in error.
`
`The potential deficiency owed is calculated as follows:
`
`Type of Fee
`
`Excess of 20' 1
`
`Claims in
`
`Small Entity
`Fee Paid
`
`$725.00
`
`Date of Small
`Entity Fee
`Payment
`
`1 04/26/2007
`
`1
`
`Large Entity
`Fee (current
`schedule)
`
`$1508.00
`
`1
`
`Deficiency
`Owed
`
`, $783.00
`
`1 On April 26, 2007, Applicants filed an Amendment adding claims 27-55,
`including 26 claims in excess of 20 and 1 independent claim in excess of 3 that were not
`previously paid for. Applicants mistakenly, however, indicated that 13 claims in excess
`of 20 and 2 independent claims in excess of 3 were not previously paid for in the
`Electronic Patent Application Fee Transmittal and charged the amount of $325 for
`claims in excess of 20 (a $400 fee deficiency), and $200 for independent claims in
`excess. of 3 (a $100 overpayment), to a deposit account. Subsequently, the USPTO
`charged the $400.00 fee deficiency for claims in excess of 20 to the deposit account as
`indicated in the Sales Receipt for Accounting, dated May 1, 2007. In the table above, the
`indicated amount for the Small Entity Fee Paid for Item 1 is the sum of the $325
`payment as indicated in the Electronic Patent Application Fee Transmittal and the $400
`
`ENDOHEART AG, EX. 2018 Page 1
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`BERGHEIM et al.
`Appl. No. 10183 1,770
`
`Type of Fee
`
`Small Entity
`Fee Paid
`
`Date of Small
`Entity Fee
`Payment
`
`Fee (current
`
`Independent
`Claims in
`Excess of
`~ h r e e '
`Extension for
`Response
`(second
`month)
`Claims in
`Excess of 20
`Independent
`Claims in
`Excess of
`Three
`Request for
`Continued
`Examination
`Extension for
`Response
`(third month)
`Request for
`Continued
`Exam inat ion
`W E )
`Extension for
`Response
`(first month)
`Request for
`Refund (RCE
`filed12
`
`fee deficiency charged to the deposit account by the USPTO. In an abundance of
`caution, however, the indicated amount for Item 2 is the amount of $100.00 for 1
`independent claim in excess of 3 as indicated in the Patent Application Fee
`Determination Record, not the actual payment of $200 resulting in an overpayment of
`$100.
`
`An RCE was filed on January 27,2010, and the RCE fee in the amount of $810
`was charged to the deposit account. Applicants, again in good faith, subsequently filed a
`Request for Refund Under 37 C.F.R. 4 1-26 on February 3, 20 10, seeking a refund in the
`
`ENDOHEART AG, EX. 2018 Page 2
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`BERGHEIM er al.
`Appl. No. 10183 1,770
`
`Type of Fee
`
`Small Entity
`Fee Paid
`
`1
`
`Total Owed:
`
`Date of Small
`Entity Fee
`Payment
`
`I
`,arge Entity
`:?.a /r...-a..+
`l-GG I L L I I I U I L
`schedule)
`
`I
`
`I
`
`I Deficiency
`1
`
`$3231.00
`
`I
`1
`
`Payment of these fees is to be treated under 37 C.F.R. 5 1.27(g)(2) as a
`notification of loss of entitlement to small entity status. 37 C.F.R. 5 1.28(d).
`
`Applicants properly established small entity status when the above-captioned
`
`application was filed and properly paid small entity fees up to the point in time small
`entity status may have been erroneously maintained. A brief summary of the
`
`circumstances surrounding the discovery of the possibly erroneous maintenance of small
`entity status is provided below.
`
`3F Therapeutics, Inc., the assignee of the above-captioned application, entered
`
`into a license agreement with Edwards Lifesciences PVT, Inc. ("Edwards") on June 2,
`
`2005. This license agreement may have provided Edwards with a license to the above-
`captioned application. A redacted copy of the license agreement is attached as Exhibit
`
`The current owner of the above-captioned application acquired ownership of the
`
`above-captioned application and many other patents and patent applications through a
`recent transaction which closed on or about August 12, 2010. During a recent review of
`
`the acquired patent and patent application assets, the current owner discovered the
`
`payments of small entity fees. Because the better practice would have been to pay large
`
`entity fees, the current owner is hereby submitting the possibly deficient fees.
`
`Applicants respectfully request that the United States Patent and Trademark
`
`Office excuse this possible error and correct the entity status to be that of a large entity.
`
`Early notice to this effect is respectfully requested.
`
`amount of $405.00 as being a small entity. The overpayment was credited to the deposit
`account on February 18, 2010. The amount indicated for Item 10 for the Small Entity
`Fee Paid is the effective amount Applicants were charged for the RCE in view of the
`credited rehnd.
`
`ENDOHEART AG, EX. 2018 Page 3
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`BERGHEIM et al.
`Appl. No. 10183 1,770
`
`The Commissioner is authorized to charge the total amount owed of $3231.00 to
`
`Deposit Account No. 01-2525. The Commissioner is authorized to charge any
`deficiencies or credit any overpayments to our Deposit Account No. 0 1-2525.
`
`The USPTO is invited to telephone the undersigned attorney at (763) 505-8426 to
`discuss any outstanding issues in this case.
`
`Respectfully Submitted,
`
`Date: PCC. 9 , 2010 0 Jef rey J. Hohenshell, Reg. No. 34,109
`
`-
`
`senior Patent Counsel
`7 10 Medtronic Parkway
`Minneapolis, MN 55432
`Tel. (763) 505-8426
`Fax (763) 505-8436
`Customer No. 2758 1
`
`ENDOHEART AG, EX. 2018 Page 4
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`EXHIBIT A
`
`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 ('3Fn), on the one hand, and Edwards Lifesciences PVT, Inc., a Delaware corporation
`('Edwards P V P ) , on the other hand. Each of 3F and Edwards PVT may be referred to herein individually as a 'Partyn or
`collectively as the 'Parties."
`.
`
`Exhibit 10.4
`
`WHEREAS 3F is the owner of certain patents, patent applications, and know-how relating to heart valves and catheterdelivered
`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.
`
`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:
`
`AGREEMENT
`
`1.
`
`1.1
`
`Definitions. he following definitions shall apply to the following terms:
`
`'3F" shall have the meaning set forth in the preamble.
`
`respect to any specified Person, a Person that directly, or indirectly through o n e or
`"Affiliate" shall mean, with
`1.2
`more intermediaries, controls, or is controlled by, or is under common control with, the Person specified.
`
`1.3
`
`"Agreement" shall have the meaning s e t forth in the preamble,
`
`1.4
`
`'Edwards PVT" shall have the meaning s e t forth in the preamble.
`
`1.5
`
`'Edwards" shall mean Edwards PVT and its Affiliates.
`
`1.6
`
`"Effective Date" shall have the meaning s e t forth in the preamble.
`
`1.7
`
`"Excluded 3F IP" shall mean the patents and patent applications listed o n Exhibit A hereto.
`
`1.8
`
`"Fields of Use" shall mean the Surgical Field of Use and the Percutaneous Field of Use.
`
`"PVT Product" shall mean the t h e Cribier-Edwards percutaneous heart valve, existing as of the Effective Date,
`1.9
`including (i) any modifications or alterations to such valve that a r e made prior to the first approval by the United States
`Food and Drug Administration ("FDA") of a premarket approval ("PMA") application submitted o n such valve in the
`,
`Percutaneous Field of Use, (ii) any modifications or alterations that are made to s u c h 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 d o not require submission of a new PMA application.
`
`ENDOHEART AG, EX. 2018 Page 5
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`"Laser Patents" shall mean the patents and patent applications listed on Exhibit B hereto, and any
`1.10
`continuations, divisionals, reexaminations, reissues, extensions and foreign counterparts thereof.
`
`"Licensed Patents" shall mean the Laser Patents and the patents and patent applications owned or licensed
`1.1 1
`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.
`
`"Licensed Product" shall mean a product in the Fields of Use utilizing the Tissue Valve Know-How or covered
`1 .I2
`by any Valid Claim of the Licensed Patents.
`
`1.13
`
`"Litigation" shall have the meaning set forth in Section 4.2.
`
`1.14
`
`'Partym shall have the meaning set forth in the preamble.
`
`1.15
`
`'Parties' shall have the meaning set forth in the preamble.
`
`.
`
`"Percutaneous Field of Use" shall mean the percutaneous insertion of a stented, tissue heart valve through
`1.16
`any vessel k i n g a catheter delivery system.
`
`"Person" shall mean any individual, partnership, firm, corporation, association, trust, unincorporated
`1.17
`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.
`
`"Surgical Field of Use" shall mean the surgical insertion through the chest cavity of a stented, tissue heart
`1.19
`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.
`
`ENDOHEART AG, EX. 2018 Page 6
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`"Tissue Valve Know-How" shall mean (i) any information owned or licensed by.3F or its Affiliates existing as
`1.21
`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.
`
`"Valid Claim" shall mean a claim of an issued and unexpired patent included in the Licensed Patents which has
`1.22
`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.
`
`3F hereby grants to Edwards a worldwide, non-transferable (except as set forth in Section 10.2.1 below), royalty
`2.1
`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
`andlor the Percutaneous Field of Use.
`
`3F hereby grants to Edwards a worldwide, non-transferable (except as set forth in Section 10.2.1 below), royalty
`2.2
`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 andlor the Percutaneous Field of Use.
`
`3F hereby grants to Edwards a worldwide, non-transferable (except as set forth in Section 10.2.1 below), royalty
`2.3
`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.
`
`Edwards agrees and acknowledges that the limited scope of the Fields of Use set forth in this Agreement are a
`2.4
`.
`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.
`
`No implied patent or other intellectual property rights or licenses are granted by 3F hereunder or in connection
`2.5
`herewith other than those licenses expressly granted in this Agreement.
`
`3
`
`ENDOHEART AG, EX. 2018 Page 7
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`' Nothing in this Agreement shall limit or preclude Edwards use of, in any manner or in any field, the Tissue Valve
`2.6
`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 itsAffiliates 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.
`
`Upon written notice from 3F of a specific Licensed Patent that applies to a specific Licensed Product, each
`3.1
`. Licensed Product sold by Edwards shall be marked in compliance with 35 U.S.C. 5 287, 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.
`
`If at any time during the term of this Agreement, Edwards learns or believes that any Third Party is infringing any
`4.1
`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.
`
`3F may, but has no obligation to, take any and all actions to enforce the Licensed Patents (including without
`. 4.2
`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 shal! bear all the expenses and costs with respect to any such Litigation and 3F shall
`be entitled to all damages recovered in such Litigation.
`
`At 3F's request, Edwards agrees to cooperate in any such Litigation, including but not limited to participating in
`4.3
`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 ils 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 perfonn its obligations hereunder and that this
`Agreement has been duly and validly authorized, executed, and delivexed by 3F;
`
`4
`
`ENDOHEART AG, EX. 2018 Page 8
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530
`
`

`
`it is the owner of, or has the exclusive license to, the Tissue Valve Know-How, such Tissue Valve Know-How, to the best
`(ii)
`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
`
`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
`
`(iii)
`licenses.
`
`EXCEPT AS EXPRESSLY SET FORTH IN SECTION 5.1 AND TO THE EXTENT THAT 3F PROVIDES
`5.2
`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.
`
`'
`
`Edwards hereby represents and warrants to 3F that it has all of the requisite power and authority to enter into
`5.3
`this Agreement and that this Agreement has been duly and validly authorized, executed, and delivered by Edwards.
`
`6.
`
`Term and Termination.
`
`The term of this Agreement shall commence on the Effective Date and, subject to earlier termination as provided
`6.1
`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.
`
`Either Party may terminate this Agreement for a material breach by the other Party that remains uncured for
`6.2
`ninety (90) days following notice to the breaching Party.
`
`This Agreement, including all licenses herein, shall automatically and immediately terminate, without any further
`6.3
`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:
`
`ENDOHEART AG, EX. 2018 Page 9
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`
`

`
`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):
`
`Reed Smith, LLP
`1901 Avenue of the Stan, Suite 700
`L;os Angeles, CA 90067
`Facsimile No.: (3 10) 734-5299
`. Attn: Michael Sanders
`
`Jf to Edwards:
`
`Edwards Lifesciences PVT. Inc.
`.
`One Edwards Way
`lrvine, CA 92614
`Facsimile No.: (949) 250-6868
`Attn: General Counsel
`
`with a copy to (which copy shall not
`constitute notice):
`
`Gibson, Dunn & Crutcher LLP
`Jamboree Center
`4 Park Plaza
`lrvine, CA 9261 4
`Facsimile No.: (949) 475-4673
`A m : 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.
`
`Edwards shall indemnify, defend, and hold 3F harmless against any and all losses arising out of a Third Party
`- 8 .
`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.
`
`'
`
`3F shall indemnify, defend, and hold Edwards harmless against any and all losses arising out of a Third Party
`8.2
`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.
`
`ENDOHEART AG, EX. 2018 Page 10
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`
`

`
`9.
`
`Limitation of Liability or Damages.
`
`EXCEPT WITH RESPECT TO EACH PARTTS RESPECTIVE INDEMNIT~ OBLIGATIONS PURSUANT TO
`9.1
`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:
`
`requiring the enforcement of any patent or patent application, including any obligation by 3F to institute any suit or action
`(i)
`for infringement of any of the Licensed Patents;
`
`reflecting a determination by 3F of the applicability of any of the Licensed Patents to the Fields of Use or any Licensed
`(ii)
`Product of Edwards;
`
`a warranty or representation by 3F as to the validity or scope of any Licensed Patents; or
`
`(iii)
`- (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.
`
`Relationship of the Parties. Nothing in this Agreement shall be construed to create a partnership, joint
`10.1.
`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.
`
`This Agreement is not assignable or transferable by Edwards, in whole or in part, except (i) with the prior written
`10.2.1
`consent of 3F; (ii) an assignment in connection with the sale of all or substantialty 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
`
`ENDOHEART AG, EX. 2018 Page 11
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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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.
`
`3F may assign or transfer this Agreement, in whole or in part; provided; however, that 3F provide written
`10.2.2
`. notice to Edwards and that such assignee agrees to be bound and comply with all applicable obligations of this
`Agreement.
`
`Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of
`10.3
`the State of California, without giving effect to the choice of law rules theieof. 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 UnitedStates District Court for the Central District of California.
`
`Attorneys' Fees. If any Party to this Agreement shall bring any action, suit, arbitration, mediation, counterclaim
`10.4
`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 inyhouse counsel), all expert fees and costs, all court
`andlor arbitration expenses, and any other costs reasonably and properly incurred, including any fees and costs incurred
`in bringing and prosecuting such.action andlor 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.
`
`Counterparts. This Agreement may be executed in two or more counterparts (including by means of facsimile),
`10.5
`, 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.
`
`Survivability. The provisions of Sections 1, 4, 5.8, 9, and 10 shall survive any termination or'expiration of this
`10.7
`Agreement.
`
`ENDOHEART AG, EX. 2018 Page 12
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
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`

`
`Headings. The headings used in this Agreement are for purpose of reference only and shall not affect the
`10.8
`meaning or interpretation of any provision of this Agreement.
`
`Drafting. Each Party has had the opportunity to consult with competent, independent counsel in connection
`10.9
`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.
`
`Entirety of Agreement. This Agreement supersedes any prior understandings or agreements, whether written
`10.1 1
`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.
`
`Is1 Walter Cuevas
`By:
`Name: Walter Cuevas
`Title: President and Chief Executive Ofticer
`
`Is1 Jay P. Wertheim
`By:
`Name: Jay P. Wertheim
`Title: Vice President, Associate General
`Counsel and Secretary
`
`ENDOHEART AG, EX. 2018 Page 13
`EDWARDS LIFESCIENCES CORPORATION (PETITIONER) v. ENDOHEART AG (PATENT OWNER)
`Case No.: IPR2016-00300, U.S Patent No. 8,182,530