Exhibit 10.1

SETTLEMENT AGREEMENT

*** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST UNDER 17 C.F.R SECTIONS 24-b-2, 200.80 (B)(4) AND
230.406.

 

1. INTRODUCTION

 

1.1 This Settlement Agreement (“the Agreement”) is made and entered into
effective on the day the last Party affixes its signature hereto (the “Effective
Date”) between, on the one hand, St. Jude Medical, Inc., and St. Jude Medical,
Cardiology Division, Inc. (d/b/a St. Jude Medical Cardiovascular Division)
(collectively “St. Jude”) and, on the other hand, Kensey Nash Corporation and
Kensey Nash Holding Corporation (collectively, “Kensey Nash”) (each a “Party”
and collectively, the “Parties”).

 

1.2 On February 13, 2012, the Parties participated in an all-day mediation
conducted by Antonio Piazza, Esq. in San Francisco, California (the
“Mediation”). During the course of the Mediation, the Parties resolved all
disputes and claims that could have been and/or were raised between the Parties
with respect to the following agreements and issues:

 

  •  

The United States and Foreign License Agreements dated September 4, 1991 between
Kensey Nash and American Home Products Corporation, since amended, to which St.
Jude is the successor-in-interest (“the 1991 Agreements”).

 

  •  

The United States and Foreign License Agreements between American Home Products
and Wouter Muijs Van de Moer and Rienk Rienks, executed on January 17, 1995 on
behalf of American Home Products, whose interest is now held by St. Jude, and
executed on February 8, 1995 by Van de Moer and Rienks, whose interest is now
held by Kensey Nash (“the 1995 Agreements”).

 

  •  

The status of certain patents and patent applications referred to herein as “the
Vascular Closure Patents.” The Vascular Closure Patents include

(i) patents and patent applications filed by, and assigned to, St. Jude, that
are listed at Schedule A, as well as their foreign counterparts; and

(ii) patents and patent applications that are:

 

  a. filed or to be filed by, and assigned or to be assigned to, St. Jude; or

 

  b. name at least one inventor having an obligation to assign to St. Jude;

 

  c. where such patents and patent applications in (a) and (b) relate to
vascular closure devices; and

 

  d. where any claim of inventorship or ownership by KNC for such patents and
patent applications in (a) and (b) is or could be based on a conception before
the Effective Date.

 

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2. SETTLEMENT

 

2.1 In exchange for the valuable consideration provided herein, the Parties
hereby settle all outstanding claims and disputes related to the 1991 Agreements
and the 1995 Agreements, including (but not limited to) disputes concerning all
past and future royalty obligations owed by St. Jude, disputes concerning claims
and rights of inventorship and/or ownership of the Vascular Closure Patents, and
disputes concerning royalties allegedly owing as a result of the acquisition of
Radi Medical Systems AB (n/k/a St. Jude Medical Systems AB) by St. Jude Medical,
Inc.

 

2.2 Other than as expressly set forth herein, the rights and obligations of the
Parties to and under the 1991 Agreements and the 1995 Agreements are hereby
terminated. The Parties further agree that, except as expressly set forth
herein, none of the provisions governing Termination in any of those agreements
apply. Without limiting the foregoing, the Parties expressly agree that they are
not obligated to undertake or perform any of the obligations set forth in
Article XV of the 1991 Agreements, or Section 11 or Section 16 of the 1995
Agreements.

 

2.3 Notwithstanding section 2.2 herein, Kensey Nash shall provide assistance to
St. Jude with respect to filings and submissions to regulatory agencies, as set
forth in section 7.3 of the 1991 Agreements, which remains in place as though
set forth herein.

 

2.4 Notwithstanding section 2.2 herein, the Parties shall retain the right to
use certain trademarks, as set forth in section 8.5 of the 1991 Agreements, as
though the terms thereof were set forth herein.

 

2.5 Notwithstanding section 2.2 herein, the Parties shall continue to have the
rights and obligations set forth in Article X of the 1991 Agreements for five
(5) years from the Effective Date ,as though the terms thereof were set forth
herein.

 

2.6 Notwithstanding section 2.2 herein, the provisions and obligations of
Article XII of the 1991 Agreements shall continue in force, as though the terms
thereof were set forth herein.

 

2.7 Notwithstanding section 2.2 herein, the warranties set forth in section 2(a)
of the 1995 Agreements shall remain in place for five (5) years from the
Effective Date, as though the terms thereof were set forth herein.

 

2.8 The Parties agree to abide by the confidentiality obligations set forth in
Article XIV of the 1991 Agreements and section 15 of the 1995 Agreements as
though the terms thereof were set forth herein. Such obligations shall remain in
place for five (5) years from the Effective Date.

 

3. PAYMENT

 

3.1

St. Jude hereby agrees to pay Kensey Nash Holding Corporation a total of
39 million (thirty-nine million) United States Dollars, in twelve equal,
quarterly installments of 3,250,000 (three million, two hundred fifty thousand)
United States Dollars each. The first quarterly payment shall be made by
March 31, 2012, by wire to the account designated by Kensey Nash, and the
remaining eleven payments shall be made by the last business day of each
subsequent consecutive calendar quarter, until the final

 

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  payment is made by December 31, 2014. In the event that any payment hereunder
is not received as provided herein, then upon ten (10) days written notice by
Kensey Nash to St. Jude and failure by St. Jude to cure within that ten (10) day
period, all the outstanding payments shall become immediately due and payable by
St. Jude to Kensey Nash Holding Corporation.

 

3.2 Upon payment in full of each of the payments set forth in the first two
sentences of section 3.1 hereof, Kensey Nash acknowledges and agrees that St.
Jude shall have no further financial responsibility to Kensey Nash, except for
(i) obligations of St. Jude to Kensey Nash regarding purchase orders for
collagen placed before the execution of this Agreement; and (ii) as otherwise
provided by the Collagen Supply Agreement described below.

 

4. PATENT LICENSES TO ST. JUDE

 

4.1 Kensey Nash agrees that St. Jude shall have a fully paid-up, worldwide
exclusive license to all patents upon which rights had been granted pursuant to
the 1991 Agreements. This license includes all patents (including any patent
application, continuation, continuation-in-part, divisional, reexamination or
reissue and any foreign counterpart thereof) that Kensey Nash has asserted, or
does assert, or could have asserted, to fall within the 1991 Agreements, except
as provided in section 5 hereof.

 

4.2 The Parties acknowledge that St. Jude, as the exclusive licensee, has the
right (but not the obligation) to enforce against third parties the patents that
Kensey Nash asserts, has asserted, or could have asserted, to fall within the
1991 Agreements. Notwithstanding section 2.5 hereof, St. Jude shall bear the
expense of any such enforcement action and shall be entitled to all damages
recovered in any such enforcement action. At St. Jude’s request, Kensey Nash
agrees to cooperate in such enforcement action, particularly as required to
avoid dismissal for nonjoinder of a necessary party. Notwithstanding Kensey
Nash’s cooperation and consent, St. Jude shall retain the full right to control
such enforcement action (including, but not limited to, the right to settle such
enforcement action).

 

4.3 Kensey Nash also agrees that St. Jude shall have a fully paid-up, exclusive
license to all patents upon which rights had been granted pursuant to the 1995
Agreements. This license includes all patents (including any patent application,
continuation, continuation-in-part, divisional, reexamination or reissue and any
foreign counterpart thereof) that KNC has asserted, or does assert, or could
have asserted, to fall within the 1995 Agreements.

 

4.4 The Parties acknowledge that St. Jude, as the exclusive licensee, has the
right (but not the obligation) to enforce against third parties the patents that
Kensey Nash asserts, has asserted, or could have asserted, to fall within the
1995 Agreements. St. Jude shall bear the expense of such enforcement action and
shall be entitled to all damages recovered in such enforcement action. At St.
Jude’s request, and expense, Kensey Nash agrees to cooperate in such enforcement
action, particularly as required to avoid dismissal for nonjoinder of a
necessary party. Notwithstanding Kensey Nash’s cooperation and consent, St. Jude
shall retain the full right to control such enforcement action (including, but
not limited to, the right to settle such enforcement action).

 

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5. PATENT LICENSES TO KENSEY NASH

 

5.1 St. Jude hereby grants to Kensey Nash a non-exclusive, royalty-free license
(including the right to sub-license) to the patents listed in the attached
Schedule B. Kensey Nash may extend a sublicense on those patents, but only with
the express written consent of St. Jude, which may not be unreasonably withheld.

 

6. PATENT ASSIGNMENTS TO KENSEY NASH

 

6.1 St. Jude hereby assigns and agrees to assign to Kensey Nash all rights,
title, and interest in the patent application listed in the attached Schedule C
as well as to any continuation, continuation-in-part, divisional, reexamination
or reissue and any foreign counterpart thereof and agrees to take all reasonable
steps to perfect such assignment(s). Kensey Nash shall be responsible for all
further prosecution and maintenance of this patent application subsequent to the
assignment.

 

6.2 Kensey Nash hereby grants to St. Jude a royalty-free, non-exclusive license
to any patent that issues on any application that St. Jude has assigned to
Kensey Nash, including any reissues, or patents that issue on divisionals,
continuations, or continuations-in-part from such applications.

 

7. PATENT INVENTORSHIP AND OWNERSHIP

 

7.1 Except for U.S. Published Patent Application Nos. 2005/0096697 and
2006/0265007 and any continuation, continuation-in-part, divisional,
reexamination, reissue, patents resulting from Inter Partes Review or from Post
Grant Review thereof, as well as any foreign counterpart of the foregoing,
Kensey Nash acknowledges that neither it, nor any present or former employee,
officer, director, consultant or affiliate of Kensey Nash, has a claim to be
named as an inventor or joint inventor of any invention disclosed or claimed in
any issued patent or patent application filed by St. Jude or any St. Jude
affiliated company or division (collectively, a “St. Jude Entity”). This
includes continuations, continuations-in-part, divisionals, reexaminations,
reissues, patents resulting from Inter Partes Review or Post Grant Review and
any foreign counterpart thereof filed by St. Jude in any country disclosing and
claiming a method, device, or component which may be used in vascular closure.

 

7.2 Except as provided in Section 6 of this Agreement, Kensey Nash acknowledges
that neither it, nor any present or former employee, officer, director,
consultant or affiliate of KNC, is an owner of, or has any ownership interest
in, any issued patent or patent application for which a St. Jude Entity is the
assignee or for which an individual with a duty or obligation to assign the
patent to St. Jude is listed as an inventor. This includes continuations,
continuations-in-part, divisionals, reexaminations, reissues, patents resulting
from Inter Partes Review or Post Grant Review and any foreign counterpart
thereof filed by St. Jude in any country disclosing and claiming a method,
device, or component which may be used in vascular closure. To the extent that
Kensey Nash had, has, or may have any ownership or ownership interest in any
such patent or patent application, Kensey Nash agrees to assign, and hereby does
assign such ownership or ownership interest to St. Jude.

 

7.3

Kensey Nash shall provide all reasonable assistance to St. Jude in establishing,
perfecting and defending St. Jude’s inventorship and/or ownership of any patent
or

 

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  patent application. This reasonable assistance shall include, but is not
limited to the following acts, undertaken in connection with the prosecution of
any patent or patent application or in any proceeding of any court, government,
or regulatory agency in which the inventorship and/or ownership of a patent or
patent application is in question: (i) executing declarations and assignments,
which shall be at Kensey Nash’s expense; and (ii) appearing at hearings,
providing documents, and/or giving deposition testimony, for which, if approved
in advance by St. Jude, which approval shall not be unreasonably withheld, St.
Jude shall bear reasonable attorney fees and expenses. The patents and patent
applications covered by this section include continuations,
continuations-in-part, divisionals, reexaminations, reissues, patents resulting
from Inter Partes Review or Post Grant Review and any foreign counterpart
thereof filed by St. Jude in any country disclosing and claiming a method,
device, or component which may be used in vascular closure.

 

7.4 Notwithstanding the provisions of Section 9 of this Agreement, nothing in
this Agreement shall prevent St. Jude from submitting statements and/or
documents in connection with the prosecution of any patent or patent application
or in any proceeding of any court, government, or regulatory agency in which the
inventorship and/or ownership of a patent or patent application is in question.
This includes continuations, continuations-in-part, divisionals, reexaminations,
reissues, patents resulting from Inter Partes Review or Post Grant Review and
any foreign counterpart thereof filed by St. Jude in any country disclosing and
claiming a method, device, or component which may be used in vascular closure.

 

7.5 Kensey Nash shall, within 30 days of executing this Agreement, expressly
abandon any patent applications that Kensey Nash has filed and that claim
priority to or the benefit of any patent application or issued patent for which
a St. Jude Entity is the assignee or for which an individual with a duty or
obligation to assign the patent to St. Jude is listed as an inventor. This
includes continuations, continuations-in-part, divisionals, reexaminations,
reissues, patents resulting from Inter Partes Review or Post Grant Review and
any foreign counterpart thereof filed by St. Jude in any country disclosing and
claiming a method, device, or component which may be used in vascular closure.
Kensey Nash further agrees that it shall not file any future patent applications
that claim priority to or benefit of any such patent application or issued
patent.

 

7.6 Kensey Nash agrees that it will not seek, or cause to be sought,
reexamination, reissue, Inter Partes Review, Post Grant Review, opposition,
revocation, cancellation, or invalidation of any Vascular Closure Patent, based
on a claim by Kensey Nash of improper inventorship or ownership.

 

8. COLLAGEN SUPPLY AGREEMENT

 

8.1 St. Jude and Kensey Nash are parties to a collagen supply agreement,
effective as of June 23, 2010 (the “Collagen Supply Agreement”).

 

8.2 As part of this settlement, the Parties agree and hereby do amend the terms
of the Collagen Supply Agreement and the Amended Agreement shall be known as the
“2012 Collagen Supply Agreement”. A copy of the 2012 Collagen Supply Agreement
is attached hereto as Schedule D.

 

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8.3 As set forth in the 2012 Collagen Supply Agreement, St. Jude agrees to place
orders totaling at least 5 million units of Collagen Plugs (as defined in the
Collagen Supply Agreement) between February 13, 2012 and the 2012 Collagen
Supply Agreement Termination Date provided therein. Such amount does not include
the 1,001,000 units previously ordered by St. Jude in the June 24, 2011 purchase
order under the 2010 Collagen Supply Agreement, but does include the
400,000-unit order specified in section 4.1 of the 2012 Collagen Supply
Agreement. Kensey Nash agrees to fill such orders in accordance with the terms
of the 2012 Collagen Supply Agreement.

 

8.4 As set forth in the 2012 Collagen Supply Agreement, St. Jude agrees that its
orders for Collagen Plugs will not exceed 2 million units in any calendar year
from 2012 (such amount including the 1,001,000 units previously ordered by St.
Jude in the June 24, 2011, purchase order under the 2010 Collagen Supply
Agreement, as well as the 400,000-unit order specified in section 4.1 of the
2012 Collagen Supply Agreement) through 2017 without the express written
permission of Kensey Nash, which will use reasonable efforts consistent with
good business practice to meet St. Jude’s requirements for quantities in excess
of 2 million units in any calendar year.

 

8.5 All other terms are set forth in the 2012 Collagen Supply Agreement.

 

8.6 Notwithstanding any provision herein to the contrary, St. Jude shall remain
obligated to Kensey Nash for all moneys due under the 2010 Collagen Supply
Agreement for purchase orders issued before the Effective Date of this
Agreement.

 

9. CONFIDENTIALITY

 

9.1 This Agreement is entered into for the purpose of settlement and is subject
to Federal Rule of Evidence 408. It is intended that, to the extent possible,
all communications made as part of its making and as part of the Mediation, are
to be held confidential between St. Jude, Kensey Nash, and each Party’s
respective agents. The actual terms of this Agreement may be disclosed, however
the parties shall limit themselves in disclosures and in discussions with others
to those terms without embellishment.

 

9.2 The terms of the Parties’ Mediation Confidentiality Agreement shall remain
in effect.

 

9.3 Notwithstanding sections 2.8, 9.1, and 9.2 hereof, promptly after the
Effective Date of this Agreement, the Parties may make the following statement
about the circumstances leading to this Agreement (but may not provide further
explanation or embellishment: (i) After a successful mediation, the Parties have
amicably resolved all of the disputes between them involving the 1991 and 1995
License Agreements; (ii) St. Jude has agreed to make payments of $3.25mm for
twelve consecutive quarters, commencing with the first payment on or before
March 31, 2012; (iii) the Parties have agreed to certain licenses and
assignments of certain patents and applications; and (iv) the Parties have
entered into a revised, long-term collagen supply agreement.

 

9.4 Nothing in this Section 9 precludes either Party from making public
disclosures or statements concerning the effect of this Settlement Agreement on
its own financial situation and operations, and nothing in this Section 9
precludes either Party from issuing a general Press Release about this
Settlement Agreement, provided such Press Release is approved in advance by the
other Party.

 

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10. MUTUAL RELEASE OF CLAIMS

 

10.1 For good and valuable consideration, the receipt of which is acknowledged,
St. Jude does hereby release, cancel, forgive and forever discharge Kensey Nash,
and its officers, directors, shareholders, employees, agents, successors, and
assigns, from all actions, claims, demands, damages, obligations, liabilities
and controversies arising under the 1991 Agreements and the 1995 Agreements
(other than obligations expressly reserved hereunder), including, but not
limited to, all issues surrounding past and future royalties due, and royalty
obligations arising following the acquisition of Radi Medical Systems AB by St.
Jude Medical, Inc.

 

10.2 For good and valuable consideration, the receipt of which is acknowledged,
Kensey Nash does hereby release, cancel, forgive and forever discharge St. Jude,
and its officers, directors, shareholders, employees, agents, successors, and
assigns, from all actions, claims, demands, damages, obligations, liabilities
and controversies arising under the 1991 Agreements or the 1995 Agreements,
including, but not limited to, all issues surrounding past and future royalties
due, claims regarding joint inventorship or incorrect inventorship of the
Vascular Closure Patents, and obligations requiring the disclosure of
inventions, improvements, patent applications and other patent filings, and
royalty obligations arising following the acquisition of Radi Medical Systems AB
by St. Jude Medical, Inc. The Parties both acknowledge that Section 7 of this
Agreement obliges Kensey Nash to provide all reasonable assistance to St. Jude
in establishing, perfecting and defending St. Jude’s inventorship and/or
ownership of its intellectual property rights.

 

11. GOVERNING LAW

 

11.1 This Agreement and matters connected with the construction and performance
hereof, including obligations related to the 1991 Agreements and 1995
Agreements, shall be governed by the substantive laws of the State of Delaware,
without regard to that state’s choice of law rules. This supersedes any
agreement to the contrary between the Parties, their successors, and their
assigns.

 

12. VENUE

 

12.1 The Parties specifically consent to jurisdiction and venue in the state and
federal courts located in Wilmington, Delaware, for any dispute concerning this
Agreement, or any obligations under the 1991 Agreements or the 1995 Agreements,
as well as any other dispute between St. Jude and Kensey Nash relating to
vascular closure technology, including (but not limited to) the Angio-Seal
family of products.

 

12.2 The Parties further acknowledge that any lawsuit brought by either Party
against the other concerning this Agreement, or any dispute relating to vascular
closure technology, including (but not limited to) the Angio-Seal family of
products, shall be brought in a state or federal court located in Wilmington,
Delaware. This supersedes any agreement to the contrary between the Parties,
their successors and assigns.

 

13. HEADINGS FOR CONVENIENCE

 

13.1 Headers used in this Agreement are for convenience only and shall be given
no effect in constructing or interpreting this Agreement.

 

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14. SEVERABILITY

 

14.1 If any provision of this Agreement is determined to be unenforceable by a
court of competent jurisdiction, the remaining portions of the Agreement will
remain in full force and effect, but only to the extent that giving effect to
the remaining portions is within the intent of the Parties. The Parties agree
that if any provision of this Agreement is determined to be unenforceable by a
court of competent jurisdiction, such provision shall be struck from the
Agreement, and the Parties shall replace that term of the Agreement with a term
that has a substantially similar economic effect.

 

15. COMPLETE AGREEMENT

 

15.1 This Agreement represents the complete agreement between the Parties of the
settlement arising out of the Mediation process. No amendment to this Agreement
will be effective unless it is in writing and signed by both Parties, and
expressly indicates mutual intent to modify the Agreement.

 

16. ASSIGNABILITY

 

16.1 The rights and obligations under this Agreement may be transferred or
assigned between or among affiliates of a Party without notice. This Agreement
cannot be assigned to third parties (that are not affiliates of a Party) without
the prior express written consent of both Parties, which consent may not be
unreasonably withheld.

 

16.2 For purposes of this Agreement, an “Affiliate” shall mean an entity that,
at any time during this Agreement, (a) a Party Controls, (b) Controls a Party or
(c) is under common Control with a Party. In addition, “Control” as used in this
Agreement shall mean the ownership, directly or indirectly, through one or more
intermediaries, or control of (i) more than fifty percent (50%) of the
outstanding shares or securities entitled to vote for the election of directors
or similar managing authority of the subject entity; (ii) more than fifty
percent (50%) of the ownership interest representing the right to make the
decisions for the subject entity; or (iii) any other ability to elect more than
half of the board of directors or similar managing authority of the subject
entity, whether by contract or otherwise.

 

17. AUTHORITY

Each of the Parties represents and warrants that it has the full right, power
and authority to execute, deliver, enter into and perform this Agreement and
that it is legally permitted to grant the rights granted and to make all
covenants and perform all obligations required by this Agreement.

 

18. INDEMNIFICATION

 

18.1 All rights and obligations concerning indemnification set forth in the 1991
Agreements shall remain in force, sections 2.2 and 10 of this Agreement
notwithstanding. For avoidance of doubt, such obligations shall also apply to
the patents and applications licensed under sections 5 and 6 herein.

 

19. MISCELLANEOUS

 

19.1 Kensey Nash and St. Jude covenant and agree that nothing in this Agreement
shall be construed as an admission of liability by any Party and that none of
the Parties will seek to use or construe this Agreement as an admission of
liability by any Party.

 

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19.2 Nothing herein contained shall be construed or deemed hereby to create a
principal/agent relationship between the Parties nor any form of partnership or
joint venture.

 

19.3 Each Party acknowledges that it has had the benefit of counsel. Each Party
agrees that this Agreement has been jointly negotiated and drafted, and that
none of the Parties shall be construed as the sole draftsman of this Agreement,
and that no provision shall be construed or interpreted for or against any of
the Parties because such provision, or any other provision, or the Agreement as
a whole, was purportedly drafted by a particular Party.

 

19.4 Each of the Parties acknowledges that it has read all of the terms of this
Agreement and enters into those terms voluntarily and without duress.

 

19.5 This Agreement may be executed in multiple counterparts, each of which for
all purposes shall be deemed an original. This Agreement shall not be binding on
the Parties and their Affiliates until all Parties (and an authorized
representative of each Party’s parent corporation) have signed the same
Agreement or identical counterparts thereof and each Party has received the
signature page signed by the other Party and that Party’s parent corporation,
whether that signature page be an original or a facsimile. If the Agreement
becomes binding based on an exchange of faxed copies of signature pages, the
Parties will thereafter exchange formal signed originals of this Agreement for
their permanent records.

 

20. NOTICE

If notice is required under any provision of this Agreement, notice shall be
given by overnight delivery to:

 

    

For St. Jude

  

For Kensey Nash

 

 

General Counsel

St. Jude Medical, Inc.

One St. Jude Medical Drive

St. Paul, MN 55117

 

AND

 

General Counsel

St. Jude Medical,

Cardiology Division, Inc.

177 Country Road B

St. Paul, MN 55117

 

AND

 

Joseph Evall

Orin Snyder

Gibson, Dunn & Crutcher LLP

200 Park Avenue

New York, NY 1016

  

 

Joe Kaufmann

Kensey Nash Corporation

735 Pennsylvania Drive

Exton, PA 19341

 

AND

 

Jeffrey C. Kelly

Kensey Nash Holding Corporation

108 Webster Building

3411 Silverside Road

Wilmington, DE 19810

 

AND

 

John Caldwell

David Wolfsohn

Woodcock Washburn LLP

2929 Arch Street

Philadelphia, PA 19104

 

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Intending to be bound, the parties enter into this Agreement by their authorized
representatives:

 

/s/ John C. Heinmiller

    

/s/ Joseph Kaufmann Mar. 16, 2012

John Heinmiller      Joseph Kaufmann For the St. Jude Parties      For Kensey
Nash Corporation March 16, 2012     

 

/s/ Joseph Kaufmann Mar. 16, 2012

Joseph Kaufmann

For Kensey Nash Holding Corporation

 

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Schedule A

 

Title    Application/Publication/Patent No. Device and Method for Positioning a
Closure Device    7,850,614 Three-Needle Closure Device    6,932,824
Three-Needle Closure Device    7,789,887 Three-Needle Closure Device   
US-2010-0145366

Method and Apparatus for Sealing an Internal Tissue Puncture

Incorporating a Block and Tackle

   US-2005-0107827 Tissue Puncture Closure Device with Automatic Tamping   
7,931,670 Tissue Puncture Closure Device with Automatic Tamping   
US-2011-0172702 Vascular Sealing Device with High Surface Area Sealing Plug   
7,621,937 Vascular Sealing Device with High Surface Area Sealing Plug   
8,075,589 Vascular Sealing Device with High Surface Area Sealing Plug   
13/305,586 Automatic Suture Locking Device    8,007,514

Suture Based Vascular Closure Apparatus and Method

Incorporating a Pre-Tied Knot

   7,731,726 Vascular Puncture Seal Anchor Nest    7,597,705 Vascular Puncture
Seal Anchor Nest    US-2009-0312790

Balloon Insertion Apparatus and Method of Sealing a Tissue

Puncture

   US-2007-0156084 Puncture Locating Device    US-2006-0264978 Flexible Tamping
Device    7,749,248 Flexible Tam ping Device    US-2010-0234883 Method and
Apparatus for Locating Vascular Punctures    7,648,493 Vascular Sealing Device
with Locking System    US-2006-0058844 Suture Loop Closure Device    8,038,687
Suture Loop Closure Device    US-2012-000467

Tissue puncture closure device with disengageable automatic

tamping system

   7,618,438

Tissue puncture closure device with disengageable automatic

tamping system

   US-2010-0023051 Percutaneous Suture Path Tracking Device with Cutting Blade
   US-2006-0178682

Tissue puncture closure device with automatic torque sensing

tamping system

   7,250,057

Tissue puncture closure device with automatic torque sensing

tamping system

   7,988,706

Tissue puncture closure device with automatic torque sensing

tamping system

   US-2011-0270302

Tissue puncture closure device with magazine fed tamping

system

   7,713,283

Tissue puncture closure device with magazine fed tamping

System

   US-2010-0191280

Puncture Closure Apparatuses, Sealing Plugs, and Related

Methods

   7,850,710

 

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Title    Application/Publication/Patent No.

Puncture Closure Apparatuses, Sealing Plugs, and Related

Methods

   US-2011-0077683

Tissue puncture closure device with scroll gear transmission

tamping system

   7,618,436 Tissue puncture closure system with retractable sheath    7,837,705

Tissue Puncture Closure Device with Coiled Automatic Tamping

System

   7,749,247 Hemostasis Valve Having Support Shoulders    5,092,857 Device for
sealing hemostatic incisions    5,540,715 Device for sealing hemostatic
incisions    5,630,833 Assembly for sealing a puncture in a vessel    5,649,959

Insertion assembly and method of inserting a hemostatic closure

device into an incision

   6,368,341 Guiding lntroducer for Endomyocardial Biopsy Procedures   
5,810,746

Measuring Device for Use with a Hemostatic Puncture Closure

Device

   6,494,848 Vascular Sealing Device with Locking Hub    US-2005-0085852 System
and Methods for Arterial Access    US-2008-0154190 Systems and Methods of
Locating and Closing a Tissue Puncture.    US-2009-0171281 Extra-Vascular
Sealing Device and Method    US-2009-0054926 Vascular Closure Device Having an
Improved Plug    US-2009-0171387 Method and Apparatus to Promote Hemostasis   
US-2008-0082123 Device and Method for Vascular Closure    US-2008-0097479 Knot
Pusher Device    US-2008-0097484 Method and Device for Automated Needle
Deployment    US-2008-0097481 Suture Attachment Device    8,080,035

Internal Suturing Device Leg Suspension System and Method of

Use

   US-2008-0097480 Vascular Closure Device Having a Flowable Sealing Material   
US-2009-0171282 Vascular Closure Device and Method for Using the Same   
61/487,997

Method and Device for Locating a Vessel and for Closing a

Vascular Puncture Site

   61/478,740 Vascular Locator Device and Method for Locating a Vessel   
61/476,979 Improved Method and System for Closing a Vascular Hole    61/487,474

Tissue Puncture Closure Device with Actuatable Automatic Spool

Driven Tamping System

   US-2010-0286727 Snap-On Vascular Closure Device and Methods    61/466,775
Monorail System for Vascular Closure Device and Methods    61/238,385

Filled Balloon Arteriotomy Locator for Vascular Closure Devices

and Methods

   61/486,470

 

12

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Title    Application/Publication/Patent No.

Compressible Arteriotomy Locator for Vascular Closure Devices

and Methods

   61/238,297 Vascular Closure Device with Automatic Suture Cutter    61/229,212
Vascular Access to Closure Sheath and Methods    12/889,733 Single Piece, Dual
Component Sealing Pad and Methods    61/236,472 Compactionless Tissue Puncture
Closure Device and Methods    13/181,013

Tissue Puncture Closure Device with Limited Force Auto

Compaction and Methods

   61/477,541 Carrier Tube for Vascular Closure Device and Methods    61/234,192
Procedural Sheath Adapter for Vascular Closure Device    61/488,097

Vascular Closure Device with Compaction Tube Suture Cutting

Port and Methods

   61/466,844 Dual Hypotube Suture Cutting Device and Methods    US-2011-0029012
Polymer Membrane Locator with Built-in Stress Relief Structure   
US-2011-0046663

Disengagable Cam System for Tissue Puncture Closure Device

and Methods

   61/378,346 Cam Driven Compaction Tube for Angio-Seal Deployment    12/901,285
Clutch or Suture Release Mechanism for Angio-Seal Cam Design    61/375,361

Circumferentially Located Suture Release Mechanism for

Vascular Closure Devices

   61/494,322 Large Bore Closure with Inner and Outer Seal    61/560,588 Large
Bore Anchor Device    61/564,237 Large Bore Closure Device    61/494,345 Suture
Locking Device    61/474,223 Large Bore Location Design    61/560,507 Suture
Locking Device    61/487,633 Distal Balloon Bond for a Temporary
Sealing/Location Device    61/478,691

Dual Bond to Seperate Flashback Lumen and Inflation Lumen

form a Coaxial Design or Dual Lumen Tube Design

   61/466,867 Bioresorbable Tip with Low Force Release and Methods    61/590,027

Bioadhesive Delivery Catheter Manifold with Mixing Fixture and

Methods

   61/589,930

Balloon Location Device Manifold for Vascular Closure Device

and Methods

   61/590,000 Procedural Sheath Securement Device and Methods    61/590,065

 

13

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Schedule B

 

U.S. Patent No.

  

Filed

  

Publication No.

7,850,654    April 24, 2003    2004/0215232 7,250,057    April 11, 2005   
2006/0229672 7,648,493    April 20, 2004    2005/0234396

 

14

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Schedule C

 

U.S. Patent Application No.

  

U.S. Patent Publication No.

  

Filed

10/939,841    2006/0058844    September 13, 2004

 

15

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Schedule D

2012 Collagen Supply Agreement to be appended here

 

16

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*** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
CONFIDENTIAL TREATMENT REQUEST UNDER 17 C.F.R SECTIONS 24-B-2, 200.80 (B)(4) AND
230.406.

2012 SUPPLY AGREEMENT

This Agreement (the “Agreement”) effective as of the day the last party affixes
its signature hereto (the “Effective Date”) is by and between Kensey Nash
Corporation, a Delaware corporation, (“Seller”) whose principal place of
business is 735 Pennsylvania Drive, Exton, PA 19341 and St. Jude Medical,
Cardiology Division, Inc. d/b/a St. Jude Medical, Cardiovascular Division a
Delaware corporation, (“Buyer”), whose principal place of business is at 177
East County Road B, St. Paul, MN 55117 .

WHEREAS, Buyer desires to purchase Products (as described below) from Seller and
Seller desires to sell Products to Buyer under the terms and conditions set
forth herein.

NOW, THEREFORE, the parties, wishing to be legally bound, agree as follows:

1. PRODUCTS:

Collagen plugs in their current design configuration and used in currently
commercially available Angio-Seal vascular closure devices (the “Collagen
Plug”). Such collagen plugs are currently designated as Buyer’s Part Numbers:

 

22934-000      Collagen plug, Certified 5 hole, 6f STS 22935-000     
Rectangular collagen, 8f STS 23378-000      Collagen plug, VIP, 6f plug
23378-001      Collagen plug, VIP, 8f plug 100000973      6f Aus collagen plug,
VIP (Australian derived) 100000974      8f Aus collagen plug, VIP (Australian
derived)

and, meeting the specifications (the “Specifications”) set forth in Schedule A,
which is attached to and made a part of this Agreement (collectively, the
“Product” or “Products”). Such Specifications may be changed from time to time
only as agreed to in writing by the parties.

2. DURATION: The duration of this Agreement shall be from the Effective Date
until December 31, 2017 (“Initial Term”) unless terminated pursuant to the terms
of this Agreement or otherwise agreed in writing by the parties.

 

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3. CO-EXCLUSIVITY: Subject to the terms of this Agreement Seller will be, along
with Buyer and/or Buyer’s affiliate(s), the co-exclusive supplier of Collagen
Plugs during the Term of this Agreement.

4. QUANTITIES:

4.1 Buyer shall purchase from Seller and Seller shall sell to Buyer a cumulative
amount of 5,000,000 units of Product (the “Cumulative Purchase Requirement”)
deliverable during the Term of this Agreement; more specifically, (i) Buyer
shall place a binding purchase order of 400,000 units of Product by March 31,
2012 to be shipped by Seller between October 1, 2012 and December 31, 2012 (the
“March 2012 Order”), (ii) Buyer shall place a binding purchase order of
1,500,001 units of Product by October 1, 2012 to be shipped by Seller between
January 1, 2013 and December 31, 2013, and (iii) Buyer shall purchase a minimum
of 400,000 units of Product each calendar year during the Term until the
Cumulative Purchase Requirement has been met. To avoid any doubt, the March 2012
Order counts toward the Cumulative Purchasing Requirement.

4.2 Buyer may purchase from Seller a maximum of 2,000,000 units of Product
deliverable in each calendar year 2012 through 2017 (“Annual Maximum”). The
maximum Purchases for Calendar year 2012 shall include the volume of units
purchased on all orders for delivery in 2012, including those scheduled for
delivery in 2012 and placed under the parties’ prior Supply Agreement dated
June 23, 2010 (“2010 Supply Agreement”). To avoid any doubt the purchases under
the 2010 Supply Agreement shall not count toward the Cumulative Purchase
Requirement in this Agreement. Seller shall use reasonable efforts consistent
with good business practice to meet Buyer’s requirements for quantities in
excess of the Annual Maximum.

4.3 For Australian derived collagen plugs, Seller is not obligated to supply in
excess of 200,000 units per calendar year. Seller is not obligated to make more
than two deliveries of Australian derived collagen per calendar year unless
otherwise agreed to in writing.

5. ORDER AND DELIVERY:

5.1 The March 2012 Order shall be for 400,000 units of U.S. derived Product at
*** per plug. Should Buyer place any additional orders in 2012 for delivery in
2012, pricing for such additional orders will be subject to Exhibit B with the
understanding that the price per plug for that order will be determined based on
the volume of units purchased on all orders for delivery in 2012 including those
scheduled for delivery and placed under the 2010 Supply Agreement.

5.2 On or before June 30 of each calendar year (including 2012) during the Term
of this Agreement, Buyer will provide Seller with a non-binding forecast of its
Product needs for the following year. On or before October 1 of each calendar
year, Buyer will issue a binding purchase order for its Product needs for the
subsequent calendar year “Initial Purchase Order”. Should Buyer need to place
any

 

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additional orders it shall issue a purchase order stating the desired shipment
date(s) and quantity being ordered. Seller shall acknowledge promptly in writing
to Buyer each purchase order issued by Buyer and confirm delivery dates to
destinations specified by Buyer, however, delivery must not conflict with
Seller’s normal manufacturing lead times.

5.3 Each delivery of Products shall be accompanied by Seller’s Certificate of
Conformance as described more fully in the Specifications for the Products. If
any terms and conditions contained in such purchase order or acknowledgment
conflict with the terms of this Agreement, the terms and conditions of this
Agreement shall apply to the transaction. Changes in delivery date(s) or
quantity specified in a purchase order may be made by Buyer by means of a
written amended purchase order, and shall become effective upon written approval
by Seller.

6. ADDITIONAL QUANTITIES: During the Term of this Agreement, Buyer shall notify
Seller in writing at least ninety (90) days in advance of Buyer’s desired
shipping date for quantities in excess of an Initial Purchase Order. Seller
shall use commercially reasonable efforts to meet Buyer’s requirements for such
quantity in excess of an Initial Purchase Order. Should Seller be unable to
supply Buyer with Product in excess of an Initial Purchase Order, Seller shall
inform Buyer within thirty (30) days of Seller’s receipt of notice whether
Seller will supply all or a portion of such excess. Should Seller be unable to
supply Buyer with any quantity of Products in excess of an Initial Purchase
Order (the “Unfulfilled Excess”), Buyer may purchase the Unfulfilled Excess from
alternative suppliers, and such actions will not be a breach of any
co-exclusivity provisions of this Agreement.

7. PRICE: Except as set forth in Section 5.1 of this Agreement the price for
Products (the “Price”) shall be as set forth in Schedule B attached to this
Agreement.

8. WARRANTY: Subject to the conditions set forth below, Seller warrants that
Products shipped hereunder meets and complies with the Specifications set forth
in Schedule A. Other than the foregoing, SELLER MAKES NO WARRANTIES OF
MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE EVEN IF THAT PURPOSE IS
KNOWN TO SELLER, NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY. Buyer assumes all
risk and liability for results obtained by the use of Products covered by this
Agreement, whether used singly or in combination with other products.

9. INDEMNIFICATION: Subject to the conditions set forth below, Buyer shall fully
indemnify Seller, and Seller’s agents, parent, subsidiaries, affiliates,
employees, officers and directors, successors or assigns against all loss and
expense (including, without limitation, reasonable attorney’s fees) for injury
to or death of any person or loss of or damage to property incurred by Seller
and resulting in any way from Buyer’s use or sale of vascular closure devices,
or any act or omission, whether negligent or otherwise, on the part of the
Buyer, its agents, employees, subcontractors or assignees, in connection with
the

 

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performance of this Agreement except: (a) when such loss and expense are caused
by a defect in any Products which were manufactured by Seller, wherein such
defect caused such Products to not meet Specifications, and wherein such
Product(s) were a component of a vascular closure device manufactured and sold
by Buyer, or an affiliate of Buyer; or (b) when caused solely by the willful
misconduct or negligence of Seller. In the event of either exception set forth
in (a) or (b) in the preceding sentence, Seller shall fully indemnify Buyer, and
Buyer’s agents, parent, subsidiaries, affiliates, employees, officers and
directors, successors or assigns against all loss and expense (including without
limitation, reasonable attorney’s fees).

The indemnifying party’s obligations under this Section shall not apply unless:

 

  A. The indemnified party gives the indemnifying party prompt written notice of
claims for which the indemnified party seeks indemnification;

 

  B. The indemnified party cooperates with the indemnifying party in the defense
of such claims at the cost of the indemnifying party;

 

  C. The indemnifying party has the sole right to defend any such claim in the
manner it deems prudent, including retaining counsel of its choice; and

 

  D. The indemnifying party shall have the sole right to settle any such claim
provided that in settling any claim the indemnifying party obtains a complete
release for the indemnified party and does not admit fault or liability on
behalf of the indemnified party.

10. USE OF TRADEMARK: Each party agrees that it will not, without the other
party’s prior written consent, use and/or associate the other party, the other
party’s corporate name or any of the other party’s trademarks, either orally or
in writing, with any of the other party’s products, except that Buyer may use
Seller’s name and associate Seller with Buyer’s use of Products as is required
by federal or state regulation in gaining approval to market or to continue
marketing any of Buyer’s devices or products.

11. CLAIMS OF NON-CONFORMITY: Buyer shall provide notice to Seller of any claim
of non-conformity to Specifications arising from Products within one hundred
twenty (120) days after the later of the actual or scheduled date of receipt of
the shipment containing the specific Products unit that is the subject of the
claim (the “Claim Period”). Except as to claims for indemnification set forth in
Section 9, failure to give notice of claim within the Claim Period, shall
constitute a waiver by Buyer of all claims in respect to such Products. No claim
of non-conformity to Specifications shall be allowed after Products has been
processed by Buyer in any manner, except that opening the packages and
inspecting Products with normal care in handling shall not constitute processing
nor disallow such claim. Payment prior to inspection of Products by Buyer shall
not constitute waiver of any rights under this Agreement. In

 

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addition, acknowledgement of receipt on packing slips or bills of lading shall
not constitute acceptance of Products by Buyer. Products shall not be returned
to Seller without Seller’s prior permission, and then only in the manner and to
the destination prescribed by Seller. Seller shall reimburse Buyer for the
actual costs of returning any Products returned in accordance with Seller’s
instructions. Upon Seller’s confirmation of non-conformity, Seller will provide
Buyer with credit, refund or replacement at Seller’s option for the
non-conforming returned Products. In no event shall either party be liable to
the other for special, indirect or consequential damages.

12. QUALITY CONTROL:

12.1 Inspection, Timing. All Products shall meet the Specifications contained in
Schedule A, and shall be subjected to quality control inspections by Seller in
accordance with Seller’s quality control standards and system which should be
consistent and in conformity with the laws and regulations set forth in
Section 17. If Buyer’s quality control inspection shows that any Products fails
to meet the Specifications contained in Schedule A, Buyer shall notify Seller
within forty-five (45) days of discovery of the non-conformity.

12.2 Lot Traceability. Vascular closure devices manufactured and sold by Buyer,
or an affiliate of Buyer, shall contain lot numbers such that collagen
components, including Products supplied hereunder, incorporated in such devices
can be traced back to the original supplier’s lot number.

13. DELIVERIES: Deliveries shall be F.O.B. Exton, Pennsylvania, USA via standard
freight carrier, using shipper of Buyer. Buyer shall be responsible for all
delivery costs and will be invoiced for such by Seller. Title to and risk of
loss in all Products sold hereunder shall pass to Buyer upon loading for
shipment at Seller’s plant.

14. TERMS OF PAYMENT: Buyer will pay to Seller the Invoiced Price net cash
thirty (30) days from date of Seller’s invoice. Seller may impose a late payment
service charge of 1.5% per month on invoices not paid when due. All payments
shall be in United States currency.

15. FINANCIAL RESPONSIBILITY: In the event Buyer fails to fulfill the terms of
payment, or in case Seller shall have reasonable doubt at any time as to Buyer’s
financial responsibility, Seller may decline to make further deliveries except
upon receipt of cash or satisfactory security.

16. FORCE MAJEURE: No liability shall result from delay in performance, or
nonperformance, caused by circumstances beyond the control of the party
affected, including, but not limited to, Act of God, fire, flood, war,
Government action, or accident. Quantities so affected may be eliminated from
the Agreement without liability, but the Agreement shall remain otherwise
unaffected, except that in the event Seller fails to deliver an amount to Buyer
under this Section 16 following a forty-five (45) day cure period, Buyer may
source Product itself or through a third party, to the extent of such failure by
Seller, without breaching any exclusivity provisions of this Agreement. Any
party claiming the benefit of this Section shall promptly so notify the other
party.

 

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17. GOVERNMENT REGULATION/APPROVALS – RESPONSES TO THIRD PARTY COMPLAINTS OR
CLAIMS: Buyer shall be responsible for obtaining all necessary government
approvals to market any device incorporating the Products. Seller shall
manufacture Products under this Agreement in material compliance with the U.S.
Quality System Regulation (QSR) and ISO 13485. Any changes to the Specifications
relating to the Products must be agreed to in writing by both parties before
such changes are implemented. Seller considers process validation to be a
requirement of the QSR; therefore, Buyer shall either fund such required
validations, subject to negotiation with Seller regarding the price and extent
of validation, or provide Seller with written confirmation that Buyer will
assume all responsibility for validation. Upon terms of confidentiality
acceptable to Seller, Seller agrees to cooperate with Buyer in obtaining any
such governmental approvals, including providing required information to the FDA
or any other governmental agency requesting the information to the extent such
information is readily available or can be developed at little or no cost to
Seller, unless Buyer agrees to fund such information research and preparation.
Similarly, Seller agrees to provide reasonable assistance, including information
and data, as needed by Buyer to respond to complaints or claims asserted by
third parties regarding devices incorporating the Products. If services or
consulting is required to respond to issues raised by a governmental agency or
in a complaint or claims asserted by a third party beyond what is customarily or
reasonably provided without charge (“Supplemental Consulting”), Seller will
notify Buyer of its intent to charge for Supplemental Consulting with an
estimate for anticipated charges. If, after notice of Seller’s intent to charge,
Buyer requests such Supplemental Consulting, Seller will charge at a rate that
is discounted by twenty percent (-20%) from its regular consulting rates.

18. DOCUMENTS INCORPORATED BY REFERENCE: The following documents are hereby
incorporated by reference:

A. Schedule A, entitled “Products Specifications”.

B. Schedule B, entitled “Pricing”.

19. ADVERSE EVENTS, COMPLAINTS AND EFFECTS: Buyer will investigate all adverse
events, complaints and effects of which Buyer has direct or indirect knowledge,
in regard to any of Buyer’s devices which incorporate Products. Buyer agrees to
promptly report to Seller any such events, complaints or effects that may relate
to Products. Buyer shall be responsible for all medical device reporting (MDR),
vigilance reporting and/or recalls associated with any devices made or sold by
Buyer which incorporate Products. Seller shall be notified in writing about any
such reports or recalls that appear to relate to Products.

 

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20. COMPLIANCE WITH LAW: Each party represents that it is and will remain in
material compliance with all applicable federal, state and local laws,
regulations and orders, regarding the manufacture and distribution of Products
or product that incorporate Products.

21. INDEPENDENT CONTRACTOR: The employees, methods, equipment and facilities of
each party shall at all times be under that party’s exclusive direction and
control. Buyer’s relationship to Seller under this Agreement shall be that of an
independent contractor and nothing in this Agreement shall be construed to
constitute either party, or any of its employees, an agent, associate, joint
venturer or partner of the other party.

22. NOTICES: All notices required hereunder shall be sent by certified mail
return receipt requested, or by facsimile confirmed by such certified mail, to
the party to be notified at its following address or at such other address as
shall have been specified in written notice from the party to be notified. If to
“Seller”, addressed to: Kensey Nash Corporation, 735 Pennsylvania Drive, Exton,
PA 19341, attention: Joseph W. Kaufmann. If to “Buyer”, addressed to: St. Jude
Medical, Cardiology Division, Inc. d/b/a St. Jude Medical, Cardiovascular
Division 177 East County Road B, St. Paul, MN 55117, attention: Vice President
Finance and Supply Chain with a copy to: Vice President and General Counsel, St.
Jude Medical, Cardiovascular Division, 177 East County Road B, St. Paul, MN
55117.

23. ASSIGNMENT: This Agreement is not assignable or transferable by one party,
in whole or in part, without the prior written consent of the other party, which
consent shall not be unreasonably withheld, provided, however, that Buyer may
assign this Agreement without Seller’s consent to an affiliate or a purchaser of
all or substantially all of Buyer’s assets.

24. CLAUSE HEADINGS: The headings of clauses contained herein are used for
convenience and ease of reference and shall not limit the scope or intent of the
clause.

25. ENTIRETY OF AGREEMENT: This Agreement embodies the entire agreement and
understanding between Seller and Buyer regarding the supply of collagen plugs
for calendar years 2012 through 2017 and any extension of this Agreement. The
parties expressly agree that this Agreement supersedes and replaces the parties’
Supply Agreement dated June 23, 2010 with the exception of the pending delivery
of Products ordered under that Agreement. No amendment, modification or release
from any provision hereof shall be of any force or effect unless it is in
writing, signed by the parties, and specifically refers to this Agreement.

26. WAIVER: No waiver by either party or any breach of the covenants herein
contained 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.

 

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27. TERMINATION: The Agreement may be terminated by either party if:

27.1 The other party is in material breach of any material term or obligation of
this Agreement and such material breach is not cured within thirty (30) days
after receipt of written notice of such material breach from the terminating
party, provided however, that if the nature of the breaching party’s obligations
are such that more than thirty (30) days are required for cure, then such party
shall not be in default if it shall have commenced performance to cure within
the thirty (30) day period and thereafter diligently attempts to complete
performance of cure; or

27.2 The other party is adjudicated insolvent, has a receiver of its assets or
property appointed, or files or has filed against it a petition in bankruptcy
and such breach is not cured within sixty (60) days of such event; or

27.3 The other party ceases or threatens to cease to carry on all or any
substantial part of its business that is relevant to this Agreement; or

27.4 The parties’ obligations pursuant to Sections 8, 9, 11, 19, 20, 28, 29 and
30 shall survive termination or expiration of this Agreement.

28. CONFIDENTIALITY: Both parties acknowledge that before and during the Term,
both parties may provide or may continue to provide the other with certain
proprietary and confidential information, including, without limitation, prices,
data, designs, plans, drawings, technical information, trade secrets, know-how,
processes, customer information, complaint analysis and investigation, marketing
strategies and competitive information (“Confidential Information”). Each agrees
that it will not, during the Term, or after, for any reason, publish or disclose
to any third party, except to the FDA or other competent regulatory agency,
without the advance, express written authorization from the other party, any
such Confidential Information, nor, except to the extent such Confidential
Information is necessary in performance of this Agreement, will it use such
Confidential Information.

28.1 Confidential Information does not include information which (i) is known to
the receiving party prior to receipt from the disclosing party; or (ii) is or
becomes public knowledge without breach of the disclosing party’s obligation; or
(iii) is rightfully acquired by the disclosing party from a third party without
restriction on disclosure or use; or (iv) is publicly disclosed or used
following disclosing party’s receipt of written consent for such disclosure or
use by an officer of the other party; or (v) disclosure is compelled by
deposition, subpoena or other judicial requirement or governmental action, as
evidenced by advice of legal counsel, provided that the receiving party give the
disclosing party prompt advanced written notice of the Confidential Information
to be disclosed as far in advance of its disclosure as is reasonably possible,
practicable and legally permissible to permit the other party to obtain a
protective order or take other responsive action.

28.2 The requirements of this Section terminate five (5) years after the
termination or expiration of this Agreement or any renewal of this Agreement.
Upon termination or expiration of this

 

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Agreement, and upon request of the other party, all materials and copies of
Confidential Information shall be immediately returned to the other party,
except that the receiving party may retain one archival copy in their respective
legal department’s files for purposes of monitoring compliance of this
Agreement, and may also retain any required documents or drawings required to be
held in the Device History File or other applicable QSR or regulatory file.

29. NO PUBLICITY: Following the Effective Date hereof, neither party will issue
any press release regarding the details of this Agreement or further
transactions contemplated by the parties pursuant to this Agreement, or
otherwise make any oral or written statements or disclosures regarding this
Agreement or transactions contemplated by this Agreement, without the prior
written consent of the other party, which consent shall not be unreasonably
withheld. The parties may, however, disclose the following:

(1) The mutually agreed upon statements set forth in Section 9 of the Settlement
Agreement between the parties dated March 15, 2012.

(2) Other information relating to this Agreement as may be required by
applicable law or by obligations pursuant to any listing agreement with or rules
of any national securities exchange. The parties agree that should a copy of
this Agreement need to be publicly filed that it shall be redacted so as to
exclude the pricing information set forth in Section 5.1 and the information in
Schedules A and B. The parties also agree that from the Effective Date and on a
quarterly basis going forward that they may disclose the quantity and dollar
value of Product purchased by Buyer from Seller.

(3) To their respective employees and representatives, the information necessary
to complete the transactions contemplated by the parties’ Agreement.

In the case of any required disclosure under subsection (2) above, the
disclosing party will: (1) provide the other party with written notice of the
required disclosure at least forty-eight (48) hours in advance of such
disclosure; and (2) limit such disclosure to the minimum required under the
applicable law or obligations.

30. GOVERNING LAW AND VENUE: This Agreement and matters connected with the
construction and performance hereof, shall be governed by the substantive laws
of the State of Delaware, without regard to that state’s choice of law rules.
This supersedes any agreement to the contrary between the Parties, their
successors, and their assigns. The Parties specifically consent to jurisdiction
and venue in the state and federal courts located in Wilmington, Delaware, for
any dispute concerning this Agreement.

31. NON-SOLICIT/NO-HIRE: During the term of this Agreement and for a period of
one (1) year thereafter, Seller and Buyer will not attempt to solicit nor
directly or indirectly hire the other party’s employees or subcontractors that
become known to Seller or Buyer through the performance of this Agreement.

 

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32. CLOSED HERD: Seller shall maintain sufficient records to demonstrate that
raw material has met the requirements of a Closed Herd per current ISO 22442-2
for any such source of raw material where the Products are specified by Buyer to
come from a Closed Herd. Specific requirements for sourcing of Products shall be
controlled by Specifications and any applicable laws or regulations.

33. COUNTERPARTS: This Agreement may be executed in counterparts, each of which
shall be deemed an original, but all of which shall constitute one and the same
instrument.

Accepted:

 

Kensey Nash Corporation     

St. Jude Medical, Cardiology Division,

Inc. d/b/a St. Jude Medical, Cardiovascular Division

By:

 

/s/ Joseph W. Kaufmann

     By:   

/s/ Jim Ufford

Name:

  Joseph W. Kaufmann      Name:    Jim Ufford

Title:

  President & CEO      Title:    Vice President - Supply Chain

Date:

  March 16, 2012      Date:    March 16, 2012

 

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SCHEDULE A

PRODUCTS SPECIFICATIONS

Specifications follow this page.

*** [13 Pages Redacted]

 

     KNC    SJM

Initials

   JWK    JU

Date

   3/16/12    3/16/12

 

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SCHEDULE B

PRICING

All Collagen Plug prices in the chart below are effective for orders placed for
delivery in calendar years 2012 through 2017 and are for closed herd derived
Product, or Australian derived Product.

*** [1 Page Redacted]

 

     KNC    SJM

Initials

   JWK    JU

Date

   3/16/12    3/16/12

 

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