Document:

Exhibit 10.11

 

PUBLIC
HEALTH SERVICE

THIRD
AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (L-068-2002/0)

 

AMENDMENT A-155-2005

 

This amendment of the Exclusive Patent License L-068-2002/0 (“Agreement”), A-155-2005 (“Third Amendment”), is made between the
National Institutes of Health (“NIH”),
the Centers for Disease Control and Prevention (“CDC”), or the Food and Drug Administration (“FDA”), hereinafter singly or collectively
referred to as (“PHS”), agencies
of the United States Public Health Service within the Department of Health and
Human Services (“DHHS”) through
the Office of Technology Transfer, NIH,
having an address at 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804, U.S.A. and Procept, Inc., having offices at
the address indicated on the Signature Page, hereinafter referred to as “Licensee”.

 

Whereas, Licensee desires
the Agreement to be amended a
third time in order to modify the assignment royalty amount under Paragraph
14.07 the Agreement; and

 

Whereas, PHS is willing to
amend the Agreement a third time
to accommodate this request in order to facilitate the assignment of the Agreement to the sublicensee.

 

Now Therefore, PHS and Licensee, intending to be bound, hereby
agree that the following changes will be made to the Agreement:

 

I.              Amended
Paragraph 14.07 shall now read:

 

14.07               This Agreement
shall not be assigned by Licensee except: a) with the prior written consent of PHS, such consent not to be withheld
unreasonably; or b) as part of a sale or transfer of substantially the entire business
of Licensee relating to operations
which concern this Agreement. Licensee shall notify PHS within ten (10) days of any
assignment of this Agreement by Licensee, and Licensee shall pay PHS,
as an additional royalty, seventeen thousand five hundred (17,500) U.S. dollars
for an assignment of this Agreement
within thirty (30) days of such assignment.

 

II.            All
terms and conditions of the Agreement
not herein amended remain binding and in effect;

 

III.           The
Agreement, the first amendment, the second amendment and this Third Amendment constitute the entire
understanding between PHS and Licensee and supersede all prior agreements
and understandings with respect to the aforementioned amendments; and

 

IV.           This Third Amendment is
effective when signed by all parties.

 

SIGNATURES BEGIN ON NEXT PAGE

 

1

 

AMENDMENT TO PHS LICENSE AGREEMENT L-068-2002/0

 

PHS
AMENDMENT TO PATENT LICENSE AGREEMENT—EXCLUSIVE

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate originals by their respective duly
authorized officers hereunto, on the day and year hereinafter written.  Any communication or notice to be given shall
be forwarded to the respective addresses listed below.

 

	
  For PHS:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  /s/ Steven M Ferguson

  	
   

  	
  February 15, 2005

  	
   

  
	
  Steven M. Ferguson

  	
  Date

  
	
  Director, Division of Technology Development and Transfer

  	
   

  
	
  Office of Technology Transfer

  	
   

  
	
  National Institutes of Health

  	
   

  
	
   

  	
   

  
	
  Mailing Address for Notices:

  	
   

  
	
   

  	
   

  
	
  Office of Technology Transfer

  	
   

  
	
  National Institutes of Health

  	
   

  
	
  6011 Executive Boulevard, Suite 325

  	
   

  
	
  Rockville, Maryland 20852-3804 U.S.A.

  	
   

  
				

 

 

For the Institution (Upon information and
belief, the undersigned expressly certifies or affirms that the contents of any
statements of the Institution made
or referred to in this Agreement are
truthful and accurate.)

by:

 

 

	
  /s/ Salvatore A. Bucci

  	
   

  	
  February 17, 2005

  	
   

  
	
  Salvatore A. Bucci

  	
  Date

  
	
  President and Chief Executive Officer

  	
   

  
	
  Paligent Inc.

  	
   

  
	
  Procept, Inc.

  	
   

  

 

 

Official and Mailing Address for Notices:

 

10 East 53rd Street, 33rd Floor

New York, NY 10022

 

Any false or misleading statements made, presented, or submitted to the
Government, including any relevant
omissions, under this Agreement and
during the course of negotiation of this Agreement are
subject to all applicable civil and criminal statutes including Federal
statutes 31 U.S.C. §3801-3812 (civil liability) and 18 U.S.C. §§1001 (criminal
liability including fine(s) and/or imprisonment).

 

2Exhibit 10.12

 

 

Execution
Copy

 

Agreement

 

This
Agreement effective as of the 9th
day of March 2005 (the “Effective Date”) is entered into by and between Keryx Biopharmaceuticals, Inc., a Delaware corporation
having an office at 750 Lexington Avenue, 26th Floor, New York, NY
10022 (“Keryx”), Procept, Inc., a Delaware
Corporation having an office at 10 East 53rd Street, 33rd Floor, New
York, NY 10022 (“Procept”), and the United States Public
Health Service, an agency of the United States Government, having an
address at Office of Technology Transfer, National Institute of Health, 6011
Executive Boulevard, Suite 325, Rockville, MA 20852-2804 (“PHS”). Each of
Keryx, Procept and PHS shall be referred to as a Party and collectively as the
Parties.

 

WHEREAS,
Procept and the Penn State Research Foundation (PSRF) are parties to a license
agreement dated February 6, 1998 as amended (the “License Agreement”) relating
to patent rights associated with 06-Benzylguanine and/or its derivatives (the “Patent
Rights”);

 

WHEREAS,
Procept has sub-licensed to AOI Pharmaceuticals, Inc. (“AOIP”) its rights to
the Patent Rights under the License Agreement pursuant to a Sublicense
Agreement executed on or about October 13, 2000, as amended (the “Sublicense
Agreement”);

 

WHEREAS,
as a result of the acquisition of AOIP by Keryx, AOIP has become a wholly-owned
subsidiary of Keryx;

 

WHEREAS,
PSRF and PHS entered into Interinstitutional Agreements executed January 29,
2002 (the “Interinstitutional Agreements”) pursuant to which PHS has exclusive
licensing rights associated with the Patent Rights;

 

WHEREAS,
the University of Chicago and PHS entered into Interinstitutional Agreement
effective February 28, 2002 (the “Interinstitutional Agreements”) pursuant to
which PHS has exclusive licensing rights associated with the Patent Rights;

 

WHEREAS, such
Interinstitutional Agreements superseded and terminated the License Agreement,
but not the Sublicense Agreement; and Procept and PHS have

 

1

 

executed a new exclusive patent license agreement dated February 28,
2002 regarding the Patent Rights, as amended (the “Revised License Agreement”);

 

WHEREAS,
Keryx desires to purchase and assume from Procept and Procept has agreed to
sell and assign to Keryx all of Procept’s rights, interests and obligations
under the Revised License Agreement, which constitutes substantially the entire
business of Procept relating to the operations which concern the Revised
License Agreement; and

 

WHEREAS,
in order to effectuate such Assignment, pursuant to Section 14.07 of the
Revised License Agreement, Procept is obligated to pay PHS the sum of seventeen
thousand five hundred dollars ($17,500).

 

NOW
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged,
the Parties hereby agree as follows:

 

1.                                       Procept hereby assigns to Keryx all of its rights and
interests under the Revised License Agreement, and Keryx hereby assumes all of
the obligations of Procept under the Revised License Agreement (whether such
obligations accrued prior to or after the date of this Agreement); provided,
however, such assignment and assumption shall become effective upon the receipt
by Procept of the First Installment. 
Procept, PHS and Keryx agree to take all reasonable steps necessary to
effectuate and perfect the actions set forth in this Paragraph.

 

2.                                       Procept
represents and warrants to Keryx that (i) the rights and interest conveyed
hereunder are free and clear from any liens or encumbrances of any nature
created by Procept and, to the knowledge of Procept, are free from any
requirement of any past payments, charges, fees or conditions, rights or
restrictions, (ii) Procept is not a party to any pending claim, litigation or
proceeding contesting the rights and interests conveyed hereunder nor, to the
knowledge of Procept, is any such claim threatened against Procept, and (iii)
Procept has not sold, assigned, conveyed, transferred  or delivered to any third party, and, to the
knowledge of Procept, no person or entity has any licenses or other rights
under the Revised License Agreement.  Keryx
represents

 

2

 

and warrants to Procept that AOIP
has performed and discharged all of its obligations under the Sublicense
Agreement.

 

3.                                       Procept
agrees to indemnify and hold Keryx, its directors, officers, employees and
agents harmless from and against any claims, liabilities, damages and expenses
in connection therewith (including reasonable attorney fees, costs and other
expenses of litigation) resulting from material misrepresentation or material
breach of a warranty by Procept under this Agreement.  Keryx agrees to indemnify and hold Procept,
its directors, officers, employees and agents harmless from and against any
claims, liabilities, damages and expenses in connection therewith (including
reasonable attorney fees, costs and other expenses of litigation) resulting
from any failure of AOIP to perform and discharge its obligations under the
Sublicense Agreement.

 

4.                                       The
Parties hereby agree that for purposes of the Revised License Agreement, AOIP
shall be deemed a third party sublicensee under the Sublicense Agreement and
not an Affiliate of Keryx, with the effect among other things, that all amounts
(including milestones and royalties) owed or to be owed by Procept under the
Revised License Agreement currently applicable to Procept as a result of the
Sublicense Agreement shall remain unchanged by the assignment, except that they
shall become the responsibility of Keryx, irrespective of the affiliated
relationship between Keryx and AOIP. 
Following this assignment, for all purposes of the Sublicense Agreement,
any reference to Procept shall be deemed a reference to Keryx.  The parties acknowledge and agree that the
Sublicense Agreement shall survive this assignment.

 

5.                                       As
full consideration for the agreements set forth herein, Keryx agrees to pay
Procept a total consideration of one hundred fifty eight thousand seven hundred
and fifty dollars ($158,750), payable in two installments, a first installment
of eighty three thousand seven hundred fifty dollars ($83,750) (the “First
Installment”), and a second installment of seventy five thousand dollars
($75,000) (the “Second Installment”). The First Installment shall be payable as
provided in Paragraph 6, and the Second Installment shall be evidenced by a
promissory note from Keryx payable to Procept, in

 

3

 

the form attached hereto as Exhibit A, which bears no interest
until after the maturity date and shall be due and payable on December 31,
2005.

 

6.                                       Within ten
(10) business days following execution of this Agreement by all Parties, Keryx shall make payment of the
First Installment as follows: (i) Keryx shall pay PHS on behalf of Procept the
sum of seventeen thousand five hundred dollars ($17,500) in full satisfaction
of the terms and conditions of Section 14.07 of the Revised License Agreement,
and (ii) Keryx shall pay Procept an amount equal to sixty six thousand two
hundred and fifty dollars ($66,250), which represents the First Installment
less the amount paid by Keryx to PHS on behalf of Procept pursuant to this
Paragraph 6(i).

 

7.                                       This
Agreement embodies the entire
understanding of the parties as to its subject matter hereof.

 

8.                                       This
Agreement shall be construed,
governed, interpreted and applied in accordance with the laws of the State of
New York, without regard to its conflict of law rules.

 

9.                                       This
Agreement has been prepared
jointly and shall not be strictly construed against any Party.

 

IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date.

 

 

SIGNATURES
BEGIN ON NEXT PAGE

 

4

 

PROCEPT-KERYX ASSIGNMENT
AGREEMENT

 

SIGNATURE PAGE

 

	
  For Keryx Biopharmaceuticals,
  Inc.

  
	
   

  
	
   

  
	
  /s/ Michael S. Weiss

  	
   

  
	
  Name: Michael S. Weiss

  
	
  Title: Chairman &
  CEO

  
	
  Date:

  	
  March 15, 2005

  	
   

  
	
   

  
	
   

  
	
  For Procept, Inc.

  
	
   

  
	
   

  
	
  By:

  	
  /s/ Salvatore A. Bucci

  	
   

  
	
  Name: Salvatore A.
  Bucci

  
	
  Title: President &
  CEO

  
	
  Date:

  	
  March 10, 2005

  	
   

  
					

 

5

 

ACKNOWLEDGEMENT
AND ACCEPTANCE

 

	
  By PHS:

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  /s/ Steven M Ferguson

  	
   

  	
  Date:

  	
  March 17, 2005

  	
   

  
	
  Steven M. Ferguson

  	
   

  
	
   

  	
   

  
	
  Director, Division of
  Technology Development and Transfer

  	
   

  
	
  Office of Technology
  Transfer

  	
   

  
	
  National Institutes of
  Health

  	
   

  
	
   

  	
   

  
	
  Official and Mailing
  Address for Notices:

  	
   

  
	
   

  	
   

  
	
  Office of Technology
  Transfer

  	
   

  
	
  National Institutes of
  Health

  	
   

  
	
  6011 Executive
  Boulevard, Suite 325

  	
   

  
	
  Rockville, Maryland
  20852-3804 U.S.A.

  	
   

  
	
   

  	
   

  
	
  By PSRF:

  	
   

  
	
   

  	
   

  
	
  /s/ David E. Branigan

  	
   

  	
  Date:

  	
  March 23, 2005

  	
   

  
	
  David
  E. Branigan

  	
   

  
	
   

  	
   

  
	
  Treasurer,
  The Penn State Research Foundation

  	
   

  
	
   

  	
   

  
	
  Official and Mailing
  Address for Notices:

  	
   

  
	
   

  	
   

  
	
  Ronald J. Huss

  	
   

  
	
  The Pennsylvania State
  University

  	
   

  
	
  Intellectual Property
  Office

  	
   

  
	
  113 Technology Center

  	
   

  
	
  University Park, PA 16802
  U.S.A.

  	
   

  
	
   

  	
   

  
	
  By the University of
  Chicago

  	
   

  
	
   

  	
   

  
	
  /s/ Alan E. P. Thomas

  	
   

  	
  Date:

  	
  March 25, 2005

  	
   

  
	
  Alan E. P. Thomas

  	
   

  
	
   

  	
   

  
	
  Director, Office of
  Technology & Intellectual Property

  	
   

  
	
  University of Chicago

  	
   

  
	
   

  	
   

  
	
  Official and Mailing
  Address for Notices:

  	
   

  
	
  University of Chicago

  	
   

  
	
  5555 South Woodlawn
  Avenue, Suite 300

  	
   

  
	
  Chicago, IL 60637 U.S.A

  	
   

  
						

 

6

 

Exhibit A

 

Promissory
Note

 

7

 

PROMISSORY NOTE

 

March 9,
2005

 

FOR VALUE RECEIVED, KERYX BIOPHARMACEUTICALS, INC., a
Delaware corporation having its principal executive offices at 750 Lexington
Avenue, 26th Floor, New York NY 10022 (“Borrower”), promises
to pay to the order of PROCEPT, INC., a Delaware corporation having its
principal executive offices at 10 East 53rd Street, 33rd
Floor, New York, NY 10022 (“Holder”), or assigns, the principal sum of
the aggregate unpaid principal amount of SEVENTY FIVE THOUSAND DOLLARS
($75,000), plus interest thereon, if any, at the rate set forth below, on December 31,
2005, or such earlier time as specified below.

 

1.                                       Terms
of Payment.

 

1.1.                              Interest.  The outstanding principal amount of this Note
shall accrue interest from and after the earliest date such loan is due to be
repaid in accordance with the terms of this Note at a rate equal to ten percent
(10%) per annum (based on a three hundred and sixty five (365) day year).

 

1.2.                              Principal
and Interest Repayment.  The
principal amount of this Note and accrued interest thereon, if any, shall be
due and payable upon the earlier of (i) December 31, 2005 and (ii) the
occurrence of an Event of Default (as defined herein).

 

1.3.                              Form of
Payment.  Both the principal amount
of this Note, and all interest accrued thereon, shall be paid in such currency
of the United States of America as shall be legal tender at the time of
payment, and all payments or prepayments of principal and interest and other
sums due pursuant to this Note shall be made by certified check to Holder at
its address set forth above, or in immediately available funds by wire transfer
to Holder’s account at such bank as Holder shall have previously designated to
Borrower.  When any date on which
principal and interest are due and payable falls on a Saturday, Sunday or legal
holiday, then such payment shall be due and payable on the first business day
immediately following such date and interest shall be payable at the rate set
forth herein for the period of such extension.

 

1.4.                              Optional
Prepayment.  This Note may be prepaid
by Borrower, in whole or in part, at any time or from time to time, without
premium or penalty.  All prepayments made
on this Note shall be applied first to the payment of all unpaid interest
accrued on this Note, and then to the outstanding and unpaid principal amount
of this Note as of the date of the payment.

 

 

2.                                       Events
of Default.

 

2.1.                              Definition
of Event of Default.  Any one or more
of the following events shall constitute an “Event of Default”:

 

2.1.1.                     Borrower
fails to make any payment of principal or interest on this Note on or before
the date such payment is due and such failure continues for a period of ten (10) business
days after the payment due date;

 

2.1.2.                     Borrower
makes an assignment for the benefit of creditors; files a petition in
bankruptcy; is adjudicated insolvent or bankrupt; petitions or applies to any
tribunal for the appointment of any receiver or trustee; or commences any
proceeding under law or statutes of any jurisdiction, whether now or hereafter
in effect, relating to reorganization, arrangement, readjustment of debt,
dissolution or liquidation, or there is commenced against Borrower any such
proceeding which shall not be dismissed within a period of sixty (60) days, or
Borrower indicates its written consent to, approval of, or acquiescence in any
such proceeding or the appointment of any receiver of or any trustee for it or
any substantial part of its property, or suffers any such receivership or
trusteeship to continue undischarged for a period of sixty (60) days; or

 

2.1.3.                     Borrower
shall default in the performance of any of its covenants or agreements
contained in this Note, and, in the case of any such default which is capable
of being cured, continues uncured for ten (10) business days
following the date notice of such default is given to Borrower.

 

2.2.                              Rights
upon Event of Default.  Upon the
occurrence of any Event of Default, the entire principal amount of this Note
then outstanding, together with accrued and unpaid interest thereon,
immediately shall be due and payable without presentment, demand, protest or
notice or other formality of any kind. 
Holder also may exercise from time to time any rights and remedies
available to it by law and under any agreement or other instrument relating to
the amounts owed under this Note.

 

2.3.                              Collection
Costs; Attorney’s Fees.  Borrower
shall promptly pay all of the reasonable costs and expenses of Holder incurred
in the collection of this Note, including reasonable attorney’s fees and
expenses, whether or not a suit to enforce such rights is actually
instituted.  All of such unpaid costs and
expenses shall be added to the principal amount of this Note.

 

3.                                       Miscellaneous.

 

3.1.                              Unconditional
Obligation; Waivers.  The obligations
of Borrower to make the payments provided for in this Note are absolute and
unconditional and not subject to any defense, set-off, counterclaim,
rescission, recoupment or adjustment whatsoever.  Borrower hereby waives presentment and demand
for payment, notice of non-payment, notice of dishonor, protest, notice of
protest, bringing of suit and diligence in taking any action to collect any

 

2

 

amount called for under this
Note, and shall be directly and primarily liable for the payment of all amounts
owing and to be owing hereon, regardless of and without any notice, diligence,
act or omission with respect to the collection of any amount called for hereunder.  No waiver of any provision of this Note made
by agreement of Holder and any other person shall constitute a waiver of any
other terms hereof, or otherwise release or discharge the liability of Borrower
under this Note.  No
failure to exercise and no delay in exercising, on the part of Holder, any
right, power or privilege under this Note shall operate as a waiver thereof nor
shall partial exercise of any right, power or privilege.  The rights and remedies herein provided are
cumulative and are not exclusive of any rights or remedies provided by law.

 

3.2.                              Notices
and Addresses.  Any notice, demand,
request, waiver, or other communication under this Note shall be in writing and
shall be deemed to have been duly given on the date of service, if personally
served or sent by facsimile by 5 p.m., EST (if after such time it shall be
deemed given on the business day thereafter); on the business day after notice
is delivered to a courier or mailed by express mail, if sent by courier
delivery service or express mail for next day delivery; and on the third (3rd)
day after mailing, if mailed to the party to whom notice is to be given, by
first class mail, registered, return receipt requested, postage prepaid and
addressed as follows:

 

To
Holder:

 

Procept, Inc.

10 East 53rd Street

33rd Floor 

New York, New York 10017

Attention: Salvatore A. Bucci, President and Chief Executive Officer

Fax: (212) 755-5463

 

To
Borrower:

 

Keryx
Biopharmaceuticals, Inc.

750 Lexington Avenue

26th Floor

New York, NY 10022

Attention: Michael Weiss, Chairman and Chief Execuive Officer

Fax: (212) 531-5961

 

3.3.                              Lost,
Stolen or Mutilated Note.  Upon
receipt by Borrower of evidence satisfactory to it of the loss, theft,
destruction or mutilation of this Note or any Note exchanged for it, and (in the
case of loss, theft or destruction) of unsecured indemnity satisfactory to it,
and upon reimbursement to Borrower of all reasonable expenses incidental
thereto, and upon surrender and cancellation of such Note, if mutilated,
Borrower will make and deliver in lieu of such Note a new Note of like tenor
and unpaid principal amount and dated as of the original date of the Note.

 

3

 

3.4.                              Severability;
Binding Effect.  Any provision of
this Note which is invalid or unenforceable in any jurisdiction shall, as to
such jurisdiction, be ineffective to the extent of such invalidity or
unenforceability without rendering invalid or unenforceable the remaining terms
and provisions of this Note or affecting the validity or unenforceability of
any of the terms and provisions of this Note in any other jurisdiction.  This Note shall be binding upon and inure to
the benefit of the parties hereto and their successors and permitted assigns.  Neither this Note nor any rights or obligations
hereunder may be assigned by Borrower without Holder’s prior written consent.

 

3.5.                              Governing
Law; Forum.  This Note and any
dispute, disagreement, or issue of construction or interpretation arising
hereunder whether relating to its execution, its validity, the
obligations provided therein or performance shall be governed and interpreted
according to the internal laws of the State of New York, without giving effect
to the principles of conflicts of laws thereof. 
Each of the parties hereto hereby irrevocably and unconditionally
submits to the exclusive jurisdiction of any court of the State of New York or
any federal court sitting in the State of New York for purposes of any suit,
action or other proceeding arising out of this Note (and agrees not to commence
any action, suit or proceedings relating hereto except in such courts).  Each of the parties hereto agrees that
service of any process, summons, notice or document by U.S. registered mail at
its address set forth herein shall be effective service of process for any
action, suit or proceeding brought against it in any such court.  Each of the parties hereto hereby irrevocably
and unconditionally waives any objection to the laying of venue of any action,
suit or proceeding arising out of this Note, which is brought by or against it,
in the courts of the State of New York or any federal court sitting in the
State of New York and hereby further irrevocably and unconditionally waives and
agrees not to plead or claim in any such court that any such action, suit or
proceeding brought in any such court has been brought in an inconvenient forum.

 

3.6.                              Amendments.  This Note cannot be changed orally or
terminated orally.  Any amendment of, or
supplement to or other modification of this Note must be in a written
instrument executed by both parties hereto.

 

3.7.                              Section Headings.  Section headings herein have been
inserted for reference only and shall not be deemed to limit or otherwise
affect, in any matter, or be deemed to interpret in whole or in part any of the
terms or provisions of this Note.

 

IN WITNESS WHEREOF, this Note has been executed and
delivered as of the date specified above.

 

	
   

  	
  KERYX
  BIOPHARMACEUTICALS, INC

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Michael S. Weiss

  	
   

  
	
   

  	
  Name:
  Michael S. Weiss

  
	
   

  	
  Title:
  Chairman and Chief Executive Officer

  

 

4

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