Exhibit 10.1

CONSULTING SERVICES AGREEMENT BETWEEN

SAVIENT PHARMACEUTICALS, INC.

AND

Lee S. Simon, MD

 

THIS CONSULTING SERVICES AGREEMENT (hereinafter referred to as the “Agreement”)
effective as of the 22nd day of January, 2009 by and between Savient
Pharmaceuticals, Inc., a corporation organized under the laws of the State of
Delaware with a place of business at One Tower Center, East Brunswick, New
Jersey 08816 (hereinafter referred to as “Company”), and Lee S. Simon, MD
(hereinafter referred to as “Consultant”).

In consideration of the promises and mutual covenants contained herein and on
the terms and conditions hereinafter set forth, it is agreed as follows:

1.       
PROVISION OF SERVICES - Consultant shall provide to Company, at the direction
and under the supervision of the Company’s Board of Directors, and in
cooperation with the Officers and employees of the Company, the following
services:
          (a)       
To the extent reasonably required in the conduct of the business of Company, to
place at the disposal of Company Consultant’s judgment and professional
expertise in the field of rheumatology, as well as clinical, medical and
regulatory affairs (the “Field”), and in rendering advice and consulting
services to the Company, including, but not limited to:
            (i)       
The day-to-day management of the Company’s Medical Affairs and Regulatory
Affairs operations with respect to all matters relating to the Biologics
Licensing Application (“BLA”) for pegloticase which is pending before the US
Food and Drug Administration (“FDA”);
    (ii)
Acting in the capacity of the Chair of the Board of Directors BLA Oversight
Committee;
    (iii)
In conjunction with the Company’s President, provide clinical, medical and
regulatory affairs oversight of the strategic review process being conducted by
the Company with the assistance of its investment bankers, Lazard;
    (iv)
In conjunction with the Company’s President, provide clinical, medical and
regulatory affairs oversight of aspects of

 

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the Company’s investor relations program relating the pegloticase BLA; and
    (v)       
other related services deemed necessary and requested by the Company’s Board of
Directors (collectively, the “Services”).
          (b)       
Consultant shall not assign any obligations hereunder or retain other third
parties for the performance of the Services without the prior written consent of
Company.
      2.       
COMPENSATION
          (a)       
(i) Company agrees and shall compensate Consultant in consideration of
Consultant’s performance of the Services hereunder by paying Consultant the
aggregate sum of $500,000, payable in eleven (11) equal installments of
$45,454.54, the first such payment being due and payable on February 27, 2009,
with the remaining payments being due and payable on the last business day of
each calendar month through December 31, 2009.
   

   
(ii) Consultant shall devote all business time, energies, attention, skill and
effort necessary for the accomplishment of the objectives set by the Company’s
Board of Directors relating to the Services. Services may be rendered by
Consultant in person at the Company’s offices or remotely from Consultant’s
office.
   

  (b)       
In addition to the compensation set forth in paragraph 2(a)(i) above, the
Company agrees to reimburse Consultant for reasonable out-of-pocket expenses
actually incurred by Consultant in the performance of the Services, including,
but not limited to telephone and facsimile charges and calls, car rental,
lodging, travel expenses, meals and associated expenses.
   

  (c)       
Consultant shall submit Invoices to the Accounts Payable department of the
Company for the unbilled amount of out-of-pocket expenses incurred by Consultant
for the prior period for which Consultant seeks reimbursement. Such Invoices
shall be payable within thirty (30) days of receipt. Consultant shall provide
Company with supporting receipts and documentation for any out-of-pocket
expenses which individually exceed $25 as an attachment to the billing
statement. The Consultant shall be responsible for all taxes owing to any and
all governmental agencies that may result

 

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due to the existence of this Agreement and the remuneration for the Services
provided hereunder.
    3.       
TERM & TERMINATION
        (a)       
This Agreement shall enter into force and effect at the date first written above
and shall remain in force and effect for the period ending on the earlier of (i)
the first pass approval of the pegloticase BLA by the FDA, (ii) the completion
of the strategic review process with the announcement of a transaction approved
by the Company’s Board of Directors, or (iii) December 31, 2009. In the event
that this Agreement terminates prior to December 31, 2009 for a reason specified
in clause (i) or (ii) of the preceding sentence, the full amount of the
consulting compensation specified in paragraph 2(a)(i) shall be deemed earned by
Consultant in full, provided, however, the monthly payments specified herein
shall continue until the full amount of the consulting compensation has been
paid.
        (b)       
Notwithstanding the foregoing, the Company may terminate this Agreement
effective immediately upon delivery of written notice to Consultant in the event
Consultant breaches in any material respect any provision of this Agreement and
such breach continues uncured for 5 days following written notice of such breach
by Company. In the event that this Agreement is terminated pursuant to this
paragraph 3(b), Consultant shall only be entitled to payment hereunder and for
expenses incurred prior to the effective date of termination.
        (c)
Paragraphs 4, 5, 6, 7, 8 and 9 of this Agreement shall survive any termination
of this Agreement.
      4.       
CONFIDENTIALITY OF INFORMATION AND DOCUMENTS - Company shall submit information
and/or documents to Consultant in order to permit Consultant to perform the
Services required under this Agreement and Consultant shall keep such
information and/or documents in the strictest confidence using the same degree
of care that Consultant uses in safeguarding Consultant’s own confidential
information both during and after the completion of the services under this
Agreement and for a period of ten (10) years after completion of the Services,
unless Consultant shall receive from Company the consent of Company in writing
to disclose such confidential information. However, nothing herein shall be
interpreted as preventing Consultant from disclosing and/or using said
information or documents which (i) are already rightfully in the possession of
Consultant

 

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without obligation of confidence, but were not obtained directly or indirectly
from Company or its affiliates; or (ii) are independently developed by
Consultant not as part of the Services rendered or called for under the terms of
this Agreement and without reliance or use of Company’s confidential information
or documents; or (iii) are or become available to the general public without
breach of this Agreement; or (iv) are rightfully received by Consultant from a
third party who is not under obligation of confidence, but who did not obtain
them directly or indirectly from Company or its affiliates; or (v) are required
to be disclosed pursuant to law or court order, or as may be authorized by
Company.
    5.       
LIABILITY OF CONSULTANT - In furnishing Company with the Services provided
herein, Consultant shall comply with all applicable laws, rules and regulations.
In addition to the foregoing, Consultant agrees to abide by the guidelines
contained in the most recent version of the Pharmaceutical Research and
Manufacturers Association (PhRMA) Code on Interactions with Healthcare
Professionals. Consultant agrees that, if Consultant as of the Effective Date of
this Agreement and for a period of two (2) years following the termination of
this Agreement is or becomes a member of a committee that sets formularies of
covered medicines or which develops clinical practice guidelines that may
influence the prescribing of medicines, Consultant shall disclose to such
committee the existence of this Agreement and the nature of the relationship
between Consultant and Company.
     
Consultant shall not be liable to Company or its creditors for errors of
judgment or for any matters, except for willful malfeasance, bad faith or gross
negligence in the performance of the Services or the negligent breach of its
obligations and duties under the terms of this Agreement. It is further agreed
and understood that Consultant may rely upon information furnished to it by
Company which Consultant reasonably believes to be accurate and reliable and
that, except as provided herein, Consultant shall not be accountable for any
loss suffered by Company by the reason of Company’s action or non-action on the
basis of any advice, recommendation or approval of Consultant, its employees,
officers, directors or agents, except as provided above.
    6.       
PUBLICATIONS - In the event, during the term of this Agreement and for a period
of five (5) years from the expiration or other termination for any reason of
this agreement, Consultant wishes to publish any scientific, business or other
articles or papers related to the Services provided to or work with the Company,
Consultant will submit such proposed articles and papers to the Company for its
review and possible action to protect its patent rights at least three (3)
months prior to the proposed publication or

 

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disclosure date. The Company will review promptly Consultant’s proposed
publications. If the Company, in its sole discretion, determines that it can do
so without compromising its present or potential patent rights or competitive
position, the Company will waive all or a portion of this three-month period.
The Company further agrees to review portions of proposed publication, as
Consultant makes such portions available, and to conduct its review of such
portions in a manner comparable to its review of complete proposed publications.
    7.       
INVENTIONS - To the extent Consultant has any invention rights, any invention,
discovery, improvement or other work product, whether or not patentable, or any
copyrightable work, which are conceived, made, created, prepared or developed
during the term of this Agreement: by Consultant, alone or with others, (i)
which are directly related to any question or problem with respect to which the
Company has utilized Consultant’s services under this agreement, or (ii) which
results from Consultant’s knowledge of confidential or non-public information
received from the Company, (hereinafter “Inventions”) all such Inventions shall
be and remain the sole and exclusive property of the Company and Consultant
shall retain no rights in or to the same. Upon the request by the Company,
Consultant will promptly execute all applications, assignments or other
instruments which the Company deems necessary in order to apply for and obtain
Letters Patent in the United States and foreign countries on any such Invention
and in order to assign and convey to the Company the sole and exclusive right,
title and interest in and to said Invention and any patent application or patent
based thereon. It is understood that the Company will bear the entire cost of
preparing and filing any such applications in the United States Patent Office
and in the patent offices of foreign countries.
    8.       
INDEPENDENT CONTRACTOR
        (a)       
Execution of this Agreement in no way creates, nor shall this Agreement be
interpreted or construed as creating, an employment, agency, partnership or
joint venture relationship between Company and Consultant and it is understood
Consultant will be acting as an independent contractor. Neither party shall have
the authority to legally bind the other in contract, debt or otherwise or to
represent itself as an agent, employee or in any other capacity of the other.
        (b)       
Consultant shall not be entitled to any benefits, coverages or privileges,
including, without limitation, social security, unemployment, medical or pension
payments, made available to employees of the Company.

 

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  (c)       
Consultant shall have sole responsibility for payment of all federal, state and
local taxes or contributions imposed or required under unemployment insurance,
social security and income tax laws and for filing all required tax forms with
respect to any amounts paid by the Company to Consultant hereunder.
        (d)       
Notwithstanding any contractual or other indemnification rights available to
Consultant in his capacity as a director of the Company, Consultant shall
indemnify and hold the Company harmless against any claim or liability of any
kind (including penalties, fees or charges of any kind whatsoever) resulting
from failure by Consultant to pay taxes as described in paragraph 8(c).
        (e)
For purposes of the indemnification provisions in each of the Company’s By-Laws
and the Indemnity Agreement dated May 23, 2006 between Company and Consultant
(the “Indemnity Agreement”), Company and Consultant agree that Consultant shall
be an “agent” of the Company for purposes of providing the Services pursuant to
the terms of this Agreement. Company and Consultant agree that this Agreement
shall not supersede any the Indemnity Agreement or any other indemnification
agreement previously signed by the parties hereto.
    9.       
MISCELLANEOUS
        (a)       
Nothing contained herein shall be deemed to require Company to take any action
contrary to its Certificate of Incorporation or By-Laws, or any applicable
statute or regulation, or to deprive its Board of Directors of their
responsibility for any control of the conduct or the affairs of Company.
        (b)       
The failure by Consultant to perform any services under this Agreement within
the time-frame or to the specifications provided by Company due to (a) acts of
God or the public enemy, fire, explosion, sabotage, flood, drought, war, riot,
accident or embargo; (b) inadequacy or shortage or failure of normal sources of
supply of materials, energy or equipment; (c) strikes or labor strike; (d)
compliance by Consultant with any law, rule, regulation, order or action, of any
governmental department, agency or authority; or (e) for any other cause or
reason beyond the reasonable control of Consultant shall not constitute a breach
of this Agreement or Consultant’s duties and obligations under this Agreement.

 

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  (c)       
This Agreement shall constitute the entire agreement between Company and
Consultant relating to the Services to be performed, and no representations,
promises, understandings, or agreements, oral or otherwise, not herein contained
shall be of any force or effect. No modification or waiver of any provision of
this Agreement shall be valid unless it is in writing and signed by both Company
and Consultant. This Agreement shall be binding upon the heirs, executors,
administrators, successors and assigns of the parties hereto.
        (d)       
Consultant warrants that Consultant is not now, nor has ever been, debarred or
suspended by any agency of the government, or is excluded from participating any
Federal healthcare program, or has received notice of intent to seek such
action. Consultant further warrants that it shall not permit any person who is
or has been debarred from performing any Services pursuant to this Agreement.
        (e)
This Agreement is not assignable by Consultant or Company without the prior
written consent of the other party, which consent shall not be unreasonably
withheld or delayed.
               (f)       
This Agreement shall be governed by, and construed in accordance with, the laws
of the State of New Jersey.
        (g)       
Any notices required to be given hereunder, shall be sent to each respective
party at the addresses first given above, addressed to the President of each
entity, and shall be effective upon receipt by the addressee.

[the next page is the signature page]

 

 

 

 

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IN WITNESS WHEREOF, the parties hereto, by their duly authorized
representatives, have signed this Agreement as of the date first above written.

Savient Pharmaceuticals, Inc.   Lee S. Simon, MD       By:
[c57430_ex10-1x8x1.jpg]                  By:         [c57430_ex10-1x8x2.jpg]  
Stephen O. Jaeger           Lee S. Simon, MD                              
Chairman      

[c57430_ex10-1x8x3.jpg]

 

 

 

 

 

 

 

 

 

 

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