Biospecifics Technologies Corp.: Exhibit 10.1 - Filed by newsfilecorp.com






Exhibit 10.1


	
      Confidential treatment requested under 17 C.F.R. §§
      200.80(b)(4) and 240.24b-2. The confidential portions of this
      exhibit have been omitted and are marked accordingly. The
      confidential portions have been filed separately with the Securities and Exchange Commission pursuant to a confidential treatment
      request. 




AMENDMENT TO 
AMENDED AND RESTATED AGREEMENT



This AMENDMENT TO AMENDED AND RESTATED AGREEMENT is made
as of the 31st day of March, 2012 (this “Amendment”) by and between MARTIN K.
GELBARD, M.D., 2601 W. Alameda Avenue, Burbank, CA 91505 (“Dr. Gelbard”) and
ADVANCE BIOFACTURES CORPORATION AND ITS AFFILIATES, 35 Wilbur Street, Lynbrook,
NY 11563 (collectively, the “Company”). 

RECITALS 

WHEREAS, Dr. Gelbard and the Company are parties to that
certain Amended and Restated Agreement, dated as of August 27, 2008 (the
“Agreement”); and 

WHEREAS, Dr. Gelbard and the Company desire to amend the
Agreement pursuant to the terms, provisions, covenants and conditions set forth
herein. 

NOW, THEREFORE, in consideration of the foregoing, and of the
mutual promises hereinafter set forth, and of other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties hereby agree as follows: 

AGREEMENT 

I.                 Recitals.
The recitals set forth above are incorporated herein by this reference with the
same force and effect as if fully set forth hereinafter.

II.               Changes
to the Agreement. Section 4 of the Agreement is hereby deleted in its
entirety and replaced with the following: 

	 	4. 	
      Compensation:

	 	 	 	 
	 		a. 	
      Dr. Gelbard shall receive from the Company in
      consideration of services to be rendered and rights granted hereunder the
      following compensation whether or not the Company has terminated his
      engagement prior thereto: (i) the fees for services described in Section 3
      above, <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
      EXCHANGE COMMISSION>, and the sum of $1,250,000 pursuant to the
      Agreement, all of which amounts/<OMITTED AND FILED SEPARATELY WITH
      THE SECURITIES AND EXCHANGE COMMISSION> have previously been paid
      or delivered by BTC to Dr. Gelbard; (ii) within ten (10) business days
      following March 30, 2012, the sum of $1,500,000; (iii) within ten (10)
      business days following the date the Biologics License Application (the
      “BLA”) in respect of the Product is submitted to the U.S. Food and Drug
      Administration (the “FDA”), the sum of <OMITTED AND FILED SEPARATELY
      WITH THE SECURITIES AND EXCHANGE COMMISSION>; (iv) upon the FDA’s approval of
      the BLA for general prescription marketing and sale of the Product by the
      Company and its licensees (the date of such FDA approval, the “FDA
      Approval Date”), the sum of <OMITTED AND FILED SEPARATELY WITH THE
      SECURITIES AND EXCHANGE COMMISSION>; (v) within ten (10) business
      days following the FDA Approval Date, the additional sum of <OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>;
      (vi) <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
      COMMISSION>, four additional payments of <OMITTED AND FILED
      SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>, each of
      which shall be paid within ten (10) business days following each of the
      first, second, third and fourth anniversaries of the FDA Approval Date
      (each, an “Anniversary Date”); and (vii) in addition, <OMITTED AND
      FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>, a
      royalty of <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
      EXCHANGE COMMISSION> of Net Sales (as defined in Section 4(c)) of
      the Product by the Company, BTC or their assignees, licensees or
      sublicensees for a period of time commencing on the date of the first
      commercial sale and terminating on the date which is <OMITTED AND
      FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>
      following the date of first commercial sale, such royalties to be
      payable on a quarterly basis together with a royalty statement. Each of
      the payments set forth in clauses (i) through (vi), inclusive, of this
      Section 4(a) is non-refundable and shall not be creditable against any
      obligation of the Company to pay royalties pursuant to clause (vii) of
      this Section 4(a).








	 	b. 	
      <OMITTED AND FILED SEPARATELY WITH THE SECURITIES
      AND EXCHANGE COMMISSION>.

	 	 	 
	 	c. 	
      For purposes of this Section 4, “Net Sales” shall mean
      the gross amount invoiced on account of sales of the Product to third
      parties, less the total of (i) trade, cash or quantity discounts not
      already reflected in the amount invoiced; (ii) excise, sales and other
      consumption taxes and customs duties to the extent included in the invoice
      price; (iii) freight, insurance and other transportation charges to the
      extent specifically included in the invoice price; (iv) returns or
      retroactive price reductions; and (v) compulsory payments and rebates
      directly related to sale of the Product accrued, paid or deducted pursuant
      to governmental regulations. The Company will make a good faith attempt,
      using commercially reasonable biotech industry practices, to differentiate
      between Net Sales of the Product and sales of similar products for
      purposes other than the treatment of Peyronie’s Disease in calculating the
      amount of the royalty due hereunder to Dr. Gelbard. Absent manifest error,
      the Company’s good faith differentiation shall be binding and conclusive
      on Dr. Gelbard; provided that, the quarterly royalty statements sent by
      the Company to Dr. Gelbard include the sales figures used by Auxilium
      Pharmaceuticals, Inc. in calculating the royalty amount payable by
      Auxilium to BTC pursuant to Section 7.1 of the Second Amended and Restated
      Development and License Agreement, dated August 31, 2011 (as amended, the
“Development Agreement”); and provided further, that said sales figures do not
differ materially from other publicly available sales data on the Product. 



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III.             
Construction Principles. The terms and conditions of this Amendment shall
amend, supersede, replace, govern and control over any conflicting or
inconsistent terms and conditions in the Agreement, but except as modified in
this Amendment, all other terms and conditions of the Agreement shall remain
unmodified and in full force and effect and are hereby ratified and reaffirmed
by each of the undersigned parties. Unless otherwise defined in this Amendment,
all capitalized terms shall have the same meanings as provided in the Agreement.


IV.             
 Governing Law. This Amendment shall be governed by, and construed
in accordance with, the laws of the State of New York, without giving effect to
any otherwise applicable principles of conflicts of laws. 

V.                 Counterparts.
This Amendment may be executed in any number of counterparts and by the
different parties hereto on separate counterparts and each such counterpart
shall be deemed to be an original, but all such counterparts shall together
constitute but one and the same agreement. Receipt by facsimile or electronic
mail message of any executed signature page to this Amendment shall constitute
effective delivery of such signature page. 

[Signatures appear on the following page] 


	
      CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
      AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
      PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.





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IN WITNESS WHEREOF, the parties have executed or caused this
Amendment to Amended and Restated Agreement to be executed by their respective
officers thereunto duly authorized, as applicable, effective as of the date
first above written. 

	 	                                                                           
      
	 	Martin K. Gelbard, M.D. 
		  
	 	Advance Biofactures Corporation 
		  
	 	By:                                                                            
      
	 	Name: Thomas L. Wegman 
	 	Title: President