-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, N6rRnGZrRsHnxOmBmpI38S355wfOaHugzFlamC4WFDFVcaSG0kvhzbF5qSejwC4f ZA/i1SxRY06LJu+zqu7/DQ== 0000950120-08-000427.txt : 20080905 0000950120-08-000427.hdr.sgml : 20080905 20080905153153 ACCESSION NUMBER: 0000950120-08-000427 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080827 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080905 DATE AS OF CHANGE: 20080905 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOSPECIFICS TECHNOLOGIES CORP CENTRAL INDEX KEY: 0000875622 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 113054851 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19879 FILM NUMBER: 081058629 BUSINESS ADDRESS: STREET 1: 35 WILBUR ST CITY: LYNBROOK STATE: NY ZIP: 11563 BUSINESS PHONE: 5165937000 MAIL ADDRESS: STREET 1: 35 WILBUR STREET CITY: LYNBROOK STATE: NY ZIP: 11563 8-K 1 form8-k.htm CURRENT REPORT form8-k.htm
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported):  August 27, 2008
 
BIOSPECIFICS TECHNOLOGIES CORP.
(Exact name of registrant as specified in its charter)

 
Delaware
0-19879
11-3054851
(State or Other Jurisdiction
of Incorporation)
(Commission File Number)
(IRS Employer
Identification No.)
 
 
35 Wilbur Street
Lynbrook, NY  11563
(Address of Principal Executive Office) (Zip Code)

516.593.7000
(Registrant's telephone number, including area code)
 


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR.425)

[  ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 
Introductory Comment

Throughout this Current Report on Form 8-K, the terms “we,” “us,” “our” and “Company” refer to BioSpecifics Technologies Corp.

ITEM 1.01.         ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
 
On September 5, 2008, the Company announced its entry into an agreement to improve the deal terms related to its future royalty obligations for Peyronie’s disease by buying down its future royalty obligations with a one-time cash payment.  A copy of the press release is attached hereto as Exhibit 99.1.
 
A copy of the form of the agreement is attached hereto as Exhibit 10.1 and is incorporated by reference into this Item 1.01.  The foregoing description of the agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement.
 
ITEM 9.01.          FINANCIAL STATEMENTS AND EXHIBITS
 
(d)           Exhibits
 
 
10.1
Agreement dated August 27, 2008 *
 
 
99.1
Press Release dated September 5, 2008
 
*  Portions of Exhibit 10.1 have been omitted pursuant to a request for confidential treatment.
 


 
SIGNATURES
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, each registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
     
     
Date: September 5, 2008
 
BIOSPECIFICS TECHNOLOGIES CORP.
——————————————————
(Registrant)
 
 
/s/ Thomas L. Wegman
   
——————————————————
Thomas L. Wegman
President
 
 
 
 

 
EXHIBIT INDEX
 
Exhibit No.
 
Description
     
10.1
 
     
99.1
 
 
EX-10.1 2 exh10-1.htm AGREEMENT DATED AUGUST 27, 2008 exh10-1.htm
Exhibit 10.1

            This AMENDED AND RESTATED AGREEMENT (the “Agreement”) is made as of the 27th day of August, 2008 by and between <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> and ADVANCE BIOFACTURES CORPORATION AND ITS AFFILIATES, 35 Wilbur Street, Lynbrook, NY 11563, hereinafter referred to, collectively, as the “Company.” <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>

            WHEREAS, the Company desires to engage <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> as an independent contractor and not as an employee to render the services and grant the rights described below and <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> desires to render such services and grant such rights,

NOW, THEREFORE, it is agreed:
 
1.  Services:  <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> will provide consulting services to the Company at its request in connection with the clinical testing and development of a pharmaceutical product based on Collagenase ABC for the treatment of Peyronie’s Disease (the “Product”), such consulting services shall be for no more than five (5) days per year unless otherwise mutually agreed.
 
 
2.  Term:  The consulting services shall be for a period of twelve (12) months commencing on the date hereof and continuing thereafter until terminated by either party on not less than three months’ prior written notice to the other party at the addresses stated above or at an address chosen subsequent to the execution of this Agreement and duly communicated to the party giving notice.
 
 
3.  Consultations:  <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> shall be available to render the services described above to the Board of Directors, the officers and scientific staff and consultants of the Company provided that the Company shall pay reasonable travel expenses and <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> per day (including time for travel).  All payments to made under this Agreement shall be made by wire transfer of immediately available funds to an account designated in writing from time to time by <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>.
 
 
4.  Compensation: <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> shall receive from the Company in consideration of the services to be rendered and rights granted hereunder the following compensation whether or not the Company has terminated his engagement prior thereto: <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>
 

 
5.  Access to Records.
 
a.  
Upon the written request of <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION>, and not more than one (1) time per calendar year, the Company shall permit <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> or an independent certified public accounting firm selected by <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> to have access upon reasonable advance notice and during normal business hours to such records of the Company or BTC as may be reasonably necessary to verify the accuracy of the quarterly royalty statements provided by the Company.  The accounting firm shall enter into a customary confidentiality agreement with the Company and BTC to maintain in confidence all information of the Company and BTC disclosed in connection with any such audit.  Any such audit shall be at the expense of <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> unless it reveals an underpayment of 5% or more of the amount that should have been paid to <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> for the period audited, in which case the Company shall bear the cost of the audit. Pursuant to Section 10.3 of the Development Agreement, any sales data conveyed to <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> or the accounting firm under this Agreement shall be maintained by him or the accounting firm in the strictest confidence, provided that <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> may disclose such info to his personal accountant, if necessary for the preparation of his personal tax returns.
 
 
b.  
The Company and BTC shall retain such books and records for a period of no less than five (5) years from the date of this Agreement.
 
 
6.  Options:  This Agreement shall have no affect on the Prior Stock Option Grant, which will continue in full force and effect in accordance with its terms.
 
 
7.  Use of Name: <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> grants the Company and BTC the right to use his name in connection with documentation prepared during his engagement relating to clinical investigation and approval of the Product subject to his approval of the scientific content of the documentation, which approval shall not unreasonably be withheld.
 
 
8.  Confidentiality and Rights: <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> agrees to keep in confidence and except as may be required by law not to disclose to anyone any information relating to the Product, or the plans or operations of the Company or BTC of which he may become aware during the engagement, and in particular shall not submit for publication or present to any forum information relating thereto without the prior written consent of the Company and agrees to assign to the Company any inventions, discoveries or improvements he may make relating to the Product without additional consideration.
 
2

 
9.  Indemnity and Insurance:  The Company will arrange for <OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION> to be named as an additional insured on the Company’s or BTC’s liability policy and will indemnify and defend him against any claim for damages allegedly caused by the Product whether or not the Company or BTC is named in the suit but only if the clinical trial that gives rise to any claim was sponsored by the Company or BTC, unless such claim is based upon his own personal negligent act or omission.
 
 
10.  Miscellaneous:  The validity, performance, construction and effect of this Agreement shall be governed by the substantive laws of the State of New York without reference to conflicts of laws provisions.  Any disputes arising under, or in connection with this Agreement, shall be submitted, by a written notice of a request to arbitrate by either party, to final and binding arbitration under the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) then in force.  The arbitration, which shall be before a single-member arbitral tribunal appointed by the AAA, shall be held in Los Angeles, California.  This Agreement may not be assigned by either party without the express written consent of the other, except that the Company may assign this Agreement to the Company or to any third party which acquires (whether by merger, sale of assets or otherwise) all or substantially all of that portion of the Company’s or the Company’s business to which this Agreement pertains.  This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all previous agreements, whether written or oral, including, but not limited to, the Prior Agreement but excluding the Prior Stock Option Grant, which shall continue in full force and effect in accordance with its terms.  This Agreement may not be modified orally, but only by an instrument in writing signed by both parties.  If any provision of this Agreement is declared invalid or unenforceable that provision shall be deemed fully severable. The remaining provisions of this Agreement shall remain in full force and effect and will be construed as if the invalid and unenforceable provision had been deleted.  It is expressly agreed that the parties are independent contractors and the relationship will not constitute a partnership or agency of any kind.  Neither party may bind the other or make statements on behalf of the other without prior written consent.  The captions used in this Agreement are inserted for convenience of reference only and shall not be construed to create obligations, benefits or limitations.  This Agreement may be executed in counterparts, each of which shall constitute an original and all of which taken together shall constitute one and the same instrument.  This Agreement shall be binding upon any successors and assigns and, in the event that the Company or all of its assets are purchased, this Agreement shall be binding upon the purchaser.
 
3

 
             IN WITNESS WHEREOF, the parties hereto have executed this Agreement.

     
Advance Biofactures Corporation
 
 
 
 
<OMITTED AND FILED SEPARATELY WITH THE  SECURITIES
 
By:
/s/ Thomas L. Wegman
  AND EXCHANGE COMMISSION>    
Thomas L. Wegman, President
 
 

EX-99.1 3 exh99-1.htm PRESS RELEASE exh99-1.htm
Exhibit 99.1
 
BioSpecifics Technologies Corp. Buys Down Royalties for Peyronie's Disease

Sep 5 08:00 AM US/Eastern

LYNBROOK, N.Y., Sept. 5 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (OTC Bulletin Board: BSTC), a biopharmaceutical company developing first in class collagenase based products, announced today that it has signed an agreement to significantly improve the deal terms related to its future royalty obligations for Peyronie's disease by buying down its future royalty obligations with a one-time cash payment.

BioSpecifics has modified its previously announced agreement to lower future royalties payable on net sales of its injectable collagenase, XIAFLEX(TM), for Peyronie's disease. The Company has taken this strategic step because of the imminent initiation of the Phase 2b clinical trial, lack of currently available desirable therapeutic options for Peyronie's patients, the strong commitment of the Company's partner Auxilium Pharmaceuticals to pursue the development for this clinical indication and the results of the three separate positive clinical trials published to date.

BioSpecifics has previously announced that its third party royalty obligations for Dupuytren's disease are 0.5% of net sales.

Auxilium is obligated to pay low double digit royalties at a flat rate as a percentage of future worldwide net sales for all clinical indications, irrespective of territory, and independent of sales volume. BioSpecifics will also receive a percentage of non royalty payments (upfront, milestones, etc.) if Auxilium sub-licenses the marketing rights to a third party. In addition, BioSpecifics will receive a certain percentage mark up on cost of goods based on Auxilium's manufacturing costs.

About Peyronie's Disease

Peyronie's disease is characterized by the presence of a collagen plaque on the shaft of the penis, which can distort an erection and make intercourse difficult or impossible in advanced cases. The plaque is not elastic and it does not stretch during erection. In some mild cases, the plaque can resolve spontaneously without medical intervention. The most common plaque forms on the top of the penis causing the penis to arc upward. In severe cases, the penis can be bent at a 90-degree angle during erection. Significant psychological distress has been noted in patients with Peyronie's disease who are sexually active. Frequent patient complaints include increased pain, painful erections, palpable plaque, penile deformity, and erectile dysfunction. Patients with Peyronie's disease have been reported to have an increased likelihood of having Dupuytren's disease, frozen shoulder, plantar fibromatosis, knuckle pads, hypertension and diabetes. Peyronie's disease typically affects males in the range of 40-70 years. The cause of Peyronie's disease is unknown, although some investigators have proposed that it may be due to trauma or an autoimmune component. A number of researchers have suggested that the incidence of Peyronie's disease has increased due to the use of erectile dysfunction drugs.

Auxilium Pharmaceuticals has estimated that there are 210,000 potential candidates in the US and Europe for XIAFLEX treatment on an annual basis.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed and licensed injectable collagenase for three clinical indications: Dupuytren's disease, Peyronie's disease and frozen shoulder (adhesive capsulitis). The positive top line results for the Phase 3 trials on Dupuytren's disease have been previously announced. BioSpecifics has a development and licensing agreement with Auxilium Pharmaceuticals, Inc. More information about the Company may be found on its website at www.biospecifics.com.
 
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