-----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, JgUefub+i+MS6zl67OU7H1Xx1RxYhXHc4y1rKSI0/YHgjJYrfV7NsP9jwerCuCDk O+2JKfSOLeO1tQSxPsPyRg== 0001144204-05-006982.txt : 20050308 0001144204-05-006982.hdr.sgml : 20050308 20050308135749 ACCESSION NUMBER: 0001144204-05-006982 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050302 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050308 DATE AS OF CHANGE: 20050308 FILER: COMPANY DATA: COMPANY CONFORMED NAME: KENSEY NASH CORP CENTRAL INDEX KEY: 0001002811 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 363316412 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27120 FILM NUMBER: 05666280 BUSINESS ADDRESS: STREET 1: MARSH CREEK CORPORATE CENTER STREET 2: 55 EAST UWCHLAN AVE STE 204 CITY: EXTON STATE: PA ZIP: 19341 BUSINESS PHONE: 6105947156 MAIL ADDRESS: STREET 1: 55 EAST UWCHLAN AVE STREET 2: STE 201 CITY: EXTON STATE: PA ZIP: 19341 8-K 1 v014063.htm Unassociated Document

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): March 2, 2005


Kensey Nash Corporation
(Exact name of registrant as specified in its charter)


 
  Delaware
 
 0-27120
 
 36-3316412
 (State or other jurisdiction
 
  (Commission File Number) 
 
  (IRS Employer Identification No.)
 of incorporation or organization)
       

 
Marsh Creek Corporate Center, 55 East Uwchlan Avenue, Exton, Pennsylvania 19341
(Address of principal executive offices and zip code)


Registrant's telephone number, including area code: (610) 524-0188

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 (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

TABLE OF CONTENTS

 
     PAGE
     
Section 1. Registrant’s Business and Operations  
     
  Item 1.01 Entry into a Material Definitive Agreement
 2
     
Section 9. Financial Statements and Exhibits   
     
  Item 9.01 Financial Statements and Exhibits
  2
       
SIGNATURES  
 3
     
EXHIBITS  
 
 
   
1

 
Item 1.01. Entry into a Material Definitive Agreement.

On March 2, 2005, Kensey Nash Corporation (the” Company”) entered into an amendment (the “Amendment”) to the Development, Manufacturing and Supply Agreement dated March 25, 2003 (the “Agreement”) with Orthovita, Inc. pursuant to which the term of the original agreement was lengthened from seven (7) to ten (10) years from February 2004, the first commercial sale of the co-developed products, or until the year 2014 (the “Initial Term”). This Agreement is subject to an automatic three (3) year extension, unless written notice is provided by either party at least six months prior to expiration of the Initial Term. The Amendment also provides a modification to the calculation of net sales upon certain events and a termination provision that the Company may elect to exercise if Orthovita fails to achieve the agreed upon net sales. The Agreement contemplates the joint development and commercialization of new products, which are directed toward the spinal surgery and orthopedic markets and are based on Orthovita’s proprietary VITOSS bone graft substitute material in combination with the Company’s proprietary biomaterials. Under the Agreement, the Company manufactures the co-developed products and Orthovita markets and sells the products worldwide through its focused distribution channel. In addition, the Company receives a royalty on the net sales of the co-developed products.

On March 3, 2005, the Company issued a press release relating to the Amendment, which is attached hereto as Exhibit 99.1 and incorporated herein by reference.


Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1 Press Release dated March 3, 2005


2


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
     
  KENSEY NASH CORPORATION
 
 
 
 
 
 
By:   /s/ Wendy F. DiCicco
 
Wendy F. DiCicco, CPA
  Chief Financial Officer
   
   
Dated: March 8, 2005  

3

EX-99.1 2 v014063_ex99-1.htm
Exhibit 99.1
FOR IMMEDIATE RELEASE

CONTACT:      
Joseph W. Kaufmann
President and Chief Executive Officer
(610) 524-0188

Joseph M. Paiva
Chief Financial Officer
Orthovita, Inc.
610-407-5233 or 800-676-8482

KENSEY NASH CORPORATION AND ORTHOVITA, INC. ANNOUNCE NEW AGREEMENTS TO JOINTLY DEVELOP SOFT TISSUE REPAIR PRODUCTS AND EXTEND CO-DEVELOPMENT RELATIONSHIP

March 3, 2005, EXTON, PA; MALVERN, PA -Kensey Nash Corporation (Nasdaq: KNSY) and Orthovita, Inc. (NASDAQ: VITA) today jointly announced they have expanded on their existing relationship and have agreed to pursue co-development of soft tissue repair products for orthopedics. In addition, the companies agreed to a lengthened term of their original co-development agreement signed in March 2003, which has led to the launching of four product lines in the last twelve months, with more products planned.

Similar to the terms of the original agreement, Kensey Nash will manufacture the new co-developed soft tissue products and Orthovita will market and sell the products worldwide through its focused biomaterials distribution channel, with Kensey Nash receiving a royalty on the net sales. The new products are expected to be available for launch in calendar year 2006 pending receipt of required regulatory clearances. In addition, the first agreement, under which the VITOSS FOAM products have been commercialized, has been extended until 2014.

“Our co-development activities with Orthovita have been very synergistic,” commented Joe Kaufmann, President and CEO of Kensey Nash Corporation. “With these new agreements, we are looking to build on the successful relationship we have already established with Orthovita, and to extend the clinical applications of our BioBlanket™ and other related soft tissue technologies. Orthovita’s distribution system, specializing in biomaterials products for the orthopedic sector, is unique in the industry. Their focus has been an important factor in the success of the co-developed VITOSS FOAM products launched to date,” he concluded.

“Orthovita continues to identify new clinical targets for biomaterials products in the orthopedic space,” said Antony Koblish, President and CEO of Orthovita. “Kensey Nash’s extensive development expertise, in combination with our own, has been very valuable for us quickly getting useful products to surgeons to meet their clinical needs. We are pleased to be able to expand and diversify our biomaterials franchise to include bone and now soft tissue management products.”

Additional terms of the new agreements were not disclosed.

About Kensey Nash Corporation. Kensey Nash Corporation is a leading developer and manufacturer of absorbable biomaterials-based products with applications in the cardiology, orthopedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets. The Company was a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal® Vascular Closure Device, which is licensed to St. Jude Medical, Inc. The Company's TriActiv® Balloon Protected Flush Extraction System for the treatment of saphenous vein graft disease is commercialized in the European Union. The Company has submitted an application for 510(k) clearance for its TriActiv® System to the U.S. Food and Drug Administration, following the completion of a major clinical study.

1

About Orthovita, Inc. Orthovita is a leading biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. The Company’s products are used in the regeneration of bone and soft tissue. Its near-term commercial business is based on its VITOSSâ Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-derived bone material to meet a broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery and extremities markets, and VITAGEL™ Surgical Hemostat, which is a safe adherent matrix and an impermeable barrier to blood flow. Orthovita’s longer-term U.S. clinical development program is focused on our CORTOSSâ Synthetic Cortical Bone technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and market novel synthetic-based biomaterial products, and continues to pursue similar relationships with other companies in biomaterials.

Cautionary Note Regarding Forward-Looking Statements. This press release contains forward-looking statements that reflect each of Kensey Nash’s and Orthovita’s current expectations about its prospects and opportunities. The companies have tried to identify these forward-looking statements by using words such as "believe," "expects," "anticipates," "will," "should" or similar expressions, but these words are not the exclusive means for identifying such statements. The companies caution that a number of risks, uncertainties, and other important factors could cause actual results, performance or achievements to differ materially from those expressed in, or implied by, these forward-looking statements, including, without limitation, the ability of Kensey Nash and Orthovita to successfully develop and commercialize the products contemplated by the new agreement. For a more detailed discussion of these and other factors, please see Kensey Nash's and Orthovita’s filings with the Securities and Exchange Commission. Except as expressly required by the federal securities laws, the companies undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.

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