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FIRST AMENDED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT

Distribution Agreement

FIRST AMENDED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT | Document Parties: REGENERATION TECHNOLOGIES INC | Exactech, Inc You are currently viewing:
This Distribution Agreement involves

REGENERATION TECHNOLOGIES INC | Exactech, Inc

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Title: FIRST AMENDED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT
Governing Law: Florida     Date: 3/16/2006
Industry: Healthcare Facilities     Sector: Healthcare

FIRST AMENDED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT, Parties: regeneration technologies inc , exactech  inc
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Exhibit 10.24

CONFIDENTIAL TREATMENT REQUESTED BY REGENERATION TECHNOLOGIES, INC. FOR CERTAIN PORTIONS OF THIS AGREEMENT IN ACCORDANCE WITH RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

FIRST AMENDED EXCLUSIVE LICENSE AND DISTRIBUTION AGREEMENT

This First Amended Exclusive License and Distribution Agreement (“Agreement”) is made effective the 19 th day of December, 2005, by and between Regeneration Technologies, Inc. (“RTI”) and Exactech, Inc. (“Exactech”).

WHEREAS, RTI and Exactech are parties to an Exclusive License Agreement effective July 1, 2002, wherein RTI granted Exactech an exclusive license to distribute products developed from the Licensed Technology for all orthopaedic procedures outside of the human spine;

WHEREAS, RTI and Medtronic Sofamor Danek, Inc. (“MSD”) are parties to a First Amended Exclusive Distribution and License Agreement effective April 15, 2004 , wherein RTI granted MSD an exclusive license to distribute Bone Paste products developed from the Licensed Technology for use in the human spine;

WHEREAS, MSD and Exactech have each indicated a desire to allow the other and RTI to distribute Bone Paste products into the exclusive licensed field and licensed territory of both MSD and Exactech; and

WHEREAS, RTI and Exactech desire to enter into a new license and distribution agreement to replace and supersede the July 1, 2002 Exclusive License Agreement and to implement the desires of MSD and Exactech.

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth below, the parties covenant and agree as follows:

I. Definitions.

 

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A. “Licensed Technology” shall refer to and mean (1) products containing a gelatin carrier and an osteoinductive substance and/or (2) products containing a gelatin carrier and an osteoconductive substance, with or without an osteoinductive substance.

B. “Bone Paste Products” shall refer to and mean any and all products comprised of the Licensed Technology, regardless of shape, size, volume, composition, storage capacity or delivery method, including, but not limited to, the products listed and described on Exhibit A and any products developed from the Licensed Technology subsequent to the execution of this Agreement.

C. “Flowable Bone Paste Products” shall refer to and mean Bone Paste Products comprised of an osteoinductive substance and a gelatin carrier.

D. “Moldable Bone Paste Products” shall refer to and mean Bone Paste Products comprised of a gelatin carrier and cortical cancellous chips, with or without an osteoinductive substance.

E. “Cortical cancellous chips” shall refer to and mean bone chips consisting of cortical bone, cancellous bone, cortical cancellous bone or a mixture or combination of cortical bone, cancellous bone and/or cortical cancellous bone.

F. “Licensed Field” shall refer to and mean the field of human orthopaedic surgical procedures.

G. “Orthopaedic” shall refer to and mean the medical specialty concerned with the preservation, restoration, and development of form and function of the musculoskeletal system, extremities, spine, and associated structures by medical, surgical, and physical methods.

 

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H. “Intellectual Property” shall refer to and mean any and all United States patent(s) and trademark(s), patent and trademark applications, and/or any pertinent continuations, continuations-in-part, and/or divisional applications, as well as foreign counterparts thereof, trade secrets, and proprietary information relating to the Licensed Technology and/or any Bone Paste Product, whether currently existing or obtained subsequent to the execution of this Agreement.

I. “Licensed Territory” shall be throughout the world, except where distribution of Bone Paste Products is unlawful.

II. Grant.

A. License .

RTI hereby grants to Exactech a license to distribute throughout the Licensed Territory any and all Bone Paste Products (both Moldable and Flowable) for use in the Licensed Field. This license shall not operate to prohibit Medtronic Sofamor Danek, Inc. (hereinafter “MSD”) from distributing Bone Paste in the Licensed Field so long as MSD shall grant Exactech permission to distribute Bone Paste for use in the human spine throughout the world and provided that this license shall not operate to prohibit RTI from distributing Bone Paste products in the Licensed Field and Licensed Territory, exclusive of Spain and Portugal. Provided further, however, that neither MSD nor RTI shall use the trade names “Optefil”, “Opteform”, “Regenafil”, or “Regenaform” with the distribution of any products. Exactech shall not use the trade names “Osteofil”, “Osteofil IC”, and “Osteofil ICM” with the distribution of any products.

B. Oral-Dental Indications.

RTI further agrees to not directly distribute Bone Paste for oral-dental indications or applications, provided Exactech achieves the following minimum annual performance levels

 

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based upon annual Transfer Distribution and License Service Fees (“TDLSF”) for Bone Paste Products for oral-dental indications and applications:

 

 

 

 

 

 

2006

  

$

[

*** ]

2007

  

$

[

***]

2008

  

$

[

*** ]

2009

  

$

[

***]

2010

  

$

[

***]

2011

  

$

[

***]

2012

  

$

[

***]

2013

  

$

[

***]

2014

  

$

[

***]

Such restriction, however, does not prohibit MSD from distributing Bone Paste Products for oral-dental indications or applications in the Licensed Territory at all times during the term of this Agreement.

C. License of RTI Marks.

During the term of this Agreement, RTI grants to Exactech a royalty-free, non-transferable license under the quality control of RTI to use the marks “Regeneration Technologies, Inc.” and “RTI” in connection with the distribution of Bone Paste Products under this Agreement. RTI warrants that it has full right and title to license such marks, and to the best of its knowledge, there are no pending or current lawsuits involving the use of the marks in the manufacture, processing or distribution of Bone Paste Products in the Licensed Territory. Exactech shall not use these marks in distribution, promotion, advertising, or any other form of publicity or external communication without the prior written approval of RTI, which will not be unreasonably withheld.

RTI also grants to Exactech during the term of this Agreement a royalty-free, non-transferable license within the quality control of RTI to use the marks listed on Exhibit B and/or any future marks obtained in connection with the development and/or distribution of Bone Paste


[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Products within the Licensed Field and the Licensed Territory. Provided however, that RTI further grants Exactech a royalty-free nontransferable license under the quality control of RTI to use any future marks obtained in the development and/or distribution of Bone Paste Products developed solely for Exactech for distribution/use in the spine. RTI warrants that it has full right and title to license such marks, and to the best of its knowledge, there are no pending or current lawsuits involving the use of the marks in the manufacture, processing or distribution of Bone Paste Products within the Licensed Territory. Exactech shall not use any of these marks in distribution, promotion, advertising, or any other form of publicity or external communication without the prior approval of RTI, which will not be unreasonably withheld.

III. Consideration.

A. Transfer Distribution and License Service Fee.

Exactech agrees to pay RTI a Transfer Distribution and License Service Fee (hereinafter “TDLSF”) for all Bone Paste Products shipped by RTI to Exactech or shipped directly by RTI to any third party subject to this Agreement at the directive of Exactech. The TDLSF shall be equal to the amounts listed on Exhibit A attached hereto and as amended from time to time. In the event of a material increase or decrease in either regulatory compliance costs or donor tissue processing costs, or any other circumstance that either party reasonably anticipates will have an immediate and material impact on the marketplace for Bone Paste Products, the parties agree to meet within ten (10) business days of a written request by either party and confer in good faith to reach mutual agreement on any adjustments to any Bone Paste Product TDLSF charged by RTI. Notwithstanding, RTI may increase the TDLSF for any and all Bone Paste Products on the first anniversary of this Agreement, and thereafter not more than once annually, upon sixty (60) days written notice to Exactech.

 

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B. [***] for Moldable Bone Paste Product Sales.

[***]

C. Accounting Payments.

1. Amounts owing to RTI under Section III.A. shall be paid by Exactech within [***] days of invoice issuance by RTI. Any amounts which remain unpaid after [***] days from the end of the month in which they were earned shall accrue interest from that date until paid at the rate of [***] percent ([***]%) per year.

2. Except as otherwise directed, all amounts owing to RTI or Exactech under this Agreement shall be paid in U.S. dollars at the addresses provided in Section XVIII. herein. All amounts owing with respect to TDLSF and royalties stated in currencies other than U.S. dollars shall be converted at the rate shown in the Federal Reserve Noon Valuation – Value of Foreign Currencies on the day preceding the payment.

3. A full accounting of all monthly distributions of Moldable Bone Paste Products in the Licensed Field, except for those products distributed by Exactech, shall be submitted by RTI to Exactech by the [***]. Such accounting shall be on a per distribution agent and per Moldable Bone Paste Product basis, and shall be summarized in a format agreed upon by the parties. [***], RTI shall provide Exactech with a written statement setting forth such fact.

IV. Product Supply and Distribution.

A. Bone Paste Product Orders.

 


[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***]

 


[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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[***]

B. Bone Paste Product Production Forecast.

[***]

V. Product Promotion and Marketing.

A. Exactech shall utilize best efforts to promote and market Bone Paste Products in the Licensed Field and in the Licensed Territory. Exactech agrees to provide educational services regarding Bone Paste Products to customers and potential customers, including, but not limited to, surgeons, hospital personnel, customer support staff, and potential buying groups in the Licensed Field. Such services shall include education on Bone Paste Product design, ordering, delivery and stocking procedures.

B. Exactech shall support the marketing and distribution of Bone Paste Products in the Licensed Field by providing, where necessary, and upon reasonable notice, personnel or marketing agents to attend surgical cases at the clinical level.

C. RTI agrees that its independent sales force shall not solicit, pursue, or target Exactech major customers. Exactech’s major customers shall be specified in writing by Exactech to RTI within thirty (30) days of this Agreement. The Exactech major customer list may be amended from time to time by Exactech with proper written notice to RTI.

The parties also agree to meet either in person or telephonically each quarter to cooperate on marketing efforts of Bone Paste Products. The parties shall, in good faith, seek to resolve any

 


[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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disputes concerning the soliciting or targeting of Bone Paste Product distribution opportunities or potential Bone Paste Product customers.

D. RTI agrees to label all Bone Paste Products that are to be distributed by Exactech subject to this Agreement with the unique Exactech name and include on all Bone Paste Product labels a statement that the product is “processed by Regeneration Technologies, Inc.”

E. Notwithstanding the above, RTI agrees to continue to provide ongoing marketing support to Exactech (as described in Section VI.D. above) to promote Bone Paste Products.

VI. Development and Distribution of New Products.

A. Subsequent to the execution of this Agreement, RTI agrees to work with Exactech to develop new Bone Paste Products for use within the Licensed Field and to rationalize the Bone Paste Product line so that Exactech can offer Bone Paste Products within the Licensed Field that Exactech customers reasonably want and need. RTI shall support the parties’ co-development of new Bone Paste Product for distribution within the Licensed Field designs by producing, at Exactech’s reasonable request, specific product prototypes for testing and clinical evaluation. Exactech agrees to reimburse RTI for its cost in producing such prototypes, with such cost mutually agreed upon between the parties at the time of Exactech’s request.

B. Any new Bone Paste Product co-developed by Exactech and RTI for use within the Licensed Field subsequent to the execution of this Agreement will be co-owned by Exactech and RTI. Any new Bone Paste Product developed independently by either party or by any other person in cooperation with either party for use within the Licensed Field will be owned by that party and any other person with whom that party collaborates. In the event RTI, without any collaboration from another person, develops a new Bone Paste Product from the Licensed Technology independently of Exactech, RTI agrees to make that Bone Paste Product available to

 

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Exactech for distribution in the Licensed Field, subject to the evaluation process and criteria described in Section VI.C. below. In the event Exactech develops a new Bone Paste Product from the Licensed Technology independently of RTI, Exactech agrees to license that Bone Paste Product to RTI for distribution subject to the terms of this Agreement and subject to the evaluation process and criteria described in Section VI.C. below.

C. The parties agree to evaluate any proposed new Bone Paste Product prior to any distribution to determine its market and economic feasibility. Evaluation criteria to be considered will include, but not be limited to, cost of product development , including any costs associated with intellectual property development, cost of processing, distribution, storage and handling, potential customer demand, and pricing. The TDLSF to be paid by Exactech to RTI for any new Bone Paste Products distributed by Exactech shall be negotiated by the parties in good faith.

D. The parties agree to conduct meetings on a quarterly basis to facilitate the development of additional Bone Paste Products and/or the improvement of Bone Paste Product design.

VII. Patents and Intellectua


 
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