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:
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2006
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$
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2007
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$
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2008
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$
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2009
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$
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2010
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$
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2011
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$
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2012
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$
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2013
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$
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2014
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$
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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
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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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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.
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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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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.
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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
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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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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