Exhibit 10.18

Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks (********) denote omissions.

2013 DISTRIBUTION AGREEMENT

This 2013 Distribution Agreement is made and entered into as of October 12, 2013
(the “Effective Date”), by and between Medtronic Sofamor Danek USA, Inc,, a
Tennessee corporation (“MSD”), and RTI Surgical, Inc., a Delaware corporation
(“RTI”).

Recitals

WHEREAS, RTI and MSD each acknowledge that the processing and use of human
tissue for human transplantation purposes are in the public interest and in the
interest of medicine generally, and that this Agreement will enhance these
interests through facilitating the availability of processed tissue for use in
medical procedures and thereby advance the medical and scientific application
thereof;

WHEREAS, up to the Effective Date of this Agreement, RTI and MSD are parties to
that certain agreement entitled “Fourth Amendment to First Amended Exclusive
Distribution and License Agreement”, having an effective date of September 12,
2006, as amended by the “First Amendment to Exhibit A to the Fourth Amendment to
the First Amended Exclusive Distribution Agreement”, having an effective date of
May 1, 2009 (the “Prior Agreement”);

WHEREAS, the Prior Agreement would have expired on June 1, 2014;

WHEREAS, the Parties desire to engage in a mutually beneficial relationship
beyond the natural term of the Prior Agreement, but on revised terms and
conditions reflecting both historical and anticipated changes in market
dynamics;

WHEREAS, concurrent with the execution of this Agreement, RTI and MSD desire to
terminate, and hereby do terminate, said Prior Agreement, as amended, in
accordance with Section 7.2(c) therein; and

WHEREAS, RTI desires to appoint MSD as a distributor of Implants throughout the
Territory for use in the Field (each capitalized term as defined below), and MSD
desires to accept such appointment in accordance with the terms and conditions
of this Agreement.

Agreement

In consideration of the mutual covenants contained in this Agreement, MSD and
RTI agree as follows:

ARTICLE I 

DEFINITIONS AND RULES OF CONSTRUCTION

1.1. Definitions.

(a) Terms Defined in this Article. For purposes of this Agreement, including the
Recitals above, the following terms shall have the following meanings:

“Adverse Event” means any adverse health event to which an Implant has or may
have contributed. The term is generally limited to those events that would be
reportable to a Regulatory Authority; e.g., applicable reporting through
MedWatch to the FDA (U.S.) or Adverse Reaction/Vigilance Reporting to Competent
Authorities (EU).

 

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“Affiliate” means, when used with reference to a Party, any individual or entity
directly or indirectly controlling, controlled by, or under common control with
such Party. For purposes of this definition, “control” means (i) the direct or
indirect ownership of at least fifty percent (50%) of the outstanding voting
securities or other ownership interest of an entity, (ii) the right to control
the policy decisions of such entity, or (iii) has the power to elect or appoint
at least fifty percent (50%) of the members of the governing body of the entity.
Affiliates of MSD include, without limitation, Medtronic Inc. and Warsaw
Orthopedics Inc.. Affiliates of RTI include, without limitation, Tutogen Medical
GmbH and Pioneer Surgical Technologies Inc.

“Agreement” means this 2013 Distribution Agreement, including its Exhibits
attached hereto, as such may be amended from time to time.

“Applicable Industry Standards” means (as applied to MSD and its Affiliates and
Marketing Partners as Distributors of Implants, and as applied to RTI and its
Affiliates as Manufacturers of Implants) all applicable standards, requirements,
rules and codes of the American Association of Tissue Banks, Advanced Medical
Technology Association and other industry organizations mutually recognized by
the Parties as authoritative bodies governing the conduct addressed in this
Agreement, as any of the foregoing may be revised.

“Applicable Laws” means (as applied to MSD and its Affiliates and Marketing
Partners as Distributors of Implants, and as applicable to RTI and its
Affiliates as Manufacturers of Implants) common law, statutes, ordinances,
rules, regulations or orders of any Governmental Authority, including Regulatory
Laws, governing the Manufacture and Distribution of Implants, as any of the
foregoing may be revised.

“Base Amount” means the cumulative total of Fees received by RTI from MSD for
the respective Implants or Implant categories, whichever is applicable, as
specified in Exhibit A, during the consecutive twelve (12) calendar month
trailing period through May 31, 2012. The Base amount will be deemed
automatically adjusted in direct proportion to the annual Fee increases, as
specified in Section 4.1.

“Business Day” means any day other than a Saturday, a Sunday or a day on which
the Federal Reserve Bank of New York is authorized or obligated by law or
executive order to remain closed.

“Change of Control” means a transaction or series of related transactions as a
result of which a Person or group of Persons acting in concert directly or
indirectly acquires, after the Effective Date, control of a Party such that
(i) said Party would meet the definition of an Affiliate of the acquiring
Person(s) or (ii) the acquiring Person(s) acquires ownership of all or
substantially all of the Party’s assets.

 

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“CPI” means the consumer price index for all urban consumers, U.S. city average
for all items, as published by the United States Department of Labor, Bureau of
Labor Statistics.

“End User” means the health care provider (including hospitals and surgical
facilities) who acquires the Implants from MSD (or its Marketing Partner) for
implantation or administration to a patient.

“Exclusive Territory” means the designated portion of the Territory in which MSD
has exclusive rights to Distribute certain specific Implants designated in
Exhibit A as exclusive to MSD for such portion of the Territory.

“FDA” means the United States Food and Drug Administration or any successor
agency having the administrative authority to grant Marketing Authorization in
the United States.

“Fees” means the tissue transfer fees (transfer pricing) to be paid by MSD to
RTI for the Implants.

“Field” means marketing efforts targeted to End Users utilizing Implants for
spine, general orthopaedic, and trauma surgical applications.

“cGTPs” means current good tissue practices as specified in the Regulatory Laws
of the applicable Regulatory Authority, as such Regulatory Laws are in effect at
the time of manufacturing and as applicable to RTI (as a tissue processor) and
to MSD (as a tissue distributor), including without limitation, Section 361 of
the Public Health Services (PHS) Act (42 U.S.C. §264), as amended from time to
time, and FDA tissue regulations, including 21 C.F.R. Part 1271, Subparts C and
D, as revised from time to time.

“Force Majeure” means any event beyond the affected Party’s reasonable control
and without the fault or negligence of the Party seeking to excuse performance,
including without limitation acts of God, fire, terrorism, Third Party criminal
acts, explosion, weather, delay or loss in transportation, flood, earthquake,
storm, war, riot, revolt, act of a public enemy, embargo, civil strife, strike
labor dispute, loss or shortage of power, impossibility of performance,
impracticability of performance, or shortage in supply of raw materials.

“Governmental Authority” means any country and all states or other political
subdivisions thereof and supranational bodies applicable thereto, including the
European Union, and all agencies, commissions, officials, courts or other
instrumentalities thereof, in which the Implants are Manufactured or
Distributed.

“Implants” means the processed and finished human allografts for transplantation
listed and described in Exhibit A to this Agreement.

“Insolvency Event” means that the Party has (i) commenced a voluntary proceeding
under any insolvency law, (ii) had an involuntary proceeding commenced against
it under any insolvency law which has continued undismissed or unstayed for
60 consecutive days, (iii) had a receiver, trustee or similar official appointed
for it or for any substantial part of its

 

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property, (iv) made an assignment for the benefit of creditors or (v) had an
order for relief entered with respect to it by a court of competent jurisdiction
under any insolvency law. For purposes hereof, the term “insolvency law” means
any applicable bankruptcy, insolvency or other similar law now or hereafter in
effect.

“Intellectual Property” means all works, including literary works, pictorial,
graphic and sculptural works, architectural works, works of visual art, and any
other work that may be the subject matter of copyright protection; Trademarks;
Confidential Information, including trade secrets; and any foreign and domestic
pending patent applications and issued, valid and enforceable patents, including
divisions, continuations, continuations-in-part, and other progeny thereof.

“Label” means the display of written, printed or graphic matter either upon the
immediate container of any article (i.e., on the outside container or wrapper,
if any, of the retail package of the article) or that is easily legible through
the outside container or wrapper.

“Laws” has the same meaning set forth for “Applicable Laws”.

“Manufacture” means those functions performed by RTI and/or its Affiliates in
their capacity as processors of allograft tissue to produce an Implant, said
functions consisting of tissue processing, packaging, storing, sterilizing,
labeling, releasing and shipping an Implant in accordance with Applicable
Industry Standards, Applicable Laws, and Specifications, as such Applicable
Industry Standards, Applicable Laws and Specifications pertain to the foregoing
specific functions.

“Marketing Authorization” means, with respect to any country or jurisdiction,
the act of the applicable Regulatory Authority that is necessary under
applicable Regulatory Laws for the Manufacture, marketing, transfer, and/or
Distribution of Implants in that country or jurisdiction, and satisfaction of
all applicable regulatory and notification requirements.

“Marketing Partner” means a Third Party that promotes, markets, and/or
distributes for fee a Party’s allografts, which may include Implants, or
products under a contractual arrangement with that Party (use of the term
Marketing Partner is for convenience only, and not intended to imply the
existence of a relationship constituting a legal partnership).

“MSD Rights” means all Intellectual Property that is subject as of the Effective
Date, or becomes subject during the Term, to MSD’s and/or its Affiliates’
control and that is necessary or useful for the Manufacture and Distribution of
the Implants and Licensed Products. For this purpose, MSD shall be considered to
control Intellectual Property if MSD owns or has a license to it and also has
the right to sublicense such rights to RTI, such rights to sublicense including,
without limitation, Intellectual Property rights assigned to Warsaw Orthopedic,
Inc.

“Net Revenue” means the aggregate amount of all gross revenue received in the
Exclusive Territory charged to Third Parties for Spinal Allografts by RTI or any
Affiliate for less (i) amounts repaid or credited in the ordinary course of
business, (ii) sales, excise, value added and/or use taxes actually paid by RTI
to the extent included in revenue received from Third Parties for Licensed
Products, (iii) trade and quantity discounts actually allowed by RTI as
customary in the trade, (iv) commissions paid, (v) duties and similar
governmental assessments

 

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paid by RTI to the extent included in revenue received from Third Parties for
Licensed Products, and (vi) customary transportation, shipping, and insurance
costs to the extent included in the revenue received from Third Parties for
Licensed Products.

“Package Inserts/Instructions for Use (IFU)” means information supplied by the
manufacturer of an implant or product that includes all the information and/or
instructions for the safe use of the Implants. Specifications for Package
Insert/IFU content vary with regulatory jurisdiction, but typically include
operating instructions, warnings and/or precautions, indications,
contraindications, information relative to sterilization, Summary of Records
instructions in the event of damage to sterile packaging, cleaning, disinfection
information, etc. The Package Insert/IFU must accompany the implant or product
in most jurisdictions, except in the U.S. where electronic provision is an
alternative.

“Parties” means MSD and RTI.

“Party” means MSD or RTI, as the context requires.

“Person” means any individual, group or entity, including Governmental
Authorities.

“Point of Destination” means the location within the Territory for shipment of
the Implants as designated by MSD in the applicable Firm Order.

“Recall” means any recall, withdrawal, field correction or removal action with
respect to any Implants by RTI or MSD due to safety, efficacy, quality or
regulatory compliance concerns, including actions to recover title to or
possession of, or to halt distribution of, Implants that previously have been
shipped to End Users.

“Regulatory Authority” means, with respect to any country or jurisdiction, any
Governmental Authority involved in granting Marketing Authorization or in
administering Regulatory Laws in that country or jurisdiction.

“Regulatory Laws” means all Applicable Laws governing (i) the import, export,
design, testing, Manufacture, or Distribution of an Implant, (ii) establishing
recordkeeping or reporting obligations for Third Party Complaints or Adverse
Events, (iii) Recalls or (iv) similar regulatory matters.

“RTI Rights” means all Intellectual Property that is subject as of the Effective
Date, or becomes subject during the Term, to RTI’s and/or its Affiliates’
control and that is necessary or useful or is used for the Manufacture and
Distribution of the Implants. For this purpose, RTI shall be considered to
control Intellectual Property if RTI owns or has a license to it and also has
the right to sublicense such rights to MSD.

“Specifications” means, with respect to each Implant, (i) RTI’s design,
functionality, processing, storing, packaging, shipping, sterilizing and
Labeling used in the Manufacture of Implants, and (ii) any standards,
instructions or protocols for processing, testing, storing, packaging, shipping,
sterilizing or labeling the Implant set forth in any approved application for
Marketing Authorization and any supplements and amendments thereto.

 

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“Spinal Allograft” means any allograft reasonably anticipated to be used
primarily for spinal procedures; provided that the term “Spinal Allograft” shall
not include (i) Non-Exclusive Specialty Allografts as indicated on Exhibit A;
(ii) allografts listed in Exhibit B attached hereto, with the exception of
Cortical Cervical Spacers; (iii) Bone Paste; (iv) stem cell allografts and
scaffolds, e.g. map3™; (v) allografts introduced to market after the Effective
Date that have been designed by RTI or its Affiliates; or (vi) any allograft
whose rights to manufacture or distribute are acquired by RTI from a third party
engaged in the manufacture or distribution of spinal allografts pursuant to a
bona fide arms-length acquisition or merger transaction closing after
September 12, 2006 and involving up-front consideration payable by RTI having a
fair market value in excess of ten million dollars ($10,000,000).

“Supply Shortfall” means a failure of RTI to timely supply at least ******** of
the Tissue Transfer Orders submitted by MSD under this Agreement for a specific
category of Implants (as designated in Exhibit A) for two (2) consecutive
months.

“Territory” means the entire world.

“Third Party” means any Person other than the Parties and their Affiliates.

“Third Party Complaint” means any expression by a Third Party of dissatisfaction
relating to the identity, durability, reliability, or safety including actual or
suspected Implant tampering, contamination, mislabeling or misformulation.

“Trademarks” means all trademarks, service marks, trade dress, logos and trade
names, together with all translations, adaptations, derivations and combinations
thereof (including all goodwill associated therewith), and all applications,
registrations and renewals in connection therewith.

“United States” or “U.S.” means the United States of America, including its
territories, commonwealths and possessions.

(b) Terms Defined Elsewhere. Capitalized terms not defined in Section 1.1(a)
shall have the meanings specified elsewhere in the text of this Agreement. Those
terms include the following:

 

Term

  

Section

Binding Forecast    Section 3.1 Claim    Section 10.1 Confidential Information
   Section 7.1(a) Confirmed Order    Section 3.2 Distribute/Distribution   
Section 2.1 Distributor    Section 2.1 Effective Date    Opening paragraph
Indemnitee    Section 10.3 Indemnitor    Section 10.3 Initial Term    Section
11.1 Interim Order    Section 3.4

 

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Term

  

Section

Licensed Products    Section 2.5(a) MSD    Opening paragraph New Implant   
Section 2.3(c) New Implant Notice    Section 2.3(c) Prior Agreement    Whereas
clauses Renewal Term    Section 11.1 Return Policy    Section 3.6 Rolling
Forecast    Section 3.1 RTI    Opening paragraph RTI Products    Section 2.5
Supply Shortfall Period    Section 2.3(b) Term    Section 11.1 Tissue Transfer
Orders    Section 3.2 TUR    Section 6.4

1.2. Rules of Construction.

(a) Elements of this Agreement. When a reference is made in this Agreement to a
Recital, an Article, a Section, or an Exhibit, such reference is to a Recital,
Article or Section of, or an Exhibit to, this Agreement, unless otherwise
indicated.

(b) Meaning of “Include” and Variations Thereof. Whenever the words “include,”
“included,” “includes” or “including” are used in this Agreement, they shall be
understood to be followed by the words “without limitation.”

(c) Use of Pronouns. Pronouns, including “he,” “she” and “it,” when used in
reference to any Person, shall be deemed applicable to entities or individuals,
male or female, as appropriate in any given case.

(d) Headings. Articles, Sections and other headings contained in this Agreement
are for reference purposes only and are not intended to describe, interpret,
define or limit the scope, extent or intent of any provision of this Agreement.

(e) Variation on Terms. Standard variations on defined terms (such as the plural
form of a term defined in the singular form, and the past tense of a term
defined in the present tense) shall be deemed to have meanings that correlate to
the meanings of the defined terms.

(f) Currency. The symbol “$” means United States dollars.

ARTICLE II 

DISTRIBUTION OF THE IMPLANTS

2.1. Distribution Rights. RTI hereby grants to MSD, and MSD hereby accepts, the
right to promote, market, transfer and distribute for fee (collectively,
“Distribute” or “Distribution”; MSD being a “Distributor”) the non-exclusive
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Territory for all uses and applications for which such Implants were distributed
in the Prior Agreement, and Implants specified as exclusive to MSD for all uses
and applications in the Field with respect to such specified Implants. Such
Distribution rights are non-exclusive throughout the Territory to MSD and its
Affiliates and Marketing Partners, unless expressly indicated otherwise in
Exhibit A. MSD’s Distribution rights include the right for MSD to authorize its
Affiliates and Marketing Partners to Distribute Implants to the full extent of
MSD’s rights to so Distribute; provided, however, that MSD’s agreements with its
Affiliates and Marketing Partners shall contain terms sufficient to require said
Affiliates and Marketing Partners to be bound by Medtronic’s Code of Business
Conduct which is available on Medtronic’s website:
http://www.medtronic.com/corporate-governance/principles-and-ethics/global-business-conduct-policy/index.htm.
For reference purposes, the current version of the Medtronic’s U.S. Business
Conduct Standards and Code of Conduct is attached hereto as Exhibit C.

2.2. Distribution Activities. MSD will use commercially reasonable efforts to
Distribute the Implants in the Territory in the Field. MSD’s Distribution
efforts may include development of collateral marketing materials, surgical
training, attendance at professional tradeshows, and pre-clinical and clinical
studies, at MSD’s cost. MSD shall provide RTI with a reasonable opportunity to
review and approve all marketing and collateral materials relating to the
Implants, which approval shall not be unreasonably withheld or delayed. MSD
shall have sole discretion to establish the transfer fee terms and other terms
and conditions in connection with the Distribution of the Implants to MSD’s
customers, provided that such transfer fees and other terms and conditions
comply with Applicable Laws.

2.3. Right to Compete.

(a) Nothing in this Agreement shall prohibit MSD from manufacturing, marketing
or distributing allograft tissue or other products that compete either directly
or indirectly, with Implants; provided that the foregoing shall not be construed
as conferring any license or other right, by implication, estoppel or otherwise,
under any Intellectual Property Rights of RTI.

(b) Supply Shortfall. In the event of a Supply Shortfall with respect to
Implants Manufactured by RTI for MSD, MSD shall have the right to utilize Third
Party suppliers for the purpose of filling its shortfall with respect to the
affected Implants until such time as RTI reasonably establishes its ability to
meet and maintain capacity sufficient to meet MSD’s demand for such affected
Implants, but in no event will MSD’s right to utilize a Third Party supplier for
such purpose be less than one year (the “Supply Shortfall Period”). During a
Supply Shortfall Period, MSD will continue ordering affected Implants from RTI
to the extent RTI can supply such Implants. MSD shall have a reasonable period
of time, not to exceed one (1) year, following the Supply Shortfall Period
during which to wind-down its supply arrangement with any Third Party supplier
utilized during the Supply Shortfall Period. These temporary rights granted by
RTI to MSD in the event of a Supply Shortfall (a “Supply Shortfall License” as
further defined in Section 8.3) shall be MSD’s exclusive remedy as to RTI and
its Affiliates with respect to any damages allegedly arising from such Supply
Shortfall. A Supply Shortfall shall not impact the Parties’ respective rights
and obligations with respect to Implants unaffected by the Supply Shortfall.
Anything herein to the contrary notwithstanding, no rights granted during a
Supply Shortfall Period will extend beyond the earlier of (i) the conclusion of
the Supply Shortfall Period (including wind-down), or (ii) the expiration or
termination of this Agreement.

 

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(c) New Implant Notice and Proposal. If MSD seeks to develop and/or distribute
any new human allograft-based tissue graft for use within the Field (a “New
Implant”) along with seeking development or supply of the New Implant internally
or from any Third Party, MSD may request from RTI a development proposal for
such New Implant by providing written notice in the form of New Implant request
(“New Implant Notice”). Within thirty (30) days after RTI receives the New
Implant Notice, RTI shall notify MSD in writing whether it is interested in
pursuing a development and/or supply arrangement with MSD for the New Implant.
The notification from RTI shall be accompanied by a proposed development
timeline and fee (such fee to be estimated in contemplation of Section 8.5(b) if
applicable). During the negotiations, MSD will continue to provide RTI with any
relevant information regarding the New Implant or that RTI reasonably requests.
MSD may continue to negotiate with any Third Party or develop the New Implant
internally until such time as terms are reached on the development (see
Section 8.5 re. Jointly-Developed New Implants) and/or supply arrangement or the
negotiations between RTI and MSD are terminated. All information provided by RTI
to MSD in connection with said proposal and negotiation shall be deemed
Confidential Information of RTI and will not be used by MSD for any purpose
other than for negotiations with RTI. Nothing herein shall require MSD to
provide RTI with a right of first offer or first refusal in the development
and/or supply of a New Implant.

2.4. Conversion of Exclusive Implants to Non-Exclusive. With respect to Implant
categories designated in Exhibit A as exclusive to MSD, such Implant categories
shall be converted to non-exclusive in the event of (i) mutual written agreement
of the Parties; or (ii) the cumulative Fees received by RTI from MSD for a
respective Implant category during any given trailing consecutive twelve
(12) calendar months during the Term declines more than ********.

2.5. RTI’s Distribution Rights. During the Term of this Agreement, RTI shall not
market or distribute in the Exclusive Territory those Implants which are
exclusive to MSD, provided such Implants remain exclusive in accordance with
this Agreement. Nothing contained herein shall otherwise limit, prevent or
prohibit RTI, including its Affiliates and Marketing Partners, from, as may be
applicable, manufacturing, marketing or distributing allografts, products and
associated surgical and surgical performance technologies (“RTI Products”),
throughout the Territory in the Field.

2.6. Royalty. RTI shall pay MSD a royalty equal to ******** of Net Revenues of
Spinal Allografts only throughout the Initial Term of this Agreement. Notice of
payments along with the report required under Section 2.7 shall be sent by RTI
to MSD address for notices in Section 12.7. All royalty payments by RTI
hereunder shall be made in U.S. dollars without deduction or offset.

2.7. Royalty Report. Within 30 days of the end of each calendar quarter, the
chief financial officer of RTI shall certify for that quarter in a written
report delivered to MSD as to the Net Revenue for Spinal Allografts during such
calendar quarter. Simultaneous with the delivery of such report, RTI shall pay
the amount of royalties due for the applicable reporting period.

 

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Further, RTI shall maintain the information described below and copies of such
information shall be made available to MSD upon reasonable request:

(a) the identity (by commercial product name, RTI product catalog name or
similar indicia) of all Spinal Allograft transferred to Third Parties.

(b) for each identified Spinal Allograft, the number of such allografts
transferred during the applicable reporting period and the resulting Net Revenue
thereof; and

(c) for each identified Spinal Allograft, RTI’s computation of the royalties
due.

2.8. Records. With respect to the royalty and reporting set forth in Section 2.6
and Section 2.7, RTI shall keep accurate records with respect to all Spinal
Allografts transferred or disposed of to Third Parties. These records shall be
retained for a period of five (5) years from the date of reporting and payment
notwithstanding the expiration or termination of this agreement. MSD shall have
the right at its expense (except as provided below), with at least four weeks’
advance written notice to RTI, to examine and audit, not more than once in any
six month period, and during normal business hours, all records and accounts as
may contain information bearing upon the amount and the calculation of royalties
payable to MSD under this Agreement. Prompt adjustment shall be made by RTI or
by MSD to compensate for any errors and/or omissions disclosed by such
examination or audit. If RTI disputes the disclosed error and/or omissions, and
provided the Parties are unable to reach a negotiated resolution within two
(2) weeks of RTI providing MSD with notice of such dispute, the Parties will
engage the services of a mutually agreeable accounting firm to audit the
findings, and the results of such audit shall be binding on the Parties. RTI
shall bear the initial cost of such audit. If, however, such error and/or
omission results in an error to RTI’s benefit exceeding five (5%) of the alleged
error and/or omission disclosed by MSD, MSD shall bear the cost of such audit.
In the event of an underpayment by RTI to MSD exceeding five percent (5%) of the
royalties due and owing in any particular period, RTI shall pay MSD for its
out-of-pocket costs and expenses and an additional fee equal to ten percent
(10%) of such underpayment. Neither such right to examine and audit nor the
right to receive such additional fee shall be affected by any statement to the
contrary appearing on checks or otherwise and shall not relieve RTI of it
obligations to make the payments required hereunder.

ARTICLE III

TISSUE TRANSFER ORDERS

3.1. Forecasts and Distribution Summaries. On or before the fifth (5th) Business
Day of each month, MSD shall issue to RTI a good faith, twelve (12) month
rolling forecast reflecting the anticipated quantities and requested delivery
dates of the Implants, by catalog number, that MSD expects to order (the
“Rolling Forecast”). The first sixty (60) days of each Rolling Forecast (as
determined by the requested delivery dates) will be binding on MSD (such portion
of the Rolling Forecast being the “Binding Forecast”). Each Binding Forecast
will specify the Tissue Transfer Order number(s), if yet submitted, applicable
to such Implants covered by the Binding Forecast. The remaining portion of the
Rolling Forecast shall be a good faith, non-binding projection used by RTI for
purposes of anticipating and facilitating the lead times needed by RTI to supply
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provide RTI with a quarterly summary of the number of Implants Distributed by
MSD and its Affiliates and Marketing Partners in the prior quarter, as well as a
summary of Implants held in their respective inventories.

(a) To the extent the requested quantity of an Implant designated for a given
delivery date in the Binding Forecast exceeds by more than ******** the
requested quantity for such Implant in the Rolling Forecast for the immediately
preceding month (i.e. the month immediately before the requested quantity of the
Implant became binding on MSD), such excess above the ten percent increase will
not be counted for the purpose of determining a Supply Shortfall.

(b) From time to time, and upon the request of a Party at a mutually agreeable
time and location, such agreement not to be unreasonably withheld, the Parties
will meet to discuss the status of MSD’s then present inventory of Implants and
anticipated future needs.

3.2. Tissue Transfer Orders. MSD will submit to RTI orders for Implants
correlating to the Binding Forecast and further specifying the Implant’s Point
of Destination and the identity of the MSD Affiliate to be invoiced (“Tissue
Transfer Orders”). Tissue Transfer Orders will be firm and binding on MSD. Due
to the inherent nature of tissue donation which results in variability in the
amount of tissue available from tissue recovery organizations for subsequent
transfer to tissue processors, such as RTI, for processing into Implants, each
Tissue Transfer Order is subject to acceptance by RTI. Within five (5) Business
Days following RTI’s receipt of a Tissue Transfer Order, RTI will notify MSD of
the number of Implants accepted for supply to MSD by the requested delivery date
(“Confirmed Order”).

3.3. Fulfillment of Orders. RTI will timely deliver to MSD those Implants
accepted by RTI in the applicable Confirmed Orders. Timely delivery for purposes
of this Agreement will be deemed fulfilled when Implants are delivered to MSD
within five (5) Business Days before or after MSD’s requested delivery date.
Though recognized by the Parties as an important customer relationship tool,
MSD’s Supplier Scorecard shall not be deemed evidence of performance of the
terms and conditions of this Agreement. To the extent the number of Implants
subject to a Tissue Transfer Order exceeds the number of Implants accepted by
RTI in the Confirmed Order, RTI will use commercially reasonable efforts to
deliver the excess Implants to MSD as soon as commercially practicable.

3.4. Interim Orders. In addition to Tissue Transfer Orders correlating to the
Binding Forecast, MSD may submit additional orders for Implants in excess of the
amount specified in the Binding Forecast (an “Interim Order”). RTI agrees to
respond in writing to each Interim Order within ten (10) Business Days of
receipt, specifying the volumes accepted for production and the estimated
date(s) by which said Implants could be delivered. Interim Orders will not be
counted for the purpose of determining a Supply Shortfall.

3.5. Shipping. RTI shall package, Label, store and ship the Implants in
compliance with Applicable Laws (including cGTPs), all applicable Specifications
and in accordance with good commercial and industry practice. The Implants
corresponding to Tissue Transfer Orders will be shipped FOB point of origin to
the facility designated by MSD in such corresponding Tissue Transfer Order via
nationally recognized courier of MSD’s choice, e.g. FedEx or UPS. If

 

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MSD does not specify a courier, RTI may select among such nationally recognized
couriers in its own discretion. Shipments will be made at least once per week at
RTI’s sole cost and expense, provided such shipments are to MSD’s facility
located in Memphis, Tennessee. MSD shall reimburse RTI for actual and reasonable
expenses incurred by RTI in expediting shipments or making additional shipments
pursuant to Interim Orders at MSD’s request. MSD shall reimburse RTI for the
actual and reasonable difference in increased expenses incurred by RTI for
(i) shipments to facilities designated by MSD other than its facility located in
Memphis, Tennessee, or (ii) to the extent the shipping charges of a courier
selected by MSD are more than ******** greater than FedEx or UPS (whichever is
lower) would have charged RTI for the same shipment.

3.6. Nonconforming Implants. MSD shall have a reasonable right of inspection to
verify that the Implants conform to the terms of this Agreement. Within fifteen
(15) days of MSD’s receipt of Implants at the Point of Destination, MSD shall
inform RTI of any claim that a shipment fails to conform. If such notice is not
provided to RTI within the prescribed time frame, and except for latent defects,
MSD shall be deemed to have accepted the shipment of the Implants as being in
conformity with this Agreement. In the event a purported defect in an Implant is
detected, regardless of whether such purported defect is discovered during the
aforementioned inspection period or is a latent defect, MSD will notify RTI,
pursuant to Section 12.7, of any related warranty claim. RTI shall bear all
costs of return (including freight and insurance) for defective Implants and
shall replace the defective Implant without charge to MSD (including payment of
freight and insurance for delivery of the replacement Implant). Returns shall be
made in accordance with the return policy set forth in Exhibit D (the “Return
Policy”).

(a) Latent Defects. With respect to latent defects, MSD shall promptly notify
RTI after receiving notification from an End User of such End User’s discovery
thereof, and MSD and such End User shall have the right to reject such Implant.
For the avoidance of doubt, and notwithstanding any provision of the Return
Policy, MSD shall be permitted to reject Implants due to latent defects at any
time after discovery of such latent defects or at any time after receiving
notification from a End User of such End User’s discovery of such latent
defects. Any notification of rejection to RTI shall state the basis for the
rejection.

ARTICLE IV

PAYMENTS AND FEES

4.1. Fees for Implants.

(a) The Fees for Implants ordered by MSD under this Agreement are specified in
Exhibit A and those Fees shall be firm through December 31, 2013.

(b) For the 2014 calendar year, the Fees for the Implants shall be adjusted as
reflected in the attached Fee schedule. The new Fee will be for grafts ordered
after January 1, 2014. Grafts received pursuant to a purchase order issued prior
to January 1, 2014, will be invoiced at the Fee in effect at the time of order.

(i) In the event extraordinary cost increases greater than ******** are incurred
by RTI in a calendar year due to changes in Laws or ********, RTI and MSD agree
to negotiate adjustments to Fees to offset such cost increases. With thirty
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written notice to RTI, MSD shall have the right, at its expense, to audit RTI’s
records concerning such costs represented by RTI to MSD as having increased more
than ******** in a calendar year.

(c) If the Parties are unable to agree on a revised Fee schedule before the
commencement of any Renewal Term, then unless and until the Parties subsequently
reach a written agreement to amend Exhibit A to reflect fees during the Renewal
Term, the new Fees for each calendar year of such Renewal Term shall be equal to
the Fees for the immediately preceding calendar year increased by the percentage
increase, if any, in the CPI during the 12-month period ending October 31 of
such immediately preceding calendar year.

4.2. ********

4.3. Taxes. MSD shall pay, in addition to the Fees, any tax imposed on the
Distribution of the Implants from RTI to MSD.

4.4. Payment Terms. Payment from MSD is due to be received by RTI within thirty
(30) days of the date of the applicable RTI invoice submitted to MSD.

ARTICLE V

PROCESSING AND SUPPLY

5.1. Inventory. RTI will use commercially reasonable efforts to maintain
******** of Implants in inventory, and an adequate source of unprocessed tissue
to meet MSD’s forecasted demand for the Implants.

5.2. ********

5.3. Processing. RTI will Manufacture all Implants in accordance with industry
standards, cGTPs, Applicable Laws and the applicable Specifications. RTI will
maintain throughout the Term and for the specified shelf-life of the Implant (or
for such longer period as may be required by Applicable Laws) accurate and
complete records relating to the Manufacture of the Implants, including all
records required under Applicable Laws and Applicable Industry Standards.

5.4. Implant Modifications. RTI will not, without written notice to MSD, modify
or amend the Implant Specifications or quality procedures for the Manufacture of
the Implants in such a manner as to affect the durability, reliability or safety
of the Implants. MSD will be allowed reasonable time to comment on the proposed
change prior to its implementation. MSD will not be required to agree to any
change that, in its reasonable discretion, would adversely impact the quality,
safety or efficacy of the Implant.

5.5. Implant Shelf-Life. Implants delivered to MSD under this Agreement shall
have at least ******** of their shelf-life remaining as measured from the date
of delivery to MSD.

 

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5.6. Right to Cease Supply. RTI shall have the right to cease supplying MSD with
a particular Implant category(ies) if RTI determines, in its own discretion,
that such supply of a particular Implant category(ies) to MSD is not
economically advantageous for RTI. RTI may exercise its right to cease supply to
MSD provided that RTI has provided MSD with at least six (6) months’ advance
written notice of its intent to cease supply. Such cessation of supply shall be
deemed a Supply Shortfall with respect to the affected Implant category(ies)
provided that MSD has place a Tissue Transfer Order for a member of such Implant
category(ies) during the one (1) year period immediately preceding RTI’s
notification of the cessation of supply.

ARTICLE VI

REGULATORY MATTERS

6.1. Packaging.

(a) Materials. Packaging materials will utilize RTI designs suited to its
production capabilities. RTI shall maintain records of packaging Specifications.

(b) Branding. Package branding shall identify RTI as the manufacturer of the
Implants and MSD as the distributor. MSD will consult with RTI regarding
branding the Implants and package design, aesthetics and Trademarks. Except for
any MSD Trademarks included on the packaging to designate MSD as a distributor
and any name for the Implants that is or has been conceived or developed by MSD
(which shall be the property of MSD), any and all Trademarks, copyrights, or
service marks shall be the property of RTI and shall be deemed RTI Rights and
works made for hire to the benefit of RTI. RTI shall have sole responsibility
for obtaining legal protection of RTI Rights in its own discretion and its own
expense. MSD shall cooperate with RTI to obtain and enforce such RTI Rights as
may be reasonably requested by RTI.

6.2. Package Inserts. RTI shall develop package inserts in consultation with
MSD, and RTI shall maintain records of package insert Specifications.

6.3. Package Labels. RTI shall develop package Labels incorporating MSD
requirements into RTI labeling materials and shall maintain records of label
Specifications.

6.4. Tissue Utilization Report. RTI shall include its customary Tissue
Utilization Report (“TUR”) in the Implant packaging. Returned TUR cards and the
information contained therein shall be the property and Confidential Information
of RTI.

6.5. Storage Records. RTI and MSD will each retain storage records documenting
equipment maintenance, calibration and monitoring for storage of Implants. RTI
shall provide handling and storage specifications to MSD. End User storage
instructions will be listed in the package insert (Section 6.2, above) and on
the package label (Section 6.3, above) that RTI will provide to MSD.

6.6. Distribution Records. MSD will maintain Distribution records sufficient to
facilitate tracing of final disposition of Implants to End Users. RTI will have
the responsibility for supplying, receiving and maintaining records of returned
TUR cards.

 

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6.7. Registrations and Licenses. RTI and MSD shall maintain appropriate federal,
state, local and foreign registrations, certifications and licenses as required
by Applicable Laws for their respective duties under this Agreement, including
applicable registrations with the FDA.

6.8. Compliance with Laws. The Parties shall at all times conduct themselves
with respect to their activities performed under this Agreement in full
compliance with all Applicable Laws, including anti-bribery Laws (e.g. the
United States Foreign Corrupt Practices Act), anti-kickback Laws, health care
provider payment sunshine Laws, and those portions of 21 C.F.R. Party 1271
applicable to tissue processors (with respect to RTI) and tissue distributors
(with respect to MSD).

6.9. AATB Compliance. The Parties shall at all times conduct themselves and all
activities performed under this Agreement in full compliance with standards of
the AATB, as may be revised, applicable to tissue processors (with respect to
RTI) and tissue distributors (with respect to MSD).

6.10. Acceptance of AdvaMed Code. The Parties recognize and accept the AdvaMed
Code of Ethics for Interaction with Health Care Professionals, as may be
revised.

6.11. Actions by Regulatory Authorities. RTI shall be responsible to Regulatory
Authorities throughout the Territory as the manufacturer of the Implants. If
either Party receives notice of an actual or threatened inspection,
investigation, inquiry, import or export ban, implant seizure, enforcement
proceeding or similar action by a Regulatory Authority with respect to any
Implant or a Party’s activities in connection with any Implant, it will notify
the other Party within forty-eight (48) hours after its receipt of notice of the
action and will deliver to the other Party, within a further twenty-four
(24) hours, copies of all relevant documents received from the Regulatory
Authority. The Parties shall cooperate with each other in formulating a response
to the action, including providing information and documentation as requested by
the Regulatory Authority (with copies of any such information and documentation
to be provided to the other Party). If the action primarily concerns MSD’s
activities, then MSD shall have primary responsibility to respond to the
Regulatory Authority; otherwise, RTI shall have primary responsibility to
respond. In either case, upon timely request of the responding Party, the other
Party shall, at its own expense, provide up to a cumulative total of twelve
(12) hours of personnel time per action by Regulatory Authority assisting the
responding Party in their response. The actual cost for Personnel time incurred
by the assisting Party in excess of the twelve (12) hours will be reimbursed by
the responding Party; provide, however, that the assisting Party first provide
the responding Party with a good-faith budget estimate of the cost and provided
the responding Party with reasonable advance notice in the event it appears that
the costs will exceed the budget estimate.

(a) In addition to providing assistance to a Party as set forth in Section 6.11,
a Party may make reasonable requests to the other Party for quality and
regulatory consulting services to be compensated at a rate agreed upon by the
Parties.

6.12. Costs. All costs associated with obtaining and/or maintaining any
regulatory or governmental authorization, within the United States, or
accreditation with AATB as set forth in Section 6.7 shall be borne solely by RTI
insofar as those costs relate to activities performed by

 

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RTI. All costs associated with regulatory requirements or AATB accreditation
related to distribution activities performed by MSD, shall be borne by MSD. All
costs associated with obtaining international market approvals, Implant
registrations and licensure for any markets outside of the United States where
MSD proposes to begin distribution and where those products have not been
previously registered, licensed and approved shall be the responsibility of MSD.

6.13. Third Party Complaints and Reports. MSD will promptly advise RTI of Third
Party Complaints attributed to the Implants that are received by MSD. If any
such complaint is an Adverse Event, MSD will report such Adverse Event to RTI
immediately. Reportable events include adverse outcomes, reported transmission
of disease and other complications. RTI will maintain complaint and Adverse
Event files, including the results of related investigations.

6.14. Traceability. With respect to the Implants, RTI shall maintain
manufacturing and traceability records, and MSD shall maintain storage and
Distribution records by tissue number, as required by Applicable Laws and
Applicable Industry Standards.

6.15. Recalls / Market Withdrawals / Field Corrections. RTI shall have the
authority and responsibility to conduct Recalls of the Implants in accordance
with Applicable Laws, at RTI’s cost and expense; provided, however, that to the
extent any such Recall is attributable to (i) statements made verbally or in
writing by representatives or agents of MSD with respect to Implants that expand
upon or are inconsistent Implant literature reviewed and approved by RTI, or
other information furnished by RTI with respect to the Implants, or (ii) the
storage or handling of Implants by MSD or its representatives or agents is
inconsistent with instructions provided by RTI, MSD shall bear all costs and
expenses associated with such Recall. In the event RTI fails to perform any
required Recall, then MSD may perform such activities. In any event, the Parties
shall cooperate and coordinate the activities necessary to effect a Recall.
Records of Recalls will be maintained by RTI.

ARTICLE VII

CONFIDENTIALITY

7.1. Confidentiality. In the course of their activities pursuant to this
Agreement, the Parties anticipate that they may disclose Confidential
Information to one another and that either Party may, from time to time, be
either the disclosing Party or the recipient of Confidential Information. The
Parties wish to protect such Confidential Information in accordance with this
Section 7.1. The provisions of this Section shall apply to disclosures furnished
to or received by a Party and its agents and representatives (which may include
agents and representatives of its Affiliates and Marketing Partners). Each Party
shall advise its agents and representatives of the requirements of this Section
and shall be responsible to ensure their compliance with such provisions.

(a) Definition of Confidential Information. For purposes hereof, “Confidential
Information” with respect to a disclosing Party means all information, in any
form or media, concerning the disclosing Party (including patient and donor
records) that the disclosing Party furnishes to the recipient, whether furnished
before or after the Effective Date, and includes all notes, analyses,
compilations, studies and other materials, whether prepared by the recipient or
others, that contain or reflect such information; provided, however, that

 

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Confidential Information does not include information that (i) is or hereafter
becomes generally available to the public other than as a result of a disclosure
by the recipient, (ii) except as noted below with respect to information
exchanged by the Parties under the Prior Agreement, was already known to the
recipient prior to receipt from the disclosing Party as evidenced by prior
written documents in its possession not subject to an existing confidentiality
obligation to the disclosing Party, (iii) is disclosed to the recipient on a
non-confidential basis by a Person who is not in default of any confidentiality
obligation to the disclosing Party or (iv) is developed by or on behalf of the
recipient without reliance on confidential information received under this
Agreement. The contents of this Agreement shall be deemed to be Confidential
Information of each Party. The Parties further agree that information previously
exchanged between the Parties which qualified as confidential information under
the terms of the Prior Agreement shall be deemed Confidential Information
exchanged pursuant to this Agreement and shall be afforded the same protections
contained herein to the extent not covered by any surviving provisions of the
Prior Agreement.

(b) Treatment of Confidential Information. The recipient of Confidential
Information will (i) maintain its confidentiality using efforts and precautions
at least as great as those it uses and takes to protect its own Confidential
Information and trade secrets, but no less than reasonable care, (ii) use such
Confidential Information solely in connection with the discharge of its
obligations under this Agreement and (iii) not disclose such Confidential
Information to any Person other than those of its agents and representatives who
need to know such Confidential Information in order to accomplish the objectives
for which it was disclosed. Notwithstanding the foregoing, the recipient of
Confidential Information may disclose it to the extent reasonably necessary to
comply with Applicable Laws or with an order issued by a court or regulatory
body with competent jurisdiction; provided that, in connection with such
disclosure, the recipient uses commercially reasonable efforts to obtain
confidential treatment or an appropriate protective order, to the extent
available, with respect to such Confidential Information. To the extent
permitted by Applicable Law, the recipient will provide notice to the disclosing
Party immediately upon recipient’s receipt of notification that such disclosure
of Confidential Information is being requested pursuant to Applicable Laws,
court or regulatory body order.

(c) Return and Destruction. Within ten (10) Business Days of receipt of the
disclosing Party’s written request, the recipient of Confidential Information,
shall return, or with the disclosing Party’s permission destroy, all originals,
copies, and summaries of documents, material, and other tangible manifestations
of the disclosing Party’s Confidential Information in its possession or control,
together with written confirmation that it has returned or destroyed all such
Confidential Information. The receiving Party will use its best efforts upon
such request to regain into its possession any materials containing the
disclosing Party’s Confidential Information that may have been or may be
transmitted to any of the receiving Party’s employees, directors or any Third
Party contractors. Notwithstanding the foregoing, (i) the receiving Party’s
legal counsel shall be permitted to retain one copy of all Confidential
Information, (ii) nothing contained in this Agreement shall require the
destruction, transfer, deletion, or modification of any backup tapes or other
media made pursuant to automated backup or archival processes in the ordinary
course of business, or (iii) nothing contained in this Agreement shall prevent
any Party to this Agreement from maintaining archival files in accordance with
its document retention policies designed to achieve compliance with Applicable
Laws.

 

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(d) Term of Obligation. The obligations under this Section shall remain in
effect from the Effective Date through the fifth anniversary of the expiration
or termination of this Agreement, except that trade secrets of the disclosing
Party shall remain confidential for so long as such trade secrets continue to
qualify for trade secret status under the Uniform Trade Secrets Act, as may be
amended, published by the National Conference of Commissioners of Uniform State
Laws or its successor organization.

7.2. Publicity. Neither RTI nor MSD shall issue any press release or otherwise
make any public statement related to the subject matter of this Agreement
without the prior written approval of the other Party, except to the extent that
such press release or other public announcement is required by the rules
governing a securities exchange on which the releasing Party’s stock is listed,
by law in the opinion of legal counsel to the releasing Party, or the substance
thereof has been previously reviewed and released by the other Party or is in
the public domain through no fault of the releasing Party. In the event of a
required press release or other public announcement, the releasing Party shall
provide the other Party with a copy of the proposed text prior to such
announcement. The Parties agree that if either Party is required to file this
Agreement with any Governmental Authority, the releasing Party shall endeavor to
redact competitively sensitive terms of the Agreement to the extent permissible
in accordance with the advice of its legal counsel and auditors.

ARTICLE VIII

INTELLECTUAL PROPERTY AND DEVELOPMENT OF NEW IMPLANTS

8.1. License of RTI Rights. During the Term of this Agreement, RTI hereby grants
to MSD a non-exclusive, non-transferable, sublicensable only to MSD’s Affiliates
and Marketing Partners, license to the RTI Rights to the extent (i) such rights
are applicable to the Implants, and (ii) such license is necessary for the sole
and limited purpose of permitting MSD and, as may be applicable, its Affiliates
and Marketing Partners to Distribute the Implants in the Field throughout the
Territory without infringing or otherwise breaching the RTI Rights. Nothing in
this Section 8.2 shall be deemed to grant (expressly, impliedly or by estoppel)
to MSD, or its Affiliates or Marketing Partners, the right to use the RTI Rights
for manufacturing or processing purposes. All right, title and interest in and
to the RTI Rights shall remain exclusively in the ownership of RTI, except that
nothing in this Agreement should be construed as an admission by MSD as to RTI’s
right, title, interest or inventorship in and to such RTI Rights. All licenses
granted pursuant to this Section 8.1 shall terminate upon the expiration or
termination of this Agreement, except to the limited extent necessary for MSD
and its Affiliates and Marketing Partners to Distribute their respective
inventories of Implants remaining in their possession at the expiration or
termination of this Agreement, until such time as the remaining inventory has
been depleted or one (1) year following the termination or expiration of this
Agreement, whichever occurs first.

(a) RTI Trademarks. To the extent Section 8.1 applies to Trademarks, MSD and its
Affiliates and Marketing Partners shall have the right to use RTI’s Trademarks
associated with the Implants as required by applicable Regulatory Laws or as
otherwise necessary to enable Distribution of the Implants. MSD and its
Affiliates and Marketing Partners shall comply with the quality control
instructions of RTI as to the form and manner in which such Trademarks may be
used. Any goodwill resulting from the use of the Trademarks pursuant to the
license granted in this Section 8.1 shall be exclusively owned by and accrue to
the benefit of RTI.

 

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8.2. Supply Shortfall License. Upon the occurrence of a Supply Shortfall, and
only during the Supply Shortfall Period (including applicable wind-down), RTI
will grant a non-exclusive, non-transferable, non-sublicensable license of RTI
Rights to a Third Party (provided such Third Party is agreeable to both MSD and
RTI, such consent not to be unreasonably withheld) to the extent such license is
necessary for said Third Party to machine, shape, package and ship for MSD and
its Affiliates and Marketing Partners those Implants subject to the Supply
Shortfall (“Supply Shortfall License”). Anything in this Agreement to the
contrary notwithstanding, RTI shall not be obligated under any circumstances
(except as required by Applicable Law) to license or disclose RTI Rights
respecting its proprietary sterilization processes, including the BioCleanse®,
Cancelle®, and Tutoplast® sterilization processes, to any Person. In the event
MSD desires for RTI to sterilize the Implants subject to the Supply Shortfall
and manufactured by a Third Party under a Supply Shortfall License, RTI and MSD
will in good faith negotiate the fees, terms and conditions under which MSD may
contract RTI to sterilize the affected Implants using an applicable RTI
proprietary sterilization process.

8.3. License of MSD Rights. During the Term of this Agreement, MSD hereby grants
to RTI a non-exclusive, non-transferable, sublicensable only to RTI’s Affiliates
and Marketing Partners, license to the MSD Rights to the extent (i) such rights
are applicable to the Implants, and (ii) such license is necessary for the sole
and limited purpose of permitting RTI and its Affiliates to Manufacture the
Implants without infringing or otherwise breaching the MSD Rights. All right,
title and interest in and to the MSD Rights shall remain exclusively in the
ownership of MSD, except that nothing in this Agreement should be construed as
an admission by RTI as to MSD’s right, title, interest or inventorship in and to
such MSD Rights.

(a) MSD Trademarks. To the extent Section 8.3 applies to Trademarks, RTI and its
Affiliates shall have the right to use MSD’s Trademarks associated with the
Implants as required by applicable Regulatory Laws or as otherwise necessary to
enable Manufacture and Distribution of the Implants. RTI and its Affiliates
shall comply with the quality control instructions of MSD as to the form and
manner in which such Trademarks may be used. Any goodwill resulting from the use
of the Trademarks pursuant to the license granted in this Section 8.3 shall be
exclusively owned by and accrue to the benefit of MSD.

8.4. Reserved.

8.5. Development of New Implants.

(a) New Implants. The Parties acknowledge that while working under this
Agreement, new Implants not listed in Exhibit A may be developed by the Parties
jointly (“Jointly-Developed New Implants”) The Parties acknowledge that the
provisions of this Section 8.5 are not intended to cover bone paste of any type.

(b) Development of Jointly-Developed New Implants. If the Parties agree to
develop a Jointly-Developed New Implant, they will do the following:

(i) At MSD’s request, and subject to Section 8.5(b)(iii) below, RTI shall
produce prototypes of any Jointly-Developed New Implant design for testing and
clinical evaluation under the terms provided in this Section 8.5.

 

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(ii) Subject to Section 8.5(b)(iii), the Parties will dedicate sufficient
engineering and other resources to the ongoing development of any
Jointly-Developed New Implants so that such development will be timely and
properly accomplished. The Parties will work to agree on Specifications,
development schedules and a budget with respect to the development of any
Jointly-Developed New Allograft. Such Specifications, schedule and budget shall
be reviewed and adjusted at least once per year, or as reasonably requested and
agreed to by the Parties, such agreement not to be unreasonably withheld.

(iii) All costs associated with the development of a Jointly-Developed New
Implant shall be shared in accordance with the budgets agreed to by the Parties;
provided, however, (i) MSD and RTI shall share equally all costs related to
regulatory tests, studies and approvals with respect to a Jointly-Developed New
Implant; (ii) RTI shall be solely responsible for all costs related to
regulatory tests, studies and approvals with respect to its Manufacturing; and
(iii) MSD shall reimburse RTI for its costs incurred in connection with the
production of prototypes requested by MSD, provided that such costs are mutually
agreed to at the time of MSD’s request for such Prototypes.

(iv) The Jointly-Developed New Implant shall be added to Exhibit A as an
Implant.

(c) Exclusivity and Fees Applicable to Jointly-Developed New Implants. With
respect to each Jointly-Developed New Implant, such Jointly-Developed New
Implant shall be an exclusive Implant; and (ii) the Parties will determine prior
to the commencement of development the Fees to be charged by RTI to MSD for such
Jointly-Developed New Implant.

(d) Initial Jointly-Developed New Implant Forecast. With respect to any
Jointly-Developed New Implant added to Exhibit A as an Implant in accordance
with the terms of this Section 8.5, MSD shall provide RTI with a mutually
agreeable binding stocking order and a good faith non-binding twelve (12) month
forecast of MSD’s demand for such Jointly-Developed New Implant. As the time for
launch approaches, MSD will include the Jointly-Developed New Implant in its
forecasts and orders pursuant to Sections 3.1 and 3.2 of this Agreement.

ARTICLE IX

REPRESENTATIONS AND WARRANTIES

9.1. Mutual Warranties. Each Party hereby represents and warrants to, and
covenants with, the other Party that:

(a) Due Organization, Good Standing and Power. It is a corporation or other
entity duly organized, validly existing and, if relevant in its jurisdiction of
organization, in good standing under the laws of its jurisdiction of
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to own, lease and operate its assets and to conduct the business now being
conducted by it. It has all requisite power and authority to enter into this
Agreement and to perform its obligations hereunder.

(b) Authorization and Validity of Agreement. The execution, delivery and
performance by it of this Agreement and the consummation by it of the
transactions contemplated hereby have been duly authorized and approved by all
necessary corporate or equivalent action on its part. This Agreement has been
duly executed and delivered by it and constitutes its legal, valid and binding
obligation, enforceable against it in accordance with its terms, except as the
same may be limited by applicable bankruptcy, insolvency, reorganization,
moratorium or other laws relating to or affecting creditors’ rights generally
and by general equity principles.

(c) Absence of Conflicts. The execution, delivery and performance by it of this
Agreement and the consummation by it of the transactions contemplated hereby do
not and will not: (i) violate any Applicable Laws; (ii) conflict with, or result
in the breach of any provision of, its certificate or articles of incorporation,
bylaws or equivalent organizational documents; (iii) result in the creation of
any lien or encumbrance of any nature upon any property being transferred or
licensed by it pursuant to this Agreement or (iv) violate, conflict with, result
in the breach or termination of, or constitute a default under (or event which,
with notice, lapse of time or both, would constitute a default under), any
permit, contract or agreement to which it is a party or by which any of its
properties or businesses are bound.

9.2. Implant Warranty. RTI warrants to MSD that the Implants, when delivered to
MSD by RTI or its Affiliates, will (i) conform to the applicable Specifications,
and (ii) have been Manufactured by RTI and/or its Affiliates in compliance with
Applicable Laws and Applicable Industry Standards. The foregoing warranties
shall be in effect with respect to each Implant for the labeled shelf-life of
the Implant. RTI further warrants to MSD that the Implants, when delivered,
shall be free and clear of any liens, security interests or encumbrances.

9.3. NO OTHER WARRANTY OR REPRESENTATION; LIMITATION OF LIABILITY. EXCEPT AS
EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, RTI MAKES NO EXPRESS OR IMPLIED
REPRESENTATIONS OR WARRANTIES OF ANY KIND, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE. MSD SHALL
NOT MAKE ANY WARRANTIES OR OTHER REPRESENTATIONS REGARDING IMPLANTS. TO THE
FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, IN NO EVENT WILL (A) RTI BE
LIABLE HEREUNDER FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES,
EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR (B) RTI’S CUMULATIVE
LIABILITY TO MSD UNDER THIS AGREEMENT EXCEED THE AMOUNTS ACTUALLY PAID TO RTI BY
MSD HEREUNDER IN THE TWELVE (12) MONTHS PRIOR TO THE DATE ON WHICH THE CLAIM
GIVING RISE TO THE LIABILITY AROSE. THIS PROVISION SHALL SURVIVE THE TERMINATION
OR EXPIRATION OF THIS AGREEMENT.

 

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ARTICLE X

INDEMNIFICATION

10.1. Indemnification by MSD. Subject to RTI’s indemnification obligations
pursuant to Section 10.2 herein, MSD shall indemnify and hold RTI, its officers,
directors, employees, agents, and Affiliates, harmless from losses, damages,
liabilities, costs and expenses that may result from any demand, claim or
litigation (collectively a “Claim”) brought by a Third Party and relating to or
resulting from criminal conduct, intentional torts, gross negligence,
negligence, misstatements or misrepresentations of MSD’s employees, Affiliates
or Marketing Partners, and all other such Third Party Claims resulting from or
arising out of (i) Distribution of the Implants; (ii) statements made verbally
or in writing by representatives or agents of MSD, including Affiliates and
Marketing Partners, that expand upon or are inconsistent with Implant literature
reviewed by RTI or other information furnished by RTI with respect to the
Implants; (iii) the storage and handling of Implants by representatives or
agents of MSD, including Affiliates and Marketing Partners, that is inconsistent
with the instructions provided by RTI; (iv) breach by an Implant of a Third
Party’s Intellectual Property rights provided that an infringing element is
attributed to an Implant design or specification provided by MSD to RTI; or
(v) actual breach by MSD of this Agreement or any warranty, representation or
covenant contained herein occurring as a result of MSD’s conduct.

10.2. Indemnification by RTI. Subject to MSD’s indemnification obligations
pursuant to Section 10.1 herein, RTI shall indemnify and hold MSD, its officers,
directors, employees, agents, and Affiliates, harmless from losses, damages,
liabilities, costs and expenses that may result from any Claim brought by a
Third Party and relating to or resulting from criminal conduct, intentional
torts, gross negligence, negligence, misstatements or misrepresentations of
RTI’s employees or Affiliates, and all other such Third Party Claims resulting
from or arising out of (i) Manufacture of the Implants; (ii) breach by an
Implant of a Third Party’s Intellectual Property rights, except as provided for
in Section 10.1(iv) above; or (iii) actual breach by RTI of this Agreement or
any warranty, representation or covenant contained herein occurring as a result
of RTI’s conduct.

10.3. Indemnification Procedure. To receive the foregoing indemnities, the Party
seeking indemnification (“Indemnitee”) must (i) provide formal written notice
(as per Section 12.7 of this Agreement) to be received by the indemnifying Party
(“Indemnitor”) within ten (10) Business Days of Indemnitee’s first written
notice of the Claim; (ii) tender to Indemnitor full control and authority over
the defense of the Claim; (iii) cooperate as reasonably requested by Indemnitor
(at Indemnitor’s expense) in Indemnitor’s defense of the Claim; and (iv) not
enter into any settlement or compromise of such Claim defended by Indemnitor
without the express written authorization of Indemnitor. Indemnitor shall not
settle or compromise a Claim without Indemnitee’s prior written consent (which
consent shall not be unreasonably withheld or delayed), unless (i) the sole
relief provided in such settlement or compromise shall be borne in full by
Indemnitor, and (ii) such settlement or compromise does not include any finding
or admission of a violation by Indemnitee of any Applicable Laws or Third
Party’s rights; or require any changes in the Indemnitor’s or Indemnitee’s
business practices that would impair performance of either Party’s obligations
under this Agreement.

 

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(a) In the event Indemnitor does not accept the tender noted above, Indemnitee
may proceed with the defense, settlement and/or compromise of a Claim with
counsel of the Indemnitee’s own choosing, with the reasonable fees, including
attorneys’ fees, costs and expenses of such defense, settlement and/or
compromise to be borne by Indemnitor, provided indemnification is validly owed
to Indemnitee by Indemnitor pursuant to the terms of this Agreement. At least
once per calendar quarter following Indemnitor’s decline of the tender,
Indemnitee will provide Indemnitor with an itemized report of all losses,
damages, liabilities, costs, expenses and attorneys’ fees that Indemnitee claims
to be owed by Indemnitor.

10.4. Survival; Waiver. The provisions of this Article X shall survive any
termination or expiration of this Agreement. Any waiver by an indemnified Party
of its rights under this Article must be set forth expressly and in writing in
order to be effective.

ARTICLE XI

TERM AND TERMINATION

11.1. Term. This Agreement will become effective on the Effective Date and shall
continue in effect until December 31, 2017 (the “Initial Term”). The Initial
Term will be renewed automatically thereafter for successive five-year terms
(each a “Renewal Term”), unless at least one (1) year in advance of the
expiration of the Initial Term or applicable Renewal Term one Party provides
written notice to the other Party that it does not intend to renew. This
Agreement may be terminated before the expiration of the Initial Term or any
renewal term only by mutual written agreement of the Parties or in accordance
with Section 11.2. The period from the Effective Date through the date of
expiration or termination of this Agreement shall be referred to as the “Term.”

11.2. Termination.

(a) Dissolution or Insolvency Event. If a Party is dissolved under applicable
corporate law or becomes subject to an Insolvency Event, this Agreement will be
terminable at will by the other Party.

(b) Default. If either Party believes the other is in default of any of its
material obligations under this Agreement, it may give notice to the other Party
describing the default with reasonable specificity. The defaulting Party shall
have sixty (60) calendar days in which to remedy such default. Such cure period
shall be extended in the case of a default not reasonably capable of being
remedied in such 60-day period so long as the defaulting Party uses diligent
efforts to remedy such default and is pursuing a course of action that, if
successful, will effect such a remedy. If such alleged default is not remedied
in the time period set forth above, then the Party alleging default shall refer
the matter to senior executive officers of each Party, who shall meet and confer
within fifteen (15) Business Days after notice from the non-defaulting Party of
its desire for such a meeting. If the Parties are unable to resolve any dispute
in such meeting, the non-defaulting Party may terminate this Agreement upon
delivery to the defaulting Party of a written notice of termination at any time
within six (6) months after the meeting but before such default is remedied. The
non-defaulting Party’s right to terminate this Agreement shall not be construed
as an exclusive remedy.

(c) Force Majeure. Either Party may terminate this Agreement in accordance with
the terms of Section 12.2.

 

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11.3. Consequences of Termination.

(a) General. Termination or expiration of this Agreement shall not relieve any
Party of any obligations that are expressly indicated to survive termination or
expiration and, accordingly, any provision of this Agreement required for the
interpretation or enforcement of any such obligation will survive the expiration
or termination of this Agreement. Termination or expiration of this Agreement
for any reason shall be without prejudice to any rights that shall have accrued
to the benefit of any Party prior to such termination or expiration.

(b) Inventory. Upon the expiration or termination of this Agreement, (i) RTI
shall continue to process and deliver to MSD all Implants that are the subject
of a Confirmed Order with a requested delivery date up to the date of expiration
or termination of this Agreement, and (ii) MSD shall be permitted to Distribute
any remaining inventory of the Implants, including any Implants delivered
pursuant to clause (i) above (and for such purpose MSD Distribution’s rights
under this Agreement shall continue in effect) until the remaining inventory has
been depleted or until the one (1) year anniversary of the termination or
expiration of this Agreement, whichever occurs first.

ARTICLE XII

MISCELLANEOUS

12.1. Agency. The Parties are independent contractors. No employee or agent of
one Party is, nor shall they be deemed to be whether impliedly or by estoppel,
an employee, agent, partner or legal representative of the other Party for any
purpose. Neither Party shall have the right, power or authority to enter into
any verbal or written contracts, agreements or representation in the name of, or
on behalf of, the other Party. Neither shall a Party have the right, power or
authority to pledge the credit of the other Party in any way or hold itself out
as having the authority to do so.

12.2. Force Majeure. If the performance of any obligation under this Agreement
is prevented, restricted or interfered with by a Force Majeure event, then the
Party so affected shall, upon giving prior written notice to the other Party, be
excused from such performance to the extent of such prevention, restriction, or
interference, provided that the Party so affected shall use commercially
reasonable efforts to avoid or remove such causes of nonperformance, and shall
continue performance hereunder with reasonable dispatch whenever such causes are
removed. If such conditions inhibiting complete performance shall continue in
excess of ninety (90) calendar days, the Parties shall attempt to arrive at a
mutually acceptable compromise within the spirit and intent of this Agreement.
If the Parties fail to reach a mutually acceptable compromise within ninety
(90) calendar days following the initial attempt to negotiate the same, then the
Party who is not affected by the Force Majeure event shall have the option, by
delivery of written notice of termination to the affected Party, to immediately
terminate this Agreement.

12.3. Entire Agreement; Amendments. This Agreement constitutes the entire
agreement between the Parties hereto concerning its subject matter and
supersedes all previous

 

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negotiations, agreements and commitments with respect thereto. This Agreement
specifically terminates, supersedes and replaces the Prior Agreement, as
amended, including any predecessor agreements incorporated therein; provided,
however, that any irrevocable rights and/or accured rights or obligations
subject to post-expiration or termination survival shall continue to survive.
This Agreement shall not be released, discharged, amended or modified in any
manner except by a written instrument signed by duly authorized officers or
representatives of each of the Parties hereto.

12.4. Governing Law. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the State of Delaware. The Parties agree
that any legal action relating to this Agreement shall be commenced and
maintained before any appropriate state or federal court located in the State of
Delaware, and the Parties hereby submit to the jurisdiction of such courts and
waive any right to challenge or otherwise raise questions of personal
jurisdiction or venue in any action commenced or maintained in such courts.

12.5. Partial Illegality. If any provision of this Agreement, or the application
thereof to any Party or circumstances, shall be declared void, illegal or
unenforceable, the remainder of this Agreement shall be valid and enforceable to
the extent permitted by Applicable Laws. In such event, the Parties shall use
their best efforts to replace the invalid or unenforceable provision by a
provision that, to the extent permitted by Applicable Laws, achieves the
purposes intended under the invalid or unenforceable provision. Any deviation by
either Party from the terms and provisions of this Agreement in order to comply
with Applicable Laws shall not be considered a breach of this Agreement.

12.6. Waiver of Compliance. No provision of this Agreement shall be waived by
any act, omission or knowledge of a Party or its agents or employees, except by
an instrument in writing expressly waiving such provision and signed by a duly
authorized officer of the waiving Party, which waiver shall be effective only
with respect to the specific obligation and instance described therein.

12.7. Notices. With the exception of forecasts, royalty reports and payments to
be provided under this Agreement, any official notice, waiver or consent
required or permitted by this Agreement to be given or delivered shall be in
writing and shall be either delivered in person, sent by a nationally recognized
courier (e.g. FedEx, UPS), sent by registered or certified mail (with postage
prepaid and return receipt requested), or sent by facsimile (if confirmed), as
follows:

 

TO RTI:    RTI Surgical, Inc.   

11621 Research Circle

Alachua, FL 32615

Attn: Chief Executive Officer

Fax No.: (386) 418-3608

 

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With copy to:   

RTI Surgical, Inc.

11621 Research Circle

Alachua, FL 32615

Attn: General Counsel

Facsimile: (386) 418-5157

 

and

 

Jerome W. Hoffman, Esq.

Holland & Knight LLP

315 S. Calhoun Street, Suite 600

Tallahassee, FL 32302-0810

Facsimile: 850-224-8832

 

and

 

Warren J. Nimetz, Esq.

Fulbright & Jaworski LLP

666 Fifth Avenue, 31st Floor

New York, NY 10103-3198

Facsimile: 202-318-3400

TO MSD:   

Medtronic Sofamor Danek USA, Inc.

2600 Sofamor Danek Drive

Memphis, TN 38132

Attn: President of Spine

With a copy to:   

Medtronic Sofamor Danek USA, Inc.

2600 Sofamor Danek Drive

Memphis, TN 38132

Attn: Michael Herringshaw, Senior Strategic Sourcing Director

 

and

 

Medtronic Sofamor Danek USA, Inc.

2600 Sofamor Danek Drive

Memphis, TN 38132

Attention: Vice President and Chief Legal Counsel

FAX: (901) 344-1576

Anything in this Agreement to the contrary notwithstanding, any notice intended
to act as a formal and official notice, waiver or consent under any provision of
this Agreement (except production forecasts and royalty reports) must be sent by
Brian Hutchison or his successor (if coming from RTI) or Douglas King or his
successor (if coming from MSD) to the designated

 

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recipients noted herein above. Any official notice, waiver or consent shall be
effective (i) upon delivery if delivered in person, (ii) the next Business Day
in the locality of the recipient if delivered by express courier service,
(iii) three (3) Business Days after post mark if sent by registered or certified
mail, or (iv) if sent by fax, at the time shown in the confirmed electronic
receipt, or on the first Business Day thereafter if the notice is not sent on a
Business Day or was sent after 5:00 pm in the recipient’s time zone. Either
Party may change its address.

12.8. Counterparts and Facsimile/Electronic. This Agreement may be executed in
counterparts, each of which shall be deemed to be an original and all of which
together shall be deemed to be one and the same instrument. A manual signature
on this Agreement or any document executed in connection with this Agreement,
the image of which is transmitted electronically (including facsimile or
e-mail), shall constitute an original signature for purposes of this Agreement.

12.9. Limitation on Liability. Except with respect to the Parties’
indemnification obligations, neither Party shall be liable to the other for
indirect, incidental, consequential, punitive or special damages, including but
not limited to lost profits, arising from or relating to any breach of this
Agreement, regardless of any notice of the possibility of such damages.

12.10. Further Actions. Each Party agrees, subsequent to the execution and
delivery of this Agreement and without any additional consideration, to execute,
acknowledge and deliver such further documents and instruments, and to do all
such other acts, as may be necessary or appropriate in order to carry out the
purposes and intent of this Agreement.

12.11. Assignment. This Agreement may not be assigned without the prior written
consent of the other Party except that no prior written consent will be required
where the assignment occurs in connection with a merger, acquisition, or other
Change in Control; provided, however, that such assignment shall not relieve the
assigning Party of its obligations hereunder. If and to the extent that a Party
assigns any of its rights and/or obligations hereunder in accordance with this
Section, then this Agreement shall be binding upon the assignee to the same
extent as if it were a Party hereto and each reference herein to the name of the
assigning Party shall be deemed to include the assignee. Any assignment not in
accordance with this Section shall be void.

12.12. Jointly Prepared. This Agreement has been prepared jointly and shall not
be strictly construed against either Party.

12.13. No Third Party Beneficiaries. This Agreement is not intended to confer
any benefits upon, or create any rights in favor of, any Third Party.

12.14. Expenses. Except as otherwise expressly provided in this Agreement, each
Party shall be responsible for its own expenses incurred in connection with this
Agreement and the transactions contemplated hereby.

12.15. Survival. The following Sections shall survive the expiration or
termination of this Agreement: 1.1; 1.2; 2.5; 4.3; 6.4; 6.5; 6.6; 6.8; 6.9;
6.10; 6.11; 6.12; 6.13; 6.14; 6.15; 7.1; 7.2; 9.2; 9.3; Article X; 11.3; 12.1;
12.2; 12.3; 12.4; 12.5; 12.6; 12.7; 12.8; 12.9; 12.12; 12.13; 12.14; and 12.15

 

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[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK;

SIGNATURES APPEAR ON FOLLOWING PAGE]

 

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IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its
respective duly authorized representative as of the Effective Date.

 

RTI SURGICAL, INC. By:   /s/ Thomas F. Rose Name:   Thomas F. Rose Title:   EVP
- Administration MEDTRONIC SOFAMOR DANEK USA, INC. By:   /s/ Michael Herringshaw
Name:   Michael Herringshaw Title:   Sr. Director Strategic Procurement

 

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EXHIBIT A

Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks (********) denote omissions.

EXHIBIT A

LIST OF PRODUCTS

Revised/Restructured October 4, 2013. New fees effective for all purchase orders
issued after

January 1, 2014. Grafts to be invoiced at the fee in effect at the time of the
purchase order issuance.

(New products since 10/1/2006 highlighted in red)

EXCLUSIVE PRODUCTS

Cornerstone SR (SR Cortical Block)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  

200511

   200511     

SR Cortical Block 5 x 11 x 11

     ********         ********         ********   

200541

   200541     

SR Cortical Block 5 x 14 x 11

     ********         ********         ********   

200544

   200544     

SR Cortical Block 5 x 14 x 14

     ********         ********         ********   

200611

   200611     

SR Cortical Block 6 x 11 x 11

     ********         ********         ********   

200641

   200641     

SR Cortical Block 6 x 14 x 11

     ********         ********         ********   

200644

   200644     

SR Cortical Block 6 x 14 x 14

     ********         ********         ********   

200711

   200711     

SR Cortical Block 7 x 11 x 11

     ********         ********         ********   

200741

   200741     

SR Cortical Block 7 x 14 x 11

     ********         ********         ********   

200744

   200744     

SR Cortical Block 7 x 14 x 14

     ********         ********         ********   

200811

   200811     

SR Cortical Block 8 x 11 x 11

     ********         ********         ********   

200841

   200841     

SR Cortical Block 8 x 14 x 11

     ********         ********         ********   

200844

   200844     

SR Cortical Block 8 x 14 x 14

     ********         ********         ********   

200911

   200911     

SR Cortical Block 9 x 11 x 11

     ********         ********         ********   

200941

   200941     

SR Cortical Block 9 x 14 x 11

     ********         ********         ********   

200944

   200944     

SR Cortical Block 9 x 14 x 14

     ********         ********         ********   

Cornerstone ASR (Composite Cortical-Cancellous Block)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
245041    245041     

ASR Cortical-Cancellous Block 10 x 14 x 11

     ********         ********         ********    245141    245141     

ASR Cortical-Cancellous Block 11 x 14 x 11

     ********         ********         ********    245241    245241     

ASR Cortical-Cancellous Block 12 x 14 x 11

     ********         ********         ********    245341    245341     

ASR Cortical-Cancellous Block 13 x 14 x 11

     ********         ********         ********    245541    245541     

ASR Cortical-Cancellous Block 5 x 14x 11 mm

     ********         ********         ********    245641    245641     

ASR Cortical-Cancellous Block 6 x 14x 11 mm

     ********         ********         ********    245741    245741     

ASR Cortical-Cancellous Block 7 x 14 x 11

     ********         ********         ********    245841    245841     

ASR Cortical-Cancellous Block 8 x 14 x 11

     ********         ********         ********    245941    245941     

ASR Cortical-Cancellous Block 9 x 14 x 11

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Cornerstone LASR (Lordotic Composite Cortical-Cancellous Block)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
345011    345011     

Cornerstone L-ASR 10 x 11 x 11

     ********         ********         ********    345041    345041     

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 11

     ********         ********         ********    345044    345044     

Cornerstone L-ASR 10 x 14 x 14

     ********         ********         ********    345111    345111     

Cornerstone L-ASR 11 x 11 x 11

     ********         ********         ********    345141    345141     

Lordotic ASR Cortical-Cancellous Block 11 x 14 x 11

     ********         ********         ********    345144    345144     

Cornerstone L-ASR 11 x 14 x 14

     ********         ********         ********    345211    345211     

Cornerstone L-ASR 12 x 11 x 11

     ********         ********         ********    345241    345241     

Lordotic ASR Cortical-Cancellous Block 12 x 14 x 11

     ********         ********         ********    345244    345244     

Cornerstone L-ASR 12 x 14 x 14

     ********         ********         ********    345511    345511     

Lordotic ASR Cortical-Cancellous Block 5 x 11x 11 mm

     ********         ********         ********    345341    345341     

Lordotic ASR Cortical-Cancellous Block 13 x 14 x 11

     ********         ********         ********    345541    345541     

Lordotic ASR Cortlcal-Cancellous Block 5 x 14x 11 mm

     ********         ********         ********    345544    345544     

Lordotic ASR Cortical-Cancellous Block 5 x 14x 14 mm

     ********         ********         ********    345611    345611     

Lordotic ASR Cortical-Cancellous Block 6 x 11x 11 mm

     ********         ********         ********    345641    345641     

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 11 mm

     ********         ********         ********    345644    345644     

Lordotic ASR Cortical-Cancellous Block 6 x 14x 14 mm

     ********         ********         ********    345711    345711     

Cornerstone L-ASR 7 x 11 x 11

     ********         ********         ********    345741    345741     

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 11

     ********         ********         ********    345744    345744     

Cornerstone L-ASR 7 x 14 x 14

     ********         ********         ********    345811    345811     

Cornerstone L-ASR 8 x 11 x 11

     ********         ********         ********    345841    345841     

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 11

     ********         ********         ********    345844    345844     

Cornerstone L-ASR 8 x 14 x 14

     ********         ********         ********    345911    345911     

Cornerstone L-ASR 9 x 11 x 11

     ********         ********         ********    345941    345941     

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 11

     ********         ********         ********    345944    345944     

Cornerstone L-ASR 9 x 14 x 14

     ********         ********         ********   

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Confidential Treatment Requested

Cornerstone LASR (Lordotic Composite Cortical-Cancellous Block)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
345011INT    8S0101     

Lordotic ASR Cortical-Cancellous Block 10 x 11 x 11 mm

     ********         ********         ********    345041INT    8S0102     

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 11 mm

     ********         ********         ********    345044INT    8S0103     

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 14 mm

     ********         ********         ********    345541INT    8S0152     

Lordotic ASR Cortical-Cancellous Block 5 x 14 x 11 mm

     ********         ********         ********    345544INT    8S0153     

Lordotic ASR Cortlcal-Cancellous Block 5 x 14 x 14 mm

     ********         ********         ********    345611INT    8S0161     

Lordotic ASR Cortical-Cancellous Block 6 x 11x 11 mm

     ********         ********         ********    345641INT    8S0162     

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 11 mm

     ********         ********         ********    345644INT    8S0163     

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 14 mm

     ********         ********         ********    345711INT    8S0171     

Lordotic ASR Cortical-Cancellous Block 7 x 11 x 11 mm

     ********         ********         ********    345741INT    8S0172     

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 11 mm

     ********         ********         ********    345744INT    8S0173     

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 14 mm

     ********         ********         ********    345811INT    8S0181     

Lordotic ASR Cortical-Cancellous Block 8 x 11 x 11 mm

     ********         ********         ********    345841INT    8S0182     

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 11 mm

     ********         ********         ********    345844INT    8S0183     

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 14 mm

     ********         ********         ********    345911INT    8S0191     

Lordotic ASR Cortical-Cancellous Block 9 x 11 x 11 mm

     ********         ********         ********    345941INT    8S0192     

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 11 mm

     ********         ********         ********    345944INT    8S0193     

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 14 mm

     ********         ********         ********    345011CAN    CS0101     

Lordotic ASR Cortical-Cancellous Block 10 x 11 x 11 mm

     ********         ********         ********    345041CAN    CS0102     

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 11 mm

     ********         ********         ********    345044CAN    CS0103     

Lordotic ASR Cortical-Cancellous Block 10 x 14 x 14 mm

     ********         ********         ********    345111CAN    CS0111     

Lordotic ASR Cortical-Cancellous Block 11 x 11 x 11 mm

     ********         ********         ********    345141CAN    CS0112     

Lordotic ASR Cortical-Cancellous Block 11 x 14 x 11 mm

     ********         ********         ********    345144CAN    CS0113     

Lordotic ASR Cortical-Cancellous Block 11 x 14 x 14 mm

     ********         ********         ********    345211CAN    CS0121     

Lordotic ASR Cortical-Cancellous Block 12 x 11 x 11 mm

     ********         ********         ********    345241CAN    CS0122     

Lordotic ASR Cortical-Cancellous Block 12 x 14 x 11 mm

     ********         ********         ********    345244CAN    CS0123     

Lordotic ASR Cortical-Cancellous Block 12 x 14 x 14 mm

     ********         ********         ********    345511CAN    CS0151     

Lordotic ASR Cortical-Cancellous Block 5 x 11 x 11 mm

     ********         ********         ********    345541CAN    CS0152     

Lordotic ASR Cortical-Cancellous Block 5 x 14 x 11 mm

     ********         ********         ********    345544CAN    CS0153     

Lordotic ASR Cortical-Cancellous Block 5 x 14 x 14 mm

     ********         ********         ********    345611CAN    CS0161     

Lordotic ASR Cortical-Cancellous Block 6 x 11 x 11 mm

     ********         ********         ********    345641CAN    CS0162     

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 11 mm

     ********         ********         ********    345644CAN    CS0163     

Lordotic ASR Cortical-Cancellous Block 6 x 14 x 14 mm

     ********         ********         ********    345711CAN    CS0171     

Lordotic ASR Cortical-Cancellous Block 7 x 11 x 11 mm

     ********         ********         ********    345741CAN    CS0172     

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 11 mm

     ********         ********         ********    345744CAN    CS0173     

Lordotic ASR Cortical-Cancellous Block 7 x 14 x 14 mm

     ********         ********         ********    345811CAN    CS0181     

Lordotic ASR Cortical-Cancellous Block 8 x 11 x 11 mm

     ********         ********         ********    345841CAN    CS0182     

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 11 mm

     ********         ********         ********    345844CAN    CS0183     

Lordotic ASR Cortical-Cancellous Block 8 x 14 x 14 mm

     ********         ********         ********    345911CAN    CS0191     

Lordotic ASR Cortical-Cancellous Block 9 x 11 x 11 mm

     ********         ********         ********    345941CAN    CS0192     

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 11 mm

     ********         ********         ********    345944CAN    CS0193     

Lordotic ASR Cortical-Cancellous Block 9 x 14 x 14 mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Frozen Cornerstone LASR (Lordotic Composite Cortical-Cancellous Block)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
345041FZ    347041     

FROZEN LASR 10 x 14 x 11mm

     ********         ********         ********    345044FZ    347044     

FROZEN LASR 10 x 14 x 14mm

     ********         ********         ********    345141FZ    347141     

FROZEN LASR 11 x 14 x 11mm

     ********         ********         ********    345144FZ    347144     

FROZEN LASR 11 x 14 x 14mm

     ********         ********         ********    345241FZ    347241     

FROZEN LASR 12 x 14 x 11mm

     ********         ********         ********    345244FZ    347244     

FROZEN LASR 12 x 14 x 14mm

     ********         ********         ********    345541FZ    347541     

FROZEN LASR 5 x 14 x 11mm

     ********         ********         ********    345544FZ    347544     

FROZEN LASR 5 x 14 x 14mm

     ********         ********         ********    345641FZ    347641     

FROZEN LASR 6 x 14 x 11mm

     ********         ********         ********    345644FZ    347644     

FROZEN LASR 6 x 14 x 14mm

     ********         ********         ********    345741FZ    347741     

FROZEN LASR 7 x 14 x 11mm

     ********         ********         ********    345744FZ    347744     

FROZEN LASR 7 x 14 x 14mm

     ********         ********         ********    345841FZ    347841     

FROZEN LASR 8 x 14 x 11mm

     ********         ********         ********    345844FZ    347844     

FROZEN LASR 8 x 14 x 14mm

     ********         ********         ********    345941FZ    347941     

FROZEN LASR 9 x 14 x 11mm

     ********         ********         ********    345944FZ    347944     

FROZEN LASR 9 x 14 x 14mm

     ********         ********         ********   

Cornerstone Lordotic MASR Pinnacle

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
645511    645511     

Lordotic MASR Cortical-Cancellous Block 5 x 11 x 11

     ********         ********         ********    645541    645541     

Lordotic MASR Cortical-Cancellous Block 5 x 14 x 11

     ********         ********         ********    645544    645544     

Lordotic MASR Cortical-Cancellous Block 5 x 14 x 14

     ********         ********         ********    645611    645611     

Lordotic MASR Cortical-Cancellous Block 6 x 11 x 11

     ********         ********         ********    645641    645641     

Lordotic MASR Cortical-Cancellous Block 6 x 14 x 11

     ********         ********         ********    645644    645644     

Lordotic MASR Cortical-Cancellous Block 6 x 14 x 14

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Cornerstone SR Assembled Cortical

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
330511    330511     

ACSR Cortical Block 5 x 11 x 11mm

     ********         ********         ********    330541    330541     

ACSR Cortical Block 5 x 14 x 11mm

     ********         ********         ********    330544    330544     

ACSR Cortical Block 5 x 14 x 14mm

     ********         ********         ********    330611    330611     

ACSR Cortical Block 6 x 11 x 11mm

     ********         ********         ********    330641    330641     

ACSR Cortical Block 6 x 14 x 11mm

     ********         ********         ********    330644    330644     

ACSR Cortical Black 6 x 14 x 14mm

     ********         ********         ********    330711    330711     

ACSR Cortical Block 7 x 11 x 11mm

     ********         ********         ********    330741    330741     

ACSR Cortical Block 7 x 14 x 11mm

     ********         ********         ********    330744    330744     

ACSR Cortical Block 7 x 14 x 14mm

     ********         ********         ********    330811    330811     

ACSR Cortical Block 8 x 11 x 11mm

     ********         ********         ********    330841    330841     

ACSR Cortical Block 8 x 14 x 11mm

     ********         ********         ********    330844    330844     

ACSR Cortical Block 8 x 14 x 14mm

     ********         ********         ********    330911    330911     

ACSR Cortical Block 9 x 11 x 11mm

     ********         ********         ********    330941    330941     

ACSR Cortical Block 9 x 14 x 11mm

     ********         ********         ********    330944    330944     

ACSR Cortical Block 9 x 14 x 14mm

     ********         ********         ********    331011    331011     

ACSR Cortical Block 10 x 11 x 11mm

     ********         ********         ********    331041    331041     

ACSR Cortical Block 10 x 14 x 11mm

     ********         ********         ********    331044    331044     

ACSR Cortical Block 10 x 14 x 14mm

     ********         ********         ********    331111    331111     

ACSR Cortical Block 11 x 11 x 11mm

     ********         ********         ********    331141    331141     

ACSR Cortical Block 11 x 14 x 11mm

     ********         ********         ********    331144    331144     

ACSR Cortical Block 11 x 14 x 14mm

     ********         ********         ********    331211    331211     

ACSR Cortical Block 12 x 11 x 11mm

     ********         ********         ********    331241    331241     

ACSR Cortical Block 12 x 14 x 11mm

     ********         ********         ********    331244    331244     

ACSR Cortical Block 12 x 14 x 14mm

     ********         ********         ********    331311    331311     

ACSR Cortical Block 13 x 11 x 11mm

     ********         ********         ********    331341    331341     

ACSR Cortical Block 13 x 14 x 11mm

     ********         ********         ********    331344    331344     

ACSR Cortical Block 13 x 14 x 14mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Lordotic SR Assembled Cortical

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
340511    340511     

L-ACSR Cortical Block 5 x 11 x 11mm

     ********         ********         ********    340541    340541     

L-ACSR Cortical Block 5 x 14 x 11mm

     ********         ********         ********    340544    340544     

L-ACSR Cortical Block 5 x 14 x 14mm

     ********         ********         ********    340611    340611     

L-ACSR Cortical Block 6 x 11 x 11mm

     ********         ********         ********    340641    340641     

L-ACSR Cortical Block 6 x 14 x 11mm

     ********         ********         ********    340644    340644     

L-ACSR Cortical Block 6 x 14 x 14mm

     ********         ********         ********    340711    340711     

L-ACSR Cortical Block 7 x 11 x 11mm

     ********         ********         ********    340741    340741     

L-ACSR Cortical Block 7 x 14 x 11mm

     ********         ********         ********    340744    340744     

L-ACSR Cortical Block 7 x 14 x 14mm

     ********         ********         ********    340811    340811     

L-ACSR Cortical Block 8 x 11 x 11mm

     ********         ********         ********    340841    340841     

L-ACSR Cortical Block 8 x 14 x 11mm

     ********         ********         ********    340844    340844     

L-ACSR Cortical Block 8 x 14 x 14mm

     ********         ********         ********    340911    340911     

L-ACSR Cortical Block 9 x 11 x 11mm

     ********         ********         ********    340941    340941     

L-ACSR Cortical Block 9 x 14 x 11mm

     ********         ********         ********    340944    340944     

L-ACSR Cortical Block 9 x 14 x 14mm

     ********         ********         ********    341011    341011     

L-ACSR Cortical Block 10 x 11 x 11mm

     ********         ********         ********    341041    341041     

L-ACSR Cortical Block 10 x 14 x 11mm

     ********         ********         ********    341044    341044     

L-ACSR Cortical Block 10 x 14 x 14mm

     ********         ********         ********    341111    341111     

L-ACSR Cortical Block 11 x 11 x 11mm

     ********         ********         ********    341141    341141     

L-ACSR Cortical Block 11 x 14 x 11mm

     ********         ********         ********    341144    341144     

L-ACSR Cortical Block 11 x 14 x 14mm

     ********         ********         ********    341211    341211     

L-ACSR Cortical Block 12 x 11 x 11mm

     ********         ********         ********    341241    341241     

L-ACSR Cortical Block 12 x 14 x 11mm

     ********         ********         ********    341244    341244     

L-ACSR Cortical Block 12 x 14 x 14mm

     ********         ********         ********    341011INT    8S0201     

L-ACSR Cortical Block 10 x 11 x 11mm

     ********         ********         ********    341041INT    8S0204     

L-ACSR Cortical Block 10 x 14 x 11mm

     ********         ********         ********    340541INT    8S0254     

L-ACSR Cortical Block 5 x 14 x 11mm

     ********         ********         ********    340641INT    8S0264     

L-ACSR Cortical Block 6 x 14 x 11mm

     ********         ********         ********    340741INT    8S0274     

L-ACSR Cortical Block 7 x 14 x 11mm

     ********         ********         ********    341011CAN    CS0201     

L-ACSR Cortical Block 10 x 11 x 11mm

     ********         ********         ********    341041CAN    CS0204     

L-ACSR Cortical Block 10 x 14 x 11mm

     ********         ********         ********    341044CAN    CS0205     

L-ACSR Cortical Block 10 x 14 x 14mm

     ********         ********         ********    341111CAN    CS0211     

L-ACSR Cortical Block 11 x 11 x 11mm

     ********         ********         ********    341141CAN    CS0214     

L-ACSR Cortical Block 11 x 14 x 11mm

     ********         ********         ********    341144CAN    CS0215     

L-ACSR Cortical Block 11 x 14 x 14mm

     ********         ********         ********    341211CAN    CS0221     

L-ACSR Cortical Block 12 x 11 x 11mm

     ********         ********         ********    341241CAN    CS0224     

L-ACSR Cortical Block 12 x 14 x 11mm

     ********         ********         ********    341244CAN    CS0225     

L-ACSR Cortical Block 12 x 14 x 14mm

     ********         ********         ********    340511CAN    CS0251     

L-ACSR Cortical Block 5 x 11 x 11mm

     ********         ********         ********    340541CAN    CS0254     

L-ACSR Cortical Block 5 x 14 x 11mm

     ********         ********         ********    340544CAN    CS0255     

L-ACSR Cortical Block 5 x 14 x 14mm

     ********         ********         ********    340611CAN    CS0261     

L-ACSR Cortical Block 6 x 11 x 11mm

     ********         ********         ********    340641CAN    CS0264     

L-ACSR Cortical Block 6 x 14 x 11mm

     ********         ********         ********    340644CAN    CS0265     

L-ACSR Cortical Block 6 x 14 x 14mm

     ********         ********         ********    340711CAN    CS0271     

L-ACSR Cortical Block 7 x 11 x 11mm

     ********         ********         ********    340741CAN    CS0274     

L-ACSR Cortical Block 7 x 14 x 11mm

     ********         ********         ********    340744CAN    CS0275     

L-ACSR Cortical Block 7 x 14 x 14mm

     ********         ********         ********    340811CAN    CS0281     

L-ACSR Cortical Block 8 x 11 x 11mm

     ********         ********         ********    340841CAN    CS0284     

L-ACSR Cortical Block 8 x 14 x 11mm

     ********         ********         ********    340844CAN    CS0285     

L-ACSR Cortical Block 8 x 14 x 14mm

     ********         ********         ********    340911CAN    CS0291     

L-ACSR Cortical Block 9 x 11 x 11mm

     ********         ********         ********    340941CAN    CS0294     

L-ACSR Cortical Block 9 x 14 x 11mm

     ********         ********         ********    340944CAN    CS0295     

L-ACSR Cortical Block 9 x 14 x 14mm

     ********         ********         ********   

Cornerstone Reserve (Cortical-Cancellous Ring)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
270050    270050     

RESERVE Cortical-Cancellous Ring 5mm

     ********         ********         ********    270060    270060     

RESERVE Cortical-Cancellous Ring 6mm

     ********         ********         ********    270070    270070     

RESERVE Cortical-Cancellous Ring 7mm

     ********         ********         ********    270080    270080     

RESERVE Cortical-Cancellous Ring 8mm

     ********         ********         ********    270090    270090     

RESERVE Cortical-Cancellous Ring 9mm

     ********         ********         ********    270100    270100     

RESERVE Cortical-Cancellous Ring 10mm

     ********         ********         ********    270110    270110     

RESERVE Cortical-Cancellous Ring 11mm

     ********         ********         ********    270120    270120     

RESERVE Cortical-Cancellous Ring 12mm

     ********         ********         ********    270130    270130     

RESERVE Cortical-Cancellous Ring 13mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Corner Select (Fibula Wedge)

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
210500    210500     

SELECT Fibula Wedge 5mm

     ********         ********         ********    210500    210500     

SELECT Fibula Wedge 6mm

     ********         ********         ********    210700    210700     

SELECT Fibula Wedge 7mm

     ********         ********         ********    210800    210800     

SELECT Fibula Wedge 8mm

     ********         ********         ********    210900    210900     

SELECT Fibula Wedge 9mm

     ********         ********         ********    211000    211000     

SELECT Fibula Wedge 10mm

     ********         ********         ********    211100    211100     

SELECT Fibula Wedge 11mm

     ********         ********         ********    211200    211200     

SELECT Fibula Wedge 12mm

     ********         ********         ********    211300    211300     

SELECT Fibula Wedge 13mm

     ********         ********         ********   

Lordotic Cornerstone SR Cortical Block

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
300511    300511     

Lordotic SR Cortical Block 5 x 11 x 11

     ********         ********         ********    300541    300541     

Lordotic SR Cortical Block 5 x 14 x 11

     ********         ********         ********    300544    300544     

Lordotic SR Cortical Block 5 x 14 x 14

     ********         ********         ********    300611    300611     

Lordotic SR Cortical Block 6 x 11 x 11

     ********         ********         ********    300641    300641     

Lordotic SR Cortical Block 6 x 14 x 11

     ********         ********         ********    300644    300644     

Lordotic SR Cortical Block 6 x 14 x 14

     ********         ********         ********    300711    300711     

Lordotic SR Cortical Block 7 x 11 x 11

     ********         ********         ********    300741    300741     

Lordotic SR Cortical Block 7 x 14 x 11

     ********         ********         ********    300744    300744     

Lordotic SR Cortical Block 7 x 14 x 14

     ********         ********         ********    300811    300811     

Lordotic SR Cortical Block 8 x 11 x 11

     ********         ********         ********    300841    300841     

Lordotic SR Cortical Block 8 x 14 x 11

     ********         ********         ********    300844    300844     

Lordotic SR Cortical Block 8 x 14 x 14

     ********         ********         ********    300911    300911     

Lordotic SR Cortical Block 9 x 11 x 11

     ********         ********         ********    300941    300941     

Lordotic SR Cortical Block 9 x 14 x 11

     ********         ********         ********    300944    300944     

Lordotic SR Cortical Block 9 x 14 x 14

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Tangent

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
160820    160820     

FROZEN Impacted Cortical Wedge 8 x 20mm

     ********         ********         ********    160826    160826     

FROZEN Impacted Cortical Wedge 8 x 26mm

     ********         ********         ********    161020    161020     

FROZEN Impacted Cortical Wedge 10 x 20mm

     ********         ********         ********    161026    161026     

FROZEN Impacted Cortical Wedge 10 x 26mm

     ********         ********         ********    161220    161220     

FROZEN Impacted Cortical Wedge 12 x 20mm

     ********         ********         ********    161226    161226     

FROZEN Impacted Cortical Wedge 12 x 26mm

     ********         ********         ********    161426    161426     

FROZEN Impacted Cortical Wedge 14 x 26mm

     ********         ********         ********    170820    170820     

Tangent - Impacted Cortical Wedge 08 X 20

     ********         ********         ********    170826    170826     

Tangent - Impacted Cortical Wedge 08 X 26

     ********         ********         ********    171020    171020     

Tangent - Impacted Cortical Wedge 10 X 20

     ********         ********         ********    171026    171026     

Tangent - Impacted Cortical Wedge 10 X 26

     ********         ********         ********    171220    171220     

Tangent - Impacted Cortical Wedge 12 X 20

     ********         ********         ********    171226    171226     

Tangent - Impacted Cortical Wedge 12 X 26

     ********         ********         ********    171426    171426     

Tangent - Impacted Cortical Wedge 14 X 26

     ********         ********         ********    171626    171626     

Tangent - Impacted Cortical Wedge 16 x 26

     ********         ********         ********   

Precision Graft

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
421266    421266     

Machined Cortical Ring 12” 12 x 26 x 26mm

     ********         ********         ********    421466    421466     

Machined Cortical Ring 12” 14 x 26 x 26mm

     ********         ********         ********    421666    421666     

Machined Cortical Ring 12” 16 x 26 x 26mm

     ********         ********         ********    421866    421866     

Machined Cortical Ring 12” 18 x 26 x 26mm

     ********         ********         ********    422066    422066     

Machined Cortical Ring 12” 20 x 26 x 26mm

     ********         ********         ********    439010    439010     

Precision Graft 10 x 26 x 26mm

     ********         ********         ********    439012    439012     

Precision Graft FD 12mm x 26mm x 26mm

     ********         ********         ********    439014    439014     

Precision Graft FD 14mm x 26mm x 26mm

     ********         ********         ********    439016    439016     

Precision Graft FD 16mm x 26mm x 26mm

     ********         ********         ********    439018    439018     

Precision Graft FD 18mm x 26mm x 26mm

     ********         ********         ********    439020    439020     

Precision Graft FD 20mm x 26mm x 26mm

     ********         ********         ********    451066    451066     

Precision Graft 10 x 26 x 26mm

     ********         ********         ********    451266    451266     

Precision Graft 12mm X 26mm X 26mm

     ********         ********         ********    451466    451466     

Precision Graft 14mm X 26mm X 26mm

     ********         ********         ********    451666    451666     

Precision Graft 16mm X 26mm X 26mm

     ********         ********         ********    451866    451866     

Precision Graft 18mm X 26mm X 26mm

     ********         ********         ********    452066    452066     

Precision Graft 20mm X 26mm X 26mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

MDII Threaded Cortical Bone Dowel Frozen

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
401114    401114     

MD-II Dowel (Threaded) 14MM X 20MM

     ********         ********         ********    401116    401116     

MD-II Dowel (Threaded) 16MM X 20MM

     ********         ********         ********    401118    401118     

MD-II Dowel (Threaded) 18MM X 20MM

     ********         ********         ********    401120    401120     

MD-II Dowel (Threaded) 20MM X 20MM

     ********         ********         ********    401214    401214     

MD-II Dowel (Threaded) 14MM X 23MM

     ********         ********         ********    401216    401216     

MD-II Dowel (Threaded) 16MM X 23MM

     ********         ********         ********    401218    401218     

MD-II Dowel (Threaded) 18MM X 23MM

     ********         ********         ********    401220    401220     

MD-II Dowel (Threaded) 20MM X 23MM

     ********         ********         ********    401222    401222     

MD-II Dowel (Threaded) 22MM X 23MM

     ********         ********         ********    401224    401224     

MD-II Dowel (Threaded) 24MM x 23MM

     ********         ********         ********    401316    401316     

MD-II Dowel (Threaded) 16MM X 26MM

     ********         ********         ********    401318    401318     

MD-II Dowel (Threaded) 16MM X 26MM

     ********         ********         ********    401320    401320     

MD-II Dowel (Threaded) 20MM X 26MM

     ********         ********         ********   

Crescent TLIF Assembled

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
293007    293007     

Lordotic Unilateral Spacer 7 x 30mm

     ********         ********         ********    293008    293008     

Lordotic Unilateral Spacer 8 x 30mm

     ********         ********         ********    293009    293009     

Lordotic Unilateral Spacer 9 x 30mm

     ********         ********         ********    293010    293010     

Lordotic Unilateral Spacer 10 x 30mm

     ********         ********         ********    293011    293011     

Lordotic Unilateral Spacer 11 x 30mm

     ********         ********         ********    293012    293012     

Lordotic Unilateral Spacer 12 x 30mm

     ********         ********         ********    293013    293013     

Lordotic Unilateral Spacer 13 x 30mm

     ********         ********         ********    293014    293014     

Lordotic Unilateral Spacer 14 x 30mm

     ********         ********         ********    293015    293015     

Lordotic Unilateral Spacer 15x30mm

     ********         ********         ********    293016    293016     

Lordotic Unilateral Spacer 16x30mm

     ********         ********         ********   

ISP Grafts

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
4578108    SB0608     

ISP Cortical Wedge, 8mm

     ********         ********         ********    4578110    SB0610     

ISP Cortical Wedge, 10mm

     ********         ********         ********    4578112    SB0612     

ISP Cortical Wedge, 12mm

     ********         ********         ********    4578114    SB0614     

ISP Cortical Wedge, 14mm

     ********         ********         ********    4578116    SB0616     

ISP Cortical Wedge, 16mm

     ********         ********         ********    4578118    SB0618     

ISP Cortical Wedge, 18mm

     ********         ********         ********    4578120    SB0620     

ISP Cortical Wedge, 20mm

     ********         ********         ********    4578710    SB0570     

ISP Cortical Spacer, 10mm

     ********         ********         ********    4578712    SB0572     

ISP Cortical Spacer, 12mm

     ********         ********         ********    4578714    SB0574     

ISP Cortical Spacer, 14mm

     ********         ********         ********    45781709    SB0079     

ISP Cancellous Spacer, 7 x 9 mm

     ********         ********         ********    45781711    SB0071     

ISP Cancellous Spacer, 7 x 11 mm

     ********         ********         ********    45781713    SB0073     

ISP Cancellous Spacer, 7 x 13 mm

     ********         ********         ********    45781909    SB0099     

ISP Cancellous Spacer, 9 x 9 mm

     ********         ********         ********    45781911    SB0091     

ISP Cancellous Spacer, 9 x 11 mm

     ********         ********         ********    45781913    SB0093     

ISP Cancellous Spacer, 9 x 13 mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Cancellous Plug

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
221019    221019     

Cornerstone Cancellous Plug, 10mm Large

     ********         ********         ********    221096    221096     

Cornerstone Cancellous Plug, 10mm Small

     ********         ********         ********    221219    221219     

Cornerstone Cancellous Plug, 12mm Large

     ********         ********         ********    221296    221296     

Cornerstone Cancellous Plug, 12mm Small

     ********         ********         ********   

Facet Fix

 

MDT CFN    RTI P/N    Description    Current Fee      New Fee      Change  
223510    223510   

FacetFix, 5mm x 10mm Facet Dowel

     ********         ********         ********   

Anatomic Cervical Allograft Spacer

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
6940541    SA0541     

Anatomic Cervical Allograft Spacer 5 x 14 x 11mm

     ********         ********         ********    6940564    SA0564     

Anatomic Cervical Allograft Spacer 5 x 16 x 14mm

     ********         ********         ********    6940641    SA0641     

Anatomic Cervical Allograft Spacer 6 x 14 x 11mm

     ********         ********         ********    6940664    SA0664     

Anatomic Cervical Allograft Spacer 6 x 16 x 14mm

     ********         ********         ********    6940741    SA0741     

Anatomic Cervical Allograft Spacer 7 x 14 x 11mm

     ********         ********         ********    6940764    SA0764     

Anatomic Cervical Allograft Spacer 7 x 16 x 14mm

     ********         ********         ********    6940841    SA0841     

Anatomic Cervical Allograft Spacer 8 x 14 x 11mm

     ********         ********         ********    6940864    SA0864     

Anatomic Cervical Allograft Spacer 8 x 16 x 14mm

     ********         ********         ********    6940941    SA0941     

Anatomic Cervical Allograft Spacer 9 x 14 x 11mm

     ********         ********         ********    6940964    SA0964     

Anatomic Cervical Allograft Spacer 9 x 16 x 14mm

     ********         ********         ********    6941041    SA0041     

Anatomic Cervical Allograft Spacer 10 x 14 x 11mm

     ********         ********         ********    6941064    SA0064     

Anatomic Cervical Allograft Spacer 10 x 16 x 14mm

     ********         ********         ********    6941164    SA0164     

Anatomic Cervical Allograft Spacer 11 x 16 x 14mm

     ********         ********         ********    6941241    SA0241     

Anatomic Cervical Allograft Spacer 12 x 14 x 11mm

     ********         ********         ********    6941264    SA0264     

Anatomic Cervical Allograft Spacer 12 x 16 x 14mm

     ********         ********         ********    6941341    SA0341     

Anatomic Cervical Allograft Spacer 13 x 14 x 11mm

     ********         ********         ********    6941364    SA0364     

Anatomic Cervical Allograft Spacer 13 x 16 x 14mm

     ********         ********         ********    6941441    SA0441     

Anatomic Cervical Allograft Spacer 14 x 14 x 11mm

     ********         ********         ********    6941464    SA0464     

Anatomic Cervical Allograft Spacer 14 x 16 x 14mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Total Facet Shim

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
609002    SB0128     

2x8x8mm Cornerstone Micro

     ********         ********         ********    609003    SB0138     

3x8x8mm Cornerstone Micro

     ********         ********         ********    609004    SB0148     

4x8x8mm Cornerstone Micro

     ********         ********         ********    609404    SB0141     

4x8x10 Cornerstone Micro

     ********         ********         ********    609405    SB0151     

5x8x10 Cornerstone Micro

     ********         ********         ********    609406    SB0161     

6x8x10 Cornerstone Micro

     ********         ********         ********    609603    SB0238     

3x8x8mm Cornerstone Micro Wedge

     ********         ********         ********    609604    SB0248     

4x8x8mm Cornerstone Micro Wedge

     ********         ********         ********   

Tricortical Block

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
320105    320105     

Tricortical Block 5mm

     ********         ********         ********    320106    320106     

Tricortical Block 6mm

     ********         ********         ********    320107    320107     

Tricortical Block 7mm

     ********         ********         ********    320108    320108     

Tricortical Block 8mm

     ********         ********         ********    320109    320109     

Tricortical Block 9mm

     ********         ********         ********    320110    320110     

Tricortical Block 10mm

     ********         ********         ********   

NON-EXCLUSIVE PRODUCTS

Cornerstone Pinnacle

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
545541    545541     

MASR Cortical-Cancellous Block 5 x 14 x 11

     ********         ********         ********    545641    545641     

MASR Cortical-Cancellous Block 6 x 14 x 11

     ********         ********         ********   

Unicortical Dowel

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
280012    280012     

Dowel, Unicortical 12mm

     ********         ********         ********    280014    280014     

Dowel, Unicortical 14mm

     ********         ********         ********    280016    280016     

Dowel, Unicortical 16mm

     ********         ********         ********   

--------------------------------------------------------------------------------

Confidential Treatment Requested

Cornerstone Iliac Block, Tricortical

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
310107    310107     

Iliac Block, Tricortical 7mm x 15mm

     ********         ********         ********    310108    310108     

Iliac Block, Tricortical 8mm x 15mm

     ********         ********         ********    310109    310109     

Iliac Block, Tricortical 9mm x 15mm

     ********         ********         ********    310110    310110     

Iliac Block, Tricortical 10mm x 15mm

     ********         ********         ********    310112    310112     

Iliac Block, Tricortical 12mm x 15mm

     ********         ********         ********    310114    310114     

Iliac Block, Tricortical 14mm x 15mm

     ********         ********         ********    310115    310115     

Iliac Block, Tricortical 15mm x 15mm

     ********         ********         ********    310116    310116     

Iliac Block, Tricortical 16mm x 15mm

     ********         ********         ********    310118    310118     

Iliac Block, Tricortical 18mm x 15mm

     ********         ********         ********    310120    310120     

Iliac Block, Tricortical 20mm x 15mm

     ********         ********         ********    310225    310225     

Iliac Block, Tricortical 25mm x 15mm

     ********         ********         ********   

Bicortical Block

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
862010    862010     

Bicortical Block 10mm x 20mm

     ********         ********         ********    862012    862012     

Bicortical Block 12mm x 20mm

     ********         ********         ********    862014    862014     

Bicortical Block 14mm x 20mm

     ********         ********         ********    862512    862512     

Bicortical Block 12mm x 25mm

     ********         ********         ********    862514    862514     

Bicortical Block 14mm x 25mm

     ********         ********         ********    862516    862516     

Bicortical Block 16mm x 25mm

     ********         ********         ********    872007    872007     

Bicortical Block 7mm

     ********         ********         ********    872008    872008     

Bicortical Block 8mm

     ********         ********         ********   

Unicortical Block

 

MDT CFN    RTI P/N      Description    Current Fee      New Fee      Change  
850612    850612     

Unicortical Block 6 x 12mm

     ********         ********         ********    850712    850712     

Unicortical Block 7 x 12mm

     ********         ********         ********    850812    850812     

Unicortical Block 8 x 12mm

     ********         ********         ********    850912    850912     

Unicortical Block 9 x 12mm

     ********         ********         ********   

--------------------------------------------------------------------------------

EXHIBIT B

 

LOGO [g644726exb_pg01.jpg]

 

Osteobiologic Implants

RTI BIOLOGICS®

--------------------------------------------------------------------------------

LOGO [g644726exb_pg02.jpg]

 

About RTI Biologics, Inc.

Strong commitment to advancing science, safety and innovation

Global leader in tissue-based innovations

Precisely shapes allograft tissue for use in surgeries

Sterilizes tissue with proprietary, validated sterilization processes

that inactivate viruses—including BioCleanse® Tissue Sterilization

Process, Tutoplast® Tissue Sterilization Process, and Cancelle® SP DBM

Sterilization Process

RTI Biologics, Inc. is the leading provider of sterile biological implants for
surgeries around the world with a commitment to advancing science, safety and
innovation. RTI prepares human donated tissue for transplantation through
extensive testing and screening, precision shaping and proprietary, validated
sterilization processes. These allograft implants are used in orthopedic,
dental, hernia and other specialty surgeries.

RTI’s innovations continuously raise the bar of science and safety for
biologics—from being the first company to offer precision-tooled bone implants
and assembled technology to maximize each gift of donation, to inventing fully
validated sterilization processes that include viral inactivation steps. These
processes sterilize tissue, are clinically successful and are scientifically
proven to address donor-to-recipient disease transmission risk while preserving
tissue strength and biocompatibility. They have a proven record of more than
four million implants distributed with zero incidence of implant-associated
infection. RTI’s worldwide corporate headquarters are located in Alachua, Fla.,
with international facilities in Neunkirchen, Germany, and Aix-en-Provence,
France. The company is accredited in the U.S. by the American Association of
Tissue Banks.

Vision

We will be recognized as the world leader in transforming donated and natural
tissue into safe and innovative biologic solutions.

Mission

We improve lives by using the body to heal the body to achieve life-restoring
results.

References

1 Archibald, LA, et al., “Seroprevalence of Bloodborne Viruses Among Cadaveric
Donors of Human Tissue: Implications for Tissue Safety.” Presented at EATB 2005.

2 Carr, AS, et. al., “Mechanical Testing of Soft Tissue Allografts Sterilized
Through the BioCleanse Process.” Unpublished data, 2005.

1About RTI Biologics

--------------------------------------------------------------------------------

LOGO [g644726exb_pg03.jpg]

 

Table of Contents

Sterilization Processes Overview 3-4

General Orthopedic Conventional Allografts

Chips and Cubes 5

Blocks and Dowels 6

Wedges and Strips 7

Shafts 8

Reconstructive Large Segmental Allografts

Heads and Condyles 9

Proximal and Distal Grafts 10

Whole Bones 11

Osteoinductive Demineralized Bone Grafts

DBM Powder 12

BioReady™ DBM Putty 12

BioSet® DBM Allograft Paste 13

BioAdapt™ Foam 13

Precision Machined Spine Spacers

Cortical Cervical Spacer 14

PROVEN

QUALITY

Table of Contents 2

--------------------------------------------------------------------------------

LOGO [g644726exb_pg04.jpg]

 

The Path from Recovery to Implantation

Donor Screening

Serological & Microbiological Testing

Tissue before processing

Tissue shaped into final form

Through its innovations, RTI Biologics, Inc.

(RTI) continuously raises the bar of science and

safety for biologics – from being the first company to

offer precision-tooled bone implants and assembled

technology, to inventing fully validated sterilization

processes that include viral inactivation steps. Three

such processes–the BioCleanse®Tissue Sterilization

Process, the Tutoplast® Tissue Sterilization Process

and Cancelle® DBM Sterilization Process – have a

proven combined record of more than four million

implants distributed with zero incidence of implant-associated

infection. Validation studies have been

performed for each process based on tissue type

using appropriate challenge microorganisms.

Serological Testing (for every donor):

•HCV Antibody

•HTLV-I & HTLV-II Antibody

•HBV Surface Antigen

•Syphilis

•HIV 1 & 2 Antibody

•HIV-I/NAT

•HBV Total Core Antibody

•HCV/NAT

After consent/authorization for donation is obtained, donor history

screening and laboratory testing is performed in accordance

with FDA regulations and AATB Standards.

Screening for Patient Safety

A complete donor risk assessment interview must be performed for every

donor including:

Cause of death: Donors are only accepted if cause of death is

established.

Donor Risk Assessment:

RTI receives donated tissue from independently licensed recovery agencies

which screen for safety prior to recovery, including conducting an interview

with the family/next of kin and a behavioral/lifestyle risk assessment.

Following receipt of tissue from the recovery agency, RTI evaluates

records from the recovery agency and performs the following donor risk

assessment:

Medical record/hospital records review

Medical examiner/coroner’s report (autopsy report, when available)

Laboratory, pathology and radiology reports

The final determination of donor eligibility is made by RTI’s medical director –

a licensed physician – utilizing all available, relevant information.

Testing for Patient Safety

An extensive panel of serological and microbiological tests are performed.

These results are subject to stringent acceptance criteria in order to release

the donor tissue.

In addition to serological testing on the donor’s blood, microbiological testing

is used throughout the process (where appropriate) to screen for potential

contamination and to provide confirmation of tissue suitability for transplant.

3 Sterilization Processes Overview

--------------------------------------------------------------------------------

LOGO [g644726exb_pg05.jpg]

 

BioCleanse® Tissue Sterilization Process

Bone and sports medicine soft tissue

Low temperature chemical process

BIOCLEANSE®

TISSUE STERILIZATION PROCESS

Tissue sterilized to SAL 10-6

Bone grafts are terminally sterilized by a validated method. Sports medicine
tendons are not terminally irradiated.

Cancelle® SP DBM Sterilization Process

DBM pastes and putties

Bone undergoes demineralization

Low-temperature terminal irradiation

CANCELLE®SP

DBM STERILIZATION PROCESS

Sterile finished graft

For most DBM-based implants**, the irradiation dose is applied terminally to
achieve an SAL of 10-6.

BioCleanse® Tissue Sterilization Process

RTI Biologics’ allograft constructs/spacers and sports medicine soft tissue
implants are sterilized to Sterility Assurance Level 10-6 through its patented
BioCleanse Tissue Sterilization Process, an automated, pharmaceutical grade
process. BioCleanse sterilization is used on grafts that provide a natural
biologic scaffold in orthopedic, spine and sports medicine procedures.

How does the BioCleanse Process work?

The BioCleanse system sterilizes tissue to SAL 10-6 using a complex, proprietary
combination of mechanical and chemical processes, working in conjunction with
each other. The mechanical component applies oscillating positive and negative
pressure in the presence of the chemical agents (including detergents and
sterilants), which gently perfuse the tissue. This combination removes blood and
lipids, and inactivates or removes pathogenic microorganisms. Repeated water
rinses throughout the process remove debris, and final water rinses remove
residual chemicals, leaving the tissue biocompatible. The BioCleanse Process
does not sterilize using irradiation.

Even if other safeguards fail, RTI’s BioCleanse technology sterilizes both bone
and soft tissue to SAL 10-6. This SAL was established using worst case testing
scenarios which included Achilles tendon (because of its dense nature) and
spores (because they are the most difficult microorganisms to remove).

Cancelle® SP DBM Sterilization Process

DBM pastes and putties are sterilized through the Cancelle SP Process, which is
a validated bone matrix sterilization process designed to preserve protein
activity. Their osteoinductive (OI) potential*is verified by 100% lot testing
after sterilization. In their final form, the DBM products serve as bone void
fillers in many applications, including spinal, general orthopedic and joint
reconstruction surgeries.

How does the Cancelle SP Process work?

Cancelle SP is a proprietary process that sterilizes DBM while simultaneously
allowing it to maintain its osteoinductive* potential. Through a combination of
oxidative treatments and acid or alcohol washes, debris is removed and pathogens
are inactivated. Cleansing rinses remove residual chemicals, maintaining
biocompatibility, and low temperature, low dose gamma irradiation preserves the
utility of the graft. For most DBM-based products**, the irradiation dose is
applied terminally to achieve a sterility assurance level (SAL) of 10-6.

*DBM or representative finished implant is either assayed in vivo in the
modified athymic nude rat for bone formation or in vitro for endogenous BMP-2 as
a surrogate test marker for osteoinductive potential. Because the combination of
various proteins is responsible for osteoinductive potential, when assayed in
vitro, DBM is also screened for the presence of BMP-7. Findings from an in vitro
assay or animal model are not necessarily predictive of human clinical results.

**Refer to implant package insert for specific processing information.

Sterilization Processes Overview 4

--------------------------------------------------------------------------------

LOGO [g644726exb_pg06.jpg]

 

General Orthopedic Conventional Allografts

Chips and Cubes

Sterilized through the BioCleanse® Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6 and

labeled STERILE

Chips and Cubes Sterilization: BioCleanse®

Code

Description Preservation

1-4mm Chips 100005

Cancellous Chips (1-4mm) 5cc FD 100015

Cancellous Chips (1-4mm) 15cc FD 100030

Cancellous Chips (1-4mm) 30cc FD 100060

Cancellous Chips (1-4mm) 60cc FD 100090

Cancellous Chips (1-4mm) 90cc FD

4-10mm Chips 100405

Cancellous Chips (4-10mm) 5cc FD 100415

Cancellous Chips (4-10mm) 15cc FD 100430

Cancellous Chips (4-10mm) 30cc FD 100460

Cancellous Chips (4-10mm) 60cc FD 100490

Cancellous Chips (4-10mm) 90cc FD 1-4mm

Chips 100505

Cancellous Chips (1-4mm) 5cc FZ 100515

Cancellous Chips (1-4mm) 15cc FZ 100530

Cancellous Chips (1-4mm) 30cc FZ 4-10mm

Chips 100605

Cancellous Chips (4-10mm) 5cc FZ 100615

Cancellous Chips (4-10mm) 15cc FZ 100630

Cancellous Chips (4-10mm) 30cc FZ 4-6mm

Cubes 100205

Cancellous Cubes (4-6mm) 5cc FD 100215

Cancellous Cubes (4-6mm) 15cc FD 100230

Cancellous Cubes (4-6mm) 30cc FD 6-10mm

Cubes 100305

Cancellous Cubes (6-10mm) 5cc FD 100315

Cancellous Cubes (6-10mm) 15cc FD 100330

Cancellous Cubes (6-10mm) 30cc FD

Cortical/Cancellous Blends 110115

Cortical Cancellous Chips 40/60 MIX (1-3mm)

15cc FD 110130

Cortical Cancellous Chips

40/60 MIX (1-3mm) 30cc FD

FD=Freeze Dried

4 - 10mm Chips

1 - 4mm Chips

6 - 10mm Cubes

4 - 6mm Cubes

Cortical/ Cancellous Blend

BIOCLEANSE

5 General Orthopedic Conventional Allografts

--------------------------------------------------------------------------------

LOGO [g644726exb_pg07.jpg]

 

General Orthopedic Conventional Allografts

Blocks and Dowels

Pre-cut to select heights and footprints

Sterilized through the BioCleanse Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6 and

labeled STERILE

Blocks Sterilization: BioCleanse®

Code Description HxLxW Preservation

D08562 Unicortical Block 6x12x12mm FD

D08572 Unicortical Block 7x12x12mm FD

D08582 Unicortical Block 8x12x12mm FD

D08592 Unicortical Block 9x12x12mm FD

D08502 Unicortical Block 10x12x12mm FD

D08706 Bicortical Block 6x15x12mm FD

D08707 Bicortical Block 7x15x12mm FD

D08708 Bicortical Block 8x15x12mm FD

D08709 Bicortical Block 9x15x12mm FD

Blocks HxLxW D08600

Bicortical Block 10x20x9mm FD D08602

Bicortical Block 12x20x9mm FD D08604

Bicortical Block 14x20x9mm FD D08650

Bicortical Block 10x25x9mm FD D08652

Bicortical Block 12x25x9mm FD D08654

Bicortical Block 14x25x9mm FD D03205

Ilium Tricortical Block 5x12x14mm FD D03206

Ilium Tricortical Block 6x12x14mm FD D03207

Ilium Tricortical Block 7x12x14mm FD D03208

Ilium Tricortical Block 8x12x14mm FD D03209

Ilium Tricortical Block 9x12x14mm FD D03210

Ilium Tricortical Block 10x12x14mm FD D03107

Ilium Tricortical Block 7x ³15x ³10mm FD

D03108 Ilium Tricortical Block 8x ³15x ³10mm FD

D03109 Ilium Tricortical Block 9x ³15x ³10mm FD

D03110 Ilium Tricortical Block 10x ³15x ³10mm FD

D03112 Ilium Tricortical Block 12x ³15x ³10mm FD

D03114 Ilium Tricortical Block 14x ³15x ³10mm FD

D03115 Ilium Tricortical Block 15x ³15x ³10mm FD

D03116 Ilium Tricortical Block 16x ³15x ³10mm FD D03118

Ilium Tricortical Block 18x ³15x ³10mm FD D03120

Ilium Tricortical Block 20x ³15x ³10mm FD D03125

Ilium Tricortical Block 25x ³30x ³14mm FD Dowels HxD D02812

Unicortical Dowel 12x15-35mm FD D02814

Unicortical Dowel 14x15-35mm FD D02816

Unicortical Dowel 16x15-35mm FD D02818

Unicortical Dowel 18x15-35mm FD

Unicortical

Block (Cervical)

12 x 12

H W L

Bicortical

Block (Lumbar)

20 x 9

L W H

W2 H L W1

Ilium Tricortical

Block (Lumbar)

³15 x ³10

W L H

Bicortical

Block

(Cervical)

15 x 12

W1 H L W2

Ilium Tricortical

Block (Cervical)

12 x 14

Unicortical

Dowel (Lumbar)

15-35mm Dia.

H D

BIOCLEANSE

General Orthopedic Conventional Allografts 6

--------------------------------------------------------------------------------

LOGO [g644726exb_pg08.jpg]

 

General Orthopedic Conventional Allografts

Wedges

Sterilized through the BioCleanse® Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6 and

labeled STERILE

L H

Measurements Recorded:

Maximum length ³ 50mm

Maximum height

Minimum width ³ 40mm

Angle measured on small end

BIOCLEANSE

HTO Wedge Sterilization: BioCleanse®

Code Description (Height) Preservation

180672 HTO Wedge 6 degrees, 7.5mm FD

180872 HTO Wedge 8 degrees, 10.0mm FD

181072 HTO Wedge 10 degrees, 12.5mm FD

181272 HTO Wedge 12 degrees, 15.0mm FD

181472 HTO Wedge 14 degrees, 17.5mm FD

190672 HTO Wedge 6 degrees, 7.5mm FZ

190872 HTO Wedge 8 degrees, 10.0mm FZ

191072 HTO Wedge 10 degrees, 12.5mm FZ

191272 HTO Wedge 12 degrees, 15.0mm FZ

191472 HTO Wedge 14 degrees, 17.5mm FZ

Strips

Sterilized through the BioCleanse® Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6

and labeled STERILE

T1 T2 W L

Measurements Recorded:

Maximum width

Minimum length >24mm

Maximum thickness >9mm

Minimum thickness

BIOCLEANSE

Ilium Tricortical Strip Sterilization: BioCleanse®

Code Description (Width) Preservation

339030 Ilium Strip Tricortical 28-45mm FZ

339050 Ilium Strip Tricortical 46-57mm FZ

339060 Ilium Strip Tricortical >58mm FZ

330030 Ilium Strip Tricortical 28-45mm FD

330050 Ilium Strip Tricortical 46-57mm FD

330060 Ilium Strip Tricortical >58mm FD

FD=Freeze Dried

FZ=Frozen

7 General Orthopedic Conventional Allografts

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General Orthopedic Conventional Allografts

Shafts

Pre-cut to select lengths to reduce OR prep time

Sterilized through the BioCleanse Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6 and

labeled STERILE

Femoral Shafts Sterilization: BioCleanse®

Code Description (Length) Preservation

639010 Femoral Shaft 98-130mm FZ

639015 Femoral Shaft 131-165mm FZ

639020 Femoral Shaft 166-202mm FZ

632010 Femoral Shaft 98-130mm FD

632015 Femoral Shaft 131-165mm FD

632020 Femoral Shaft 166-202mm FD

Hemi Femoral Shafts

639110 Hemi Femoral Shaft 98mm-130mm FZ

639115 Hemi Femoral Shaft 131mm-165mm FZ

639120 Hemi Femoral Shaft 166mm-202mm FZ

632110 Hemi Femoral Shaft 98mm-130mm FD

632115 Hemi Femoral Shaft 131mm-165mm FD

632120 Hemi Femoral Shaft 166mm-202mm FD

Humeral Shafts

699060 Humeral Shaft 50mm-100mm FZ

699010 Humeral Shaft 101mm-150mm FZ

691060 Humeral Shaft 50mm-100mm FD

692010 Humeral Shaft 101mm-150mm FD

Tibial Shafts

789060 Tibial Shaft 50mm-75mm FZ

789010 Tibial Shaft 76mm-102mm FZ

789015 Tibial Shaft 103mm-152mm FZ

781060 Tibial Shaft 50mm-75mm FD

782010 Tibial Shaft 76mm-102mm FD

782015 Tibial Shaft 103mm-152mm FD

Fibula Shafts Sterilization: BioCleanse®

Code Description (Length) Preservation

669060 Fibula Shaft 50mm-75mm FZ

669080 Fibula Shaft 76mm-98mm FZ

669010 Fibula Shaft 99mm-125mm FZ

661060 Fibula Shaft 50mm-75mm FD

661080 Fibula Shaft 76mm-98mm FD

662010 Fibula Shaft 99mm-125mm FD

FD=Freeze Dried

FZ=Frozen

Femoral Shaft

ML AP L

Hemi Femoral Shaft

ML AP L

Humeral Shaft

AP ML L

Tibial Shaft

AP L

Measurements Recorded:

Length

AP diameter and ML diameter

Minimum cortical-wall thickness of 3mm

BIOCLEANSE

Fibula Shaft

ML AP L

Measurements Recorded:

Length

AP diameter and ML diameter

Minimum cortical-wall thickness of 1.5mm

BIOCLEANSE

General Orthopedic Conventional Allografts 8

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Reconstructive Large Segmental Allografts

Heads and Condyles

Existing cartilage still attached (except femoral head)

Sterilized through the BioCleanse® Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6

and labeled STERILE

Femoral Head Sterilization: BioCleanse®

Code Description Preservation

620100 Femoral Head w/o Cartilage FZ

Humeral Head Left Right Description Preservation

680001 680002

Humeral Head FZ

Distal Tibial Condyle

Left

Right

Description

Preservation

770301

770302

Distal Tibial Condyle

FZ

Femoral Head

Humeral Heads

Distal Tibial Condyles

BIOCLEANSE

FZ=Frozen

9 Reconstructive Large Segmental Allografts

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Reconstructive Large Segmental Allografts

Proximal and Distal Grafts

Existing cartilage still attached

Sterilized through the BioCleanse Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6

and labeled STERILE

Femur Sterilization: BioCleanse®

Left Right Description Length Preservation

640207 640208 Distal Femur Short 150-250mm FZ

640217 640218 Distal Femur Long 251-350mm FZ

640107 640108 Proximal Femur Short 150-250mm FZ

640117 640118 Proximal Femur Long 251-350mm FZ

Humerus

Left Right Description Length Preservation

670101 670102 Proximal Humerus Short 130-200mm FZ

670111 670112 Proximal Humerus Long 201-270mm FZ

670201 670202 Distal Humerus Short 130-200mm FZ

670211 670212 Distal Humerus Long 201-270mm FZ

Tibia

Left Right Description Length Preservation

760201 760202 Distal Tibia Short 150-200mm FZ

760211 760212 Distal Tibia Long 201-300mm FZ

760101 760102 Proximal Tibia Short 150-200mm FZ

760111 760112 Proximal Tibia Long 201-300mm FZ

Distal

Femur

Proximal

Femur

Proximal

Humerus

Distal

Humerus

Measurements Recorded:

Distal Femur

Length

ML measurement of distal condyle

AP measurement of distal condyle

Shaft’s outer diameter

Cortical-wall thickness

Proximal Femur w/Head

Length

Femoral head outer diameter

Shaft’s outer diameter

Cortical-wall thickness

Proximal Humerus

Length

Shaft’s outer diameter

Cortical-wall thickness

Proximal condyle’s outer diameter

Distal Humerus

Length

Shaft’s outer diameter

Cortical-wall thickness

BIOCLEANSE

Measurements Recorded:

Distal Tibia

Length

ML measurement of distal condyle

AP measurement of distal condyle

Shaft’s outer diameter

Cortical-wall thickness

Proximal Tibia

Length

ML measurement of proximal condyle

AP measurement of proximal condyle

Shaft’s outer diameter

Cortical-wall thickness

Distal Tibia

Proximal

Tibia

BIOCLEANSE

FZ=Frozen

Reconstructive Large Segmental Allografts 10

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Reconstructive Large Segmental Allografts

Whole Bones

Existing cartilage still attached

Sterilized through the BioCleanse® Process

Terminal sterilization after the BioCleanse Process achieves SAL 10-6

and labeled STERILE

Femur Sterilization: BioCleanse®

Left Right Description Length Preservation

640001 640002 Whole Femur Variable FZ

Humerus

Left Right Description Length Preservation

670001 670002 Whole Humerus Variable FZ

Tibia

Left Right Description Length Preservation

760001 760002 Whole Tibia Variable FZ

Fibula

Left Right Description Length Preservation

650001 650002 Whole Fibula Variable FZ

Radius

Left Right Description Length Preservation

730001 730002 Whole Radius Variable FZ

Ulna

Left Right Description Length Preservation

790001 790002 Whole Ulna Variable FZ

Measurements Recorded:

Whole Ulna Whole Humerus Length Length

ML measurement of proximal condyle

Shaft’s outer diameter

AP measurement of proximal condyle

Proximal head outer diameter

Shaft’s outer diameter

ML measurement of distal condyle

Whole Tibia

AP measurement of distal condyle

Length

ML measurement of proximal condyle

Whole Radius

AP measurement of proximal condyle

Length

Shaft’s outer diameter

ML measurement of proximal condyle

ML measurement of distal condyle

ML measurement of distal condyle

Shaft’s outer diameter

Whole Fibula

Length

Whole Femur

ML measurement of proximal condyle

Length

ML measurement of distal condyle

ML measurement of distal condyle

Shaft’s outer diameter

Shaft’s outer diameter

Femoral head outer diameter

AP measurement of distal condyle

FZ=Frozen

Whole Ulna

Whole Radius

Whole Femur

Whole Humerus

Whole Tibia

Whole Fibula

BIOCLEANSE

11 Reconstructive Large Segmental Allografts

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LOGO [g644726exb_pg13.jpg]

 

Osteoinductive Demineralized Bone Grafts

DBM Powder

Osteoinductive* (OI) potential is verified by 100% lot testing after
sterilization

Sterilized through the Cancelle® SP DBM Sterilization Process using
low-temperature,

low dose gamma irradiation to achieve SAL 10-6

DBM Powder Sterilization: Cancelle® SP

Code Description Preservation

004805 DBM Powder 5cc FD

004810 DBM Powder 10cc FD

004815 DBM Powder 15cc FD

CANCELLE SP

DBM Powder

FD=Freeze Dried

BioReady™ DBM Putty

Ready-to-use, 100% allograft

Pliable without becoming hard or setting

Osteoinductive* (OI) potential is verified by 100% lot testing after
sterilization

Sterilized through the Cancelle® SP DBM Sterilization Process using
low-temperature,

low dose gamma irradiation to achieve SAL 10-6

Putty Sterilization: Cancelle® SP

Code Description Preservation

D00100 BioReady™ DBM Putty 0.5cc Pre-hydrated

D00101 BioReady™ DBM Putty 1cc Pre-hydrated

D00102 BioReady™ DBM Putty 2cc Pre-hydrated

D00105 BioReady™ DBM Putty 5cc Pre-hydrated

D00110 BioReady™ DBM Putty 10cc Pre-hydrated

Putty with Chips

Code Description Preservation

D00300 BioReady™ DBM Putty with Chips 0.5cc Pre-hydrated

D00301 BioReady™ DBM Putty with Chips 1cc Pre-hydrated

D00302 BioReady™ DBM Putty with Chips 2cc Pre-hydrated

D00305 BioReady™ DBM Putty with Chips 5cc Pre-hydrated

D00310 BioReady™ DBM Putty with Chips 10cc Pre-hydrated

D00320 BioReady™ DBM Putty with Chips 20cc Pre-hydrated

*DBM or representative finished implant is either assayed in vivo in the
modified athymic nude rat for bone formation or in vitro for endogenous BMP-2 as
a

surrogate test marker for osteoinductive potential. Because the combination of
various proteins is responsible for osteoinductive potential, when assayed in
vitro,

DBM is also screened for the presence of BMP-7. Findings from an in vitro assay
or animal model are not necessarily predictive of human clinical results.

CANCELLE SP

Osteoinductive Demineralized Bone Grafts 12

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Osteoinductive Demineralized Bone Grafts

BioSet® DBM Allograft Paste

Can be hydrated with fluid of choice

Sets once implanted

Osteoinductive* (OI) potential is verified by 100% lot testing after

sterilization

Sterilized through the Cancelle® SP DBM Sterilization Process using
low-temperature,

low dose gamma irradiation to achieve SAL 10-6

BioSet® DBM Allograft Paste Sterilization: Cancelle® SP

Code Description Preservation

005700 BioSet® RT Allograft Paste, Syringe, 0.5cc DR

005701 BioSet® RT Allograft Paste, Syringe, 1cc DR

005705 BioSet® RT Allograft Paste, Syringe, 5cc DR

005710 BioSet® RT Allograft Paste, Syringe, 10cc DR

005800 BioSet® Allograft Paste, Syringe, 0.5cc FZ

005801 BioSet® Allograft Paste, Syringe, 1cc FZ

005805 BioSet® Allograft Paste, Syringe, 5cc FZ

005810 BioSet® Allograft Paste, Syringe, 10cc FZ

006702 BioSet® IC, RT Allograft Paste, 2cc DR

006705 BioSet® IC, RT Allograft Paste, 5cc DR

006710 BioSet® IC, RT Allograft Paste, 10cc DR

006720 BioSet® IC, RT Allograft Paste, 20cc DR

006805 BioSet® IC Moldable Allograft Paste, Syringe, 5cc FZ

006810 BioSet® IC Moldable Allograft Paste, Syringe, 10cc FZ

006820 BioSet® IC Moldable Allograft Paste, Syringe, 20cc FZ

007820 BioSet® IC Allograft Full Disc, 20 x 3mm, 1cc FZ

007890 BioSet® IC Allograft Full Disc, 90 x 5mm, 32cc FZ

007830 BioSet® IC Allograft Full Disc, 30 x 3mm, 2cc FZ

007845 BioSet® IC Allograft Full Disc, 45 x 5mm, 5cc FZ

007875 BioSet® IC Allograft Partial Disc, 75 x 5mm, 15cc FZ

007891 BioSet® IC Allograft Partial Disc, 90 x 5mm, 22cc FZ

008850 BioSet® IC Moldable Strip, 50mm (2 each), 6cc FZ

008890 BioSet® IC Moldable Strip, 90mm (2 each), 10cc FZ

DR=Dried

FZ=Frozen

BioSet® RT Allograft Paste

BioSet®

Allograft

Paste

BioSet® IC, RT Allograft Paste

BioSet® IC

Allograft

Full Disc

BioSet® IC

Allograft

Partial Disc

BioSet® IC

Moldable Strip

CANCELLE SP

*These products induced bone formation when evaluated using the modified athymic
nude rat assay.

Findings from an animal model are not necessarily predictive of human clinical
results.

13 Osteoinductive Demineralized Bone Grafts

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Osteoinductive Demineralized Bone Grafts

BioAdapt™ Foam

Can be hydrated with fluid of choice

Pre-shaped DBM that expands with hydration to provide a contoured fit to the

bony defect

Osteoinductive* (OI) potential is verified by 100% lot testing after
sterilization

Sterilized through the BioCleanse® Process and Cancelle® SP DBM Sterilization

Process using low-temperature, low dose gamma irradiation to achieve SAL 10-6

BioAdapt™ Foam Sterilization: BioCleanse®, Cancelle® SP

Code Description L x W x H, Volume Preservation

DU0110 BioAdapt™ Foam, Skinny Strips 100 x 10 x 8mm, 16cc DR

DU0125 BioAdapt™ Foam, Large Strip 100 x 25 x 5mm, 12cc DR

DU0025 BioAdapt™ Foam, Medium Strip 50 x 25 x 5mm, 6cc DR

DU0015 BioAdapt™ Foam, Small Strip 15 x 15 x 8mm, 2cc DR

DU0060 BioAdapt™ Foam, Disc 60 (diam.) x 5mm, 14cc DR

Precision Machined Spine Spacers

Cortical Cervical Spacer

Available in 12x14mm (small) and 14x16mm (large) footprints

Available in parallel and lordotic (7°) profiles

Sterilized through the BioCleanse® Process

Terminal Sterilization after BioCleanse achieves SAL 10-6 and labeled STERILE

12mm (AP) x 14mm (ML) Sterilization: BioCleanse®

Code Description Preservation

D0P146 Cortical Cervical Spacer, Parallel - Small 6mm FD

D0P147 Cortical Cervical Spacer, Parallel - Small 7mm FD

D0P148 Cortical Cervical Spacer, Parallel - Small 8mm FD

D0P149 Cortical Cervical Spacer, Parallel - Small 9mm FD

D0P140 Cortical Cervical Spacer, Parallel - Small 10mm FD

D0L146 Cortical Cervical Spacer, Lordotic - Small 6mm FD

D0L147 Cortical Cervical Spacer, Lordotic - Small 7mm FD

D0L148 Cortical Cervical Spacer, Lordotic - Small 8mm FD

D0L149 Cortical Cervical Spacer, Lordotic - Small 9mm FD

D0L140 Cortical Cervical Spacer, Lordotic - Small 10mm FD

14mm (AP) x 16mm (ML)

Code Description Preservation

D0P166 Cortical Cervical Spacer, Parallel - Large 6mm FD

D0P167 Cortical Cervical Spacer, Parallel - Large 7mm FD

D0P168 Cortical Cervical Spacer, Parallel - Large 8mm FD

D0P169 Cortical Cervical Spacer, Parallel - Large 9mm FD

D0P160 Cortical Cervical Spacer, Parallel - Large 10mm FD

D0L166 Cortical Cervical Spacer, Lordotic - Large 6mm FD

D0L167 Cortical Cervical Spacer, Lordotic - Large 7mm FD

D0L168 Cortical Cervical Spacer, Lordotic - Large 8mm FD

D0L169 Cortical Cervical Spacer, Lordotic - Large 9mm FD

D0L160 Cortical Cervical Spacer, Lordotic - Large 10mm FD

Skinny Strips

Large

Strip

Medium

Strip

Small Strip

Disc

BIOCLEANSE

CANCELLE SP

*DBM or representative finished implant is either assayed in vivo in the
modified athymic

nude rat for bone formation or in vitro for endogenous BMP-2 as a surrogate test
marker

for osteoinductive potential. Because the combination of various proteins is
responsible

for osteoinductive potential, when assayed in vitro, DBM is also screened for
the presence

of BMP-7. Findings from an in vitro assay or animal model are not necessarily
predictive

of human clinical results.

Cortical Cervical Spacer

BIOCLEANSE

DR=Dried

FD=Freeze Dried

Osteoinductive Demineralized Bone Grafts 14

--------------------------------------------------------------------------------

LOGO [g644726exb_pg16.jpg]

 

PROVEN

QUALITY

To order, call RTI directly: 800.624.7238.

RTI BIOLOGICS®

11621 Research Circle

Alachua, FL 32615

Toll Free: 877.343.6832

Fax: 386.418.0342

www.rtibiologics.com

Accredited by American Association of Tissue Banks

ISO 13485 Certified

• AdvaMed Member

REIMBURSEMENT INFO: Call 877.839.7152

BioCleanse® and Cancelle® are U.S. registered trademarks of RTI Biologics, Inc.

Tutoplast® is a U.S. registered trademark of Tutogen Medical GmbH.

©2013 RTI Biologics, Inc. 6056 R3 02-13-13

--------------------------------------------------------------------------------

EXHIBIT C

 

Global Business Conduct Policy    Page 1 of 8

 

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Global Business Conduct Standards Policy

ON INTERACTIONS WITH CUSTOMERS

Introduction

Our Mission is to make and sell devices that alleviate pain, restore health and
extend life. We recognize that healthcare professionals – those best suited to
understand the needs of their patients, the performance of medical devices in
the clinical setting and unmet treatment needs – are critical partners in our
ability to fulfill our Mission. We collaborate with physicians to create new
products and therapies and to improve existing products. We provide world-class
training and education on the safe and effective use of our products and
therapies to healthcare professionals. We sponsor scientific research conducted
by healthcare professionals to gather clinical evidence related to our products.
All of these interactions are for the ultimate benefit of patients.

In no instance will Medtronic offer or provide a payment to a Customer as an
unlawful inducement to purchase, lease, recommend, use, arrange for the purchase
or lease of, or prescribe a Medtronic product. We define “Customer” to include
any institution or individual, other than an individual patient, including any
medical or healthcare professional or entity, in a position to purchase, lease,
recommend, use, arrange for the purchase or lease of, or prescribe Medtronic
products. Medtronic also considers persons employed by a Customer, a close
family member of a Customer (including spouse or life partner, their children
and parents of the Customer) or an organization affiliated with a Customer
(meaning that it is controlled by or under common control with the Customer or
if the Customer is on the Board of the organization, receives material
compensation from, or has an investment interest in the organization) to be
within scope when determining whether an entity or individual should be treated
as a “Customer” under our policies.

We are committed to adhering to applicable laws regarding physician-initiated
use of our products and respect a physician’s right to make independent medical
decisions when treating patients. Our marketing, education and promotional
activities are consistent with these commitments, and we comply with governing
laws regarding appropriate promotion of our products.

Index

Standard 1 | General Provisions

Standard 2 | Discounts and Evaluation Products

Standard 3 | Donations, Research and Educational Grants

Standard 4 | Educational Items and Gifts

Standard 5 | Business Meetings

Standard 6 | Services Arrangements

Standard 7 | Training and Education

Standard 8 | Third-Party Conferences

Standard 9 | Activities Benefiting Patient Care

Statement of Principles

Partnership between industry and its Customers must be based on solid ethical
principles, as it presents the potential for conflicts of interest. These
conflicts, both real and perceived, can affect patient and stakeholder
confidence in clinicians, products, companies – and the entire industry. To
sustain and enhance medical innovation through principled cooperation so that
patients continue to benefit from advances in medical care, Medtronic is guided
by two central principles:

Preserve the integrity of the physician-patient relationship

The relationship between physician and patient is a uniquely trusting one
because of the special role that physicians play in saving and enhancing human
life. Appropriate safeguards and regulations are necessary to ensure these
relationships are not compromised by the cooperation between a physician and
industry in the development and testing of new products, or the training and
education of other physicians on the safe and effective use of products.

Remain transparent

To provide patients and physicians with information to make informed treatment
decisions, and to develop trust and minimize actual and perceived conflicts,
Medtronic is committed to transparency and appropriate disclosure of policies
regarding its relationships with Customers. We believe also that promoting
greater transparency into collaboration with Customers will help people better
understand the critical role that these interactions play in innovation,
advancing patient care, and ultimately, saving and improving lives.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 2 of 8

 

Commitment to Ethics and Compliance

Medtronic has adopted and fully embraces certain local industry codes of ethics,
for example, the AdvaMed Code, the Eucomed Code, and many others. The Medtronic
Global Anti-Corruption Policy (“ACP”) sets forth guiding principles across
Medtronic for avoiding any corrupt interactions with Customers. The Medtronic
Global Business Conduct Standards (“BCS”) give more specific instructions for
common categories of interactions with Customers. Where additional local
requirements or exceptions are necessary for conforming this common approach to
local rules, or additional information is needed for local operation of the BCS,
those local provisions are provided in the BCS Playbook (in the U.S.) and the
BCS International Procedures. Medtronic requires its employees, and others
acting on its behalf to follow the ACP, BCS, and applicable BCS Playbook or BCS
International Procedures, as well as all other applicable laws, regulations,
company policies and industry standards whenever interacting with Customers.
Medtronic will address violations of the BCS and related policies promptly and
with appropriate corrective action. See the Global Code of Conduct and BCS
Violations Procedure.

The BCS provides a framework to guide interactions across the globe with
Customers that purchase, lease, recommend, use, arrange for the purchase or
lease of, or prescribe Medtronic products. Because it cannot account for every
situation, exceptions to this policy may be approved where the action
contemplated does not raise legal, regulatory or ethical concerns.

Standard 1 | General Provisions

Core Rule. In no instance will Medtronic offer or provide a payment or any other
item of value to a Customer as an unlawful inducement to purchase, lease,
recommend, use, arrange for the purchase or lease of, or prescribe a Medtronic
product. To ensure that all Customer interactions are legal and ethical, they
must be consistent with Medtronic’s Business Conduct Standards.

Scope of Business Conduct Standards. The BCS are mandatory for interactions
involving a transfer of anything of value from Medtronic to a Customer (a
“Customer Interaction”). If you are unsure of the scope of the BCS, you must
consult with Legal or Compliance before entering into a transaction or
initiating a discussion with a Customer.

Business Conduct Standards are Country-Specific. Customers remain subject to the
regulations of the country where they are located (healthcare organizations) or
where they work (healthcare professionals), irrespective of where the
interaction occurs. All Medtronic employees, distributors and agents are
expected to become familiar with the BCS and other rules applicable to an
individual Customer before initiating an interaction, regardless of the
employee’s geographic location. If you plan to enter into an agreement or other
interaction with a Customer who works in a country outside your geography,
please contact your compliance or legal contact prior to any negotiation with
the Customer. Your compliance or legal contact will help you determine what is
required before entering into such interaction.

Compliance with the BCS is required. All Medtronic employees involved in
Customer interactions are expected to know and comply with the Global
Anti-Corruption Policy, the BCS and the applicable BCS International Procedures
(outside the U.S.) or BCS Playbook (U.S.), and any other applicable laws,
regulations, company policies, procedures and interpretative guidance. As a
requirement of working at Medtronic, all employees are expected to know and
follow the BCS. Managers are responsible for ensuring that their reports comply
with the BCS and any BCS-related requirements such as mandatory training.
Medtronic distributors and agents must be required by contract to comply with
the Medtronic Anti-Corruption Policy and with applicable principles of the BCS.
See the Medtronic International Distributor and Sales Agent Appointment,
Contracting and Management Policy.

If Medtronic is restricted from doing something, so are its employees and third
party intermediaries. If these Standards restrict Medtronic’s interactions with
a Customer, Medtronic employees and third party intermediaries are likewise
restricted, even if no reimbursement request is made to Medtronic. This means
that Medtronic employees or agents may not give prohibited items to Customers
even if they pay for them from their own personal funds.

BCS Violations. Employees who violate the BCS are subject to discipline, up to
and including termination. See the Global Code of Conduct and BCS Violations
Procedure.

Interpretation of Business Conduct Standards. Any employee with questions about
the BCS should contact his/her Manager or Legal or Compliance. Distributors and
agents should contact their Medtronic business contacts. Legal and Compliance
are responsible for final interpretations of the BCS.

Reporting Concerns and Prohibition against Retaliation. Any employee, agent or
business consultant who is concerned that others may be engaging in, or
requiring that the employee, agent or business consultant engage in, conduct
that is inconsistent with the BCS, should discuss the concern with a Manager,
the Human Resources department, Legal/Compliance, or contact the confidential
Medtronic Voice Your Concern Line at www.VoiceYourConcernLine.com. This website
includes phone numbers for the Voice Your Concern Line in the U.S.
(1-800-488-3125) and other countries. Reports can be made in many different
languages. Retaliation against any individual for making a good faith report of
a potential BCS violation is prohibited.

Method of Payment to Customers. Except as specified below, payments to, or on
behalf of, or reimbursed to a Customer must be made by a Medtronic bank transfer
only (except for countries where payments are made by check). Whenever possible
and practical, payment for travel expenses incurred by a Customer (e.g. lodging,
meals, or transportation) must be paid directly to the vendor (e.g., the hotel,
airline and travel agency). When reimbursement is made to the Customer, original
receipts or other supporting documentation are required. When a Customer is
expected to pay directly for reimbursable travel expenses, the Customer should
be provided with modest per-diem spending guidelines in advance.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 3 of 8

 

Exceptions and Amendments to the BCS. Because the BCS cannot account for every
situation, exceptions to the BCS may be approved where the action contemplated
does not raise legal, regulatory or ethical concerns, following the appropriate
Business Conduct Exceptions Process.

BCS Spending Limits. Spending limits are established for business-related
expenditures on modest meals, refreshments and lodging; reasonable travel and
occasional educational items provided to Customers. In addition, employees are
expected to follow any applicable Customer-related restrictions. These include,
for example, more restrictive laws or employer policies. See the Authorization
Levels in the Worldwide Finance Manual to determine the level of authorization
necessary to approve payments. For specific spending limits, see the BCS
International Procedures or Playbook.

Proper Reporting of Expenses. Payments and all other benefits transmitted to
Customers or on behalf of Customers must be timely reported to Medtronic using
the applicable expense reporting system and attributed to individual Customers
accurately and completely.

Modest Meals and Refreshments. We may provide modest meals as an occasional
business courtesy so long as the meal is incidental to the purpose of the
business interaction, provided in a manner and setting conducive to the exchange
of information and attended by a Medtronic representative. We will not pay for
meals for an individual Customer not in attendance at the meeting. We will not
pay for or provide excessive alcohol at business meetings, as excessive alcohol
undermines the legitimacy of the business meeting. Such meals or refreshments
may be provided to Customers in conjunction with:

 

  •   Standard 5 | Business Meetings

 

  •   Standard 6 | Services Arrangements

 

  •   Standard 7 | Training and Education

 

  •   Standard 8 | Third-Party Conferences

No Entertainment. Medtronic does not provide or pay the costs for a Customer’s
participation in entertainment or recreational events.

No Subsidy of Spouses, Partners or Guests. Medtronic may not pay for meals,
other hospitality, travel or lodging for a spouse, partner or other guest of a
Customer.

Reasonable Travel. Depending on the local rules, Medtronic may be able to pay
reasonable travel costs for Customers in conjunction with:

 

  •   Standard 5 | Business Meetings

 

  •   Standard 6 | Services Arrangements

 

  •   Standard 7 | Training and Education

 

  •   Standard 8 | Third-Party Conferences (generally not for U.S. healthcare
professionals)

As a general rule, economy class travel should be used on all flights. The
appropriateness of business class travel for Customers, according to Medtronic
policy, shall only be considered for certain longer flights in accordance with
local policy (see the International Procedures or BCS Playbook). Medtronic will
not pay for upgrades, provide Customers cash in lieu of a ticket or pay any
costs associated with a private plane.

Locations and Lodging for Customer Interactions. Depending on the local rules,
Medtronic may be able to provide modest lodging for Customers in conjunction
with the following interactions:

 

  •   Standard 5 | Business Meetings

 

  •   Standard 6 | Services Arrangements

 

  •   Standard 7 | Training and Education

 

  •   Standard 8 | Third-Party Conferences (generally not for U.S. healthcare
professionals)

When Medtronic is responsible for selecting location and lodging for a Customer
interaction, it must be selected based upon program requirements, convenience of
attendees, and cost savings to Medtronic. Where most or all of the Customer
attendees are from the same country, the interaction should be held in that
country unless there is a legitimate business purpose to hold the meeting
elsewhere.

 

  •   Medtronic training and education programs requiring “hands-on” training in
surgical procedures should be held at Bakken Educational Centers, surgical
training facilities, medical institutions or other facilities appropriate for
such purposes.

 

  •   Medtronic manufacturing or research and development facilities may be
appropriate locations for business or consultant meetings.

Requisition and BCS Approval Procedure. Approval processes involving evaluation
by qualified, non-sales personnel are required for many Customer interactions
(for example consulting agreements, donations and grants all require advance
approval according to local processes). See the International Procedures or
Playbook for more information. Where an approval process is required by these
Standards, Medtronic personnel may not proceed or make a commitment to a
Customer before obtaining all required approvals. Failure to obtain the
necessary approval may result in a BCS violation.

Training on anti-corruption and the Business Conduct Standards is mandatory for
all Medtronic employees interacting with Medtronic’s Customers. Third Party
Intermediaries, such as distributors, consultants or agents are also subject to
training requirements. Minimum training requirements are specified on the
Legal/Compliance website. Such training may occur at the time of hire, annually,
or at such other times as may be required. For questions about required
training, contact Legal or Compliance.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 4 of 8

 

Standard 2 | Discounts and Evaluation Products

With proper documentation and in compliance with applicable legal and regulatory
requirements and other Medtronic policies and guidelines such as pricing and
rebate guidelines, Medtronic may provide products to Customers at a reduced or
no charge, including:

 

  •   Demonstration products/Samples

 

  •   Products or other allowances provided under a Medtronic warranty

 

  •   Products provided at discounted pricing

 

  •   Products sold under rebate programs

 

  •   Pricing programs that include multiple products

 

  •   No-charge evaluation products

 

  •   No-charge replacement products provided as a result of a regulatory action

 

  •   Discounts that are applied for a particular purpose

Notification to Customers should be provided when a product or accessory is sold
at a discount or provided or loaned to a Customer at no charge. This requirement
can be met through a purchase agreement, invoice or other notice that reflects
the discounted price or zero charge and is provided to the Customer.

For evaluation purposes, only a reasonable number of single-use or disposable
products should be provided to a Customer. Products that are covered by pricing
arrangements such as discounts, rebates, and warranties are not “evaluation”
products.

Provision of capital equipment or multiple-use products free of charge must be
accompanied by a written agreement addressing, among other things, term of use
and return or purchase of the equipment at the end of the term, if less than the
useful life of the equipment. This requirement does not apply to equipment or
products that have been determined by Legal to have “no independent value.” Be
sure to check BCS International Procedures and Playbook for additional local
requirements.

Discounts, warranties, multi-line discount programs, no-charge products and
accessories and other pricing arrangements should adhere to local pricing
policies and procedures or be reviewed by Medtronic legal counsel before being
offered.

Standard 3 | Donations, Research and Educational Grants

Purpose. Medtronic may make monetary and product donations for appropriate
scientific, educational, health care, or other charitable purposes. Donations
are limited to certain institutions or organizations and are not always allowed
for individuals who are Customers; see the appropriate country-specific guidance
for more detail.

The donation or grant may not be connected to the purchase of Medtronic products
and cannot be made to influence the judgment of an individual Customer related
to the institution.

Types of Grants and Donations

Educational Grants. Medtronic makes a variety of charitable contributions,
including educational grants. Educational grants can include supporting an
endowed chair at an academic institution, the education of fellows in recognized
medical training programs, programs that educate the public on health care
topics, and support for educational and policy making conferences and meetings.
Educational grants are provided to institutions; not individual people. Refer to
Third Party Conferences (BCS 8) for the support of medical congresses or
conferences that relate to Medtronic products and therapies.

Fellowships / Scholarships. Medtronic may provide educational donations to
recognized medical training institutions or professional societies for
fellowships and scholarship awards (to underwrite appropriate related costs such
as travel, tuition, lodging, meals, etc.) in fields associated with Medtronic
products and therapies, so long as they relate to a bona fide educational need
of the fellow and his or her institution.

The selection of fellows should be within the discretion of the teaching
institutions at which they will be trained. Donations must be provided to either
the teaching institution or the fellow’s home institution (where and to the
extent that the teaching institution charges tuition or costs to the home
institution for the fellowship program), not to individual fellows. Grants may
not be tied to an institution’s purchase of Medtronic’s products, or otherwise
be based on an institution’s past or potential future, undefined use of
Medtronic’s products or services.

Scientific Research Grants. Medtronic funds scientific research including, for
example, donations to support basic scientific research and general research
grants to study new therapeutic uses of approved devices. However, Medtronic
will not use such research for the purpose of unlawfully promoting uses of our
products and therapies that have not been approved. Generally, the funding of
research protocols related to Medtronic products and therapies should be carried
out as an agreement under BCS 6 rather than a donation under this Business
Conduct Standard. Other guidelines and requirements may apply to decisions for
funding such research protocols, such as the need for review by appropriate
Medtronic scientific personnel or an External Research Program board.

Fundraising Events. Medtronic may support a healthcare organization’s
fundraising event (for example, a golf outing or a formal gala) when the grantee
is a registered charity and at least a portion of the donation qualifies for a
charitable tax deduction. The tickets may be used by Medtronic employees or
Medtronic guests who are not Customers, or they may be given back to the
charity. See the International Procedures or U.S. BCS Playbook for more details.

--------------------------------------------------------------------------------

Global Business Conduct Policy

 

   Page 5 of 8

 

Prior Approval. All Customer-related grants and donations require prior approval
under BCS approval procedures before a commitment may be made to the recipient.
Donation / grant requests must be reviewed to ensure that a funding proposal has
a permissible purpose, regardless of the volume or value of purchases made by,
or anticipated from, the recipient and that funding is not used as a reward for
prior sales or inducement for future sales. In general, it is not appropriate to
provide retrospective financial support for research, educational or other
projects already completed. Donations made to privately owned medical
institutions require careful review to ensure appropriate project budgeting for
use of funds.

Standard 4 | Educational Items and Gifts

Except in the very limited circumstances below, the giving of gifts to Customers
is generally prohibited. Medtronic may occasionally provide items that have a
genuine educational function or benefit patients, such as textbooks or
anatomical models, if they are modest in value and in accordance with the
national and local laws, regulations and industry and professional codes of
conduct of the country where the Customer is located. It is never appropriate to
give items such as cash or cash equivalents, or personal items (e.g., clothing,
perfume, iPods, iPads, iPhones, etc.).

Medtronic adheres to industry codes of ethics regarding whether it is
appropriate to provide gifts to a Customer or a Customer’s close family member.
Consult the BCS International Procedures or Playbook for country-specific
standards on items that may be appropriate to give to Customers as well as
monetary limits on such gifts.

The description and purpose of items given to Customers should be documented and
approved on an expense report or through a comparable authorization process.

Standard 5 | Business Meetings

We conduct business meetings with Customers to discuss features or other
important aspects of Medtronic products or therapies, product-related service
concerns, sales terms, contracts, patient access to therapies and other business
topics. We do not use business meetings to promote our products or therapies in
a manner that would be inappropriate under local law.

Business Purpose. A business meeting is defined as a meeting held with one or
more Medtronic employees or independent sales representatives and a Customer for
one of the following business purposes:

 

  •   discussion of product features; instruction on the use or other aspects of
Medtronic products, therapies or services;

 

  •   product or service-related concerns;

 

  •   sales terms;

 

  •   contracts;

 

  •   coding and reimbursement;

 

  •   patient access to therapies; or

 

  •   other bona fide scientific, educational or business topics relevant to
Medtronic.

Often, these meetings occur at or close to the Customer’s place of business and
require either time away from the clinic or a commitment of the Customer’s
non-working time. We host such business meetings only at settings that are
conducive to bona fide scientific, educational or business discussions. In
addition to providing occasional modest meals and refreshments in connection
with such meetings, when necessary we may pay for reasonable travel costs and
modest lodging of meeting attendees. Costs for such meetings must be in
accordance with the respective country limits.

Plant tours and other such product- or manufacturing-oriented business meetings
with Customers must follow the processes that have been previously reviewed and
approved by Compliance/Legal. See the applicable BCS International Procedures or
Playbook for more detail.

For more guidance on meals provided in the context of a third-party conference
or training session, see BCS 7 or BCS 8, as appropriate.

Entertainment. Medtronic may not provide or pay for any entertainment or
recreational event, such as golfing, attendance at sporting events, theatre,
etc. for a Customer. This includes paying for, contributing to or holding
parties for Customers for the purpose of celebrating a non-business event, such
as a holiday, retirement, promotion, etc.

Expense Reporting. For payment of meals/transport, it is the responsibility of
the involved employee and the employee’s manager to confirm the appropriateness
of the type and amount of the event. The description and purpose of meals and
related transportation should be documented and approved on an expense report or
through a comparable authorization process.

BCS Spending Limits. For detailed information on meal limits, please see the BCS
International Procedures or Playbook.

Standard 6 | Services Arrangements

Business Purpose and Need. Services agreements with Customers must be entered
into only where a specific, legitimate business purpose and need for services in
the areas of training and education; product research and development; advisory
services; or clinical research is identified in advance and documented. For
example:

 

  •   Agreements to obtain services from Customers must match the business need
of a specific project for required services.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 6 of 8

 

  •   Research or Clinical Trial Agreements to conduct non-clinical or clinical
research, including post-market outcome studies, must be based on a demonstrable
need for data.

 

  •   Intellectual Property agreements must be based on a Customer having made,
or the expectation that a Customer will make, a novel, significant, or
innovative contribution to the development of a product, technology, process or
method.

Limitations. The use of Customer service providers is limited:

 

  •   Customer service providers may not be paid to endorse or otherwise
recommend the purchase, use or ordering of Medtronic products.

 

  •   Customer service providers may be retained to speak, write and present
training and education programs, but are subject to local legal restrictions on
product promotion.

See the BCS International Procedures and Playbook for more detail on the process
required to be followed in advance of entering into discussions with a Customer
about a potential agreement.

Selection of Customer service providers must be on the basis of the Customer’s
qualifications, expertise and capacity to address the identified purpose. While
it is possible that the qualifications for a task could include experience with,
usage of, or familiarity with a Medtronic product or therapy, the selection of a
Customer service provider may not be used to reward past usage or constitute an
unlawful inducement.

Compensation may not exceed the fair market value of services provided. Fair
market value must be assessed in accordance with requirements of the country
where the Customer normally practices (in the case of an individual Customer) or
is located (in the case of an institutional Customer). Compensation must be
structured on a measurable basis, such as payment based on a daily, hourly or
per-project rate, deliverables or milestones. Compensation paid to a Customer
service provider may not be based on the volume or value of the Customer’s past,
present or anticipated business.

Services agreements must be in writing, must describe all services to be
provided, must be approved in advance following the appropriate process and
signed by the parties, including an appropriate Medtronic approver as indicated
in the BCS International Procedures or Playbook, and entered into prior to the
start of services and payment. Agreements providing for general services or
services on an as-needed basis with payment prior to receipt of services
(“retainer agreements”) are prohibited. In addition to the written agreement,
the responsible business person must maintain accurate files documenting the
services or intellectual property received in exchange for Medtronic’s payments.

Any reimbursement for reasonable travel expenses should be paid, whenever
possible and practical, directly to the hotel, airline, and travel agency and
not to the Customer. If not paid directly, any reimbursement should be supported
by original receipts or other supporting documentation. No payments for the
Customer’s family members are permitted. Medtronic should not arrange for the
travel or lodging of a Customer’s guests or family members.

Consultant Meetings. The venue and circumstances for meetings with consultants
should be appropriate to the subject matter of the consultation. Hospitality
that occurs in conjunction with a consultant meeting should be modest, in
accordance with the respective country limits, and should be subordinate in time
and focus to the primary purpose of the meeting.

Medtronic must comply with applicable national and local laws with regard to the
disclosure, transparency or approval requirements to any third parties
associated with engaging Customers as service providers. See the BCS
International Procedures and Playbook for local requirements as well as the
detail on compensating for travel time.

Standard 7 | Training and Education

Purpose. Medtronic may organize sessions with Customers for the purpose of
instruction, education and training to explain the safe and effective use of
Medtronic products. This education and training includes “hands on” product
training as well as education on topics associated with the appropriate use of
our products, therapies and related services and support programs. This may
involve training and education on:

 

  •   how to use or implant a Medtronic product;

 

  •   indications or therapies appropriate for use of a Medtronic product;

 

  •   the technical features, properties, quality and/or design characteristics
of a Medtronic product;

 

  •   disease states treated by Medtronic products;

 

  •   the benefits and risks of use of the product and appropriate precautions
for use;

 

  •   the appropriate use of the product in the continuum of care; and

 

  •   product-related reimbursement support and economic outcomes.

Training and education must generally constitute a substantial majority of the
program on each program day.

Appropriate Setting. Training and education programs are to be conducted in
appropriate settings - places that are conducive to the program’s training and
education purpose, convenient for the attendees and reasonable in cost. See the
BCS International Procedures or Playbook for more detail on appropriate training
locations.

Travel Expenses. Where appropriate, we subsidize Customers’ expenses to travel
to Medtronic-conducted training and education programs. Lodging, setting, meals
and refreshments provided in conjunction with training and education programs
must be modest and in accordance with the applicable country limits and must not
overshadow the training and education purpose of the program.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 7 of 8

 

Payments to Customers to conduct Medtronic training and education sessions and
reimbursement of travel expenses must be under a written agreement and in
accordance with BCS 6. Medtronic may not pay an honorarium fee for simply
attending a Medtronic training and education event.

Prior Approval. Training and education programs involving Customer travel must
be reviewed and approved according to a written process that requires prior
approval of the course content, agenda (covering all events from arrival to
departure), budget, location/venue types and numbers of attendees and faculty.
Agenda items may not include uses of our products or therapies that would be
inappropriate under local law, nor may agendas include entertainment or
recreation.

Faculty may include qualified Medtronic sales personnel, other Medtronic
technical experts, as well as healthcare professionals with the proper
qualifications and expertise to conduct the training and education.

Standard 8 | Third-Party Conferences

Purpose. Medtronic may support independent educational, scientific and
policymaking conferences and professional meetings that promote scientific
knowledge, advance the practice of medicine and enhance the delivery of
effective healthcare if they are generally recognized and respected within the
medical community and relate to our products and therapies. The rules and
practices in supporting third party conferences vary greatly by geography, but
regardless of region, Medtronic never provides funding support for purposes of
rewarding a Customer’s past purchases or improperly influencing future ones.

Rules for Funding Conferences by Medtronic U.S.

Conferences in the U.S. – Medtronic’s funding must be consistent with the rules
of the body accrediting the educational activity. This means:

 

  •   Faculty selection and content development must be at the sole discretion
of the conference organizer;

 

  •   Medtronic does not directly support the attendance of U.S. Customers at
U.S. conferences by paying admission fees, honoraria or travel and lodging.

However, Medtronic may provide grants to conference organizers to reduce overall
conference costs, defray faculty costs and expenses, support modest meals or
receptions and allow attendance by healthcare professionals-in-training, or
Medtronic may give a grant to a training institution to allow an HCP-in-training
to attend a third-party conference or professional meeting.

Conferences outside the U.S. – Proposed sponsorship of such conferences requires
review under the BCS process in the geography of the conference site. See the
BCS Playbook for further detail, including the rules on U.S. Customers attending
third-party conferences occurring outside the U.S.

Rules for Funding Conferences by Medtronic International

Where permitted under national and local laws, regulations and professional
codes of conduct, and with prior approval, Medtronic may provide financial
support to cover the cost of conference attendance by individuals who are
Customers. Such financial support should be limited to the conference
registration fee and reasonable travel, meals and accommodation costs relating
to attendance at the event. Medtronic must ensure full compliance with national
and local laws with regard to the disclosure or approval requirements associated
with such sponsorship and where no such requirements are prescribed, shall
nevertheless maintain appropriate transparency, for example, by requiring prior
written notification of the sponsorship is made to the hospital administration,
the individual Customer’s superior or other locally-designated competent
authority.

Note that Eucomed has established a process to approve conferences occurring in
Europe which Medtronic will use as a guide for determining conference support.
See the International Procedures for further detail.

Standard 9 | Activities Benefiting Patient Care

Reimbursement Support. Patient access to our products and therapies depends on
the availability of timely and complete coverage, reimbursement, and health
economic information. Where appropriate, Medtronic may provide this information
to Customers, payors and patients, provided such reimbursement support is
accurate, objective and related to Medtronic products, therapies, procedures and
services. We may also collaborate with Customers, patients and organizations
representing their interests, to achieve government and commercial payor
coverage and adequate reimbursement levels that allow patients to access
Medtronic products and therapies.

Medtronic-provided reimbursement support may never suggest mechanisms for either
billing for services that are not medically necessary or that facilitate
fraudulent practices to achieve inappropriate reimbursement.

Other Activities to Support Patient Access. Medtronic also undertakes other
activities to support patient access to our products and therapies to improve
patient outcomes. Medtronic may engage in market development activities and
conduct educational and awareness programs with its customers. In addition,
Medtronic may provide health and disease management programs that include the
provision of items, services and provider and patient health management tools
such as critical pathways, remote monitoring and patient compliance and
education support.

--------------------------------------------------------------------------------

Global Business Conduct Policy    Page 8 of 8

 

Last updated: 23 May 2012

Additional information

Contact Us

Contact the Audit Committee and/or Board of Directors

Related Links

 

  •   Investor Relations

 

  •   SEC Filings

© 2014 Medtronic, Inc.

--------------------------------------------------------------------------------

EXHIBIT D

Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks (********) denote omissions.

 

LOGO [g644726exd_pg01.jpg]

Alachua, Florida

   Policy   

Document No.: 3418

Revision No.: R0

Supercedes: N/A

Effective Date: 11/28/05

Title: RTI Domestic Return Policy

This return policy is applicable in all cases where grafts are supplied by RTI
Biologics, Inc. (RTI) to a healthcare facility.

RTI cannot accept grafts for return unless RTI has issued a Return Authorization
Number. Please do not return grafts without this number.

The healthcare facility is responsible for all shipping costs.

FROZEN TISSUE

Frozen Tissue will not be accepted for return by RTI except under the following
conditions:

 

  1. The healthcare facility informs RTI within 48 hours of initial receipt that
the graft(s) did not meet receiving requirements.

Authorized returns of frozen tissue must be returned in an unopened (without
violation of tamper evident tape) 5-day RTI validated cooler received at RTI
within the 5-day time span.

A ******** restocking fee will apply to all accepted returns unless related to a
valid complaint or per contract agreement.

 

  2. The grafts did not meet storage condition requirements.

 

  3. The healthcare facility becomes aware of a latent defect – (A defect that
is not discoverable by reasonable or customary inspection).

In any of the above instances, a complaint investigation may be initiated.

FREEZE DRIED TISSUE

Freeze-dried tissue will be accepted for return by RTI only if the following
conditions are met:

 

  1. The healthcare facility informs RTI, within 5 days of initial receipt, that
the graft (s) did not meet receiving requirements.

Authorized graft returns must be in their original, sealed packaging.

A ******** restocking fee will apply to all accepted returns unless related to a
valid complaint with exception of HTO Wedges, consignment tissue, or contract
agreement.

 

  2. The grafts did not meet storage condition requirements.

 

  3. The healthcare facility becomes aware of a latent defect – (A defect that
is not discoverable by reasonable or customary inspection).

 

 

Page 1 of 2

 

For Use By Affiliates of RTI

This document contains proprietary information. It may not be reproduced or
disclosed without prior written approval.

>>THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT EFFECTIVE
DATE BEFORE USING THIS DOCUMENT>>

Printed 02/27/14

--------------------------------------------------------------------------------

Confidential Treatment Requested

 

LOGO [g644726exd_pg01.jpg]

Alachua, Florida

   Policy   

Document No.: 3418

Revision No.: R0

Title:

CREDIT

No credit will be issued until and unless the evaluation of the returned graft
(s) indicates the return/complaint is valid. Restocking fees will be subtracted
from applicable credit.

PROCEDURES

 

  •   For any RTI tissue-related return or complaint, contact the RTI Customer
Service Department at 800-624-7238 to receive a Return Authorization Number.

 

  •   All returns require:

 

  •   tissue ID number (s) (Note: If the tissue number is unknown, all possible
tissue numbers that could be applicable for that graft must be provided).

 

  •   original packaging

 

  •   Detailed explanation of the reason for the return.

 

  •   Credit cannot be issued without this information.

 

  •   No credit will be issued until the evaluation of returned tissue indicates
the return/complaint is valid. The healthcare facility has the right to request
a copy of the return evaluation report in case of dispute.

 

  •   When returning the tissue, the Return Authorization Number must be marked
on the outside of the shipping package before shipping to RTI.

 

  •   Return Authorization Numbers will remain open for ten business days from
issuance. After 10 days, if the graft(s) have not been received, contact will be
made with the healthcare facility to inquire about the return. If no response is
received, the Return Authorization will be cancelled, the return will not be
accepted, and no applicable credit issued.

 

  •   All opened grafts much be treated as potential biohazards and must be
shipped according to applicable shipping guidelines. The graft (s) must be
placed in a doubled leak-proof bag labeled and designed for bio hazardous
material. The outer (second) bag should be protected from potential
contamination. The double-bagged product should then be placed into a sturdy
outer package of corrugated fiberwood, wood, metal or rigid plastic of a minimum
size of 7x4x2. This can be a plain cardboard box of FedEx Clinical Pack.

 

  •   Any opened grafts that have been exposed to a known infectious disease
will need to be packaged in conjunction with IATA, DOT, FAA, OSHA and CDC
packing instruction guidelines for shipping known infectious disease substances,
and this information must be conveyed to customer services.

 

Ship To:      RTI Biologics, Inc.     

Attn: Returns

11621 Research Circle

     Alachua, FL 32615

 

 

Page 2 of 2

 

For Use By Affiliates of RTI

This document contains proprietary information. It may not be reproduced or
disclosed without prior written approval.

>>THE USER OF THIS DOCUMENT IS RESPONSIBLE FOR CHECKING THE CURRENT EFFECTIVE
DATE BEFORE USING THIS DOCUMENT>>

Printed 02/27/14

--------------------------------------------------------------------------------

EXHIBIT E

Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks (********) denote omissions.

Exhibit E

 

Agreement Qtr

   1    2    3    4    5    6    7    8    9

Calendar Qtr

   Nov-Jan
2014    Feb-April
2014    May-July
2014    Aug-Oct
2014    Nov-Jan
2015    Feb-April
2015    May-July
2015    Aug-Act
2015    Nov-Jan
2016 ********    ********    ********    ********    ********    ********   
********    ********    ********    ******** ********    ********    ********   
********    ********    ********    ********    ********    ********    ********
********    ********    ********    ********    ********    ********    ********
   ********    ********    ********