FOURTH AMENDMENT TO FIRST AMENDED EXCLUSIVE DISTRIBUTION AND LICENSE AGREEMENT

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

FOURTH AMENDMENT TO FIRST AMENDED EXCLUSIVE

DISTRIBUTION AND LICENSE AGREEMENT

THIS FOURTH AMENDMENT TO FIRST AMENDED EXCLUSIVE DISTRIBUTION AND LICENSE AGREEMENT (this “ Amendment ”) is made and entered into as of September 12, 2006 (the “ Fourth Amendment Effective Date ”) by and between Regeneration Technologies, Inc., a Delaware corporation (“ RTI ”), and Medtronic Sofamor Danek USA, Inc. (“ MSD ”), a Tennessee corporation.

WITNESSETH:

WHEREAS, MSD and RTI are parties to a First Amended Exclusive Distribution and License Agreement having an effective date of April 15, 2004, as amended by the First Amendment to First Amended Exclusive Distribution and License Agreement dated March 1, 2005, as amended by the Second Amendment to First Amended Exclusive Distribution and License Agreement dated December 15, 2005, as amended by the Third Amendment to First Amended Exclusive Distribution and License Agreement dated December 15, 2005 (the “ Agreement ”); and

WHEREAS, MSD and RTI desire to amend the Agreement on the terms and conditions set forth herein.

AGREEMENT

NOW THEREFORE, in consideration of the representations, warranties, covenants and agreements contained herein, and for other valuable consideration, the receipt and adequacy of which is hereby acknowledged, the parties mutually agree as follows:

1. Amendment . The parties mutually agree that the Agreement shall be amended and restated as of the Fourth Amendment Effective Date to read in its entirety as set forth in Exhibit A hereto. The provisions set forth in Section 2 of the Third Amendment to First Amended Exclusive Distribution and License Agreement dated December 15, 2005 shall remain in full force and effect.

2. Ratification . Except as amended hereby, the Agreement is hereby ratified and confirmed in all respects. As amended by Section 1 of this Amendment, the Agreement shall be read and construed as one and the same instrument. The execution of this Amendment is not intended to be, and shall not be construed as, a waiver by either party of any breach of any provision hereof.

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IN WITNESS WHEREOF, each of the parties has caused this Fourth Amendment to First Amended Exclusive Distribution and License Agreement to be executed by their respective duly authorized representatives as of the date first above written.

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Exhibit A

Form of Amended and Restated Distribution and License Agreement (as amended by the Fourth Amendment)

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AMENDED AND RESTATED

DISTRIBUTION AND LICENSE AGREEMENT

Specialty Allografts and Bone Paste

This Amended and Restated Distribution and License Agreement (this “ Agreement ”) is effective as of the 15th day of April, 2004, (the “ Effective Date ”) by and between Regeneration Technologies, Inc., a Delaware corporation (“ RTI ”), and Medtronic Sofamor Danek USA, Inc., a Tennessee corporation (“ MSD ”). RTI and MSD are sometimes individually referred to herein as a “ Party ” and collectively as the “ Parties .”

WHEREAS, RTI and MSD each acknowledge that the processing and use of human tissue for human transplantation purposes is 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, the Parties are successors in interest to each of that certain Management Services Agreement, dated July 23, 1996, between The University of Florida Tissue Bank, Inc. (“ UFTB ”) and Sofamor Danek Group, Inc. (“ SDG ”), as amended (the “ 1996 Management Services Agreement ”), and that certain Management Services Agreement—Bone Paste, dated May 11, 1998, between UFTB and SDG, as amended (the “ 1998 Management Services Agreement ” and, together with the 1996 Management Services Agreement, the “ Original Agreements ”);

WHEREAS, the Parties entered into that certain Exclusive Distribution and License Agreement (the “2002 Agreement”) as of June 1, 2002 (the “Original Effective Date”) and the Parties now wish to redefine the terms governing their relationship by entering into this Agreement;

WHEREAS, MSD and RTI each desire that RTI process and produce certain human specialty allograft tissue listed in Schedule 2.1 attached hereto (the “ Specialty Allografts ”) and paste products containing demineralized bone, gelatin, and particulate mineral (“ Bone Paste ”) including but not limited to cortical and/or cancellous chips listed in Schedule 2.1 attached hereto, and MSD desires to distribute such Specialty Allografts and Bone Paste in accordance with the terms and conditions contained herein;

WHEREAS, MSD desires to obtain a license from RTI to market, promote and distribute Specialty Allografts and Bone Paste; and

WHEREAS, the Parties desire to work together to develop new technology and products for use in medical procedures;

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

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ARTICLE I

AMENDMENT AND TERMINATION OF ORIGINAL AGREEMENTS AND 2002 AGREEMENT

1.1 Amendment . In order to facilitate continued service to patients and efficient use of human tissue, prior to November 1, 2002, (the “ Implementation Date ”) the Parties continued to operate under the Original Agreements and agreed as follows:

(a) Management Services Fee . Beginning on the Original Effective Date and ending on the day immediately prior to the Implementation Date, (i) with respect to UFTB Allografts, the Management Services Fee (as such terms are defined in the 1996 Agreement) was [###] %) and (ii) with respect to UFTB Paste Products, the Management Services Fee (as such terms are defined in the 1998 Agreement) was [###].

(b) Effect . Except as set forth expressly herein, all terms of the Original Agreements remained in full force and effect until the Implementation Date.

1.2 Termination . As of the Implementation Date, the Parties agree and acknowledge that, without any additional action on either Party’s behalf, the Original Agreements terminated and are of no further force or effect; provided, however, such termination did not relieve either Party from liabilities arising prior to the Implementation Date under the terms of the Original Agreements. The parties further acknowledge and agree that as of the Effective Date, the 2002 Agreement terminated and was superseded in all respects by this Agreement.

1.3 Arbitration . RTI and MSD covenant and agree to use best efforts to resolve all outstanding disputes under the Original Agreements by the Effective Date, including but not limited to those matters currently in arbitration.

ARTICLE II

LICENSE GRANT

2.1 License; Sublicensing Rights; Field of Use . Subject to the provisions of this Agreement, RTI hereby grants to MSD a worldwide and royalty free license to distribute Specialty Allografts and Bone Paste throughout the world (the “ Territory ”). Schedule 2.1 attached hereto contains a list of all Specialty Allografts and Bone Paste as of the date hereof, including a list of Specialty Allografts for which the license grant hereunder is exclusive in the Exclusive Territory (as defined in Section 3.1(a) herein) and non-exclusive in the remainder of the Territory, and a list of Specialty Allografts for which the license grant hereunder is nonexclusive throughout the Territory. The license grant hereunder for Bone Paste is non-exclusive throughout the Territory.

2.2 License of RTI Marks . RTI grants to MSD a royalty free license to use under the quality control of RTI the RTI name and logo and all goodwill associated therewith, and all

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trademarks, service marks, trade names, designs, graphics and logos associated with the Specialty Allografts or the Bone Paste, (the “ Current RTI Marks ”) in connection with the marketing and distribution of Specialty Allografts and Bone Paste as provided in this Agreement. RTI further grants to MSD a royalty free license to use under the quality control of RTI service marks or trademarks adopted and/or used by RTI and associated specifically with Specialty Allografts or Bone Paste (the “ Future RTI Marks ,” and, together with the Current RTI Marks, the “ RTI Marks ,”) in connection with the marketing and distribution of Specialty Allografts and Bone Paste as provided in this Agreement. A list of all Current RTI Marks and their filing status (if any) is attached hereto as Schedule 2.2. RTI shall update Schedule 2.2 with all Future RTI Marks within thirty (30) days after they have been adopted or used by RTI.

2.3 Additional Specialty Allografts and Bone Paste . The parties may mutually agree from time to time to amend Schedule 2.1 to add or delete Specialty Allografts or Bone Paste products. In addition, the parties may from time to time mutually agree to modifications to existing Specialty Allograft designs. To the extent that the parties agree to a design modification to an Exclusive Specialty Allograft, RTI shall not have any right to process or distribute the prior design of such Exclusive Specialty Allograft in the Exclusive Territory except as specifically provided in Section 3.1(b).

The license grant hereunder for Bone Paste includes the current formulation (and any previous formulations) of Bone Paste.

ARTICLE III

MSD DISTRIBUTION SERVICES; SPECIALTY ALLOGRAFT AND BONE PASTE SUPPLY

3.1 Exclusive Distribution Rights .

(a) Distributor Appointment . Subject to MSD’s right to subcontract or delegate in whole or in part to one or more third parties its obligations and responsibilities as distributor of Specialty Allografts as expressly set forth in this Agreement, during the term of this Agreement, MSD is granted (i) exclusive distribution rights in the United States, Canada and Puerto Rico (the “Exclusive Territory”) for those Specialty Allografts indicated as “exclusive” on Schedule 2.1 (the “Exclusive Specialty Allografts”) and non-exclusive distribution rights throughout the rest of the world for such allografts, (ii) non-exclusive distribution rights throughout the world for those Specialty Allografts indicated as “non-exclusive” on Schedule 2.1 (the “Non-exclusive Specialty Allografts”) and (iii) non-exclusive distribution rights for Bone Paste throughout the world; provided, however, with respect to Bone Paste, the grant of rights herein shall be exclusive for the use of the trademark, service mark, trade name, design, graphics and logos associated with “Osteofil.” RTI agrees that any Bone Paste delivered other than pursuant to this Agreement shall contain a different brand name and label than the Bone Paste delivered pursuant to this Agreement. MSD shall be entitled to distribute Bone Paste for use in all applications, including all musculoskeletal applications (orthopedic, trauma, etc.). RTI shall not, and RTI shall ensure that any third party

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distributor does not, utilize or reference, directly or indirectly, in any manner the “Osteofil” name or any data with respect to the Osteofil product (including clinical and pre-clinical data) in any marketing and promotional materials or in any materials filed with any applicable regulatory authority.

(b) Conversion of Exclusive Specialty Allograft to Non-exclusive . MSD may, in its sole discretion, convert an Exclusive Specialty Allograft to a Non-exclusive Specialty Allograft by providing written notice to RTI. RTI may provide written notice during the month immediately prior to the Review Month of Exclusive Specialty Allografts that it believes should be converted to Non-exclusive Specialty Allografts. MSD agrees to confer with RTI during each Review Month in good faith regarding whether it may be appropriate to convert an Exclusive Specialty Allograft to a Non-exclusive Specialty Allograft and MSD agrees to take into reasonable consideration any decline in the volume of MSD orders for such Exclusive Specialty Allografts as well as market conditions and other relevant factors. As used herein, the term “Review Month” means the first full calendar month after each anniversary of the Fourth Amendment Effective Date.

(c) MSD Right to Compete; no Obligation to Market or Promote . Nothing in this Agreement shall prohibit MSD from manufacturing, marketing or distributing allograft tissue or other products (including Specialty Allografts and Bone Paste) that compete, either directly or indirectly, with Specialty Allografts and Bone Paste; 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. MSD shall have no obligation to market or promote Bone Paste or Specialty Allografts.

(d) Distribution . MSD’s agreement in Section 3.1(a) hereof to allow the distribution of Exclusive Specialty Allografts in territories outside of the Exclusive Territory is specifically conditioned on the following conditions being met at all times:

(i) Prior to any such distribution RTI must use commercially reasonable efforts to assure that no Exclusive Specialty Allografts will be distributed to anyone who further distributes or intends to distribute such Exclusive Specialty Allografts into the Exclusive Territory and if such Exclusive Specialty Allografts are distributed by any party other than MSD in the Exclusive Territory then RTI will cease all distribution to that customer and immediately use its best efforts to enjoin such distribution and recover inventory from that distributor;

(ii) Exclusive Specialty Allografts for MSD’s distribution shall receive priority with respect to donors, processing and manufacturing over any distribution by RTI or third parties, except for tissue suitable for Bone Paste to be distributed by Exactech, which is subject to Section 3.3(e)(ii)(B); and

(iii) Distribution by RTI or any third party as allowed by this Section 3.1(d) will not violate any MSD Intellectual Property Rights.

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(e) RTI Right to Cease Supply . RTI shall have the right to cease supply of particular Specialty Allografts or Bone Paste if it is economically unfeasible for RTI to supply such Bone Paste or Specialty Allografts to MSD under the terms of this Agreement; provided that:

(i) RTI may exercise such right only with respect to Specialty Allografts or Bone Paste identified in the written notice delivered pursuant to Section 5.2(c) herein during the calendar month immediately prior to a Review Month;

(ii) RTI may exercise such right only by providing written notice during the calendar month after the Review Month and RTI shall not have the right to cease supply of any specific Specialty Allograft or Bone Paste if the parties have mutually agreed to a fee adjustment for such Specialty Allograft or Bone Paste during the immediately preceding Review Month; and

(iii) RTI shall be required to provide MSD in writing with reasonable financial justification for such economic unfeasibility.

RTI’s right to cease supply of particular Specialty Allografts or Bone Paste shall be effective [***] months after delivery to MSD of the notice required by clause (ii) above. RTI shall not have the right to cease supply of any Specialty Allografts in a Product Family hereunder if it is supplying any Specialty Allograft in such Product Family (or any comparable allograft) to any third party at a fee equal to or less than that charged to MSD hereunder.

3.2 Taxes . MSD shall have the sole responsibility for collection and payment to the appropriate taxing authorities of any taxes, tariffs, duties or excise, sales or use, value added or other taxes or levies imposed upon Specialty Allografts or Bone Paste, as the case may be, as a result of MSD’s distribution of Specialty Allografts or Bone Paste, as the case may be, to customers. RTI shall have the sole responsibility for payment to the appropriate taxing authorities of any taxes, tariffs, duties or excise, sales or use, value added or other taxes or levies imposed on the services provided by RTI under this Agreement.

3.3 Specialty Allograft and Bone Paste Supply; Forecasts . The Parties acknowledge and agree that donated human tissue is necessary for the production of Specialty Allografts and Bone Paste, and that at times the demand for such products may exceed the supply due to limited amounts of donated human tissue. Accordingly, the Parties agree to do the following:

(a) MSD Forecasts . [***]

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(b) RTI Forecasts . [***]

(c) Transmission of Forecasts . [***]

(d) Binding Orders . [***]

(e) Annual Non-Binding Forecasts . [***]

(e) Allocation Priority . [***]

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[***]

(f) Supply Shortfall License . [***]

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[***]

3.4 Shipping Procedures . RTI shall ship Specialty Allografts and Bone Paste corresponding to Binding Orders to MSD at least once per week at RTI’s sole cost and expense, provided that 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.

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3.5 Returned and Rejected Specialty Allografts and Bone Paste .

(a) Returned Specialty Allografts and Bone Paste . The return policy for Specialty Allografts and Bone Paste is set forth in Schedule 3.5(a) (the “ Return Policy ”).

(b) Rejected Specialty Allografts and Bone Paste . With respect to latent defects, MSD shall promptly notify RTI after receiving notification from a customer of such customer’s discovery thereof, and MSD and such customer shall have the right to reject such Specialty Allografts or Bone Paste. For the avoidance of doubt, and notwithstanding any provision of the Return Policy, MSD shall be permitted to reject Specialty Allografts or Bone Paste due to latent defects at any time after discovery of such latent defects or at any time after receiving notification from a customer of such customer’s discovery of such latent defects. Any notification of rejection to RTI shall state the basis for the rejection.

(c) Effect of Return or Rejection . The customer shall be bound by the terms of the Return Policy; provided, however, that in the event of a conflict between the terms of the Return Policy and the terms of this Agreement, the terms of this Agreement shall govern and control in all respects. Neither MSD nor the customer shall be obligated to pay for any rejected shipment of Specialty Allografts or Bone Paste shipped to such customer which fails to meet the Specialty Allograft Specifications or the Specialty Allograft Packaging Specifications or the Bone Paste Specifications or the Bone Paste Packaging Specifications or otherwise breaches the RTI Specialty Allograft Warranty or Bone Paste Warranty, as the case may be, set forth on Schedule 4.3(a) and Schedule 4.3(b), respectively, hereof. The customer shall not be obligated to pay for any shipment of Specialty Allografts or Bone Paste rejected by a customer. If a customer fails to pay for any rejected shipment of Specialty Allografts or Bone Paste, MSD shall not be obligated to pay any license or service fee to RTI for such Specialty Allografts or Bone Paste, and MSD shall be entitled to receive, in its sole discretion, either (i) a credit against future license or service fees in the amount of any such fee MSD had previously paid to RTI for any such rejected Specialty Allografts or Bone Paste or (ii) a replacement Specialty Allograft or Bone Paste, as the case may be. Unless otherwise waived by MSD, all Specialty Allografts and Bone Paste shipped to MSD by RTI under this Agreement shall have remaining shelf life of at least sixty percent (60%) of the appropriate shelf life for such Specialty Allografts or Bone Paste (as the case may be).

ARTICLE IV

SPECIFICATIONS; PACKAGING SPECIFICATIONS; SPECIALTY ALLOGRAFT

AND BONE PASTE LABELING; REGULATORY APPROVAL; RTI WARRANTIES

4.1 Specifications .

(a) Specialty Allografts . Specialty Allografts shall meet the specifications set forth on Schedule 4.1(a) hereto (the “ Specialty Allograft Specifications ”).

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(b) Bone Paste . Bone Paste shall meet the specifications set forth on Schedule 4.1(b) hereto (the “ Bone Paste Specifications ”).

4.2 Packaging Specifications .

(a) Specialty Allografts . RTI shall supply all packaging and labeling information and designs, including without limitation all artwork and pharmacological information, usage instructions and warnings to be applied to Specialty Allografts (the “ Specialty Allograft Packaging Specifications ”). Once Specialty Allografts are supplied and initially packaged by RTI, MSD will not without RTI’s concurrence remove, alter or modify any Specialty Allograft Packaging Specifications of such Specialty Allografts.

(b) Bone Paste . RTI shall supply all packaging and labeling information and designs, including without limitation all artwork and pharmacological information, usage instructions and warnings to be applied to Bone Paste (the “ Bone Paste Packaging Specifications ”). Once Bone Paste is supplied and initially packaged by RTI, MSD will not without RTI’s concurrence remove, alter or modify any Bone Paste Packaging Specifications of such Bone Paste.

4.3 Warranties .

(a) Specialty Allografts . RTI has listed specific warranty information with respect to Specialty Allografts on Schedule 4.3(a) and RTI shall use its best efforts to keep Schedule 4.3(a) updated to include all applicable warranties.

(b) Bone Paste . RTI has listed specific warranty information with respect to Bone Paste on Schedule 4.3(b) and RTI shall use its best efforts to keep Schedule 4.3(b) updated to include all applicable warranties.

(c) Warranty Obligation . All warranty obligations of the respective Parties listed with respect to Specialty Allografts and Bone Paste shall be solely the obligation and responsibility of RTI.

4.4 Labeling . All Specialty Allografts and Bone Paste distributed pursuant to this Agreement shall be labeled by RTI in accordance with this Section 4.4. Any Specialty Allograft or Bone Paste which is improperly labeled shall not be deemed delivered until properly identified by MSD, and RTI shall credit MSD’s account for its reasonable costs incurred while (i) identifying Specialty Allografts and Bone Paste that were inappropriately labeled and (ii) correcting orders both to RTI and from its customers.

(a) RTI Processed Specialty Allografts and Bone Paste . All Specialty Allografts and Bone Paste processed or manufactured by RTI (the “ RTI Processed Specialty Allografts and Bone Paste ”) shall be sterilized, labeled and packaged by RTI using the RTI Marks. The costs of labeling the RTI Processed Specialty Allografts and Bone Paste is included in the applicable LSF (as defined in Section 5.1) and shall not be charged to MSD.

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(b) Third Party Processed Specialty Allografts and Bone Paste . In the event MSD exercises its right to process or manufacture, or appoints a Third Party Supplier to process or manufacture, Exclusive Specialty Allografts pursuant to Section 3.3(f) herein (the “ Third Party Processed Specialty Allografts ”), at MSD’s sole discretion and expense, RTI shall sterilize, package and label as sterilized by RTI such Third Party Processed Specialty Allografts. MSD shall pay RTI a commercially reasonable fee for such sterilization, packaging and labeling of the Third Party Processed Specialty Allografts; provided, however, such fee shall not exceed the consideration RTI receives from any other third parties for substantially similar services.

(c) Sterilization Validation . During the term of this Agreement, RTI shall use commercially reasonable efforts to validate its processes to allow for and substantiate a “sterile” product label claim on all Specialty Allografts and Bone Paste.

4.5 Regulatory Approval .

(a) United States . RTI warrants that Specialty Allografts, Bone Paste, Specialty Allograft Specifications, the Bone Paste Specifications, the Specialty Allograft Packaging Specifications and the Bone Paste Packaging Specifications shall be in conformity in all respects with all applicable federal, state, and local laws, rules and regulations relating thereto within the United States, including, without limitation, the Federal Food, Drug and Cosmetic Act (including Good Tissue Practices Regulations), the National Organ Transplant Act, FDA tissue regulations, and American Association of Tissue Banks (the “ AATB ”) or other generally accepted industry standards. RTI will continue to maintain and fulfill such regulatory approval of the federal, state and local governing bodies, and be responsible for all filings and other documents necessary to continue to meet said regulatory requirements, including, without limitation, fulfilling all applicable reporting, tracking and other requirements of regulatory agencies, self-regulatory organizations or governmental entities that have jurisdiction with respect to RTI, Specialty Allografts and Bone Paste. MSD shall cooperate in preparing any such filings to the extent reasonably requested by RTI. MSD shall be fully responsible for compliance with regulatory requirements with respect to all Specialty Allograft and Bone Paste distribution activities performed by MSD, including, if necessary, registration as a Tissue Bank under FDA 21 CFR 1271 and under any state licensure requirements. MSD shall be responsible for assuring that applicable AATB requirements are met with respect to MSD’s distribution activities. RTI shall be responsible for any market withdrawal or recall activities with respect to Specialty Allografts or Bone Paste as required pursuant to applicable laws, rules, regulations or standards. In the event RTI fails to perform any required market withdrawal or recall activities with respect to Specialty Allografts or Bone Paste, then MSD may perform such market withdrawal or recall activities. Each Party shall fully cooperate in any market withdrawal or recall activities on request of the other Party. MSD shall provide post-market feedback information to RTI in accordance with regulatory requirements.

(b) AATB Accreditation . The Parties acknowledge that RTI is a member of the AATB. RTI warrants that it will use its best efforts to continue its membership in

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good standing in the AATB and retain its AATB accreditation at all time during the term of this Agreement.

(c) All International Markets . MSD shall be fully responsible for market approvals, product registration and licensure for all markets in the Exclusive Territory and any other countries where MSD proposes to begin distributing RTI products and those products have not been previously registered, licensed and approved. RTI will use commercially reasonable efforts to support such registration activities. The purpose of this Section is to assign responsibility to satisfy licensure requirements in particular countries. The inability of MSD or RTI to obtain licensure in a particular market shall not, in and of itself, constitute a material breach of this Agreement. Further, the failure of MSD or RTI to utilize any degree of efforts to seek or maintain regulatory approvals shall not constitute a breach of this Agreement, provided that both RTI and MSD at the request of the other, will make commercially reasonable efforts to support the other’s efforts to seek or maintain such regulatory approvals.

(d) Costs . All costs associated with obtaining and/or maintaining any regulatory or governmental approval, within the United States, or accreditation with AATB as set forth in this Section 4.5 shall be borne solely by RTI insofar as those costs relate to activities performed by 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, product registrations and licensure for any markets outside the Exclusive Territory where MSD proposes to begin distributing RTI products and where those products have not been previously registered, licensed and approved shall be the responsibility of MSD. MSD shall be responsible for costs associated with its responsibilities under Section 4.5(c).

(e) Allograft or Bone Paste products to be used in clinical investigations . MSD shall inform RTI in advance of any and all clinical investigations where Specialty Allografts or Bone Paste are to be used to ensure that proper donor consent, if required, has been received. MSD shall provide RTI with study outlines and all results of any such clinical investigations pertinent to the use and performance of Specialty Allografts or Bone Paste. RTI shall assist in clinical activities in regard to provision of information to FDA in support of MSD clinical investigations.

4.6 Additional RTI Representations and Warranties . RTI hereby represents and warrants to MSD the following:

(a) it is the owner of or the exclusive licensee under patent rights, if any, stemming from U.S. Patent Application S/N 08/816,079, dated March 13, 1997, attached as Exhibit A, including any continuations, continuations-in-part, or divisions of this patent application, or as well as foreign counterparts thereof and patents issuing thereon which relates to Bone Paste;

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(b) it is the owner of the Dowel products listed in Exhibit B which are comprised solely from allograft for use in medical procedures in the human spine;

(c) has the right to grant the licenses granted to MSD in this Agreement;

(d) as of the Effective Date, RTI has not received notice, nor is it aware, that the Specialty Allografts or Bone Paste infringe upon any patent which has been issued to any third party;

(e) Specialty Allografts and Bone Paste shall be processed, packaged, stored and shipped (i) biomechanically suitable for use in medical procedures in which human tissue is needed to replace human tissue, (ii) in accordance with the Specialty Allograft Specifications and Specialty Allograft Packaging Specifications or the Bone Paste Specifications and Bone Paste Packaging Specifications, as the case may be, for use as prescribed by a physician for medical procedures in which human tissue is needed or used and (iii) in accordance with Section 4.5;

(f) Specialty Allografts and Bone Paste are and shall be delivered free of any liens, encumbrances, pledges, or claims of any third party;

(g) the rights granted herein do not violate any rights previously granted by RTI to any third party;

(h) it is fully authorized to enter into and perform this Agreement;

(i) Specialty Allografts and Bone Paste have been and will be professionally processed and have come and will come packaged for further distribution throughout the Territory;

(j) that it has obtained the materials for production of Specialty Allografts and Bone Paste in compliance with all applicable federal, state and local laws, rules and regulations associated with Specialty Allografts or Bone Paste, as the case may be, and all applicable AATB standards; and

(k) that its execution and performance of this Agreement will not (i) conflict with, or result in a breach or default under, any agreement, contract, arrangement, mortgage or indenture to which it is bound, (ii) result in the creation of any lien, encumbrance or pledge upon any of the properties or assets (other than raw materials) of RTI, or (iii) violate any statute, rule, regulation or order applicable to RTI.

Except as specifically set forth in clause (d) above, RTI shall be deemed to have reaffirmed each representation and warranty contained in this Section 4.6 on and as of the date of each delivery of Specialty Allografts or Bone Paste hereunder.

4.7 MSD Representations and Warranties . MSD hereby represents and warrants to RTI the following:

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(a) it is fully authorized to enter into and perform this Agreement;

(b) that its execution and performance of this Agreement will not (i) conflict with, or result in a breach or default under, any agreement, contract, arrangement, mortgage or indenture to which it is bound, (ii) result in the creation of any lien, encumbrance or pledge upon any of the properties or assets (other than raw materials) of MSD, or (iii) violate any statute, rule, regulation or order applicable to MSD; and

(c) as of the Effective Date, MSD has not received notice, nor is it aware, that the Specialty Allografts or Bone Paste infringe upon any patent which has been issued to any third party.

Except as specifically set forth in clause (c) above, MSD shall be deemed to have reaffirmed each representation and warranty contained in this Section 4.7 on and as of the date of each acceptance of delivery of Specialty Allografts or Bone Paste hereunder.

4.8 Quality Procedures . The Parties acknowledge the importance of ensuring that the Specialty Allografts and Bone Paste are of the highest quality and are safe and effective for their intended or expected uses. Accordingly, within ten (10) days after signing this Agreement, RTI shall provide MSD with a full and complete copy of its policies and procedures for ensuring the quality and safety of Specialty Allografts and Bone Paste (the “Quality Procedures”). The Quality Procedures shall be consistent with the terms of this Agreement and provide greater detail for the arrangement and responsibilities of the parties in the procurement, processing, testing and delivery of Specialty Allografts and Bone Paste hereunder as well as regulatory reporting functions and the exchange of information relevant to any of the foregoing. The Quality Procedures shall also set forth material specifications and acceptability criteria for the Specialty Allografts and Bone Paste, which specifications and criteria shall be no less stringent than industry standards and shall include, at a minimum, standards and procedures for donor screening, intake evaluation, tissue processing, tissue storage, tissue record keeping, retained samples, maintenance and access to documentation. Within ten (10) days after signing this Agreement, the parties shall each designate in writing an appropriate contact person for communications regarding the Quality Procedures, and the parties will promptly notify each other in writing of any changes in such personnel. The designated contacts for each party, and other reasonably appropriate safety and quality assurance personnel as the parties may designate from time to time, shall meet in person or via other appropriate means no less often than quarterly to review the Quality Procedures and consider modifications thereto. Quality Procedures will be amended from time to time by RTI with the advice and comment from MSD to reflect changes in technology, laws, regulations and industry standards, provided that no party will be required to agree to any change to the Quality Procedures that, in the reasonable discretion of such party, would adversely impact the quality, safety or efficacy of any Specialty Allograft or Bone Paste. RTI will not modify or amend the Quality Procedures without providing prompt written notice to MSD.

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ARTICLE V

LICENSE AND SERVICE FEE

5.1 License and Service Fee . Beginning on the Implementation Date, MSD shall pay to RTI a license and service fee (“ LSF ”) for Specialty Allografts and Bone Paste delivered to MSD from RTI pursuant to a Binding Order. The LSF for each Specialty Allograft and for Bone Paste is set forth on Schedule 2.1. The fees set forth on Schedule 2.1 shall be effective on October 1, 2006. In addition, MSD will be obligated to remit to RTI a processing fee surcharge related to allograft processed and shipped during the months of June, 2006 through September, 2006 as follows: June, 2006, Six Hundred Seventy Two Thousand Dollars ($672,000), July, 2006, Five Hundred Thousand Dollars ($500,000), August, 2006, Five Hundred Thousand Dollars ($500,000), and September 2006, Three Hundred Twenty Eight Thousand Dollars ($328,00).

RTI acknowledges receipt of Six Hundred Seventy Two Thousand Dollars ($672,000) for the month of June 2006.

5.2 Most Favored Fee; Fee for Samples .

(a) Most Favored Customer Fee . The LSF for Bone Paste shall not exceed the comparable LSF for comparable bone paste received by RTI from any third party and the LSF for Specialty Allografts shall not exceed the comparable LSF for comparable allografts received by RTI from any other third party. If, however, during the term of this Agreement, RTI offers or accepts lower fees, RTI shall immediately notify MSD and shall thereafter charge MSD based upon such lower fees and this Agreement shall be deemed amended as appropriate to incorporate such lower fees.

Not more than once every 6 months, MSD may conduct a review of the books and records of RTI relating to the foregoing provision. If MSD determines as a result of such review that RTI is not in compliance with the foregoing provision, RTI will immediately adjust its fees hereunder to be in compliance and RTI will reimburse MSD for its out-of-pocket expenses incurred in connection with such review.

The fees set forth on schedule 2.1 relative to Cornerstone SR (mono only) shall remain effective provided that RTI produces and delivers to MSD the minimum monthly quantity of specialty allograft indicated below, subject to receipt by RTI of Binding Forecasts from MSD in those amounts or greater during the relevant month.

If RTI fails to produce and deliver to MSD the indicated Minimum Monthly Quantity of Cornerstone SR allograft for any [***] months during a particular calendar

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quarter, subject to receipt by RTI of Binding Forecasts from MSD in those amounts or greater during the relevant month, then the fees for Cornerstone SR allograft for that quarter only shall thereafter shall be a fee that is [***] %) less than the fee otherwise in effect at that time.

Fees for the Cornerstone SR allograft in subsequent quarters shall