CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 24B-2

Exhibit 10.5

CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO RULE 24B-2

        Certain portions, indicated by [*****], of this exhibit have been omitted pursuant to Rule 24b-2 of the Securities Act of 1934. The omitted materials have been filed separately with Securities and Exchange Commission.

EXCLUSIVE
DISTRIBUTION AND LICENSE AGREEMENT

Specialty Allografts and Bone Paste

         This Exclusive Distribution and License Agreement (this “Agreement”) is effective as of the 1st day of June, 2002, (the “Effective Date”) by and between Regeneration Technologies, Inc., a Florida 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 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 including but not limited to cortical and/or cancellous chips listed in Schedule 2.1 attached hereto (“Bone Paste”), and MSD desires to distribute such Specialty Allografts and Bone Paste in accordance with the terns 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:

ARTICLE I

AMENDMENT AND TERMINATION OF ORIGINAL AGREEMENTS

         1.1      Amendment. In order to facilitate continued service to patients and efficient use of human tissue, prior to the earlier of (i) the date on which the Parties mutually agree to terminate the Original Agreements and implement the distribution arrangement described in this Agreement or (ii) November 1, 2002, (the earlier date being referred to herein as the “Implementation Date”) the Parties shall continue to operate under the Original Agreements and agree as follows:

         1.2      Termination. On the Implementation Date, the Parties hereby agree and acknowledge that, without any additional action on either Party’s behalf, the Original Agreements shall terminate and be of no further force or effect; provided, however, such termination shall not relieve either Party from liabilities arising prior to the Implementation Date under the terns of the Original Agreements.

         1.3      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 except with respect to the country of Italy (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 and Bone Paste for which the license grant hereunder is exclusive and a list of Specialty Allografts for which the license grant hereunder is nonexclusive.

         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 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.

         2.3      Additional Specialty Allografts and Bone Paste. The Parties shall update Schedule 2.1 to include all line extensions of Specialty Allografts and Bone Paste and any jointly developed products as described in Section 6.3 herein. Line extensions shall include any improvements or modifications to, or substitute or alternative products for, Specialty Allografts or Bone Paste reasonably anticipated to be used primarily for spinal fusion surgery that are competitive with any Specialty Allograft and/or Bone Paste identified in Schedule 2.1.

ARTICLE III

EXCLUSIVITY; MSD DISTRIBUTION SERVICES; SPECIALTY ALLOGRAFT AND
BONE PASTE SUPPLY

         3.1      Exclusivity.

         3.2      MSD’s Distribution Services. MSD shall use commercially reasonable efforts to distribute, or facilitate the marketing and distribution of, Specialty Allografts and Bone Paste in the Territory, in accordance with this Agreement (the “Services”). The Services shall include, without limitation: (i) developing marketing and training literature and aids for Specialty Allografts and Bone Paste; (ii) training MSD marketing and distribution personnel; (iii) conducting training courses and seminars to educate medical professionals, surgeons, customer support staff, hospital personnel and buying groups related to Specialty Allografts and Bone Paste in the use of Specialty Allografts and Bone Paste, including educating surgeons and staff on Specialty Allograft and Bone Paste design,’ ordering, delivery and stocking procedures; (iv) exhibiting Specialty Allografts and Bone Paste at medical society meetings; (v) promoting Specialty Allografts and Bone Paste in association with MSD’s other educational services and marketing efforts; and (vi) supporting at a clinical level the marketing and distribution efforts of both RTI and MSD by providing surgical case coverage for Specialty Allografts and Bone Paste. Subject to RTI’s ability to satisfy each Scheduled Order (as defined in Section 3.4(d)) and each Interim Order (as defined in Section 3.4(d)), MSD shall order from RTI and maintain sufficient units of Specialty Allografts and Bone Paste for samples, exhibits and training purposes. MSD shall be solely responsible for training, service and support for Specialty Allografts and Bone Paste distributed by MSD, and shall have no right to reimbursement or contribution for any costs related to such responsibilities.

         3.3      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.

         3.4      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 presently the demand for such products exceeds the supply due to limited amounts of donated human tissue. The Parties agree to use their mutual best efforts, including MSD’s knowledge of the needs of its customers and RTI’s expertise in processing tissue, to match the available supply to the requirements of patients and healthcare providers for Specialty Allografts. Accordingly, the Parties agree to do the following:

         3.5      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.

         3.6      Returned and Rejected Specialty Allografts and Bone Paste.

ARTICLE IV

SPECIFICATIONS; PACKAGING SPECIFICATIONS; SPECIALTY ALLOGRAFT AND BONE PASTE
LABELING; REGULATORY APPROVAL; RTI WARRANTIES

         4.1      Specifications.

         4.2      Packaging Specifications.

         4.3      Warranties.

         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.

         4.5      Regulatory Approval.

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

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

         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 the parties 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 provide prompt written notice to MSD

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.

         5.2      Initial Fees.

         5.3      Adjustment to License and Service Fee. Subject to the limitations contained in this paragraph, RTI may increase the LSF for any or all Specialty Allografts and Bone Paste on the first anniversary of the Implementation Date, and thereafter not more than twice annually,

upon sixty (60) days advance written notice to MSD. RTI may not increase the LSF for any Specialty Allograft such that the LSF for such Specialty Allograft or Bone Paste is greater than [*****] of the ANDF (excluding items placed on consignment) received by MSD for such Specialty Allograft over the preceding [*****]. RTI may not increase the LSF for any Bone Paste such that the LSF for such Bone Paste is greater than [*****] of the ANDF (excluding items placed on consignment) received by MSD for such Bone Paste over the preceding [*****]. In the event of a significant technological advance a material increase in regulatory compliance costs that either Party reasonably anticipates will have an immediate and material impact on the marketplace for Specialty Allografts or Bone Paste, the Parties will meet and confer in good faith on adjustments to the applicable LSFs, with the objective of adjusting each LSF to equal approximately [*****] of the ANDF expected to be received by MSD as a result of distribution of such Specialty Allografts, and [*****] of the ANDF expected to be received by MSD as a result of distribution of such Bone Paste, as the case may be.

         5.4      Payment Terms. All LSF payments shall be paid in U.S. Dollars within thirty (30) days of the later of MSD’s receipt of Specialty Allografts or Bone Paste, as the case may be, pursuant to a Binding Order, or the receipt of RTI’s invoice therefor. All LSF fees shall be FOB MSD’s place of business in Memphis, Tennessee, or such other locations within the 48 contiguous United States as the Parties may agree to designate.

ARTICLE VI

CERTAIN AGREEMENTS OF RTI AND MSD

         6.1      Inspections. The Parties shall permit, once annually, on reasonable notice, a representative of the other Party to inspect those processing facilities and methods of operation used by the other Party in connection with Specialty Allografts and Bone Paste as considered necessary or desirable by the other Party for the purpose of determining the other Party’s compliance with the undertakings set forth in this Agreement or satisfying a Party’s legal or regulatory obligations. The representative shall sign an agreement promising not to use any information obtained from the inspection except for its determination of such Party’s compliance. No such observation shall serve to waive any rights of MSD or RTI hereunder.

         6.2      Ownership and Licensing of Intellectual Property Rights.

         6.3      Development of New Allografts.

         6.4      Inspection Rights. RTI and MSD shall keep complete and accurate books and records which allow verification of the information contained in fee schedules, invoices and shipping notices and other documentation required under this Agreement. Each Party shall be permitted access during normal business hours and upon reasonable notice during the term of

this Agreement to such books and records of the other Party that are necessary in order to verify the other Party’s compliance with the terms of the Agreement.

         6.5      Confidentiality. While this Agreement is in effect, and for two (2) years after the termination of this Agreement (or for such longer period as any such Confidential Information may constitute a trade secret), none of MSD or RTI, their affiliates, or any directors, shareholders, officers, employees or agents of the foregoing (collectively, the “Affiliates”) shall divulge to anyone any Confidential Information (as hereinafter defined), except: (i) as required in the course of performing the obligations hereunder; (ii) to attorneys, accountants and other advisors; (iii) with the express written consent of MSD or RTI (as the case may be); or (iv) as required by law. The term “Confidential Information” shall mean any information relating to MSD or RTI or their business which is, (1) disclosed to the other (or to the other’s Affiliates) during the negotiation of and performance of this Agreement and (2) is marked “Confidential” if provided in writing, or if delivered verbally, is reduced to writing within thirty (30) days and marked “Confidential.” “Confidential Information” shall also include the terms and conditions of this Agreement and all Intellectual Property Rights relating to Specialty Allografts and Bone Paste. “Confidential Information” shall not include any information which (i) becomes public knowledge without breach by the other of this Agreement; (ii) is obtained by the other (or the other’s Affiliates) from a person or business entity under circumstances permitting its disclosure to others; (iii) may be demonstrated to have been known at the time of receipt thereof as evidenced by tangible records; or (iv) is required to be disclosed as a result of a judicial order or decree or governmental law or regulation. If a Party makes a disclosure of Confidential Information which is permitted by the terms of this Agreement, such Party shall give prior notice to the other Party, cooperate with the other Party in efforts to prevent or restrict such disclosure and be responsible for ensuring that the person to whom it is disclosed maintains the confidentiality of such Confidential Information in accordance with the terms of this Agreement.

         6.6      Opinion of Counsel. RTI shall provide an opinion from Holland & Knight L.L.P., as counsel to RTI, dated as of the date hereof, affirming (i) the legality of the commercial relationship described in this Agreement, (ii) the enforceability of this Agreement, (ii) that the execution and delivery of this Agreement by RTI will not conflict with, or result in a breach or default under, RTI’s charter, bylaws or other organizational documents or any agreement, contract, arrangement, mortgage or indenture to which it is bound, and (iv) that this Agreement complies in all respects with all statutes, rules, regulations or orders applicable to RTI and Specialty Allografts and Bone Paste.

         6.7      Determination of Inventorship and Ownership of Future Inventions. The Parties acknowledge that while working under this Agreement, they may develop inventions relating to Specialty Allografts or Bone Paste having application in the spine (“Subject Inventions”). The Parties acknowledge that they may prepare patent applications directed to obtaining patent protection for Subject Inventions (“Subject Patent Applications”). The Parties desire to properly determine inventorship and ownership rights between the Parties in any Subject Patent Application. Therefore, the Parties agree that going forward, they will follow the process described in subsections (a) through (f) below to properly determine inventorship and ownership rights in any Subject Patent Application.

ARTICLE VII

TERM AND TERMINATION

         7.1      Term. Unless terminated earlier in accordance with Section 7.2 herein, this Agreement shall be effective as of the Effective Date and shall continue until June 1, 2014 (the “Original Termination Date”); provided, however, upon the mutual written agreement of the Parties, this Agreement shall continue in effect until June 1, 2026 (the “Renewal Termination Date”).

         7.2      Early Termination. Either Party hereto may terminate this Agreement: (a) due to a material breach by the other Party of any of its obligations or covenants hereunder upon thirty (30) calendar days written notice to the breaching Party of its intent to so terminate if such breaching Party fails to remedy such breach within such thirty (30) calendar days, or if such breach cannot be remedied within such thirty (30) calendar days, only if such breaching Party has not undertaken good faith efforts to remedy such breach, (b) immediately upon the insolvency or filing for bankruptcy by the other Party or (c) upon the mutual written consent of the Parties.

         7.3      Accrued Obligations. In the event that this Agreement is terminated pursuant to Section 7.2 hereof, the duties and obligations of the Parties which have accrued prior to

termination, including without limitation, the obligation to process and deliver quantities of Specialty Allografts and Bone Paste for which orders have been validly issued prior to the effective date of termination and the correlative obligation to pay for such quantities, shall not be released or discharged by such termination.

ARTICLE VIII

INDEMNIFICATION

         8.1      Indemnification by MSD. Subject to RTI’s indemnification obligations pursuant to Section 8.2 herein, MSD shall indemnify and hold RTI, its officers, directors, employees, agents, and affiliates, harmless from any and all losses, damages, liabilities, costs and expenses, including, without limitation, reasonable attorneys fees and court costs, that may result from any demand, claim or litigation 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, or independent representatives, and all other claims, demands, or litigation relating to, resulting from or arising out of (i) the Services provided by MSD, including breach of this Agreement and any representations, warranties, or covenants contained herein, or (ii) any claim of patent infringement with respect to the Intellectual Property Rights licensed by MSD to RTI pursuant to Section 6.2(b).

         8.2      Indemnification by RTI. Subject to MSD’s indemnification obligations pursuant to Section 8.1 herein, RTI shall indemnify and hold MSD, its officers directors, employees, agents, and affiliates harmless from any and all losses, damages, liabilities, costs and expenses, including, without limitation, reasonable attorneys fees and court costs, that may result from any demand, claim or litigation brought by a third party and relating to, resulting from or arising out of (i) the failure of any Specialty Allografts or Bone Paste to comply with the Specialty Allograft Specifications or the Bone Paste Specifications, as the case may be, (ii) a breach by RTI of this Agreement or any warranty, representation or covenant contained herein, (iii) the failure of the packaging related to Specialty Allografts or Bone Paste to comply with the Specialty Allograft Packaging Specifications or the Bone Paste Packaging Specifications, as the case may be, or any other claim, demand or litigation relating to or resulting from Specialty Allografts or Bone Paste, or (iv) any product liability claim for Specialty Allografts or Bone Paste.

         8.3      Indemnification Procedure. If a Party (the “Indemnitee”) receives notice of any claim or the commencement of any action or proceeding with respect to which the other Party (the “Indemnifying Party”) is obligated to provide indemnification pursuant to Article VI hereof, the Indemnitee shall promptly give the Indemnifying Party notice thereof and shall permit the Indemnifying Party to participate in the defense of any such claim, action or proceeding by counsel of the Indemnifying Party’s own choosing and at the Indemnifying Party’s own expense. In addition, upon written request of the Indemnitee, the Indemnifying Party shall assume carriage of the defense of any such claim, action or proceeding. In any event, the Indemnitee and the Indemnifying Party shall cooperate in the compromise of, or defense against, any such asserted liability.

         8.4      Survival of Obligations. The respective obligations of the Parties hereto pursuant to Article VIII shall survive the termination of this Agreement.

ARTICLE IX

MISCELLANEOUS

         9.1      Entire Agreement. This Agreement constitutes the entire agreement of the Parties hereto with respect to the subject matter hereof and supersedes any prior expression of intent or agreement of the Parties with respect thereof.

         9.2      Amendments. This Agreement shall not be modified, altered, or amended except by an agreement in writing signed by duly authorized representatives of each of the Parties hereto.

         9.3      Governing Law; Jurisdiction. This Agreement shall be governed by the laws of the State of Florida (regardless of the laws that might otherwise govern under applicable principles of conflicts of law) as to all matters, including but not limited to matters of validity, construction, effect, performance and remedies. Any action or proceeding arising under or relating to this Agreement shall be brought in the courts of the State of Florida, County of Alachua or State of Tennessee, County of Shelby, or, if it has or can acquire jurisdiction, in the United States District Court for the Middle District of Florida or the Western District of Tennessee, and each Party consents to the jurisdiction of such courts (and the appropriate appellate courts) in any such action or proceeding and waives any objection to venue laid therein.

         9.4      Force Majeure. The Parties shall be excused from performing their obligations under this Agreement if performance is delayed or prevented by any event beyond such Party’s reasonable control and without the fault or negligence of the Party seeking to excuse performance, including, but not limited to, acts of God, fire, terrorism, explosion, weather, plague, war, insurrection, civil strife or riots, provided, however, such performance shall be excused only to the extent of and during such disability and such Party takes reasonable efforts to remove the disability. Any Party seeking to excuse or delay performance under this Section 9.5 shall provide detailed written notice to the other Party of the nature and anticipated duration of the delay.

         9.5      Severability. In the event that any Part of this Agreement shall for any reason be finally adjudged by a court of competent jurisdiction or determined by a governmental body to be invalid or unenforceable, then, unless such part is deemed material by either or both Parties, this Agreement shall continue in effect and such part shall be excised hereof. If either Party determines that such part hereof found to be invalid or unenforceable is material to the operation or performance of this Agreement, then such Party may, by written notice to the other Party, request that the Parties attempt to renegotiate this Agreement to alleviate or eliminate any difficulty caused to such Party by such invalidity or unenforceability.

         9.6      Waiver. No failure or delay on the part of either Party to enforce any provision of this Agreement or to exercise any right granted hereby shall operate as a waiver thereof unless or until the right to enforce any such provision or to exercise any such right has been waived in

writing by such Party. Any waiver of any provision hereof or right hereunder shall be effective only in accordance with its terms and may be restricted in any way. No waiver of any provision hereof or any right hereunder shall constitute a waiver of a continuance or reoccurrence of the failure to perform, except as provided in such waiver.

         9.7      No Third Party Beneficiaries. This Agreement shall be construed to be for the benefit of the Parties hereto only and shall confer no right or benefit upon any other person.

         9.8      Independent Contractors. The Parties each acknowledge that they intend by this Agreement to establish the relationship of independent contractors with regard to the subject matter hereof and do not intend to undertake any relationship of principal and agent or to create any joint venture or partnership between them or their respective successors in interest.

         9.9      Notices. With the exception of the RTI Forecast and the MSD Forecast described in Section 3.4 herein, any notice, report or consent required or permitted by this Agreement to be given or delivered shall be in writing and shall be deemed given or delivered if delivered in person, or sent by courier or expedited delivery service, or sent by registered or certified mail, postage prepaid, return receipt requested, or sent by facsimile (if confirmed), as follows:

         Any such notice, report or consent shall be effective upon delivery if given or delivered in person, or sent by courier or expedited delivery service, or upon receipt if sent by facsimile which is confirmed, or on the third business day following mailing if mailed. Either Party hereto may change its address for purposes hereof by giving the other Party written notice of such change as above provided.

         9.10    Assignment. Except as provided hereafter, neither Party may assign its rights and obligations hereunder without the prior written consent of the other Party and such consent shall not be unreasonably withheld. No permitted assignment hereunder shall be deemed effective until the assignee shall have executed and delivered an instrument in writing reasonably satisfactory in form and substance to the other Party pursuant to which the assignee assumes all of the obligations of the assigning Party hereunder. Notwithstanding any of the prior terms in this Section 9.10, either Party may freely assign this Agreement or any of its rights or obligations hereunder in connection with a sale involving substantially all of the Party’s assets or to a company which is a wholly owned subsidiary of the assigning Party, and MSD may assign this Agreement or any of its rights or obligations hereunder, in whole or in part, to Medtronic, Inc. or to any entity in which Medtronic, Inc. holds a direct or indirect interest of at least fifty percent (50%). RTI may assign this Agreement, or any of its rights or obligations hereunder, in whole or in part, to any entity in which RTI holds a direct or indirect interest of at least 50%.

         9.11    Counterparts. This Agreement may be executed in two or more counterparts, all of which shall be considered one and the same agreement, and shall become effective when signed by each of the Parties hereto.

         9.12    Arbitration. Any dispute or claim arising under or with respect to this Agreement, including the interpretation, performance or non-performance of this Agreement other than the items addressed by Section 6.7, shall be resolved by arbitration in Atlanta, Georgia, in accordance with the Commercial Arbitration Rules then in effect of the American Arbitration Association, modified as follows to include these provisions:

The decision or award of the arbitrators will be final and binding upon the Parties. The arbitrators will have the discretion to impose the cost of the arbitration upon the losing Party or divide it between the Parties on any terms which they deem equitable; provided, however, that

each Party will bear its own legal fees. Any decision or award rendered by the arbitrators may be entered as a judgment or order in any court of competent jurisdiction.

[Signature Page to Follow]

         IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective duly authorized representatives as of the Effective Date.

[SIGNATURE PAGE TO DISTRIBUTION AND LICENSE AGREEMENT]