First Amended International Distribution Agreement

1.1

“ Affiliate ” shall mean an entity that controls, is controlled by, or is under common control with a party. For purposes of this definition, “control” shall mean the possession, directly or indirectly, of a majority of the voting power of such entity (whether through ownership of securities or partnership or other ownership interests, by contract or otherwise); provided that, such entity shall be deemed an Affiliate only so long as such control continues.

1.2

“ Contract Year ” shall mean the one-year period following the Effective Date of this Agreement and each one-year period following each anniversary of the Effective Date of this Agreement.

1.3

“ Effective Data ” of this Agreement shall mean March 8, 2000.

1.4

“Field of Use’ shall mean all uses of processed xenograft and donated allograft bone tissue in and adjoining the human spine.

1.5

“ Permitted Successor ” shall mean any individual, corporation, partnership, joint venture, association, trust, or any other entity or organization of any kind or character that assumes the obligations of a party under this Agreement as permitted according to the terms of this Agreement.

1.6

“ Products ” shall mean the xenograft and allograft bone tissue products manufactured by Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen and listed on Schedule A attached hereto. The parties shall mutually agree on the addition of Products to Schedule A.

1.7

“ RTI Agreement ” shall mean the Shaft Recovery and Service Reimbursement Agreement between Tutogen and Regeneration Technologies Inc. (“RTI”), as successor to the University of Florida Tissue Bank, effective as of 29 September 1998, including an amendment thereto dated 28 June 1999, pursuant to which Tutogen supplies certain human donor bone tissue to RTI, which RTI processes for use in spinal applications.

1.8

“ Sub-Territory ” shall mean one of the following geographic regions or countries comprising in part the Territory: [***]

1.9

“ Territory ” shall mean the entire world, exclusive of the United States, its territories and possessions.

1.10

“ Third Party ” shall mean a person or entity other than Tutogen, any Tutogen Affiliate, Sulzer, any Sulzer Affiliate or any officer, director, or employee of Tutogen, any Tutogen Affiliate, Sulzer, or any Sulzer Affiliate.

2.1

Exclusive Distribution. Tutogen hereby appoints Sulzer, and Sulzer hereby accepts the appointment during the term of this Agreement as the exclusive distributor of the Products in the Territory for the Field of Use.

2.2

Consideration . In consideration of the transfer of distribution rights in the Products for the Field of Use from Tutogen’s existing international distributors to Sulzer, Sulzer agrees to pay Tutogen US[***] as follows: US[***] upon execution of this Agreement and, provided that Tutogen has commenced delivery of Products to Sulzer in response to Sulzer’s purchase orders, US[***] on October 1, 2000.

3.1

Marketing Efforts. Sulzer agrees to use commercially reasonable efforts to market and sell the Products throughout the Territory for the Field of Use. Sulzer shall have no right or obligation to market the Products for any use other than the Field of Use.

3.2

Support Services . Sulzer agrees to use commercially reasonable efforts to provide usual and customary support services to the surgeon-customer for the Products.

3.3

Instruments . Sulzer shall develop appropriate surgical instruments, as needed, to assist the surgeon in implanting each of the Products. Sulzer shall also develop a standard surgical procedures for implanting the Products. Tutogen shall assist Sulzer, as necessary, in developing the instruments and surgical procedures.

3.4

Forecasting . Commencing with the third calendar quarter of 2000 and continuing quarterly thereafter, Sulzer shall provide Tutogen, no later than 15 days prior to each calendar quarter, with a rolling monthly forecast of sales of the Products for the succeeding 12 months. Sulzer’s forecasts shall specify the anticipated sales by Product, by Sub-Territory, and by month. Sulzer Shall incur no liability to Tutogen in the event that actual sales of the Products differ from Sulzer’s forecasts.

3.5

Minimum Annual Product Sales. As consideration tor the exclusive right to sell the Products in the Territory, commencing with the ninth month of the second Contract Year and continuing with each Contract Year thereafter, Sulzer and Tutogen will establish certain minimum annual goals for sales of the Products during the Contract Year as a means of ensuring that Sulzer is using reasonable efforts to sell the Products in each sub-territory within the Territory. Sulzer and Tutogen agree to confer and mutually agree upon the minimum annual sales goals in each Sub-Territory for each Contract Year, which shall be recorded on Schedule 8, during the three-month period commencing with the sixth month of the second Contract Year. In the event that the sales for the Products in a Sub-Territory in any Contract Year are less than the goals established under Schedule B, provided that Sulzer’s failure to meet the minimum goals is not a result of a Force Majeure as described in Section 9.2, Tutogen shall have the right, in its sole discretion, to undertake for itself or to employ the services of an additional third party, on. an exclusive or a non-exclusive basis, to sell the Product in that Sub-Territory only and for the Field of Use. Tutogen shall exercise its option, if at all, by giving Sulzer written notice of its election no later than 60 days following the end of the Contract Year in question.

3.6

Sales Personnel. Sulzer shall use reasonable efforts to train its sales personnel in techniques for proper use and implantation of the Processed Tissues.

4.1

Product Supply. Tutogen agrees to use its best efforts to acquire xenograft and donor allograft bone tissue, process the tissue using the Tutoplast® process according to Sulzer’s forecasts for demand for Products, manufacture the Products, and sell the Products to Sulzer pursuant to purchase orders issued by Sulzer at the transfer prices to which the parties shall agree and list in Schedule C attached hereto. Sulzer shall pay the transfer price to Tutogen within 45 days from the date of Tutogen’s invoice. In no event shall Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen during the term of this Agreement supply allograft bone tissue, whether processed or unprocessed, to a Third Party for further distribution in the Territory for the Field of Use; provided that, Tutogen shall be permitted to deliver unprocessed allograft bone tissue

pursuant to the RTI Agreement so long as Tutogen’s supply of allograft bone tissue exceeds the demand for Products under this Agreement.

4.2

Termination of Distribution Contracts. Tutogen shall terminate the right of its existing distributors, excluding [***] to distribute the Products for the Field of Use as soon as possible after the Effective Date according to the terms of existing distribution agreements, if any, Schedule D sets forth the dates by which termination of Tutogen’s existing distributors, excluding [***], shall be effective. Sulzer shall have an immediate nonexclusive right to sell the Products for the Field of Use in all countries listed in Schedule D, pending termination of existing distribution agreements, to the extent permissible under existing distribution agreements. The parties shall consult regarding Tutogen’s distributors in [***], which together represent a significant portion of Tutogen’s current revenue from sales of the Products, and Tutogen shall use its best efforts to accommodate Sulzer’s desired distribution in those countries and terminate Tutogen’s existing distributors, if so determined by Sulzer after consultation. Tutogen agrees to insure that any substantial inventory of the Products held by the distributors at the time of their termination is either returned to Tutogen or transferred to Sulzer.

5.1

Import Compliance . Tutogen agrees to comply with and maintain compliance with all governmental rules, regulations, statutes, and other laws of any kind necessary to acquire xenograft and donor allograft tissue, manufacture the Products, and deliver the Products to Sulzer within the Territory.

5.2

Regulatory Responsibilities . The parties understand that as of the Effective Date of this Agreement, the Products are regulated by governmental authorities in most of the countries in the Territory, and Tutogen has obtained approvals from such regulatory authorities to sell many of the Products in such countries. As to Products for which Tutogen has not obtained regulatory approval in a particular country as of the Effective Date, or Products that first become regulated in a particular country after the Effective Date, Sulzer, at its own cost, shall be responsible for obtaining regulatory approval for such Product in such country, as an agent for Tutogen; provided that, Sulzer may elect upon written inquiry from Tutogen to remove such Product from Schedule A (for purposes only of the particular country) rather than to seek regulatory approval therefor. In the event that Sulzer elects to remove a regulated Product from Schedule A (as to a particular country), Tutogen shall have the right to seek regulatory approval therefor at its own expense and to sell such Product in the particular country without obligation to Sulzer under this Agreement.

5.4

Clinical Trial Costs . Tutogen agrees to bear all costs related to pre-clinical trials in support of Sulzer’s efforts to obtain regulatory approval for a Product, Sulzer agrees to bear all costs related to clinical trials and filing for, obtaining, and maintaining the regulatory approval.

5.5

Ownership of Approvals . Tutogen shall be the record owner of all regulatory approvals to sell Products in the Territory and for the Field of Use.

6.1

License Grant . Tutogen grants Sulzer a nonexclusive license under Tutogen’s trademarks, Tutoplast®, Tutobone®, and Spline Line®, to use the trademarks solely in connection with the Products and the marketing thereof within the Territory for the Field of Use.

6.2

Publication Approvals . Sulzer shall provide Tutogen with samples of all marketing and other printed materials utilizing a trademark of Tutogen in advance of publication of the same. Tutogen shall be deemed to have approved such samples for actual use unless it objects in writing within 10 business days following Sulzer’s delivery of same.

6.3

Labeling . Tutogen agrees to include the trademarks of Sulzer on Product labels in a manner mutually agreeable to the parties.

7.1

Term. This Agreement shall be effective on the Effective Date and shall remain in effect for an initial term of 10 Contract Years, unless sooner terminated according to the terms set forth in this Agreement. At the end of the tenth Contract Year and each succeeding anniversary of the Effective Date, this Agreement shall renew automatically for a successive one-year term unless one party gives the other party written notice of termination at least 12 months in advance of the renewal date.

7.2

Material Breach . If either party is in material breach of any obligation in this Agreement, the non-breaching party may give written notice to the breaching party of its intention to terminate this Agreement, and this Agreement will terminate 60 days after the giving of such notice unless during the 60-day period (i) the breach has been cured, or (ii) if a breach is incapable of cura within the 60-day period, the breaching party has commenced action which is calculated to result in a cure of the breach to the reasonable satisfaction of the non-breaching party within 120 days after the giving of notice. If at the end of the 60-day or 120-day period following a notice of termination the parties disagree as to whether the Agreement has terminated as provided in this paragraph, the parties shall continue to perform under this Agreement until an arbitration tribunal constituted as provided in this Agreement has ruled on the matter.

7.3

Insolvency. Either party may terminate this Agreement immediately on delivery of written notice to the other party (i) upon the institution by or against such other party of insolvency, receivership, or bankruptcy proceedings or any other proceedings for the settlement of such party’s debts; provided that, with respect to involuntary proceedings, such proceedings are not dismissed within 120 days, (ii) upon such other party’s making an assignment for the benefit of creditors, or (iii) upon such other party’s dissolution or ceasing to do business.

7.4

Termination Without Cause . Sulzer shall have the right to terminate this Agreement with or without cause at any time on or after January 15, 2002 provided that Sulzer shall have given Tutogen written notice of termination at

least 12 months in advance of the termination date. Sulzer’s notice of termination, if any, shall not relieve Sulzer of the obligation thereafter to make the payments set forth in Section 2.2 above, and Sulzer’s termination under this Section 7.4 does not give Sulzer any right to recover payments made prior to the effective date of termination. In the event that Sulzer shall terminate this Agreement without cause as provided in this Section 7.4, neither Sulzer nor any Affiliate of Sulzer shall for a period of one year following the effective date of termination enter into an agreement, either directly or indirectly, to own, operate, advise, or have any interest in any business relating to the Products in the Territory for the Field of Use.

7.5

Reimbursement of Regulatory Expenses . In the event that the Agreement terminates (i) by reason of Tutogen’s notice of termination under Section 7.1, or (ii) by reason of Tutogen’s material breach under Section 7.2, then Tutogen shall be obligated to reimburse Sulzer’s out-of-pocket expenditures, or a portion thereof as determined in this Section 7.5, in obtaining or attempting to obtain regulatory approval for Products under Section 5.2, including the out-of-pocket cost of all pre-clinical, if any, and clinical trials and other expenses directly related to the regulatory approval process (the “Clinical Expenses”). For each Product as to which Sulzer has obtained or attempted to obtain a regulatory approval, Tutogen shall be obligated to reimburse an amount determined by multiplying the Clinical Expenses for that Product by the Reimbursement Ratio. The “Reimbursement Ratio” is

[***]

[***]

[***]

[***] The reimbursement amount shall be paid in three equal annual installments due on the date of termination, one year after termination, and two years after termination, without interest.

8.1

Tutogen . Tutogen represents and warrants to Sulzer, as follows:

does not infringe or violate any valid patent, trademark, or copyright or any other intellectual property rights of any third party. Tutogen has disclosed to Sulzer all patents and other intellectual property rights which, to Tutogen’s knowledge, may have a material effect on Sulzer’s ability to market the Products.

8.1.4

Tutogen has not received notice that the manufacture, use, or sale of the Products violates any patent rights or any other intellectual property right or constitutes a misappropriation or misuse of trade secrets or proprietary information.

8.1.5

Tutogen shall promptly notify Sulzer of any claim of infringement or misappropriation relating to the Products.

8.1.6

To the best of Tutogen’s knowledge and belief, Tutogen’s procurement of donor allograft tissue complies fully with all laws of the country in which the donor tissue is collected, including all national, regional, and local laws.

8.1.7

To the best of Tutogen’s knowledge and belief, Tutogen possesses all governmental and other approvals required for the collection and processing of donor allograft tissue, and Tutogen shall use commercially reasonable efforts to maintain all such approvals throughout the term of this Agreement.

8.1.8

For a period of 12 months from the date of Tutogen’s delivery to Sulzer, each Product shall be free from defects in material, manufacturing, and workmanship, including, but not limited to, disease, excluding defects caused by the abuse, misuse, neglect, or by improper testing, handling, storage, or use by a party other than Tutogen.

8.1.9

During the term of this Agreement, except as required by law or by a pre-existing contractual obligation of Tutogen, Tutogen will not, directly or through an Affiliate, assign, sell, transfer, convey, or otherwise alienate in whole or in part any right to receive donated allograft bone tissue without the prior written agreement of Sulzer.

8.4

Sulzer. Sulzer represents and warrants to Tutogen, as follows:

8.5

Indemnity by Tutogen.

8.6

Indemnity by Sulzer.

attention; (b) allows Sulzer to control the defense or settlement of such Claim; (c) does not enter into any settlement or compromise of such Claim without the express authorization of Sulzer; and (d) reasonably cooperates with Sulzer in the defense of such Claim, subject to Sulzer’s payment of all reasonable out-of-pocket expenses associated with such cooperation by Tutogen. Tutogen shall have the right to participate in a non-controlling fashion in such legal proceeding at its sole expense.

8.6.2

No undertaking of Sulzer under this section shall extend to any such alleged Infringement or violation to the extent that it: (a) arises from adherence to design modifications, specifications, drawings, or written instructions which Sulzer is directed by Tutogen to follow, but only if such alleged infringement or violation does not reside in corresponding Product of Sulzer’s design or selection; or (b) arises from adherence to instructions to apply Tutogen’s trademark, trade name, or other company identification; or (c) resides in a Product which is not of Sulzer’s origin and which is furnished by Tutogen to Sulzer for use under this Agreement; or (d) relates to use of Products or other items provided by Sulzer in combination with other Products or other items, furnished either by Sulzer or others, which combination was not installed, recommended or otherwise approved by Sulzer. In the foregoing cases numbered (a) through (d), Tutogen will defend and hold Sulzer harmless, subject to the same terms and conditions and exceptions stated above with respect to Sulzer’s rights and obligations under this clause.

9.1.1

This Agreement, together with the First Amended Umbrella Agreement, the First Amended Option Agreement, the First Amended U.S. Service Agreement, and the First Amended Processed Tissue Development and

License Agreement, all between the parties or their Affiliates, embodies the final, complete, and exclusive understanding between the parties and supersedes all previous agreements, understandings, or arrangements between the parties with respect to its subject matter, including the International Distribution Agreement dated March 8, 2000.

9.1.2

The International Distribution Agreement dated March 8, 2000 is hereby cancelled entirely and superseded by this Agreement.

9.1.3

No modification or waiver of any terms or conditions hereof, nor any representations or warranties will be of any force or effect unless such modification or waiver is in writing and signed by an authorized officer of the party against whom enforcement is sought.

9.4

Governing Law . Recognizing that the laws within different international jurisdictions vary in their content and effect with respect to similar subject matter, and that the parties desire uniformity and predictability in interpretation and enforcement of this Agreement and related agreements with International scope made contemporaneously by the parties and their Affiliates, the parties have agreed to the following provisions regarding applicable law to govern this Agreement. All matters affecting the interpretation, form, validity, and performance of this Agreement shall be decided under the laws of Switzerland (without application of the United Nations Convention on the International Sale of Goods).

9.5

Partial-Invalidity . In the event that any provision of this Agreement will be unenforceable or invalid under any applicable law or be so held by applicable court decision, such unenforceability or invalidity will not render this Agreement unenforceable or invalid as a whole, and, in such event, such provision will be changed and interpreted so as best to accomplish the objectives of such unenforceable or invalid provision within the limits of applicable law or applicable court decisions.

9.6

Independent Contractors . Each party will act as an Independent contractor under the terms of this Agreement. Except as otherwise provided in this Agreement, neither party is, nor will it be deemed to be, an employee, agent, partner, co-venturer, or legal representative of the other for any purpose.

9.7

Nonassignability . Neither this Agreement nor any of the rights, interests, duties, or obligations under this Agreement shall be assigned or delegated, in whole or in part, by operation of law or otherwise by any party without the prior written consent of the other party, except that either party may assign this Agreement to an Affiliate of such party; provided that, in no event shall a party assign to an Affiliate less than the entirety of its rights and obligations under this Agreement. Any assignment made in violation of this Section 9.7 will be void and of no effect. Subject to this Section 9.7, this Agreement shall be binding upon, inure

to the benefit of, and be enforceable by and against, the parties and their Permitted Successors.

9.8

Compliance With Laws . Notwithstanding other provisions in this Agreement regarding a failure to comply with laws, in performing this Agreement, each Party shall comply with all laws and government regulations applicable in a particular country at all times.

9.9

Arbitration .

9.10

Confidentiality . The parties acknowledge that by reason of their relationship hereunder, each has had and will continue to have access to certain information and materials concerning the other’s business, plans, customers, technology, and/or products that is considered by a party to be confidential (“Confidential Information”) and of substantial value to that party, which value would be impaired if such information were disclosed to third parties. To the extent that such information is considered confidential, the disclosing party will so indicate to the receiving party, in the case of information in documentary or other tangible form, by labeling it conspicuously as “CONFIDENTIAL” (or words of similar import) and in the case of information conveyed verbally, by identifying same in writing within ten days after the first verbal disclosure. Each party agrees that it will not use in any way other than as expressly authorized or contemplated under this Agreement, nor disclose to any third party, any such Confidential Information revealed to it by the other party, and will take commercially reasonable precautions (and will cause its Affiliates to take commercially reasonable precautions) to protect the confidentiality of such information and with no less restrictive precautions than it takes to protect its own confidential Information. Each party will disclose Confidential Information only to those of its employees who have a need to know such information. If Confidential information is required to be disclosed in response to an order by a court or other government body, or if otherwise required to be disclosed by law, or if necessary to establish the rights of a party under this Agreement, the receiving party shall use commercially reasonable efforts to provide the disclosing party with advance notice of such required disclosure to give the

disclosing party sufficient time to seek a protective order or other protective measures, if any are available, for such Confidential Information. “Confidential Information” does not include information, materials, technical data or know-how which: (i) is rightfully in the possession of the receiving party at the time of disclosure as shown by the receiving party’s files and records immediately prior to the time of disclosure; (ii) prior to or after the time of disclosure becomes part of the public knowledge or literature, not as a result of any inaction or action of the receiving party; (iii) is independently developed by a party without the use of any Confidential Information of the other parties; (iv) is obtained from any third party who is authorized to disclose such data and information without obligation of confidentiality, or (v) is approved for release by the disclosing party. This Section 9.10 shall survive termination of this Agreement for a period of two years.

9.11

Public Relations And Announcements . The parties shall agree upon and issue a press release upon the signing of this Agreement including a summary of the relationship established under this Agreement. No party shall issue a press release or any other published statement that refers to another party, its Affiliates or the other party’s products without first obtaining the agreement of such other party as to the form and content of the statement, which approval shall be timely and not unreasonably withheld.

Tutogen Medical GmbH

Sulzer Spine-Tech, Inc.

/s/ Manfred Krüger

By:

/s/ P. Richard Lunsford

Manfred Krüger

P. Richard Lunsford

Managing Director

President

Date: 29 September, 2000

Date: 29 Sept 2000

1.1

“ Affiliate ” shall mean an entity that controls, is controlled by, or is under common control with a party. For purposes of this definition, “control” shall mean the possession, directly or indirectly, of a majority of the voting power of such entity (whether through ownership of securities or partnership or other ownership interests, by contract or otherwise); provided that, such entity shall be deemed an Affiliate only so long as such control continues.

1.2

“ Allograft ” shall mean donated human cells and/or tissue intended for transplantation into another human.

1.3

“ Binding Annual Minimum Forecast ” shall have the meaning set forth in Section 3.9.

1.4

“ Binding Order ” shall have the meaning set forth in Section 3.6.

1.5

“ Biologic Implants ” shall mean Xenograft and Allograft bone tissue processed and manufactured by Tutogen or an Affiliate of Tutogen or a Permitted Successor of Tutogen, as listed in Exhibit A attached hereto. The parties shall mutually agree as to the addition of processed tissues to Exhibit A.