DEVELOPMENT AGREEMENT

and

AMENDMENT TO UNITED STATES
DISTRIBUTION AGREEMENT

        DEVELOPMENT AGREEMENT and AMENDMENT TO UNITED STATES DISTRIBUTION AGREEMENT (this "Agreement"), dated September 30, 2002 (the "Agreement Date"), between GENZYME BIOSURGERY CORPORATION, a corporation duly organized and existing under the laws of the Commonwealth of Massachusetts and a subsidiary of GENZYME CORPORATION, (hereinafter "Genzyme"), and INAMED CORPORATION ("Inamed"), a corporation duly organized and existing under the laws of the State of Delaware.

        WHEREAS, prior to the date hereof Genzyme has been engaged in the development and manufacture of the Agreement Products (as hereinafter defined);

        WHEREAS, Genzyme, as assignee of and successor in interest to Biomatrix, Inc., and Inamed, as assignee of and successor in interest to Collagen Corporation, on June 14, 1996, entered into a United States Distribution Agreement, as subsequently amended (the "U.S. Agreement"), pursuant to which Genzyme granted to Inamed exclusive promotion, marketing, sale and distribution rights for Hylaform® in the United States (the "Distribution Rights") on the terms and subject to the conditions set forth therein;

        WHEREAS, under the U.S. Agreement Inamed agreed to pay Genzyme [*] upon the receipt of FDA Approval (as hereafter defined) for Hylaform in connection with and as part of the consideration for the grant by Genzyme of the Distribution Rights to Inamed;

        WHEREAS, Genzyme and Inamed executed a Non-Binding Letter of Intent, dated October 22, 2001, and subsequent correspondence related to such letter (together, the "Letter of Intent"), relating to development work on the Agreement Products;

        WHEREAS, Genzyme and Inamed have agreed that, as anticipated by the Letter of Intent, but in accordance with new understandings relating to the development work on the Agreement Products, Genzyme and Inamed shall develop the Agreement Products cooperatively as described below; and

        WHEREAS, in order to clarify certain provisions of the U.S. Agreement relating to payments contemplated thereunder, Genzyme and Inamed have agreed to amend certain provisions of the U. S. Agreement.

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        NOW, THEREFORE, in consideration of the premises and of the mutual covenants of the parties hereto, it is hereby agreed as follows:

1.    Definitions and Interpretation

        1.1  In addition to the defined terms that are defined elsewhere in this Agreement, the following words and expressions shall have the following meanings:

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        1.2  In this Agreement, unless the context otherwise requires:

2.    Steering Committee and Development Coordinators.

        2.1  Committee Formation and Operation. To facilitate the performance of the parties under this Agreement, the parties shall establish a steering committee (the "Committee"). The Committee shall be comprised of not less than four (4) voting representatives, with two (2) members designated by each party. The initial members of the Committee are identified on Schedule 2.1 attached hereto. The size of the Committee may be changed from time to time by mutual agreement of the parties so long as the

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number of representatives designated by each party is equal. Upon the request of either party, the Committee may allow persons other than its voting members to attend and participate on a non-voting basis at meetings of the Committee. The Committee will be administered by a chairman, who shall serve for period of one year and shall be one of the members of the Committee. The chairman shall be appointed by Inamed. The Committee shall meet either in person or by teleconference, and will meet weekly during the Transition Period, monthly until the Hylaform PMA is initially submitted and on a quarterly basis thereafter. The chairman shall be responsible for the preparation of written minutes of each meeting, which minutes shall be subject to Committee approval. Decisions of the Committee shall be made by consensus (a majority of the members of the Committee). If, after a period of seven (7) days, a matter is still not resolved, it shall be resolved in accordance with Section 15(b).

        2.2.  Committee Duties. The Committee shall be responsible for overseeing Development Work and for ensuring that any and all obstacles or issues that arise are resolved promptly and efficiently. The Committee shall coordinate the development of the Agreement Products, including specifically the performance by each party of their respective Development Work obligations. Except as set forth in Section 3.4(a) hereof, the Committee shall not have the authority to change the responsibilities of either party under this Agreement, or to otherwise amend this Agreement.

        2.3  Development Work Managers. To implement the decisions of the Committee, and to assure clarity of responsibility and accountability for the performance of their respective obligations under this Agreement, upon the commencement of Development Work for any Agreement Product the parties agree to designate three employees, one of whom shall be responsible for coordinating generally each party's performance of its duties under this Agreement (the "Program Manager"), one of whom shall be responsible for coordinating the Clinical Activities (the "Clinical Manager"), and one of whom shall be responsible for coordinating the Regulatory Activities (the "Regulatory Manager") of each party. Any Program Manager, Clinical Manager and Regulatory Manager may be a member of the Committee, and may be changed at any time by the party responsible for their appointment. Each party shall consult with the other party regarding the selection or change of their respective Managers, and shall attempt in making such selection or change to accommodate the interests and preferences of the other party. The Managers for each party shall communicate regularly with each other to furnish information, to coordinate activities and to consider issues relevant to the successful completion of the Development Work for the relevant Agreement Product.

3.    Hylaform Development.

        3.1  Development Plan. The parties acknowledge that Genzyme has prepared and delivered to Inamed a number of planning documents, budgets and materials that collectively constitute a Development Plan for Hylaform. The parties acknowledge that Inamed intends to develop a revised Development Plan during the Transition Period to provide for an accelerated PMA submission timeline. The revised Development Plan shall be considered by the parties and implemented in accordance with the terms of this Agreement.

        3.2  Development Work during the Transition Period. During the Transition Period, Genzyme will continue to perform Development Work, including both Clinical Activities and Regulatory Activities, in a diligent manner. During the Transition Period, both parties agree to use reasonable commercial efforts to mitigate any negative impact on pending Clinical Activities from arising as a direct result of activities performed or not performed during the Transition Period.

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        3.3  Development Costs prior to the Cut-Off Date. Each of the parties agrees that it shall be responsible for all Development Costs incurred by it in performing Hylaform Development Work prior to the Cut-Off Date. Genzyme shall be responsible for all third party Development Costs relating to services rendered prior to the Cut-Off Date, and Inamed shall be responsible for all third party Development Costs relating to services rendered after the Cut-Off Date.

        3.4  Hylaform Development after the Transition Period.

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        3.5  Transition Plan. The parties agree to work diligently and in good faith to complete a transition of the Hylaform Clinical Activities to Inamed prior to the Transition Completion Date in accordance with a transition plan established by the Committee. Certain critical actions necessary to accomplish the transition and the anticipated completion dates for such actions are set forth on Exhibit B attached hereto. Genzyme and Inamed shall each use reasonable commercial efforts to prevent this transition from causing a negative impact or delay on the Hylaform Development Work.

        3.6  Ownership Rights and Inamed Authority after the Transition.

        3.7  Hylaform Development Costs after the Cut-Off Date. After the Cut-Off Date, the parties shall assume responsibility for Hylaform Development Costs as follows:

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        3.8  Hylaform Payments. In lieu of and in substitution for any payments that Inamed has made or may be obligated to make under Section 7.1(b) of the U.S. Agreement, Inamed shall make payments to Genzyme totaling [*], subject to certain conditions, as described below. Genzyme and Inamed confirm that any one or more payments made pursuant to this Section 3.8 represent a payment in consideration of the Distribution Rights granted by Genzyme to Inamed under the U.S. Agreement. Except in connection with a Fee Payment Default (as defined in the U.S. Agreement), the failure by Genzyme to receive all or any portion of these payments shall not invalidate, rescind, diminish or otherwise effect the grant of the Distribution Rights by Genzyme to Inamed.

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        3.9  Subcontracting of Clinical Activities to Genzyme. The parties acknowledge that in performing the Clinical Activities, Inamed may propose that Genzyme, as a vendor to Inamed, perform certain Clinical Activities. Genzyme, at its option, may elect to respond to such a proposal. The terms of any arrangement that may arise from such discussions shall be mutually acceptable to the parties and shall be memorialized in an amendment to this Agreement or in a separate instrument.

4.    Follow-On Products

        4.1  Inamed Proposal and Committee Election. Inamed may notify the Committee in writing of its intention to pursue Development Work for one or more Follow-On Products. This notification shall be accompanied by a Development Plan that includes, at a minimum, a description of the proposed Clinical and Regulatory Activities, a projected budget for the contemplated Development Work and a timeline for achieving FDA Approval. Genzyme may take up to fourteen (14) days to provide

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comments regarding the Development Plan, which will be received and considered in good faith by Genzyme. Provided that the allocation of Development Work contemplated by the Development Plan is in accordance with Section 4.4 hereof, and provided further that no Genzyme or Inamed SOPs or FDA regulations are violated, and the Development Plan is consistent with Good Clinical Practices ("GCPs"), the Committee shall be obligated to adopt the Development Plan and Inamed and Genzyme shall proceed with the proposal (thereupon, a "Designated Follow-On Product") and initiate Development Work.

        4.2  Genzyme Proposal and Committee Election. Genzyme may notify the Committee in writing of its intention to pursue Development Work for one or more Follow-On Products. This notification shall be accompanied by a Development Plan that includes, at a minimum, a description of the proposed Clinical and Regulatory Activities, a projected budget for the contemplated Development Work and a timeline for achieving FDA Approval. Inamed may take up to fourteen (14) days to provide comments regarding the Development Plan, which will be received and considered in good faith by Genzyme. If Inamed elects not to participate with Genzyme in the development of the Follow-On Product pursuant to the proposed Development Plan, Genzyme, at its election, may proceed with the Development Plan, and any distribution rights that Inamed may have under the U.S. Agreement for the relevant Follow-On Product shall terminate upon the submission of a Filing seeking FDA Approval of such product.

        4.3  Funding for a Designated Follow-On Product. Inamed shall fund all Development Costs for each Designated Follow-On Product incurred by Genzyme under the relevant Development Plan; provided, that if Inamed elects not to participate with Genzyme in the development of Follow-On Product pursuant to Section 4.2, Inamed shall not be obligated to fund any Development Costs for the relevant Follow-On Product. Inamed shall have the right to perform customary financial audits of Development Costs incurred by Genzyme in connection with a Follow-On Product upon reasonable prior notice to Genzyme.

        4.4  Development Work for a Designated Follow-On Product. Development Work for each Designated Follow-On Product shall be allocated between the parties in a manner substantially similar to the allocation of Development Work for Hylaform. Inamed shall be primarily responsible for Clinical Activities and Genzyme shall be primarily responsible for Regulatory Activities, as more specifically described in Exhibit A and subject to the rights reserved for each party in Exhibit A. If required or deemed necessary for each Designated Follow-On Product, a new exhibit may be prepared with the approval of both parties and attached to this Agreement without amendment hereof that will be based upon Exhibit A and shall be modified or supplemented to reflect the specific elements, and the allocation of specific responsibility between the parties, of the Development Work relevant to the Designated Follow-on Product not currently reflected in Exhibit A.

        4.5  Hylaform Plus Development Work. The parties acknowledge that Inamed intends to pursue Hylaform Plus as the first Designated Follow-On Product and is currently developing a Development Plan for submission to the Committee as described in Section 4.1.

5.    Additional Genzyme Support

        5.1  Product Supply. Genzyme will provide sufficient quantities of Hylaform and any Follow-On Product necessary to complete the Development Work for Hylaform and for the Development Work of any Follow-On Product. The cost of such quantities of Hylaform shall be absorbed by Genzyme.

        5.2  Advisory Assistance. Genzyme shall provide without cost to Inamed reasonable amounts of clinical, medical, market and other technical assistance as Inamed may reasonably request to facilitate Inamed's performance of the Clinical Activities and other duties required of Inamed under this Agreement.

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6.    Term

        6.1  Effective Date. This Agreement shall be considered binding and enforceable and shall be deemed in effect as of the Agreement Date.

        6.2  Term. This Agreement shall remain in effect until the later of (i) the earlier of (A) twelve (12) months after the date of the confirmation of receipt from the FDA of a completed, PMA or 510K application for Hylaform, and (B) six (6) months after the date FDA Approval is granted for Hylaform, or (ii) if Development Work is initiated for any Follow-On Product, twelve (12) months after the date of the initial filing of the PMA or 510K for the last Follow-on Product for which Development Work is being furnished.

.      Confidentiality and Public Announcement.

        7.1  Confidentiality. All information acquired by either party (the "Recipient") from the other party or any of its Affiliates (the "Discloser") during the term of this Agreement or prior to the Effective Date, relating directly or indirectly to the present or potential business, operations, corporate, technical or financial situation of the Discloser, or to manufacturing know-how, patents, data, test results, techniques, processes, procedures, raw materials, dealer, supplier and customer lists, pre-clinical and clinical protocols and regulatory documents or any improvements thereof of the Discloser ("Confidential Information") is confidential, and shall be held in trust by the Recipient for the exclusive benefit of the Discloser. Unless otherwise agreed to in writing by the Discloser, the Recipient shall not at any time, either during or subsequent to the term of this Agreement, use for itself (other than in accordance with the terms of this Agreement) or any other Person, or disclose or divulge to any Person, other than to those of its employees and advisors and Affiliates who require the same for the purposes hereof and who are bound by the same obligations of confidentiality, non-disclosure and non-use as set forth herein, any Confidential Information or any other confidential or proprietary information of the Discloser of which the Recipient may acquire knowledge; provided, however, that the confidentiality, non-disclosure and non-use provisions contained in this Section 7.1 shall not apply to any information or data to the extent that the Recipient:

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Confidential Information shall be immediately returned to the Discloser upon termination of this Agreement, along with any copies, reproductions, digests, abstracts or the like of all or any part thereof in the Recipient's possession or under the Recipient's control, and upon such return any computer entries or the like relating thereto shall, to the extent legally permissible, be destroyed. Such return (and destruction) will not affect the Recipient's obligations hereunder which shall survive indefinitely.

        7.2  Public Announcement. Except as shall be necessary for governmental notification purposes or to comply with applicable laws and regulations, and except as otherwise agreed to by the parties hereto in writing, the parties agree to keep the existence of this Agreement, and the transactions contemplated hereby, strictly confidential. In the event that a party must file this document or otherwise disclose any of its subject matter pursuant to public filing requirements, such party shall seek confidential treatment of those portions of the Agreement as the parties shall mutually agree upon. Any public announcements regarding Development Work, this Agreement or the transactions contemplated herein shall also be approved by the Committee and agreed upon in writing by the parties prior to any release thereof.

8.    Representations of Genzyme. Genzyme represents, warrants and covenants as follows:

        8.1  It is a corporation duly organized and validly existing under the laws of the Commonwealth of Massachusetts with the full power to conduct its affairs as currently conducted and contemplated hereunder. All necessary action has been taken to enable it to execute and deliver this Agreement and perform its obligations hereunder.

        8.2  This Agreement is a valid and binding obligation of Genzyme enforceable in accordance with its terms. Genzyme has the unencumbered right to enter into this Agreement and to fulfill its duties hereunder. It is not and will not become a party to any agreement in conflict herewith. Accordingly, the performance of Genzyme's obligations hereunder will not constitute a breach of any existing contractual or other arrangements between the Genzyme and any Affiliated or non-Affiliated third party, nor shall the performance by Genzyme of its obligations hereunder infringe the rights of any Affiliated or non-Affiliated third party.

        8.3  No approval, consent, order, authorization or license by, giving notice to or taking any other action with respect to, any governmental or regulatory authority is required in connection with the execution and delivery of this Agreement by Genzyme and the performance by Genzyme of its obligations hereunder.

        8.4  The vendor agreements, investigator agreements and independent panel review agreements identified in Exhibit B constitute to the knowledge of Genzyme all of the material Clinical Agreements as of the Agreement Date.

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9.    Representations of Inamed. Inamed represents, warrants and covenants as follows:

        9.1  It is a corporation duly organized and validly existing under the laws of Delaware with full power to conduct its affairs as currently conducted and contemplated hereunder. All necessary action has been taken to enable it to execute and deliver this Agreement and perform its obligations hereunder.

        9.2  This Agreement is Inamed's valid and binding obligation enforceable in accordance with its terms. Inamed has the unencumbered right to enter into this Agreement and to fulfill its obligations hereunder. It is not and will not become a party to any agreement in conflict herewith. Accordingly, the performance of Inamed's obligations hereunder will not constitute a breach of any existing contractual or other arrangements between Inamed and any Affiliated or non-Affiliated third party, nor shall it infringe the rights of any Affiliated or non-Affiliated third party.

        9.3  No approval, consent, order, authorization or license by, giving notice to or taking any other action with respect to any governmental or regulatory authority is required in connection with the execution and delivery of this Agreement by Inamed and the performance by Inamed of its obligations hereunder.

10.  Termination and Effects of Termination

        10.1 Expiration and Termination.

        10.2 Rights upon Expiration or Termination.

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11.  Indemnification and Limitation of Liability.

        11.1 Indemnification. Each party shall indemnify, defend and hold harmless the other party and its officers, employees and agents and their respective successors, heirs and assigns (the "Indemnitees") against any liability, damage, loss or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon the Indemnitees arising from the activities undertaken by such party under this Agreement; provided, however, that such indemnification shall not apply to any liability, damage, loss or expense to the extent attributable to (a) the negligence or reckless or intentional misconduct of the Indemnitees or (b) the settlement of a claim, suit, action or demand by Indemnitees without the prior written approval of such party.

        11.2 Limitation on Liability for Consequential Damages. It is agreed by the parties that no party shall have a right to or shall claim special, indirect or consequential damages (including lost profits) for breach of this Agreement by the other party; provided, that the limitation on liability shall not apply to liability arising from the other party's intentional misconduct hereunder.

12.
Infringement. Each of the Inamed and Genzyme will promptly notify the other party in writing of any infringement of a Patent or Trademark or unauthorized disclosure or use of any Confidential Information, of which it becomes aware. Genzyme shall have the exclusive right at its own cost to take all legal action it deems necessary or advisable to eliminate or minimize the consequences of such infringement of a Patent or Trademark. For the purpose of taking any such legal action, Genzyme shall have the right, subject to Inamed's consent which consent shall not be unreasonably withheld or delayed, to use the name of Inamed as plaintiff, either solely or jointly in accordance with the applicable rules of procedure; provided, that Genzyme shall give Inamed prior notice of such use of Inamed's name. Inamed shall promptly furnish Genzyme with whatever written authority may be required in order to enable Genzyme to use Inamed's name in connection with any such legal action, and shall otherwise cooperate fully and promptly with Genzyme in connection with any such action. All proceeds realized upon any judgment or settlement regarding such action shall belong to Genzyme.

13.
Further Assurances. The parties hereto agree to execute such further or other documents and assurances as are necessary from time to time in order to give effect to the provisions of this Agreement.

14.
Assignment. The Agreement shall not be assigned or otherwise transferred without the consent of the other party, except that either party may assign its rights and obligations under the Agreement without such consent (i) to an Affliate, (ii) in connection with a corporate reorganization of the party, or (iii) in connection with a merger, consolidation, spin-off or sale of all or substantially all of the assets of a party or that portion of the business of the party that pertains to this Agreement.

15.
Governing Law, Dispute Resolution and Injunctive Relief.

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16.  Amendment of U.S. Agreement.

        The U.S. Agreement is hereby amended as follows:

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17.
Force Majeure. Each of the parties shall be excused from the performance of its obligations hereunder in the event such performance is prevented by force majeure, and such excuse shall continue as long as the condition constituting such force majeure continues. For the purpose of this Agreement, force majeure is defined as contingencies beyond the reasonable control of either party, including, without limitation, acts of God, judicial or regulatory action, war, civil commotion, destruction of production facilities or materials by fire, earthquake or storm and labor disturbances (whether or not any such labor disturbance is within the power of the affected party to settle).

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Interest. Any overdue amounts payable by any party hereunder shall bear interest compounded monthly at the rate of ten percent (10%) per annum from the due date until the date of payment.

19.
Notices. All communications in connection with this Agreement shall be in writing and sent by postage prepaid first class mail, courier, or telefax, and if relating to default, late payment or

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or to such other address as the addressee shall last have designated by notice to the communicating party. The date of giving any notice shall be the date of its actual receipt.

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20. Survival. The provisions of Sections 7, 10, 11, 15 and 19 of this Agreement shall survive the termination or expiration of this Agreement (as the case may be) and shall remain in full force and effect. The provisions of this Agreement that do not survive termination or expiration hereof (as the case may be) shall, nonetheless, be controlling on, and shall be used in construing and interpreting the rights and obligations of the parties hereto with regard to, any dispute, controversy or claim which may arise under, out of, or in connection with this Agreement.

21. Severability. In the event that any provision of this Agreement shall be held by a court of competent jurisdiction or by any governmental body to be invalid or unenforceable, such provision shall be deemed severable and the remaining parts and provisions of this Agreement shall remain in full force and effect.

22. Headings. The captions to the several Sections hereof and Exhibits hereto are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Sections hereof.

23. Independent Contractors. It is expressly agreed that Genzyme and Inamed shall be independent contractors and that the relationship between the two parties shall not constitute a partnership, joint venture or agency. Neither Genzyme nor Inamed shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior written consent of the other party to do so.

24. Waiver. The waiver by either party hereto of any right hereunder or the failure to perform or of a breach by the other party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other party whether of a similar nature or otherwise.

25. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Counterparts may be exchanged by facsimile if mutually agreed by the parties.

26. Entire Agreement. This Agreement, together with the attached Schedule and Exhibits hereto, sets forth the complete and final agreement between Genzyme and Inamed with regard to its subject matter and supersedes and terminates all prior agreements and understandings with regard to the same subject matter between the parties, whether oral or in writing, excluding from the foregoing the U.S. Agreement and the International Agreement.

[Remainder of Page Intentionally Left Blank]

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        IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date and year first above written.

  INAMED CORPORATION

 

 

By:


Nicholas L. Teti, Jr.
Chairman and Chief Executive Officer

 

 

GENZYME BIOSURGERY CORPORATION,
a subsidiary of Genzyme Corporation

 

 

By:


Earl M. Collier, Jr.
President

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SCHEDULE 2.1

STEERING COMMITTEE
INITIAL MEMBERSHIP

Inamed Designees

Genzyme Designees

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EXHIBIT A

HYLAFORM DEVELOPMENT WORK

INAMED/GENZYME DUTIES AND RIGHTS

This Exhibit is attached to, and is deemed a part of, the Development Agreement, dated September 30, 2002, between Genzyme Corporation and Inamed Corporation. Capitalized terms used in this Exhibit and not otherwise defined shall have the meanings given such terms in the Development Agreement.

PART A: CLINICAL ACTIVITIES

Section 1: Duties and Rights of Inamed

General

Clinical Trial

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Independent Panel Review

Data Management

Biostatistical Analysis

Section 2: Duties and Rights of Genzyme

General

Clinical Trial

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Data Management

Biostatistical Analysis

PART B: REGULATORY ACTIVITIES

Section 1: Duties and Rights of Inamed

General

PMA Application, Submission and Prosecution

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Adverse Event Reporting

Section 2: Duties and Rights of Genzyme

General

PMA Application, Submission and Prosecution

Adverse Event Reporting

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EXHIBIT B

HYLAFORM DEVELOPMENT WORK

TRANSITION PLAN

This Exhibit is attached to, and is deemed a part of, the Development Agreement, dated September 30, 2002, between Genzyme Corporation and Inamed Corporation. Capitalized terms used in this Exhibit and not otherwise defined shall have the meanings given such terms in the Development Agreement.

Prior to the Transition Date, primary responsibility for the Hylaform Clinical Activities shall be transitioned from Genzyme to Inamed. Inamed and Genzyme shall each use reasonable commercial efforts in performing this to assure that no negative impact on the conduct of the pending clinical studies results from the actions undertaken in the Transition Period.

Following is a list of specific transition responsibilities, all of which are projected to be completed by the Transition Completion Date

Activity

   
Description of Tasks
to be Completed

Clinical Trial   
    
Vendor, Investigator and Independent Panel Review ("IPR") Agreements Delivery of notice of designation of Inamed as an authorized agent of Genzyme to vendors, investigators and members of the IPR with respect to the following agreements:
    
  Vendor Agreements (6):
    
  Canfield Scientific—(Photograph processing and scoring)
    
  StatProbe (Celeris)—(Monitoring)
    
  CRL Medinet—(General laboratory services- hematology and chemistry)
    
  Southern Research Institute (SRI)—(Sample processing for antibody testing)
    
  New England Institutional Review Board—(IRB review and approval service)
    
  Aerotek (Site Coordinator for Dr. Gendler)
    
  Investigator Agreements (10):
    
  University of Miami (Dr. Bauman, Miami)
  Ellen Gendler PC (Dr. Gendler, New York)
  Richare Glogau Inc. (Dr. Glogau, San Francisco)

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  Minimally Invasive Aesthetics (Dr. Klein, Beverly Hills)
  Clinical Research Specialists, Inc. (Dr. Lowe, Santa Monica)
  Dr. Matarasso, San Francisco, CA.
  Texas Dermatology Research Institute (Dr. Menter, Dallas)
  Gary Mihneit PC (Dr. Monheit, Birmingham)
  Dr. Price (Miami).
  Wexler Dermatology (Dr. Wexler, New York).
    
  IRP Agreements (3):
    
  Dr. Paul W. Gross
  Dr. Lisa Bonofario
  Dr. Deborah Jaliman
    
Vendor File Transfer Produce and deliver to Inamed copies of all relevant files located at Genzyme's offices for the following vendors:
    
  Canfield Scientific—(Photograph processing and scoring)
    
  StatProbe (Celeris)—(Monitoring)
    
  CRL Medinet—(General laboratory services (hematology and chemistry)
    
  Southern Research Institute (SRI)—(Sample processing for antibody testing)
    
  New England Institutional Review Boar—(IRB review and approval service)
    
  Aerotek (Site Coordinator for Dr. Gendler)
    
Investigator File Transfer Produce and deliver to Inamed copies of all relevant files located at Genzyme's offices for the following investigators:
    
  Dr. Bauman, Miami, FL.
  Dr. Gendler, New York, N.Y.
  Dr. Glogau, San Francisco, CA.
  Dr. Klein, Beverly Hills, CA.
  Dr. Lowe, Santa Monica, CA
  Dr. Matarasso, San Francisco, CA.
  Dr. Menter, Dallas, TX.
  Dr. Monheit, Birmingham, AL.

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  Dr. Price, Miami, FL.
  Dr. Wexler, New York, N.Y.
IPR File Transfers Produce and deliver to Inamed copies of all relevant files located at Genzyme's offices for the following members of the IRP:
    
  Dr. Paul W. Gross
  Dr. Lisa Bonofario
  Dr. Deborah Jaliman
Biostatistic and Data Management   
Data Management Agreements Notice of designation of Inamed as authorized agent to vendors with respect to the following biostat vendor agreements:
    
  [None]
    
Data Management File Transfer Electronic or hard copy transfer of all data, management files and documents listed below located within Genzyme's offices *:
    
  1.Case Report Forms
  2.Case Report Instructions
  3.Annotated Case Report Forms
  4.Data Entry Guidelines
  5.Data Review Guidelines
  6.Database design meeting notes
  7.Clintrial v.3.3.3 Database Panel Schemas
  8.Clintrial v.3.3.3 Database Form/Multiform Schemas
  9.Clintrial v.3.3.3 Database Code lists
  *The transfer, or attempted transfer, of these items will constitute satisfaction of this activity notwithstanding the inability or difficulty of Inamed to receive, access or use this data due to Inamed system or software incompatibility

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Source: OneCLE Business Contracts.