Process Development And Clinical Supply Agreement Dated June 30, 2004

Exhibit 10.28


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PROCESS DEVELOPMENT AND

CLINICAL SUPPLY AGREEMENT


This Clinical Supply Agreement (the " Agreement" ) is made as of June 30, 2004, (the " Effective Date" ) by and among Cambrex Bio Science Walkersville, Inc., a Delaware corporation (" CBSW" ), Smith & Nephew Wound Management (La Jolla), a Delaware partnership (" SNWMLJ" ), Inamed Medical Products Corporation, a California corporation (" Inamed" ), and SkinMedica, Inc., a Delaware corporation (" SkinMedica" , and each of SNWMLJ, Inamed or SkinMedica individually referred to as " Client" and collectively referred to as " Clients" , and each of CBSW and Clients individually referred to as " Party" and collectively referred to as the " Parties" ).


RECITALS

A. CBSW operates a multi-client production facility located at 8830 Biggs Ford Road, Walkersville, Maryland 21793 (the " Facility" ).


B. Clients desire to have CBSW develop one or more processes to produce cell banks containing human cells and intended for therapeutic use in humans, and thereafter to produce such cell banks, and CBSW desires to develop such process and produce such cell banks.


NOW, THEREFORE, in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, CBSW, SNWMLJ, Inamed and SkinMedica, intending to be legally bound, hereby agree as follows:

AGREEMENT


1. DEFINITIONS

When used in this Agreement, capitalized terms will have the meanings as defined below and throughout the Agreement. Unless the context indicates otherwise, the singular will include the plural and the plural will include the singular.


1.1 " Affiliate" means a legal entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with a Party. For purposes of this definition only, " control" and, with correlative meanings, the terms " controlled by" and " under common control with" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a legal entity; provided, however , that if local law restricts foreign ownership, control will be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests.


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1.2 " Batch" means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture


1.3 " Batch Record" means the production record pertaining to a Batch.

1.4 " CBSW Inventions" means any know-how, media, assays, methods or other inventions, whether or not patentable, conceived, developed or reduced to practice by CBSW: (a) on or before the Effective Date; or (b)(i) in connection with the performance of the Development Plan or the Production Plan, and (ii) relating generally to CBSW' s business of producing biological materials; but excluding any Client Inventions.


1.5 " CBSW Operating Documents" means the standard operating procedures, standard manufacturing procedures, raw material specifications, protocols, validation documentation, and supporting documentation, such as environmental monitoring, for operation and maintenance of the Facility and CBSW equipment used in the process of producing the Product, excluding any of the foregoing that are unique to the manufacture of Product.

1.6 " CBSW Parties" has the meaning set forth in Section 14.1.


1.7 " cGMP" means current Good Manufacturing Practices as contained in 21 CFR Parts 210 and 211 as amended from time to time.

1.8 " Change Order" has the meaning set forth in Section 2.2.


1.9 " Client Development Materials" has the meaning set forth in Section 2.3.

1.10 " Client Inventions" means: (a) any know-how or inventions, whether or not patentable, conceived, developed or reduced to practice by one or more Clients (i) on or before the Effective Date, or (ii) in connection with the performance of the Development Plan or the Production Plan; and (b) any patentable inventions conceived, developed or reduced to practice by CBSW, solely or jointly with one or more Clients, directly in the course of performance of the Development Plan or Production Plan and relating to Product and/or the manufacture or use thereof, including, without limitation, the Process and any related Master Production Record (excluding any CBSW Operating Documents or CBSW Confidential Information included therein).

1.11 " Client Materials" means the Client Development Materials and the Client Production Materials.


1.12 " Client Personnel" has the meaning set forth in Section 3.8.1


1.13 " Client Production Materials" has the meaning set forth in Section 3.2.

1.14 " Commencement Date" means the date set forth in the Production Plan for the commencement of the production of the Product.


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1.15 " Development Plan" has the meaning set forth in Section 2.1.


1.16 " FDA" means the U.S. Food and Drug Administration, and any successor agency thereof.


1.17 " Lead Time" has the meaning set forth in the Production Plan.


1.18 " Master Production Record" means the documentation developed jointly by CBSW and Clients that contains a detailed description of the Process, Materials, Chemicals, Equipment, Aids and any other instructions to be followed by CBSW in the production of the Product.


1.19 " Materials" means all raw materials and supplies to be used in the production of the Product.


1.20 " Monthly Fee" has the meaning set forth in Schedule 8.1, attached hereto and hereby incorporated herein by reference.


1.21 " Process" means the manufacturing process for the Product pursuant to the terms of this Agreement.


1.22 " Product" has the meaning set forth in Schedule 1.22 attached hereto and hereby incorporated herein by reference.

1.23 " Product Unit" has the meaning set forth in Schedule 1.22.


1.24 " Product Warranties" means those warranties as specifically stated in Section 4.1.


1.25 " Production Plan" has the meaning set forth in Section 3.1.


1.26 " Production Suite" means a production facility and associated common space that is validated and meets FDA standards and applicable guidelines.

1.27 " Production Term" means the period commencing on the Commencement Date and terminating on the date of expiration or termination of this Agreement.


1.28 " Regulatory Approval" means the approval by the FDA to market and sell the Product in the United States.

1.29 " SOP" means a standard operating procedure.


1.30 " Specifications" means the Product specifications set forth in Schedule 1.22 attached hereto, or as modified by the Parties in connection with the production of a particular Batch of Product hereunder.

1.31 " Third Party" means any party other than CBSW, Clients or their respective Affiliates.

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2. PROCESS DEVELOPMENT

2.1 Development Plan . If development of the Process is to be performed by CBSW, the Parties will collaborate to develop a final plan describing the activities to be performed by the Parties, or to be subcontracted by CBSW to Third Parties, in the development of the Process and the Master Production Record (the " Development Plan" ). A draft outline of the Development Plan is included in Schedule 2.1. The final Development Plan will be binding on the Parties if and when signed by all Parties. If development of the Process is to be performed by CBSW under the terms of this Agreement and the Parties are unable to agree on a final Development Plan within 90 days after the Effective Date, any Party may terminate this Agreement by written notice effective upon receipt.

2.2 Modification of Development Plan . Should Clients want to change the Development Plan or to include additional services to be provided by CBSW, Clients may in a written notice executed by each of them propose to CBSW an amendment to the Development Plan with the desired changes or additional services (" Change Order" ). If CBSW determines that it has the resources and capabilities to accommodate such Change Order, CBSW will prepare a modified version of the Development Plan reflecting such Change Order and will submit such modified version of the Development Plan to Clients for review and comment. The modified Development Plan shall be binding on the Parties only if signed by all Parties, whereafter such modified version of the Development Plan will be deemed to have replaced the prior version of the Development Plan.

2.3 Client Deliverables . Within the time period specified in the Development Plan, Clients will provide CBSW with (a) the materials listed in the Development Plan, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Development Plan or the Production Plan, and (b) any protocols, SOPs and other information and documentation in possession or control of Clients and necessary for the performance of the Development Plan, the preparation of the Master Production Record, and the manufacture of Product pursuant to the Master Production Record in conformance with cGMP, including, without limitation, process information, SOPs, development data and reports, quality control assays, raw material specifications (including vendor, grade and sampling/testing requirements), product and sample packing and shipping instructions, and product specific cleaning and decontamination information, (collectively, the " Client Development Materials" ).


2.4 Performance by CBSW . Subject to the provision by Clients of the Client Development Materials pursuant to Section 2.3, CBSW will use commercially reasonable efforts to perform, directly or, subject to written approval by each of the Clients (such approval not to be unreasonably withheld), through a Third Party contractor, the Development Plan in a professional and workmanlike manner in accordance with the terms of this Agreement. CBSW will use commercially reasonable efforts promptly to notify Clients of any material delays that arise during the performance of the Development Plan.


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2.5 Master Production Record.

2.5.1 Based on the Process developed by CBSW and Clients pursuant to the Development Plan, CBSW will prepare the Master Production Record for the Process. Clients will inform CBSW of any specific requirements Clients may have relating to the Master Production Record, including, without limitation, any information or procedures Clients wish to have incorporated therein. If CBSW intends to include in the Master Production Record the use of any assay, medium, or other technology that is not commercially available, CBSW will inform Clients of such intention and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process.


2.5.2 Clients will cooperate with CBSW to assist CBSW to develop the Master Production Record and Process, including, without limitation, by providing CBSW with additional information and procedures as may be required to create the Master Production Record, Process, and/or any of the following: (i) manufacturing process information, SOPs, development reports, (ii) quality control assays, (iii) raw material specifications (including vendor, grade and sampling/testing requirements), (iv) Product and sample packing and shipping instructions, (v) Product specific cleaning and decontamination information, (vi) Product Specifications.


2.5.3 CBSW will deliver a draft version of the Master Production Record to Clients for review and approval, within the time period specified in the Development Plan. Clients will notify CBSW in writing of any objections to the Master Production Record, and upon such notification, representatives of CBSW and Clients will meet promptly to resolve such objections.


2.5.4 The Process, Master Production Record, Specifications, and any improvements or modifications thereto developed during the term of this Agreement, but excluding any CBSW Operating Documents or CBSW Confidential Information included in any of the foregoing, will be deemed Confidential Information of Clients and subject to the provisions set forth in Section 9. Each of the Clients has the right to use (itself or through a Third Party) the Process and/or the Master Production Record, conditioned on the following: such Client and any such Third Party must agree in writing to protect CBSW Confidential Information contained therein and such Client' s and/or any such Third Party' s use shall be limited to uses related to Product.

3. MANUFACTURE OF PRODUCT; ORDER PROCESS; DELIVERIES


3.1 Production Plan . Together with the draft version of the Master Production Record described in Section 2.5.3 above, CBSW will deliver to Clients for review and comment, a proposed final plan describing the activities to be performed by CBSW, or to be subcontracted by CBSW to Third Parties, in the production of the Product (the " Production Plan" ). CBSW will deliver the proposed final Production Plan within the time period set forth in Schedule 3.1. A draft outline of the Production Plan is included in Schedule 3.1, attached hereto and hereby incorporated herein by reference. The final Production Plan will be binding on the Parties if and when signed by all Parties. If the Parties are unable to agree on a final Production Plan within 90 days after the time period specified in Schedule 3.1 for the first submission of such plan by CBSW to Clients, Clients may collectively agree to terminate this Agreement by written notice signed by each of them effective upon receipt by CBSW.


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3.2 Client Deliverables. Within the time period specified in the Production Plan, Clients will provide CBSW with (a) the materials listed in the Production Plan required for the production of the Product, and any handling instructions, protocols, SOPs and other documentation necessary to maintain the properties of such materials for the performance of the Production Plan (collectively, the " Client Production Materials" ).


3.3 Commencement Date . The Production Plan will include a Commencement Date agreed upon by the Parties.

3.4 Forecasting and Order Process . A development and production timeline for delivery of Product will be jointly developed with CBSW and Clients. Commercially reasonable efforts on the part of the Parties will be made to deliver on the dates set forth in the Development Plan and Production Plan.


3.5 Manufacture by CBSW . During the Production Term, CBSW will use commercially reasonable efforts to manufacture, package, ship, handle quality assurance and quality control for the Product, all as set forth in the Production Plan, and to deliver to Clients the quantities of Product requested by Clients pursuant to Section 3.4, all in accordance with the terms set forth in Section 3.6 below.


3.6 Packaging and Shipping . CBSW will package and label the Product for shipment in accordance with the Master Production Record and CBSW' s standard practices in effect at the time of performance by CBSW. CBSW will ship the Product FCA (Incoterms 2000) delivered at the Facility to a common carrier designated by Clients to CBSW in writing not less than ten days prior to scheduled delivery date set forth in the applicable order submitted pursuant to Section 3.4. Clients will provide to CBSW one or more account numbers with the selected carrier and will pay for all shipping costs in connection with each shipment of Product. Each shipment will be accompanied by the documentation listed in the Production Plan. CBSW will use commercially reasonable efforts to deliver each shipment of Product to Clients (or the designated individual Client agreed to by the Clients) on the requested delivery date for such shipment. Should CBSW at any time during the term of this Agreement have reason to believe that it will be unable to meet a delivery date, CBSW will promptly notify each of the Clients.


3.7 Records . CBSW will maintain accurate records for the production of the Product, as required by applicable laws and regulations. CBSW will retain possession and ownership of the Master Production Record, all Batch Records and CBSW Operating Documents, and will make copies thereof available to Clients upon any Client' s request and at the requesting Client' s expense. CBSW Operating Documents will remain CBSW Confidential Information. Clients will have the right to use and reference any of the foregoing in connection with a filing for Regulatory Approval of the Product or as otherwise authorized by the Agreement.

3.7.1 Accessibility . All documents developed and produced by one or more Clients and CBSW or documents that have been jointly developed by the Parties


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relating to or used in the preparation or production of Product shall be accessible and provided to Clients and, upon written request from each of the Clients or pursuant to applicable law, to a Third Party (examples: Regulatory agency, partner of SNWMLJ). However, if such documents are given to a Third Party other than a regulatory agency, any such Third Party must agree in writing to protect CBSW Confidential Information contained therein, and each Client' s and/or any such Third Party' s use shall be limited to uses related to Product. One (1) year after the Effective Date, the reasonable cost of providing accessibility of the documentation to any Third Party other than a regulatory agency shall be passed through to the Client requesting such access.

3.7.2 Retention . All documents used in the production of Product will be maintained and retained by CBSW for a minimum time period of 30 years after manufacture of Product. Any exceptions must be approved by each of the Clients in writing.

3.8 CLIENT ACCESS.

3.8.1 Each Client' s employees and agents (including its independent contractors) (collectively, " Client Personnel" ) may participate in the production of the Product in such capacities as may be approved in writing in advance by CBSW. Client Personnel working at the Facility are required to comply with CBSW' s Operating Documents and any other applicable CBSW facility and/or safety policies.


3.8.2 Client Personnel working at the Facility will be and remain employees of the applicable Client, and the applicable Client will be solely responsible for the payment of compensation for such Client Personnel (including applicable Federal, state and local withholding, FICA and other payroll taxes, workers' compensation insurance, health insurance, and other similar statutory and fringe benefits). The applicable Client covenants and agrees to maintain workers' compensation benefits and employers' liability insurance as required by applicable Federal and Maryland laws with respect to all Client Personnel working at the Facility.

3.8.3 The applicable Client will pay for the reasonable cost of repairing or replacing (to the extent that CBSW determines, in its reasonable judgment, that repairs cannot be adequately effected) any property of CBSW damaged or destroyed by its Client Personnel, provided such Client shall not be liable for repair or replacement costs resulting from ordinary wear and tear.

3.8.4 Client Personnel authorized to have access to the Facility will abide by the security procedures established by CBSW. The applicable Client will be liable for any breaches of security by its Client Personnel. In addition, the applicable Client will reimburse CBSW for the cost of any lost security cards issued to its Client Personnel, at the rate of $50 per security card. All Client Personnel will agree to abide by CBSW policies and SOPs established by CBSW, and will sign a confidentiality agreement in the then-current form used by CBSW.

3.9 Disclaimers . Clients acknowledge and agree that CBSW will not engage in any Product refinement or development of the Product, other than as expressly set forth in this Agreement. Clients acknowledge and agree that CBSW Parties have not participated in the invention or testing of any Product, and have not evaluated its safety or suitability for use in humans or otherwise.


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3.10 Client Insurance . Each Client will maintain, at all times during the Term of this Agreement and for *** years thereafter, a products liability insurance policy (the " Insurance Policy" ) with limits of not less than *** per occurrence, and will provide a Certificate of Insurance to CBSW that the Insurance Policy has been endorsed to designate CBSW as an additional named insured. Each Client will maintain the Insurance Policy with an insurance company that is licensed to do business in the State of Maryland and that is reasonably acceptable to CBSW. Each Client must give at least 30 days' prior written notice to CBSW before the Insurance Policy can be terminated.


3.11 CBSW will maintain during the Term of this Agreement and for *** years thereafter, a liability insurance policy (the " CBSW Insurance Policy" ) with limits of not less than *** per occurrence, and will provide a Certificate of Insurance to each Client that the Insurance Policy has been endorsed to designate each Client as an additional named insured. CBSW will maintain the CBSW Insurance Policy with an insurance company that is licensed to do business in the State of Maryland and that is reasonably acceptable to each Client. CBSW must give at least 30 days' prior written notice to each Client before the Insurance Policy can be terminated.

4. PRODUCT WARRANTIES; ACCEPTANCE AND REJECTION OF PRODUCTS


4.1 Product Warranties . CBSW warrants that any Product manufactured by CBSW pursuant to this Agreement, at the time of delivery pursuant to Section 3.6: (a) conforms to the Specifications; (b) was manufactured in accordance with the Master Production Record; and (c) was manufactured in accordance with cGMP. Documentation demonstrating the above statement will be provided at the request of any Client in the form of certificates of conformance, certificates of analysis or other forms of documentation reasonably requested by such Client.


4.2 Approval of Shipment.


4.2.1 When a shipment of Product ordered by Clients pursuant to Section 3.4 is ready for delivery, CBSW will notify Clients and supply Clients with the required shipping documentation set forth in the Production Plan. CBSW will not ship any shipment of Product until the required shipping documentation for such shipment has been approved in writing by each of the Clients.

4.2.2 Clients will have *** after receipt of all documentation specified in the Production Plan for each shipment of Product (such period, the " Acceptance Period" ) to review such documentation. If any Client asserts that the Product does not comply with the warranties set forth in Section 4.1 above (" Product Warranties" ), such Client will deliver to CBSW, in accordance with the notice provisions set forth in Section 16.4 hereof, written notice of disapproval (the " Disapproval Notice" ) of such Product, stating in reasonable detail the basis for such assertion of non-compliance with the Product Warranties. If a valid Disapproval Notice is received by CBSW during the Acceptance Period, then CBSW and Clients will provide one another with all related paperwork and records (including, but not limited to, quality control tests) relating to both the production of the Product and the Disapproval Notice.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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4.2.3 If one or more Clients do not approve or disapprove the shipment of Product , within the Acceptance Period, CBSW will charge storage fees at the then current rate for such Product. CBSW' s current storage rates are set forth in Schedule 8.1.

4.3 Dispute Resolution.

4.3.1 CBSW and Clients will attempt to resolve any dispute regarding the conformity of a shipment of Product with the Product Warranties. If such dispute cannot be settled within 45 days of the submission by each Party of such related paperwork and records to the other Parties, and:

(a) if the Product is alleged not to conform with the Product Warranties set forth in Section 4.1(a), then Clients will submit a sample of the batch of the disputed shipment to an independent testing laboratory of recognized repute selected by Clients and approved by CBSW (such approval not to be unreasonably withheld or delayed) for analysis, under Quality Assurance approved procedures, of the conformity of such shipment of Product with the Specifications. The costs associated with such analysis by such independent testing laboratory will be paid by the Party whose ass ...