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OPERATION SERVICES AGREEMENT

Servicing Agreement

OPERATION SERVICES AGREEMENT | Document Parties: ALPHARMA INC | Zhejiang Hisun Pharmaceutical Co, Ltd You are currently viewing:
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ALPHARMA INC | Zhejiang Hisun Pharmaceutical Co, Ltd

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Title: OPERATION SERVICES AGREEMENT
Date: 10/30/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

OPERATION SERVICES AGREEMENT, Parties: alpharma inc , zhejiang hisun pharmaceutical co  ltd
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Exhibit 10.1 - Confidential Materials Omitted And Filed Separately With The Securities And Exchange Commission. Asterisks Denote Omissions

Final

OPERATION SERVICES AGREEMENT

THIS OPERATION SERVICES AGREEMENT (the " Agreement ") is entered into in Taizhou, China on July 3, 2007 (the " Effective Date ") between:

Zhejiang Hisun Pharmaceutical Co., Ltd., 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang, The Peoples Republic of China (hereinafter referred to as " Hisun "), whose legal representative is Mr. Bai Hua, who holds the position of President, and is of Chinese nationality; and

Alpharma (Taizhou) Pharmaceutical Co., Ltd., 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, The Peoples Republic of China (hereinafter referred to as " Alpharma "), whose legal representative is Mr Carl-Ake Carlsson, who holds the position of Chairman of the Board, and is of Norwegian nationality.

WHEREAS, Alpharma and Hisun have concurrently herewith entered into an Acquisition and Construction Agreement concerning Alpharma's purchase from Hisun of certain of Hisun's assets used to produce Vancomycin, including final handling, and Hisun 's construction for Alpharma of an additional manufacturing facility to produce Vancomycin ;

WHEREAS, The Parties have, also concurrently herewith, entered into a Lease Agreement relating to the buildings and premises and fermentation assets and certain existing equipment used for the manufacture of Vancomycin;

WHEREAS, Alpharma's Parent and Hisun have entered into a Manufacturing and Supply Agreement pursuant to which Hisun will manufacture and supply to Alpharma's Parent Vancomycin until such time tha t the new manufacturing facility has been completed and Alpharma has obtained its Pharmaceutical Manufacturing License all pursuant to the terms and conditions set forth in the Manufacturing and Supply Agreement; and

WHEREAS, Alpharma desires Hisun to perform certain services related to Alpharma's manufacture of Vancomycin in accordance with the terms and conditions of this Agreement, and Hisun desires to perform those services for Alpharma in accordance with the terms and conditions of this Agreement.

NOW, THEREFORE, IT IS HEREBY AGREED as follows:

1. Definitions

    • 1.1 Capitalized terms not defined in this Agreement shall have the meanings set forth in the Index of Definitions attached as Schedule 1 to the Acquisition and Construction Agreement. In addition, the following terms shall have the respective meanings set forth below:

 

Agents

has the meaning specified in Clause 24.2.

Agreement

has the meaning specified in the preamble above.

Change

has the meaning specified in Clause 13.1.

****

has the meaning specified in Clause 14.2.

Environmental Permit

has the meaning specified in Clause 9.5.

Initial Term

has the meaning specified in Clause 25.1.

****

has the meaning specified in Clause 14.2.2.

****

has the meaning specified in Clause 14.2.

Production Plan

has the meaning specified in Clause 11.1.

Recipient

has the meaning specified in Clause 24.1.

Renewal Term

has the meaning specified in Clause 25.1.

Service Fee

has meaning specified in Clause 14.1.

Shared Service Fee

has meaning specified in Clause 6.1.

Term

means the term of the Agreement as provided in Clause 25.1.

Territory

means worldwide.

Trademarks

means the trademarks of Alpharma listed in Appendix 1.



2. Services

    • 2.1 Hisun agrees to perform the Services from the Effective Date and during the Term in accordance with this Agreement and the Appendices. The Services will include those activities that are specified as Hisun's responsibility in the Agreement or its Appendices. The division of responsibility between the Parties concerning the manufacturing of the Product is specified in particular in the Technical (GMP) Agreement.

3. Services related to the Maintenance of the Manufacturing Facility; Utilities

    • 3.1 Hisun will, at its cost, provide and make available all utilities ( i.e. heating, electricity, hot and cold water, steam and any other relevant utilities) required for the manufacture of the Product in the Manufacturing Facility as requested by Alpharma. Alpharma will compensate Hisun for the costs incurred in this respect as provided in Clause 14.5 and Appendix 2 .

      3.2 Hisun will use reasonable commercial efforts to maintain the Manufacturing Facility in accordance with written maintenance plans to be established in writing by Alpharma. Hisun shall carry out such maintenance plans in a timely and workmanlike manner which shall not jeopardize the continued effectiveness of the Regulatory Documents. The costs of maintaining the Manufacturing Facility shall be divided between the Parties as set out in Clauses 3.3 and 3.4.

      3.3 Alpharma is responsible for the out-of-pocket costs of maintaining the Manufacturing Equipment except the Leased Manufacturing Equipment. Alpharma shall compensate Hisun for the out-of-pocket cost incurred in this respect according to Clause 14.5 and Appendix 2, provided the costs are incurred by Hisun in accordance with the maintenance plan approved by Alpharma as provided above. Alpharma is also responsible for the costs of obtaining any new or replacement machinery and equipment that Alpharma determines is necessary which shall be automatically considered part of the Manufacturing Equipment, and thus shall also be maintained by Hisun at Alpharma's cost. Alpharma shall also be responsible for all maintenance costs caused directly by Alpharma's failure to use commercially reasonable efforts to follow the manufacturer's operating guidelines for the Manufacturing Equipment.

      3.4 Hisun is responsible for all of its obligations under the Lease Agreement, including the costs of maintaining the Leased Buildings and the Leased Manufacturing Equipment. For the avoidance of doubt, Hisun is also responsible for maintenance cost related to any other facilities used by Hisun in the performance of the Services.

      3.5 All Manufacturing Equipment shall be owned by Alpharma (except for the Leased Manufacturing Equipment leased under the Lease Agreement), and Hisun must ensure that all such Manufacturing Equipment is clearly identified as such at all times by having a label clearly stating " Property of Alpharma - Not to be removed without the prior written permission of Alpharma " or such other identification reasonably requested by Alpharma. Hisun shall, at Alpharma's reasonable request, sign any documents reasonably necessary in order to secure Alpharma's title to such machinery and equipment including written acknowledgement to the effect that Alpharma owns such machinery and equipment with a detailed identification of such machinery and equipment.

      3.6 Hisun undertakes to preserve and safeguard the Manufacturing Equipment owned by Alpharma at all times with at least the same degree of care as Hisun uses in respect of its own machinery and equipment and in no event less than reasonable care. Hisun agrees not to use the Manufacturing Equipment and the Leased Buildings for any purpose other than performing the Services under this Agreement without Alpharma's prior written approval.

4. Services related to Quality Control and Quality Assurance

    • 4.1 Hisun shall perform all necessary quality control and quality assurance services and activities as specified in the Technical (GMP) Agreement provided that these services shall be provided by Hisun only for a reasonable period after the Effective Date and until Alpharma is able to perform the services itself.

      4.2 The Services shall be performed in accordance with (i) the provisions of this Agreement, (ii) the Specifications, (iii) the Technical (GMP) Agreement, (iv) cGMP and (v) all other instructions, standards and specifications regarding the manufacture not inconsistent with the requirements of this Agreement as reasonably requested by Alpharma from time to time.

      4.3 Hisun shall perform the Services with all reasonable skill and care and in no event with less skill and care than is required by the cGMP.

      4.4 Alpharma shall be responsible for release of the Product. Hisun shall perform and provide analysis and testing of the Product in this respect in accordance with the Technical (GMP) Agreement and Appendix 7 .

      4.5 Alpharma shall reimburse Hisun the out-of-pocket costs related to the quality control and quality assurance services in accordance with Clause 14.5.

5. Services related to Environmental and Fire Prevention

    • 5.1 Hisun will be responsible for compliance with Environmental, Health and Safety Laws and fire prevention laws related to the Manufacturing Facility, including establishing and maintaining the necessary plans for environmental and fire prevention matters and the implementation of such plans including regular tests and ongoing preparedness.

      5.2 In addition, Hisun shall be responsible for waste water discharge and solid waste disposal from the Manufacturing Facility and the other volume-dependent environmental operating costs that are specifically listed in Appendix 2 . Alpharma shall reimburse Hisun for its costs incurred in this respect according to Clause 14.5 and Appendix 2 .

      5.3 It is Hisun's obligation to ensure that the environmental and fire prevention plans are in compliance with all applicable laws and regulations in The Peoples Republic of China.

6. Shared Services

    • 6.1 Hisun shall perform certain additional services that shall be performed by service providers not devoted exclusively to the Vancomycin operations such as construction and maintenance of ingress and egress roads, provision of meals, dormitories and medical treatment and commuter bus service for Alpharma Employees to the same extent as provided for similarly situated employees of Hisun, site security, gardening and other site services (the " Shared Services "). Alpharma shall compensate Hisun for providing the Shared Services by payment of **** payable as set forth in Clause 15.2 (the " Shared Services Fee ").

7. Services related to purchase and storing of Raw Materials

    • 7.1 Hisun shall provide adequate storage facilities for raw materials used by Alpharma in accordance with the Technical (GMP) Agreement and Alpharma's instructions, standards and specifications at appropriate storage facilities.

      7.2 Hisun will provide purchasing and procurement services related to the raw material including quality control of raw material, handling, administration of purchasing and procurement, etc., in accordance with the Technical (GMP) Agreement, Appendix 3 and Appendix 5 and any additional guidelines to be agreed between the Parties.

      7.3 Alpharma will, at its own cost, be responsible for purchasing all raw materials and packaging materials required for the manufacture of the Product and for the selection of such raw materials and raw material suppliers. However, the Parties may agree that certain raw materials and packaging materials required for the manufacture and packaging of the Product may, upon the agreement of the Parties, be provided by Hisun. In such case, Alpharma will compensate Hisun for its out-of-pocket costs incurred in this respect in accordance with Clause 14.5 and Appendix 2 unless otherwise agreed.

8. Services related to Alpharma Employees

    • 8.1 Hisun shall permit Alpharma, all Alpharma Employees and all designated consultants and agents of Alpharma full, free and unrestricted access at all times to the Leased Buildings. If Alpharma believes that it has a need for access to other buildings within the Hisun site, Alpharma shall notify Hisun of that belief, and Hisun will agree to provide such access to other buildings provided that such access is reasonably required by Alpharma in order to manufacture the Product, and provided further that Alpharma agrees to adhere to any restrictions or guidelines for such access to other buildings set out by Hisun.

      8.2 Alpharma is entitled to station Alpharma Employees and other representatives at the Leased Buildings for any purposes related to the production of the Product and the operation of the Manufacturing Facility. Hisun will provide necessary office space and equipment for the Alpharma Employees in the Leased Buildings.

      8.3 Hisun will provide advice to Alpharma in relation to Alpharma's performance of payroll and administration services related the Alpharma Employees for a transitional period after the Effective Date.

      8.4 Hisun agrees that neither it nor its Affiliates will actively seek to employ any Alpharma Employee during the Term who is a manager or senior employee.

9. Services related to Manufacturing Authorizations and Certificates

    • 9.1 Alpharma shall be responsible for procuring and will own or validly hold a valid Manufacturing Authorization for the Product, Certificate of Good Manufacturing Practices for Pharmaceutical Products of The People's Republic of China, relevant environmental permits and such other governmental permits, licenses and authorizations not required to be procured by Alpharma or Hisun prior to the Effective Date which are necessary to manufacture and sell the Product as contemplated by this Agreement. In the event that Hisun becomes aware of any facts or circumstance that could adversely affect any such authorization or permits in a material way, Hisun will promptly notify Alpharma.

      9.2 Hisun agrees to participate, and request its counsel to participate, in the procurement and retention of the permits, licenses and authorizations referred to in Clause 9.1 to the extent reasonably requested by Alpharma. Both parties covenant and agree that, in all contacts with governmental officials undertaken pursuant to this Agreement, it will not take any action which would cause it, the other party, or any Affiliate of either party, to be in violation of any laws applicable to either party.

      9.3 ****

      9.4 Hisun shall have and maintain all certificates and permits required for providing the Services required under the laws of The People's Republic of China.

      9.5 The Environmental Permit obtained by Alpharma from Zhejiang Province Environmental Protection Bureau on ****, a copy of which is attached hereto as Appendix 8A (the " Environmental Permit ") includes a term that Hisun must cease production of certain products. Hisun hereby warrants and undertakes to comply with those terms of the Environmental Permit specifically relating to Hisun including without limitation to cease production of the products specified in the Environmental Permit on the terms specified therein, and to take all such actions as reasonably required by the environmental agencies of the People's Republic of China in respect of obtaining and maintaining the Environmental Permit. In addition to the above, and without in any way limiting the obligations set forth above, Hisun hereby agrees to sign the separate letter agreement concerning waste water volumes attached as Appendix 8B attached hereto.

10 Services related to Storage and Shipping of Product

    • 10.1 Upon completion of manufacture, Product manufactured in the Manufacturing Facility will be stored by Hisun in accordance with the Technical (GMP) Agreement and Alpharma's instructions, standards and specifications at appropriate warehouse facilities at **** until shipment to Alpharma's customers or Alpharma's Affiliates. Hisun shall provide the services under this Clause 10.1 only until such time as the New Facility has been delivered to Alpharma according to the Acquisition and Construction Agreement and is fully qualified and operational, as Alpharma will take over the storage of Product (but not raw materials) at the warehouse facilities at **** at such time.

      10.2 Alpharma is responsible for arranging for shipment of the Product to Alpharma's customers. Hisun shall assist in respect of loading, discharge and related matters in accordance with Alpharma's commercially reasonable instructions. Alpharma shall be responsible for all logistical and sales support-related activities and all communications with its customers. Hisun will not be responsible for the loss of the Product except for that caused by the fault of Hisun during storage.

      10.3 For the avoidance of doubt, title to Product shall remain with Alpharma at all time and shall not at any time pass to Hisun.

      10.4 Hisun will provide commercially reasonable assistance requested by Alpharma in order to enable Alpharma to supply, in a timely manner, an export Certificate of Origin for all Products requiring such a Certificate and any other supporting documentation that Alpharma may require to export the Product to any destination country.

11 Production Plan

    • 11.1 On or before 1 October of each Calendar Year, Alpharma shall submit to Hisun in writing Alpharma's non-binding estimate of quantity of Product Alpharma intends to manufacture at the Manufacturing Facility during the next Calendar Year (the " Production Plan "). Alpharma will revise and update the Production Plan before the beginning of each Calendar Quarter or more frequently if appropriate.

12. Interruptions and Delays

    • 12.1 Hisun shall use reasonable commercial efforts to provide the Services in accordance with the Production Plan. If any activity constituting a part of the Services becomes subject to interruption or delay that may involve a risk of delays in respect of the Production Plan, for any reason, Hisun shall provide Alpharma with prompt written Notice of each such interruption or delay.

      12.2 Hisun shall, contemporaneously with the Notice in Clause 12.1, give Alpharma written Notice about when it reasonably believes it will be capable again of performing the Services in accordance with the Agreement, including information on the actions Hisun will take to overcome the interruption or delay. If the interruption or delay lasts for more than 30 (thirty) days, the Parties will review the situation and discuss possible additional measures to be taken by Hisun in order to overcome the interruption or delay and remedy the consequences thereof.

13 Change Management

    • 13.1 Alpharma may at any time during the Term request changes to the Services (hereinafter a " Change "). All Changes will be decided and implemented in accordance with the following:

        • 13.1.1 If Hisun reasonably believes that a Change requested by Alpharma will result in increased out-of-pocket costs for Hisun that should not reasonably be covered by the Service Fee, Hisun shall inform Alpharma of its belief as soon as possible after having received the Change request. Alpharma shall then have the option of confirming or canceling the Change. Should Alpharma confirm the Change, any actual increased out-of-pocket costs shall be charged by Hisun and paid by Alpharma pursuant to Clause 14.5 only if Hisun can establish such increased cost has been incurred.

          13.1.2 Unless a requested Change cannot be implemented within a reasonable time because the Know-How or the status or condition of the Manufacturing Facility cannot support such Change, if Hisun does not implement a requested Change within a reasonable time, and the change is required by a governmental regulation or the terms of an Alpharma DMF, Alpharma is entitled to terminate this Agreement with 3 (three) months written Notice, unless Hisun implements the requested Change during such 3 (three) months' period.

          13.1.3 Hisun shall not make any Changes without the prior written request or consent of Alpharma.

      13.2 All changes to the manufacturing process or other matters that may have an impact on any Regulatory Document shall be decided and implemented in accordance with Appendix 6 . Hisun shall not make any such changes without the prior written request or consent of Alpharma. Once a Regulatory Document has been filed by Alpharma with a Governmental Agency, Hisun agrees to take no action that would invalidate, require a modification or otherwise jeopardize the information included in such Regulatory Document.

14. Fees

    • 14.1 In consideration of the Services provided by Hisun to Alpharma under the Agreement, Alpharma shall pay the " Service Fee " specified in Clause 14.2 and reimburse certain direct costs as specified in Clause 14.5.

      14.2 ****

      14.3 ****

      14.4 ****

      14.5 In addition to the Services Fee and the Shared Services Fee, Alpharma shall reimburse (a) Hisun's documented actual and direct costs as specified in Appendix 2 relating to (i) the supply of utilities in accordance with Clause 3 and (ii) waste water discharge and other environmental volume-dependent operating costs expressly specified in Appendix 2 and in accordance with Clause 5.2; and (b) Hisun's documented actual and direct out-of-pocket costs relating to the following: (i) the supply of maintenance in accordance with Clause 3, (ii) quality control and quality assurance services in accordance with Clause 4.5; (iii) Changes in


 
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