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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
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Agents
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has the meaning specified in Clause 24.2.
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Agreement
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has the meaning specified in the preamble
above.
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Change
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has the meaning specified in Clause 13.1.
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****
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has the meaning specified in Clause 14.2.
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Environmental Permit
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has the meaning specified in Clause 9.5.
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Initial Term
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has the meaning specified in Clause 25.1.
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****
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has the meaning specified in Clause 14.2.2.
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****
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has the meaning specified in Clause 14.2.
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Production Plan
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has the meaning specified in Clause 11.1.
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Recipient
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has the meaning specified in Clause 24.1.
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Renewal Term
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has the meaning specified in Clause 25.1.
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Service Fee
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has meaning specified in Clause 14.1.
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Shared Service Fee
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has meaning specified in Clause 6.1.
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Term
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means the term of the Agreement as provided in
Clause 25.1.
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Territory
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means worldwide.
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Trademarks
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means the trademarks of Alpharma listed in Appendix
1.
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2. Services
3. Services related to the
Maintenance of the Manufacturing Facility; Utilities
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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:
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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
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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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