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EXHIBIT 10.33
PROCESSING SERVICES AGREEMENT
PROCESSING SERVICES AGREEMENT (the "Agreement") made and effective as of
December 16, 1997 by and between Amgen Inc. ("Amgen"), Amgen Center, 0000
XxXxxxxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000-0000 and Xxxxx-Xxxxx Division
of Xxxxxx-Xxxxxxx Company ("PD"), 000 Xxxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000.
WITNESSETH:
WHEREAS, Amgen is engaged in the development and commercialization of
pharmaceutical products.
WHEREAS, PD possesses suitable facilities to formulate, sterile filter,
aseptically fill, lyophilize, label and package pharmaceutical products
according to the Amgen specifications set forth herein and in accordance with
the terms of this Agreement.
WHEREAS, Amgen and PD now desire to contract for the Processing (as
hereinafter defined) by PD of certain quantities of Amgen products on the terms
and conditions set forth herein.
NOW THEREFORE, in consideration of the foregoing premises and the mutual
covenants which are recited herein, the parties agree as follows:
ARTICLE I
DEFINITIONS
1.1 "ACTUAL YIELD" shall mean the actual number of Vials in compliance with
all Specifications resulting from the Processing of a given quantity of
Product.
1.2 "BATCH" shall mean a single lot of Product.
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1.3 "CONFIDENTIAL INFORMATION" shall mean all confidential information
disclosed by one party to this Agreement to the other party at any time
prior to or during the term of this Agreement which disclosure is
pursuant to or in furtherance of this Agreement, except that which the
party receiving such Proprietary Information can establish by competent
evidence:
(i) was known to the receiving party at the time of disclosure; or
(ii) was generally available to the public or was otherwise part of
the public domain at the time of disclosure; or
(iii) became generally available to the public or became otherwise
part of the public domain after disclosure and other than
through any act or omission of the receiving party, its agents
or employees, in breach of this Agreement; or
(iv) was independently developed by the receiving party without the
aid, application or use of the Proprietary Information
disclosed; or
(v) became known to the receiving party after disclosure from a
source who had the lawful right to disclose such information,
other than the disclosing party, and other than from a third
party who had an obligation to the disclosing party not to
disclose such information to others.
(vi) legal counsel to the receding party has determined is required
by law to be disclosed, provided however, prior to disclosure
by the receiving party the receiving party shall notify the
disclosing party and provide the disclosing party with the
opportunity to seek an appropriate protective order.
1.4 "EXPECTED YIELD" shall mean (i) with respect to formulated bulk Product
the quantity of finished Vials that can reasonably be achieved in PD's
judgment from the Processing of a Batch in accordance with the
Specifications in light of fluid losses due to filtration, overfills,
etc. and vial losses due to container or product defects and (ii) with
respect to unformulated bulk Product shall be as agreed by the parties
and shall be based on PD's specific experiences at the Facility with
Product
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and PD's experience with other products of similar fill and product
characteristics. This yield is to be acceptable to both parties.
1.5 "FACILITY" shall mean Xxxxx-Xxxxx' facility located at 000 Xxxxxxxxx
Xx., Xxxxxxxxx, Xxxxxxxx 00000.
1.6 "FINISHED PRODUCT" shall mean Product Processed in accordance with the
Specifications.
1.7 "MATERIALS" shall mean bulk Product (formulated and/or unformulated)
and Processing Materials.
1.8 "ORTHO BIOTECH" shall mean Ortho Biotech Division of Ortho
Pharmaceutical Corporation.
1.9 "PROCESSING MATERIALS" shall mean filling and/or packaging components
as are reasonably necessary for utilization in the Processing,
including, without limitation, vials, filters, seals, stoppers,
silicone and silicone tubing, labels, unit cartons, shelf cartons,
packaging inserts and plastic trays.
1.10 "PROCESS" shall mean with respect to any Product, receive, store,
filter, formulate, sterile filter, aseptically fill, lyophilize (if
applicable), inspect, label, package and ship Product according to the
Specifications. "Processing" and "Processed" shall have comparable
meanings.
1.11 "PROCESSING FEE" SHALL mean the fee for Processing calculated as set
forth in Exhibit B and payable as set forth in Section 2.8.
1.12 "PRODUCT" shall mean EPOGEN(R) (epoetin alfa), NEUPOGEN(R)
(filgrastim), STEMGEN(R) (ancestim), XXXX, XXXX, XX-0, XXX, Xxxxxx and
any other biological or chemical product intended for human
pharmaceutical use provided by Amgen to PD for Processing.
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1.13 "RESERVATION FEE" shall mean the annual reservation fee as set forth in
Section 2.8.
1.14 "REWORK" shall mean with respect to any Batch of Product which
following Processing fails to meet Specifications, the recovery,
sterile filtration and filling of such Product into Finished Product.
Rework methodology shall be prepared by Amgen and be subject to
approval by PD Quality Assurance. Reworked Product will be processed in
accordance with the requirements of Section 2.3 and the Specifications.
1.15 "SPECIFICATIONS" shall mean the procedures, test results, requirements,
standards and other data and shall include the services set forth
herein and made part hereof as Exhibit A, as such Exhibit may be
revised from time to time upon mutual agreement of the parties.
1.16 "THEORETICAL YIELD" shall mean that quantity of vials that is
achievable by dividing the amount of Product supplied by Amgen by the
target fill weight or volume agreed upon by the parties.
1.17 "Vial" shall mean single chamber vials of between two (2) and twenty
(20) milliliter volumes.
ARTICLE II
SUPPLY AND PROCESSING OF MATERIALS AND WARRANTIES
2.0 AMGEN AUTHORIZED REPRESENTATIVES.
(a) Exhibit C lists the Amgen representatives authorized to act on
Amgen's behalf during interactions with Xxxxx-Xxxxx pursuant to this
Agreement.
(b) The Amgen Contract Manufacturing representatives set forth on
Exhibit C are the sole authorized Amgen representatives for
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delivering Processing requests, production information and scheduling
information ("Production Information").
(c) Production Information which does not originate from an Amgen
Contract Manufacturing representative are for information only and
non-binding. All such production information must be confirmed with
an Amgen Contract Manufacturing representative.
(d) PD will deliver all invoices hereunder to an Amgen Contract
Manufacturing representative for approval.
(e) Amgen Contract Manufacturing may modify Exhibit C from time to
time.
2.1 PRODUCT FORECAST ESTIMATES.
(a) Forecast Estimates. Exhibit D, attached hereto and incorporated
herein, sets forth a good faith estimate of Amgen's requirements for
Processing of commercial and clinical Batches for the calendar year
1998. No less than thirty (30) days before January 1, 1998 and by the
tenth (l0th) of each month thereafter, Amgen will be required to
provide PD with a written rolling six (6) month estimate of Amgen's
requirements for Processing for commercial and clinical Batches. With
respect to commercial Batches, the first two (2) months of this rolling
schedule will be binding upon Amgen plus or minus twenty-five percent
(+/- 25%) such that if Amgen fails to order the quantities specified,
it shall be obligated to pay PD the difference between seventy-five
percent (75%) of the number of Batches set forth in the estimate and
the number of Batches actually Processed. The first two (2) months of
this rolling schedule will be also be binding upon PD plus twenty-five
percent (+ 25%) and PD commits to make the Facility and appropriate PD
personnel available in order to comply with the estimate.
(b) Guarantee. Notwithstanding anything stated in this Agreement to the
contrary, in the event circumstances arise in which Amgen's ability to
finish and fill Product (clinical or commercial) at its own
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facilities is materially impaired as determined in good faith by Amgen,
PD agrees to guarantee Amgen up to four (4) days (wherein one (1) day
consists of twenty-four (24) consecutive hours) of Processing per one
(1) week period on PD's Filling Line 6 or other such Filling Line
(including a Lyophilization Unit as required) mutually agreed to by the
parties, upon fifteen (15) days advance written notice from any
authorized representative of Amgen.
2.2 PROCESSING SCHEDULE. PD will provide Amgen with a proposed Processing
schedule for (i) commercial Batches for the first two (2) months of
Amgen's rolling six (6) month estimate within ten (10) days of receipt
of the estimate and (ii) for clinical Batches for those Batches with
respect to which Amgen shall have submitted a Purchase Order as set
forth in Section 2.2 below within three (3) days of receipt of the
Purchase Order. The parties shall promptly finalize the Processing
schedules. PD agrees to exercise its best efforts to meet the
Processing schedule set forth below.
(a) PD will ship test samples of quantities of Finished Product
specified by Amgen to Amgen within three (3) working days after the
completion of fill or lyophilization.
(b) PD will inspect Vials of Finished Product within five (5) calendar
days after the completion of fill or lyophilization for all Batches.
(c) PD Quality Assurance will send by overnight mail, telecopy or
facsimile, Batch disposition to Amgen within twenty-eight (28) calendar
days of completion of fill or lyophilization.
(d) PD will have Finished Product available for shipment to Amgen
within fourteen (14) calendar days following fill or lyophilization.
Except to the extent set forth in Section 2.1, PD shall not be required
to give preference to Processing Materials over processing of other
products at the Facility. PD shall Process as close to the schedule
(established pursuant to this Section 2.2) as possible, but, in no
event shall PD commence Processing of liquid vial fills later than
fourteen
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(14) days beyond the schedule for commencement of Processing. In the
event that PD Processes liquid vial fills later than the fourteen (14)
days beyond such scheduled completion date of Processing, for reasons
other than sterility or force majeure, in which case PD shall have no
liability for any such delay or failure to process as scheduled, PD's
sole liability shall be to reduce the applicable Processing Fee (as
hereinafter defined) by fifty percent (50%) except that repeated
failure to Process on schedule, for reasons other than sterility or
force majeure, will constitute the basis for termination of this
Agreement by Amgen, repeated failure being defined as during any
successive two (2) month period the failure to Process fifty percent
(50%) or more of Products as scheduled.
2.3 PURCHASE ORDERS. Amgen shall place purchase orders, upon the terms
mutually agreed upon, with PD at least fourteen (14) days prior to the
time scheduled for Processing and PD shall promptly accept such orders
in writing. The terms of this Agreement shall govern any such Purchase
Order and in the event a Purchase Order shall include terms beyond
Product, quantity and date for Processing, none of such other terms
will be enforceable. PD shall use its best efforts to accommodate
Amgen's scheduling requirements taking into due account its own
scheduling requirements. PD will use its best efforts to accommodate
Amgen's request to amend a purchase order to increase or decrease the
number of Batches to be Processed, provided that if Amgen requests
reduced production less than fifteen (15) days prior to the Processing
date, then PD shall not be obliged to comply unless it can reasonably
schedule replacement production with product which had not already been
scheduled for production. If PD is not able to comply, Amgen shall be
obligated to pay PD one-half (1/2) of the Processing Fee(s) which would
otherwise be payable for scheduled Processing which is not undertaken
as scheduled.
2.4 MATERIALS.
(a) Supply. Amgen shall (i) deliver bulk Product intended for
Processing to the Facility at least seven (7) days in advance of
scheduled Processing and (ii) supply approved label text for Amgen
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Product in accordance with the Processing schedule. PD shall provide
all Processing Materials unless otherwise agreed by the parties. Bulk
Product delivered to PD shall have at least fourteen (14) days of shelf
life remaining at 9:00 a.m. on the date such Product is scheduled for
Processing.
(b) Warranty. Amgen warrants that the Product and any Materials
approved and provided by Amgen shall meet the applicable Product and
Material specifications and shall have been produced in compliance with
applicable federal, state and local laws and regulations including,
without limitation, the Good Manufacturing Practices Regulations of the
United States Food and Drug Administration in effect at the time of
Processing ("GMPs").
(c) Conditional Release. Notwithstanding subsection (b) above, Amgen
may ship Materials under conditional release. If Amgen ships Materials
to PD under conditional release, PD shall Process said Materials at
Amgen's written request. PD shall have no liability for such Materials
(other than to store such Materials in a reasonable manner) until PD
has received written notice from Amgen that such Materials comply with
all applicable quality standards or specifications. In the event such
notice is not received by PD within (i) twenty-eight (28) days of
receipt by PD of commercial Materials or (ii) ninety (90) days of
receipt by PD of clinical Materials or if Amgen notifies PD that the
Materials (commercial or clinical) fail to comply with such standards
and specifications, PD shall return such Materials to Amgen at Amgen's
cost. In no event will Amgen deliver to PD materials under conditional
release which may cause damage to the Facility.
2.5 PROCESSING.
(a) Specifications and Applicable Law. PD warrants that Processing
shall be performed in accordance with the Specifications and applicable
federal, state and local laws and regulations, including without
limitation, the GMPs and in the case of clinical/research Materials any
labeling shall include any required cross-references to
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PD's internal production control system. Before, during and after each
Processing, PD shall, with respect to such Processing, obtain samples,
monitor the Processing and Processing environment and keep such records
as all of the foregoing are required by the Specifications and/or Batch
card. PD hereby disclaims any express or implied warranties whatsoever
not expressly set forth in this Agreement with respect to Processing or
performing any other obligations pursuant to this Agreement. The
parties agree that the only remedies of Amgen at law or equity with
respect to damages or losses arising from failure of PD to Process
Batches in accordance with Specifications or as otherwise arising out
of this Agreement shall be as set forth in Sections 2.4, 2.4, 2.7 and
article V of this Agreement.
(b) Yields. A Theoretical Yield will be calculated and an Expected
Yield will be estimated for each Batch and shall be provided to Amgen
prior to Processing of the applicable Batch. If Amgen does not agree
with the PD estimated Expected Yield, the parties shall in good faith
agree, upon a third party to review the data in which PD determined the
Expected Yield and to review PD records and other relevant data
developed by both parties relating thereto. The findings of such third
party shall be binding on both parties. In the event that the Actual
Yield of any commercial Batch is less than ninety-five percent (95%) of
the Expected Yield, Amgen shall be entitled to an investigation of the
reason(s) for the reduced yield of the commercial Batch and, Amgen
shall be entitled to an equitable reduction in the Processing Fee
credited towards the Reservation Fee, if appropriate.
(c) Improvements. Upon the written request of Amgen, PD under the
assistance and direction of Amgen personnel as required, shall
implement any request made by Amgen for the purpose of increasing the
efficiency of Processing ("Improvements") if the requested Improvements
are reasonable and will not adversely affect other operations of PD.
Improvements shall apply but not be limited, to any equipment
operational qualifications, performance qualifications and process
validations. Expenditures made by PD hereunder shall be
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billed directly to Amgen and shall be payable within thirty (30) days
of date of invoice from PD.
2.6 STORAGE, HANDLING, SHIPMENT.
(a) Storage. PD shall store and handle Materials and Finished Product
as required by the Specifications. In addition, PD shall take such
actions as are reasonably necessary to protect Materials from damage
and deterioration.
(b) Shipment. Upon PD quality assurance written release of a Processed
Batch, PD shall promptly ship Finished Product to Amgen or, at Amgen's
discretion, warehouse Finished Product for a maximum of sixty (60) days
at no cost, and thereafter at charges to be mutually agreed upon, to
the extent warehousing space is available. Furthermore under normal
circumstances, PD shall provide Amgen with properly completed Batch
records, prepared in conformance with the Specifications, within five
(5) days following PD's quality control written release of such Batch
but, in no event more than four (4) weeks from the date the Processing
run is completed (i.e., the date the filling or lyophilization is
completed). Amgen shall promptly accept tender of delivery of Finished
Product, either through Amgen employees or authorized shipping agents.
(b) Risk of Loss. Amgen shall retain title to and risk of loss of
Materials supplied by it and shall be responsible for any losses to
such Materials and Finished Product, except for losses directly
attributable to the sole and gross negligence or intentional
malfeasance of PD or its agents or employees and except as expressly
set forth in the other terms of this Agreement.
(c) Shipment to Ortho Biotech. Amgen hereby authorized PD to package
and deliver to Ortho Biotech (pursuant to the Agreement between PD and
Ortho Biotech) such Batches of EPOGEN(R), or portions thereof, as shall
be designated orally or in writing by Amgen. Amgen shall retain title,
risk of loss and be responsible for any losses relating thereto until
such time as labeling is complete on such
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Batches and the FDA releases and Amgen approves the vialed EPOGEN(R)
designated for Ortho Biotech. Amgen will notify PD of any event or
change in circumstance resulting in the withdrawal by the FDA of Ortho
Biotech's ability to receive and distribute EPOGEN(R).
2.7 BATCH TESTING: REJECTION.
(a) Testing. Within sixty (60) days following Amgen's receipt of PD
Quality Assurance written approval of a Batch, Amgen shall complete
testing of such Batch in accordance with the test procedures set forth
in the Specifications.
(b) Rejection. Amgen may reject any Batch of Finished Product failing
to meet any of the Specifications by giving written notice of rejection
to PD within sixty-seven (67) days, following receipt by Amgen of PD
Quality Assurance written approval of such Batch and the applicable
Batch Records. Any claim by Amgen submitted to PD pursuant to this
Section 2.7 shall be accompanied by a report of analysis (including a
product sample from the Batch analyzed), and shall be handled as set
forth below. Amgen's failure to reject Finished Product in the manner
set forth above shall constitute acceptance thereof except to the
extent that any defect in the Batch, which defect substantially impairs
the value of the Batch to Amgen and which would have otherwise
permitted Amgen to reject such Batch pursuant to this Section, was not
discovered by Amgen after exercising due diligence and using customary
testing procedures accepted in the industry and provided that Amgen
notifies PD of any such defect within a reasonable time after Amgen
discovers or should have discovered the defect and before any
substantial change in the condition of the Batch which is not caused by
such defect.
(c) Credits. Should Amgen reject any Batch pursuant to this Section and
PD shall agree that such rejection was justified, PD shall promptly
credit Amgen's account for the Processing Fee paid pursuant to Section
2.8 and for the cost of Materials, (other than Product used in such
Batch), or at Amgen's option, Rework the Batch, at no additional cost
to Amgen, on a priority basis, as mutually agreed to by both
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parties. Should Amgen reject any Batch pursuant to this Section and
should PD, after good faith negotiation, fail to agree that such
rejection was justified, the parties shall mutually agree, such
agreement not to be unreasonably withheld, upon a third party to test
samples of such Batch and to review records and test data and other
relevant information developed by both parties relating thereto to
ascertain liability for the breach. The findings of such third party
shall be binding on both parties. If Amgen is found liable, Amgen shall
pay the costs of such tests and shall be deemed to have accepted the
affected Batch. If PD is found liable, PD shall pay the costs of such
tests and shall promptly credit Amgen's account for the Processing Fee
paid pursuant to Section 2.8 and for the cost of Materials (other than
Product) used in such Batch, or at Amgen's option, Rework the Batch, at
no additional cost to Amgen, on a priority basis, as mutually agreed to
by both parties. Notwithstanding anything to the contrary stated in
this Section, if Amgen and PD are found to be comparatively at fault,
each shall pay the costs of such tests and for the cost of Materials
(other than Product) used in such Batch according to the percentage of
the respective Party's fault.
2.8 PROCESSING FEE AND RESERVATION FEE.
(a) Processing Fees. Amgen shall pay to PD Processing Fees at the rates
set forth in Exhibit B for each Batch of Product Processed. Within
thirty (30) days after the completion of Processing for a Batch, PD
will provide to Amgen an invoice setting forth the Processing Fees for
the Batch. Processing for a Batch will be considered complete for
invoicing purposes when the Batch card has been delivered to Amgen.
(b) Guaranteed Minimum. In consideration of PD's commitment to reserve
for Amgen sufficient Facility capacity to conduct Processing for Amgen
as set forth in the six (6) month rolling forecast delivered by Amgen
to PD in accordance with Section 2.1, Amgen will guarantee to pay PD a
minimum of eight million dollars ($8,000,000) in for Product Processing
hereunder in 1998.
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(c) Payments. In the event Amgen does not incur Processing Fees
hereunder equal to or greater than the Guaranteed Minimum Payment, any
shortfall between the actual Processing Fees for the year and the
Guaranteed Minimum Payment will be payable at year end thirty (30) days
following Amgen's receipt of PD's invoice for all Processing Fees
payable for the year.
2.9 ADDITIONAL COSTS.
(a) Media Fill. In the event that PD's standard media fill, as set
forth in Exhibit A, Number 16, does not fulfill Amgen's requirements or
in the event a media fill of greater than 10,000 Vials per quarter is
required, then Amgen shall be obligated to pay for such media fill at a
rate that does not exceed fifty percent (50%) of the filling and
labeling fee per unit in effect at that time.
(b) Processing Materials. Amgen shall pay for PD's actual costs of all
Processing Materials provided by PD for Product Processing thirty (30)
days of date of invoice from PD.
2.10 INVOICES. All invoices for Processing Services, Processing Materials or
any other costs accruing hereunder shall be delivered to an Amgen
Authorized Representative.
2.11 RECORDS. The parties shall maintain all records and accounts pertaining
to the Processing services performed for a period of at least two (2)
years after final payment. Either Party shall have the right to audit,
copy and inspect said records and accounts at all reasonable times
during the course of the services and for the above two (2) year period
for the purpose of verifying costs incurred and Processing Fees
credited towards the Reservation Fee.
2.12 FACILITIES. PD will provide secure basic office facilities at PD's
Facility including but not limited to, a desk, computer, telephone and
facsimile access, for use by Amgen personnel.
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2.13 PD PERSONNEL. PD shall provide such training of its appropriate
personnel as may be required to Process Batches in a professional
manner, consistent with the Specifications.
ARTICLE III
INDEMNIFICATION
3.1 INDEMNIFICATION BY AMGEN.
(a) Amgen agrees to indemnify, defend and hold harmless
Xxxxxx-Xxxxxxx Company, its divisions and affiliates and their
officers, directors, agents and employees, from and against
all costs, claims, suits, expenses (including attorneys' fees)
and damages arising out of or resulting from the use, sale
and/or distribution of any Finished Product unless such costs,
claims, suits, expenses or damages result from the gross
negligence or willful misconduct of PD. Amgen agrees that in
the event of a personal injury of an Amgen employee in the
course of his/her employment, Amgen will waive and/or cause
its insurance carrier to waive its rights of subrogation to
recover Workmen's Compensation payments made to such employee,
if due to Amgen negligence.
(b) Amgen will defend at its expense any claim brought against
Xxxxx-Xxxxxxx Company, its divisions, affiliates and their
officers, directors, agents and employees to the extent, based
on a claim, that any Product Amgen produces and delivers to PD
for Processing infringes a United States patent or that PD's
Processing of such Product is an infringing use by PD under
such United States patent(s). Amgen will indemnify the above
entitles and persons for any expenses incurred and directly
attributable to any such claim, but only on condition that:
(i) Amgen is promptly notified in writing of any such
claim;
(ii) Amgen shall have sole control of the defense: and
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(iii) PD gives Amgen reasonable information and assistance
for such defense at Amgen's cost.
The foregoing states the entire liability of Amgen concerning
infringement with respect to a Product.
(c) Amgen will indemnify, hold harmless and defend Xxxxxx Xxxxxxx
Company, its divisions, affiliates and their officers,
directors, agents and employees from and against any claim,
demand, action or proceeding which may be brought or asserted
against such persons or entitles to the extent such claim is
based on or arises out of or relates to the sale of EPOGEN(R)
by Amgen to Ortho Biotech.
3.2 LIMITATION OF LIABILITY. Neither Party shall be liable to the other for
indirect, incidental or consequential damages arising out of any terms
or conditions in this agreement or with respect to the performance
thereto. Except as otherwise specifically set forth herein, PD shall in
no event be liable for any costs, expenses, damages, liability of any
kind aggregating more than $200,000 in any one contract year resulting
from or arising out of the services performed hereunder (excluding
Processing Fees for Batches rejected by Amgen pursuant to Section 2.7)
unless there was gross negligence or intentional misconduct by a PD
employee in which case PD's liability will not exceed $500,000 per
occurrence. In the event costs, expenses, damages, liability of any
kind resulting from or arising out of the services performed hereunder
exceed the amounts set forth above, Amgen shall, upon written notice to
PD be entitled to terminate this Agreement.
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ARTICLE IV
CONFIDENTIAL INFORMATION
4.1 NONDISCLOSURE OF CONFIDENTIAL INFORMATION. Except to the extent expressly
authorized by this Agreement, during the term of this Agreement and for
five (5) years after the expiration or termination of this Agreement,
neither Party shall:
(a) disclose, publish or make available any Confidential Information
disclosed to it by the other to any third party, including employees
who do not need to know or have access to such Propriety Information;
(b) sell, transfer or otherwise use or exploit any such Confidential
Information.
4.2 ANNOUNCEMENTS. During the term of this Agreement, neither party shall make
any press release or other disclosure of the terms of this Agreement
without the prior written consent of the other party, except as required by
a court of competent jurisdiction or pursuant to the disclosure
requirements of federal or state regulatory agencies including the
Securities and Exchange Commission.
ARTICLE V
TERM: TERMINATION
5.1 TERM. The initial term of the Agreement shall start on January 1, 1998 and
shall expire on December 31, 1998. Upon written notice to PD no less than
six (6) months prior to December 31, 1998, Amgen shall have the option to
extend this Agreement for an additional one (1) year on the terms and
conditions set forth herein and, in such case, this Agreement will
terminate on December 31, 1999.
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5.2 TERMINATION.
(a) Amgen. Amgen may terminate this Agreement immediately
upon giving notice to PD if (i) PD fails to provide Processing in accordance
with Section 2.1 or (ii) Amgen property rejects, pursuant to Section 2.7, two
(2) consecutive Batches or four (4) Batches within two (2) months for other than
force majeure causes. To be effective, Amgen shall provide notice of termination
within seventy-five (75) days after (i) the end of the quarter in which PD has
failed to provide Processing in accordance with Section 2.1 or (ii) the date of
notice of rejection of the Batch which gives rise to the right of termination.
Upon the termination of this Agreement by Amgen pursuant to this subsection (a),
PD shall within thirty (30) days refund to Amgen any portions of the Reservation
Fee which have not been applied to Processing services hereunder prior to the
date of termination.
(b) Either Party. Either party may terminate this Agreement upon giving sixty
(60) days prior notice to the other if the other party commits or permits a
material breach of any of the terms of this Agreement and if such breaching
party does not remedy such breach within the sixty (60) days following receipt
of notice from the nonbreaching party. Upon the termination of this Agreement by
Amgen pursuant to this subsection (b), PD shall within thirty (30) days refund
to Amgen any portions of the Reservation Fee which have not been applied to
Processing services hereunder prior to the date of termination. Upon the
termination of this Agreement by PD pursuant to this subsection (b), Amgen shall
within thirty (30) days pay PD for all Processing services hereunder prior to
the date of termination which have not been credited against the Reservation
Fee.
(c) Bankruptcy. Either party may terminate this Agreement, effective
immediately upon the giving of written notice, if the other party shall file a
petition for bankruptcy, or shall be adjudicated as bankrupt, or shall take
advantage of the insolvency laws of any state of the United States, or shall
make an assignment for the benefit of creditors, or shall have a receiver,
whether appointed by private instrument or court officer appointed for its
property. Upon the
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termination of this Agreement by Amgen pursuant to this subsection (c),
PD shall within thirty (30) days refund to Amgen any portions of the
Reservation Fee which have not been applied to Processing services
hereunder prior to the date of termination. Upon the termination of
this Agreement by PD pursuant to this subsection (c), Amgen shall
within thirty (30) days pay PD for all Processing services hereunder
prior to the date of termination which have not been credited against
the Reservation Fee.
5.3 EFFECT OF TERMINATION. The termination of this Agreement shall not
operate to relieve PD from its obligation to Process and deliver all
Finished Product ordered by Amgen prior to receipt of notice of such
termination unless such termination is effected pursuant to Section 5.2
(b) or (c) or of Amgen's obligation to accept delivery of Finished
Product and pay for such Processing, unless such termination is
effected as a result of a breach of this Agreement by PD pursuant to
Section 5.2(b) or (c). In the event of a termination pursuant to this
Agreement, PD shall return to Amgen or its designee all equipment and
unused Materials and equipment theretofore supplied by or on behalf of
Amgen. return shall be at the expense of PD if termination is by Amgen
pursuant to Section 5.2 (a), (b) or (c) and, if not, shall be at
Amgen's expense.
ARTICLE VI
MISCELLANEOUS
6.1 NO WAIVER. Failure of either party to insist upon strict observance of
or compliance with any of the terms of this Agreement in one or more
instances shall not be deemed to be a waiver of its rights to insist
upon such observance or compliance with the other terms hereon with
respect to subsequent failures in the future.
6.2 NOTICES. All notices and demands required or permitted to be given or
made pursuant to this Agreement shall be in writing and given by
certified or registered mail, postage prepaid and properly addressed,
to
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the address of the party to be notified as shown below, except as
otherwise specified in the other terms of this Agreement.
If to Amgen: Amgen Inc.
Amgen Center
0000 XxXxxxxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Attn: Xxxxxx Xxxxxx
Xx. Vice President, Operations and
Process Development
If to PD: Xxxxx-Xxxxx Division of Xxxxxx-Xxxxxxx
Company
000 Xxxxxxxxx Xxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: Xxxxxx Xxxxx
Vice President
With a Copy To: Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attn: Vice President, General Counsel
or to such other address as to which either Party may notify the
other. Notice shall be effective on the date it is received.
6.3 ASSIGNMENT. This Agreement shall be binding upon and inure to the
benefit of the parties, their successors and permitted assigns.
Neither party may assign this agreement without the prior written
consent of the non-assigning party, which consent will not be
unreasonably withheld, provided that PD may assign this Agreement to
any purchase of all or substantially all of the assets of the Facility.
6.4 GOVERNING LAW. This Agreement is governed by the laws of the State of
Delaware.
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6.5 FORCE MAJEURE. Neither party shall be liable to the other for loss or
damages, or, except as expressly provided in this Agreement, have any
right to terminate this Agreement for any default or delay preventing
or materially impairing performance by a party to this Agreement and
attributable to any act of God, flood, fire, explosion, breakdown of
plant, strike, lockout, earthquake, labor dispute, casualty, accident,
war, revolution, civil commotion, act of a public enemy, blockade,
embargo injunction, law, order, proclamation, regulation, ordinance,
demand or requirement of any government, or any other cause beyond the
reasonable control of such party. In the event such a default or delay
occurs, the party affected shall notify the other party and shall
exercise diligent efforts to resume performance of its obligation as
soon as possible.
6.6 FURTHER ACTIONS. The parties (but at no out-of-pocket expense to PD)
agree to execute, acknowledge and deliver such further instruments and
to do all such other incidental acts as may be reasonably necessary or
appropriate to carry out the purpose and intent of this Agreement.
6.7 SEVERABILITY. In the event any one or more of the provisions of this
Agreement should for any reason be held by any court or authority
having jurisdiction over either of the parties or this Agreement to be
invalid, illegal or unenforceable, such provision or provisions shall
be validly reformed so as to as nearly approximate the intent of the
parties as possible or, if unreformable, shall be divisible and
deleted in such jurisdiction; elsewhere, this Agreement shall not be
affected.
6.8 INDEPENDENT CONTRACTORS. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee
or joint venture relationship between the parties. All activities by
the parties hereunder shall be performed by them as independent
contractors. Neither party shall incur any debts or make any
commitments for the other party, except to the extent specifically
provided herein.
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6.9 NONSOLICITATION. During the term of this Agreement including renewals
and for one (1) year thereafter, Amgen agrees not to solicit in any
manner directly or indirectly the employment of PD employees who work
at the Facility excepting those employees who have been terminated or
laid off by PD. Similarly, PD agrees during the term of this Agreement
including renewals and for one (1) year thereafter, not to solicit
directly or indirectly the employment of Amgen employees who have
physical contact with the Facility in connection with the performance
of this Agreement. The foregoing limitation shall not apply to general
solicitations through advertising and similar means not specifically
directed to PD or Amgen, as the case may be.
6.10 EXCLUSIVE PROCESSING. PD agrees that it shall not perform Processing
of Product for any other party, not a licensee of Amgen, during the
term of this Agreement.
6.11 PRECEDENCE. In the event of an inconsistency between the terms of the
text of this Agreement and the Specifications or other Exhibits, the
terms of this text of this Agreement shall take precedence and control.
6.12 CAPTIONS. The parties agree that the headings in the Agreement are
used for the convenience of the parties only and are not intended to
be used in the interpretation of this Agreement.
6.13 REFERENCE TO PD. Finished Product shall be marketed without label
reference to PD or any of its subsidiaries or affiliates except to the
extent required by law in which case any label reference shall be to
Xxxxxx-Xxxxxxx Company as manufacturer only.
6.14 SURVIVAL. The warranties, indemnification and confidentiality
obligations expressly set forth herein shall survive the termination
or expiration of the term of this Agreement.
6.15 AMENDMENTS. The terms of this Agreement represent the entire agreement
of the parties with respect to the subject matter herein and shall not
be amended or supplemented except in a written document
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duly executed by a duly authorized representative of each party. No terms
of any purchase order of Amgen issued pursuant to and in accordance with
the terms of this Agreement and accepted in writing by PD shall be binding
on the parties except for Batch quantities and Batch Processing and
delivery dates set forth in such purchase orders.
6.16 CHANGES IN PD PLANT OPERATING PROCEDURES. In the event that PD, during the
term of this Agreement, makes changes in its plant operating procedures
applicable, in whole or part, to the Facility, which it shall be free to
do, PD shall promptly notify Amgen of the nature and effective date of such
changes on a quarterly basis, the first month of the following calendar
quarter.
6.17 EQUAL EMPLOYMENT/AFFIRMATIVE ACTION. Unless otherwise specifically
exempted, this Agreement must be performed in material compliance with all
applicable equal employment/affirmative action requirements and all
amendments thereto and any applicable federal, state and local regulations,
rules and orders issued thereunder including, without limitation, Title VII
of the Civil Rights Act of 1964, Executive Order Xx. 00000, Xxxxxxxxx Xxxxx
Xx. 00000 as amended by Executive Order 11375, sections (1) and (3) of
Executive Order 11625 relating to the promotion of minority business
enterprises and the implementing rules and regulations of the General
Services Administration, the Americans with Disabilities Act, the Vietnam
Veterans Readjustment Assistance Act of 1974, the Fair Labor Standards Act
and the Rehabilitation Act of 1973, all of which including the contract
clauses required and regulations promulgated thereunder are incorporated
herein by reference.
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IN WITNESS WHEREOF, the parties have executed this Agreement effective on
the date first set forth above.
AMGEN INC. XXXXX-XXXXX DIVISION OF
XXXXXX-XXXXXXX
/s/ Xxxxxx Xxxxx 12/17/97 /s/ Xxxx Xxxxxxxx
------------------------------------ ------------------------------
BY: Xxxxxx Xxxxx BY: Xxxx Xxxxxxxx
TITLE: Vice President TITLE: Vice-President
Manufacturing
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