CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED
MANUFACTURING and SERVICE
CONTRACT
For Commercial and Developmental Products
This document
hereinafter the “AGREEMENT” is made effective as of
December 20, 2005 (the “Effective Date”), by
Pharmion, Inc., a corporation organized and existing under the laws
of Delaware, with its principal office at 2525 28
th Boulder, CO 80301 (hereinafter
“CUSTOMER”), and Ben Venue Laboratories, Inc., a
corporation organized and existing under the laws of Delaware, with
its principle office at 300 Northfield Road, Bedford, Ohio, 44146
(hereinafter “BVL”).
WHEREAS,
CUSTOMER is active in the pharmaceutical business and is the owner
of all rights or licensee of all rights to certain proprietary
technical information, patents and patent applications relating to
the PRODUCT(s) included in Attachment(s) A — PRODUCT
Supplements, which are attached here to and maybe be amended in
writing upon mutual agreement of the parties, (hereinafter
“PRODUCT”); and
WHEREAS, BVL
provides services to the pharmaceutical industry as a contract
manufacturer which supplies its customers with sterile finished
dosage forms which it has converted from materials supplied by
those customers and/or supplied by BVL and provides developmental
services for sterile dosage forms, and
WHEREAS,
CUSTOMER and BVL desire to formalize their relationship through
this AGREEMENT for the development and MANUFACTURE of PRODUCT;
and
WHEREAS, BVL
possesses the requisite expertise, personnel and FACILITIES for the
development, MANUFACTURE and supply of finished sterile dosage
forms of the PRODUCT and is willing to provide development
services, MANUFACTURE of such PRODUCT(S) on a contract basis to
CUSTOMER;
NOW, THEREFORE,
in consideration of the foregoing and of the mutual covenants and
conditions herein contained, CUSTOMER and BVL agree as
follows:
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Section 1
— Definitions
Section 2 — Description of Work
Section 3 — Manufacturing Facilities
Section 4 — Volumes and Second Source
Section 5 — Forecast and Purchase Orders
Section 6 — Price and Payment
Section 7 — Quality Agreement
Section 8 — Indemnification
Section 9 — Confidentiality
Section 10 — Term and Termination
Section 11 — Notices
Section 12 — Waiver
Section 13 — Assignment
Section 14 — Governing Law
Section 15 — Force Majeure
Section 16 — Title of Materials
Section 17 — Debarment
Section 18 — Entire Agreement
Section 19 — Severability
Section 20 — Independent Contractor
Section 21 — Amendments
Section 22 — Headings
Section 23 — Review by Legal Counsel
Section 24 — Recalls
Article 25 — English Language
Attachment A
— PRODUCT Supplements
Attachment B — Purchase Order Requirements
Attachment C — Storage Fees
Attachment D — Documents Supplied with BATCH Release
Attachment E — Quality Agreement
Attachment F — Customer Supplied Equipment
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1.1 Active
pharmaceutical ingredient hereinafter “API”, shall mean
bulk supplies of the pharmacologically active compounds listed for
the PRODUCT(S) included in Attachment(s) A, which CUSTOMER will
provide to BVL in bulk form, from time to time, for the sole
purpose of MANUFACTURING and/or DEVELOPMENT of the PRODUCTS for
CUSTOMER.
1.2
“AFFILIATE” shall mean (1) any corporation or
business entity fifty percent (50%) or more of the voting stock or
voting equity interests of which are owned directly or indirectly
by a party; or (2) any corporation or business entity which
directly or indirectly owns fifty percent (50%) or more of the
voting stock or voting equity interests of a party; or (3) any
corporation or business entity directly or indirectly controlling
or under control of a corporation or business entity as described
in (1) or (2).
1.3
“AGENCY” or “AGENCIES” shall mean the U.S.
Food and Drug Administration (hereinafter the “FDA”)
Canadian Health Protection Branch, European Agency for Evaluation
of Medicinal Products, hereinafter the “EMEA” and/or
any successor organization of any such entity and any other
government regulatory authority involved in granting approvals for
the MANUFACTURING of the PRODUCTS for any TERRITORY, as such other
AGENCIES are mutually agreed upon by the parties in
writing.
1.4
“BATCH” shall mean a standard quantity of PRODUCT for
each MANUFACTURE expressed in units as defined in Attachment(s) A
of this agreement.
1.5
“cGMP” shall mean all laws and regulations relating to
the MANUFACTURING of PRODUCT(S), including, but not limited to, the
Current Good Manufacturing Practices as specified in the United
States Code of Federal Regulations, the EU Good Manufacturing
Guidelines and any other applicable laws, guidelines and/or
regulations. In the event of conflict Current Good Manufacturing
Practices as specified in the United States Code of Federal
Regulations specifically as defined by 21 Code of Federal
Regulation Sections 210, 211, et seq. will
prevail.
1.6
“CALENDAR QUARTER” shall mean shall mean each period of
three full consecutive calendar months ending March 31,
June 30, September 30 and December 31, as the case
may be.
1.7
“COMPOSITION” shall mean any components and/or raw
materials that are used in the MANUFACTURING of PRODUCTS as listed
in ATTACHMENT(s) A, hereto.
1.8
“DELIVERY” shall be FCA FACILITY (Incoterms 2000) as
per CUSTOMER’S instructions required on PURCHASE
ORDERS.
1.9
“EQUIPMENT” shall mean the equipment described in the
BVL Master BATCH Record which is owned or leased by BVL or owned
and leased by the CUSTOMER, included in Attachment
F—(Customer Supplied Equipment List) and will be used by BVL
for MANUFACTURING of PRODUCTS in accordance with the terms and
conditions of this
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1.10
“FACILITY” or “FACILITIES” shall mean
BVL’S FACILITY located at 300 Northfield Road, Bedford, Ohio
and all other BVL FACILITIES used in the MANUFACTURING of PRODUCTS;
provided that such other FACILITIES have been agreed upon by the
parties in writing in advance.
1.11
“FIRM ORDER” shall mean a binding commitment, as
established by a PURCHASE ORDER by CUSTOMER to have a BATCH as
defined in Attachment(s) A of PRODUCT(S) MANUFACTURED by BVL
hereunder.
1.12
“IMMEDIATE/IMMEDIATELY” shall mean within twenty-four
(24) hours.
1.13
“INVESTIGATION” shall mean a detailed and thorough
review of any atypical or MANUFACTURING deviation (or any other
matter requiring review pursuant to the terms of this AGREEMENT)
documented in a written report, approved at a senior management
level. Each such written report shall include, without limitation,
a detailed description of the atypical event, deviation or other
matter, all steps taken to review such atypical event, deviation or
other matter, a root cause analysis, what other lots of CUSTOMER
PRODUCT were affected, if any, the proposed and/or taken corrective
actions with applicable timelines and a recommendation for
permanent correction.
1.14
“MANUFACTURE / MANUFACTURING/ MANUFACTURED” shall mean
all operations of BVL in the production, packaging, labeling,
warehousing, quality control testing, including in-process, release
and stability testing when applicable, release and shipping of
PRODUCTS to meet the SPECIFICATIONS for the PRODUCTS.
1.15
“NDA” shall mean New Drug Application.
1.16
“PRODUCT(S)” shall mean the final packaged dosage forms
listed separately in each Attachment(s) A to this
agreement.
1.17
“PROMPT/PROMPTLY” shall mean within thirty
(30) days.
1.18
“PURCHASE ORDER” shall mean a written form submitted by
CUSTOMER to BVL authorizing the MANUFACTURE of the PRODUCT or other
services as specified on the form, which references this agreement,
or a quotation number provided by BVL or other document provided by
BVL outlining the services to be performed and the price to be paid
for each service listed on the PURCHASE ORDER according the
PURCHASE ORDER requirements contained in Attachment B.
1.19
“SPECIFICATIONS” shall mean the specifications,
SOP’s and quality standards for PRODUCT(S) contained or
referenced in the Master BATCH Record for each PRODUCT or as
otherwise mutually agreed to in writing by the parties in
accordance with standard procedures of BVL.
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1.20
“TERRITORY” shall mean all countries of the
world.
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ARTICLE 2 — DESCRIPTION OF
WORK
2.1 CUSTOMER
shall at its own expense supply BVL with sufficient quantities of
API and CUSTOMER supplied COMPOSITION needed for the MANUFACTURE of
the PRODUCT as specified in the forecast and supporting PURCHASE
ORDERS, in order to meet CUSTOMER’S requirements for
commercial and/or developmental quantities of PRODUCT in finished
dosage form. CUSTOMER supplied COMPOSITION shall be delivered to
BVL at least four weeks in advance of the scheduled MANUFACTURING
date.
2.2 Pursuant to
subsequent provisions of this AGREEMENT, BVL shall MANUFACTURE
CUSTOMER’S requirements for commercial and clinical
quantities of PRODUCT in finished packaged dosage form as defined
in Attachment(s) A. Such PRODUCT shall meet the SPECIFICATIONS.
Subject to BVL’S prior written consent, such consent not to
be unreasonably withheld, CUSTOMER may, from time to time, change
SPECIFICATIONS, which may be subject to new pricing provided by BVL
to CUSTOMER.
2.3 Upon
CUSTOMER’S request and at its expense BVL will perform
development work on the PRODUCT(s) per outlined proposals that are
submitted to CUSTOMER by BVL based on information provided to BVL
by CUSTOMER and that are agreed upon by both parties in writing via
a PURCHASE ORDER for the service referencing the Quotation Number
provided.
2.4 Upon
written request BVL will provide CUSTOMER with a written proposal
to provide services for preparing summary reports of all BATCH
MANUFACTURING during a calendar year to be used by CUSTOMER in
preparing its Annual Report for the product. CUSTOMER will confirm
its acceptance of proposal via a non-cancelable PURCHASE ORDER
authorizing BVL to commence such service.
3.1 BVL
represents that it has obtained, and will maintain at its sole cost
and expense throughout the term of this AGREEMENT, all relevant non
PRODUCT specific approvals required (so far as they are made known
to BVL) by the AGENCIES for its MANUFACTURING FACILITIES and that
its MANUFACTURING FACILITIES conform, and will throughout the term
of this AGREEMENT conform, to the applicable cGMP and conform, or
will conform, to similar requirements of all AGENCIES having
jurisdiction over the MANUFACTURE of the PRODUCT at any time during
the term of this AGREEMENT. No change affecting any government
submission or approval required for the PRODUCT, either foreign or
domestic, shall be made without prior written consent of CUSTOMER
and in accordance with the Quality Agreement Attachment E of this
AGREEMENT between both parties. Further, BVL will, at its sole cost
and expense, obtain and maintain all non PRODUCT specific licenses,
permits, certifications and approvals from any other local state,
or federal governmental authorities which are or may become
necessary for the MANUFACTURE of the PRODUCT. No changes to
BVL’S MANUFACTURING FACILITIES, equipment, testing
procedures, validation, suppliers of raw materials and components,
or documentation systems that are specific to the PRODUCT shall be
made without the prior written consent of
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CUSTOMER,
unless required by an AGENCY, in such case BVL will notify
CUSTOMER.
3.2 BVL
warrants that PRODUCT delivered to CUSTOMER pursuant to this
AGREEMENT shall conform with the SPECIFICATIONS, and be in
compliance with all applicable laws and regulations, and be in
compliance with all regulatory requirements of AGENCIES, in the
event of conflicting laws and regulations, compliance will be
referenced by the then current 21 Code of Federal Regulation
Sections 210, 211, et seq .
3.3 All
documents and updates with regard to the MANUFACTURE of the PRODUCT
which are required by any AGENCY shall be provided by BVL, and BVL
shall submit to all inquiries and inspections by any such AGENCY.
All PRODUCT specific documents provided by BVL to any AGENCY shall
be provided to CUSTOMER, in advance if feasible, and in no case
shall such documents be provided to CUSTOMER no later than five
(5) business days after such documents are provided to any
AGENCY. BVL shall promptly notify CUSTOMER of all scheduled AGENCY
inspections concerning the PRODUCT, whereupon CUSTOMER shall have
the right to be present for such inspection. Any and all redacted
written communications from any AGENCY pertaining to or affecting
the PRODUCT shall be provided to CUSTOMER no more than five
(5) business days after such communications are received by
BVL. CUSTOMER shall provide BVL with copies of all regulatory
agency approvals for PRODUCT(S) for both clinical studies and
commercial use, in addition CUSTOMER shall provide BVL with two
year advance plans for all planned filings with any
AGENCY.
3.4 For all
routine commercial and/or special BATCH MANUFACTURE, BVL will
conduct all MANUFACTURING and development operations required for
the MANUFACTURE of the PRODUCT. Dispensing operations are to be
performed using appropriate safety measures and containment
techniques as dictated by current health, safety and environmental
regulations, laws, AGENCY rules and regulations, and industry
standards, provided such safety measures and containment techniques
are harmonized.
ARTICLE 4 — VOLUMES &
SECOND SOURCE
4.1 BVL shall
supply CUSTOMER with CUSTOMER’S requirements of clinical and
commercial PRODUCT in accordance with the terms of this AGREEMENT
and for the TERRITORY. CUSTOMER will purchase from BVL and BVL will
supply to CUSTOMER the quantities of the PRODUCT listed in
Attachment A for the TERRITORY pursuant to the terms of the
AGREEMENT and subject to the limitation in
Article 5.
4.2 CUSTOMER
appoints BVL as the principal supplier for its requirements of
those PRODUCT(S) listed in ATTACHMENT A(s). Principle supplier
shall mean that CUSTOMER will procure from BVL at least 65% of its
total requirements for all TERRITORIES for the PRODUCT(s). CUSTOMER
may qualify at its discretion and cost other Third-Party
contractors as it deems necessary to ensure uninterrupted supply
and/or regulatory approvals in its TERRITORY, such quantities will
not be included in Attachment(s) A. BVL and CUSTOMER acknowledge
that quantities provided in forecasts in accordance with this
AGREEMENT shall represent at least 65% of the total demand for
PRODUCT by CUSTOMER on an annual basis.
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CUSTOMER may
qualify a second source of supply other than BVL and may secure
PRODUCT(S) from that second source. However, no Confidential
Information, as defined in Article 9, disclosed there under by
BVL to CUSTOMER shall be disclosed to such second source, it being
understood that any PRODUCT specific information contained in the
Master Batch Record is not confidential to BVL and may be disclosed
to the second source.
4.3 In addition
CUSTOMER can qualify a second source principal supplier of
PRODUCT(S) for TERRITORY if (i) BVL has materially failed to
meet CUSTOMER’S orders for a period of more than three (3)
consecutive months on accepted PO’s and said orders have been
placed according to the terms of this AGREEMENT, or (ii) BVL
has committed to an anticipatory breach of this AGREEMENT, or
(iii) a Force Majeure has occurred which CUSTOMER reasonably
believes will affect BVL’s ability to supply PRODUCT for a
period of at least three (3) months (iv) BVL is
non-Compliant with the regulations required to MANUFACTURE PRODUCT
and is unable to cure such non-compliance. In the case of a Force
Majeure, any of the above four types of occurrences or other
material failure, both parties agree that CUSTOMER may use a second
source as a principal supplier to supply all or some of the
CUSTOMER’S needs until BVL is able to recommence production;
provided that both parties shall agree upon a date to resume such
production for CUSTOMER in an orderly manner. BVL shall assist
CUSTOMER in transferring the MANUFACTURING Process to a Third-Party
Contractor by providing technical assistance and documentation as
necessary at mutually agreed upon fees provided.
ARTICLE 5
— Forecasts and Purchase Orders
5.1 Forecasts
and Purchase Orders
CUSTOMER and
BVL shall cooperate in estimating and scheduling the MANUFACTURING
of PURCHASE ORDERS. The annual quantity contained in forecast will
be divided into individual BATCH PURCHASE ORDERS evenly distributed
over the course of any 12 months period, provided that the
total quantities ordered by these PURCHASE ORDERS meets the
requirements of Article 5. BVL and CUSTOMER may upon written
mutual agreement plan production to accommodate varying monthly
demand for the PRODUCT.
5.1.1 Five Year
Planning Forecasts
CUSTOMER will
determine its good faith projected five year PRODUCT MANUFACTURE
needs, and the initial forecast for each PRODUCT will be included
in Attachment A for each presentation of the PRODUCT. The format of
the forecast will be outlined in Attachment A.
The first five-year forecast will be incorporated in Attachment A
for each presentation of the PRODUCT to be MANUFACTURED under this
AGREEMENT. The five-year forecast will be updated at least annually
by CUSTOMER, which will be due by February 28 each
year.
In the event
the updated five-year forecast represents an increase of greater
than [...***...] in any given year included in the prior
year five-year forecast or [...***...] over the last year
planned in the previous forecast, then the updated forecast will be
subject to acceptance by BVL based on available capacity. BVL shall
confirm its rejection of the quantities for the first two years
of
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each annual
update to the five year forecast which are in excess of such
[...***...] increase by written notice to CUSTOMER within
one hundred and eighty (180) days after receipt of
CUSTOMER’s annual update to the 5 year
forecast.
5.1.2 Rolling
12 Month Forecast
One Hundred and
Twenty (120) days in advance of the first day of each calendar
quarter CUSTOMER will provide BVL with a 12 month rolling
forecast for all presentations of the PRODUCT(S) included in
Attachment(s) A. The first three (3) months or first calendar
quarter will be considered FIRM ORDERS for which CUSTOMER will
provide PURCHASE ORDERS for each BATCH of production required.
BATCHES are defined in the PRODUCT Description incorporated in
Attachment(s) A.
5.1.3
Additional Services
In the event
that CUSTOMER request or an AGENCY requires additional services in
support of PRODUCT(S), BVL will provide CUSTOMER with a proposal
for such services. BVL will provide such services only upon receipt
from CUSTOMER of a binding PURCHASE ORDER referencing the proposal
number provided for the required service.
5.3 It is
BVL’S responsibility to maintain a sufficient inventory of
BVL supplied COMPOSITION from mutually approved vendors, to meet
the forecast. It is CUSTOMER’S responsibility to supply API
or CUSTOMER COMPOSITION as indicated in Attachment(s) A. CUSTOMER
will coordinate with BVL Materials Management Department according
to BVL SOP’s on the specifics related to each shipment of API
to BVL. BVL will be responsible to receive, sample, store and
maintain the inventory at BVL. At the beginning of each month BVL
will provide a standard monthly inventory report of CUSTOMER
COMPOSITION. BVL will notify CUSTOMER IMMEDIATELY when the amount
of CUSTOMER supplied materials available at BVL reaches the minimum
quantity of material as agreed by both parties.
5.4
Manufacturing Capacity — Obligation of BVL MANUFACTURE and of
CUSTOMER to Purchase PRODUCT(S)
5.4.1 BVL shall
be obligated to MANUFACTURE PRODUCT only (i) in accordance
with quantities forecasted by CUSTOMER in accordance with this
Article 5, or (ii) as accepted by BVL for increased
forecasts which require BVL’s acceptance pursuant to
Section 5.1.1 hereof.
5.4.2 In the
event that CUSTOMER does not order at least [...***...] of
the quantities of the PRODUCTS forecasted by CUSTOMER for the
[...***...] in the initial or subsequent five year forecast
(as such forecasts may be modified from on an annual basis by
CUSTOMER as provided in this Article 5), then BVL shall provide
written notice to CUSTOMER of such failure. If CUSTOMER does not
within [...***...] after the date of such notice place
orders for a. quantity of the PRODUCTS necessary to satisfy at
least [...***...] of such forecasted quantities, then
CUSTOMER shall be obligated to pay BVL a fee [...***...] )
for the quantities of the PRODUCTS not ordered during the relevant
[...***...] period to satisfy such [...***...]
requirement. Fees payable pursuant to this Section 5.4.2 shall be
due on a monthly
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basis in
installments in accordance with the schedule of deliveries of the
PRODUCTS that should have occurred in accordance with the
then-current forecast.
5.4.3 In the
event of early termination of this AGREEMENT by CUSTOMER for any
reason other than breach of this AGREEMENT by BVL then CUSTOMER
shall be obligated to pay BVL a fee equal to [...***...] for
quantities of the PRODUCTS each BATCH not ordered for the remaining
[...***...] period up to the termination date of the
AGREEMENT forecasted, but not MANUFACTURED during that
period.
5.4.4. The
payment of fees by CUSTOMER to BVL pursuant to this
Section 5.4 shall not apply (i) if CUSTOMER is entitled
to qualify a supplier pursuant to Section 4.3 hereof, or
(ii) BVL is in breach of this Agreement.
ARTICLE 6 — PRICE &
PAYMENT
6.1.1 The
prices to be paid by CUSTOMER for the services and/or quantities of
PRODUCT purchased pursuant to Article 5 of this AGREEMENT are
specified in Attachment A(s) — PRODUCT Supplements or in
quotations provided to CUSTOMER and confirmed by CUSTOMER’S
PURCHASE ORDERS.
6.1.2 All
prices are FCA (Incoterms 2000), Ben Venue FACILITIES.
6.1.3 CUSTOMER
is responsible for all shipment cost, shipping charges will be paid
directly by CUSTOMER.
6.2.1 Annual
Price Adjustments
Prices are
subject to adjustment on an annual basis by BVL for the next
succeeding year. BVL shall notify CUSTOMER of price adjustments for
each presentation of the PRODUCT included in Attachment(s) A by
October 31 of each year for the following year beginning Jan
1.
The Annual Price adjustment shall be automatically calculated
[...***...] for the Producers Price Index for Pharmaceutical
commodity code [...***...] .
In the event
that average for the Producers Price Index for Pharmaceutical
commodity code [...***...] is negative in any year, then the
price will remain unchanged for the subsequent year.
6.2.2 Price
Adjustment on PRODUCT or Process SPECIFICATION Changes
BVL reserves
the right to adjust prices based on changes to the SPECIFICATIONS
for the PRODUCT or Process regardless of the event or action
causing the SPECIFICATIONS change, including but not limited to
changes in inspection, packaging and labeling. All changes to
the
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SPECIFICATIONS
and prices shall be mutually agreed to in writing by BVL and
CUSTOMER.
6.2.3 Prices
for Developmental Services and Developmental MANUFACTURE
Pricing for
Developmental Services and Developmental MANUFACTURE will be
provided to CUSTOMER in written proposals provided to CUSTOMER by
BVL based on the services requested. CUSTOMER will confirm
acceptance of the proposals by way of issuance of a PURCHASE ORDER
referencing the quotation number provided on the
proposal.
The purchase
price for PRODUCT or services shall be paid to BVL no later than
thirty (30) days after the date of BVL’S invoice to
CUSTOMER. BVL will issue an invoice at such time that BVL’S
Quality Control Department has completed its testing, found the
PRODUCT suitable to be shipped and has shipped the documents
identified in Attachment D or upon completion of other services as
described in proposals. CUSTOMER may request that a BATCH be
shipped before CUSTOMER release i.e., shipment in Quarantine. In
the event a Quarantine shipment is made BVL will invoice on the
shipment day. CUSTOMER will notify BVL in writing that a lot can be
shipped in Quarantine and BVL will make all effort to honor this
request.
In the event of
nonpayment of balances without reasonable cause within forty-five
(45) days of the invoice date, CUSTOMER agrees to pay BVL a
monthly late payment charge equal to one and one-half percent
(1.5%) of the unpaid balance. Should unpaid balances extend beyond
60 days after an invoice has been issued, BVL reserves the
right to require CUSTOMER to pay one-half (1/2) of the price for
each BATCH at the time of PURCHASE ORDER issuance and the remaining
one-half (1/2) of the price prior to the delivery of those BATCHES
until all unpaid balances, including interest charges, have been
paid. Should unpaid balances extend beyond 90 days BVL
reserves the right to terminate this AGREEMENT unless cured by
CUSTOMER within 30 days of notice, or may cease production
and/or service performance until cured. CUSTOMER notify BVL in
writing within 30 days of the invoice date that CUSTOMER is
disputing payment of the invoice and the reason for such
dispute.
6.4 Payment for
Non Validated Services or Production and Obsolete
Materials
CUSTOMER will
be required to pay BVL for all PRODUCT MANUFACTURED during any
period when any MANUFACTURING Process and Testing Procedures have
not been fully developed and validated, regardless of whether the
PRODUCT is accepted or rejected by the CUSTOMER unless such
rejection is due to the gross negligence of BVL.
CUSTOMER will
be required to pay BVL for all packaging components and raw
materials which were purchased by BVL for use specifically in the
MANUFACTURE of the PRODUCT covered by this AGREEMENT should any of
the BVL supplied COMPOSITION become obsolete due to the action of
CUSTOMER or any AGENCY.
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CUSTOMER will
pay a cancellation fee equal to [...***...] of the price of
the BATCH if cancellation or postponement is made four
(4) weeks in advance of the scheduled MANUFACTURING date. If
cancellation or postponement is made less than four (4) weeks
in advance of the scheduled MANUFACTURING date, CUSTOMER is
responsible for payment of the full price of the scheduled
MANUFACTURE of the BATCH(ES).
CUSTOMER is
responsible for storage charges as specified in Attachment C for
PRODUCT stored for more than one month beyond BVL’S release.
Short-term storage of PRODUCT in BVL’S warehousing FACILITIES
beyond one month must receive prior approval from BVL. Such
approval will be granted only on a space-available
basis.
During the term
of the this AGREEMENT and upon CUSTOMER request and BVL agreement,
BVL will conduct and support, at CUSTOMER’S expense, all
stability studies in progress or planned (e.g. NDA annual stability
studies) as of the Effective Date until such studies are concluded.
CUSTOMER shall be responsible for all costs of conducting any
stability studies. Stability Program cost will be covered in a
separate quotation provided by BVL to CUSTOMER based on the agreed
upon protocol. CUSTOMER may also make arrangements for stability
work to be performed at a facility other than BVL at CUSTOMERS
expense.
6.8 Inspection,
Packaging and Labeling.
CUSTOMER shall
be responsible for and bear all costs associated with the design,
development, quality release and Regulatory Approval of all
labeling and packaging materials for PRODUCT. CUSTOMER shall
perform its design, development, quality release and Regulatory
Approval obligations hereunder in a timely manner sufficient for
BVL to satisfy its MANUFACTURE obligations hereunder for the
PRODUCT. Labeling and packaging developed by CUSTOMER will conform
to labeling and packaging SPECIFICATIONS mutually agreed to in
writing. Any change in the inspection, labeling and packaging
SPECIFICATIONS will be evaluated by BVL for cost impact and BVL
reserves the right to issue a price quotation pursuant to
Article 6.
7.0 All items
relating to the Quality Operations are incorporated in Attachment E
— Quality Agreement.
ARTICLE 8 —
INDEMNIFICATION
8.0. CUSTOMER
hereby holds harmless and indemnifies BVL its employees, officers
and affiliates against any and all claims, losses, liabilities,
lawsuits, proceedings, costs and expenses, including, without
limitation, reasonable attorneys’ fees, and the cost of
recalls, resulting from, arising out of or in connection with
injuries and/or death resulting from, arising out of or in
connection with any use of the PRODUCT, including, without
limitation, claims based on
Page 12 of
38 BVL
— PHARMION Manufacturing and Service Agreement
*** Confidential Treatment
Requested
negligence,
warranty, strict liability or any other theory of PRODUCT liability
or violation of any applicable laws or regulations, (collectively,
“Claims”) except to the e
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