EXHIBIT NO. 10.9
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
NEW LONG TERM SUPPLY AGREEMENT
This New Long Term Supply Agreement (the "Agreement") is entered into as
of the first (1st) day of January 2003, between Millennium Pharmaceuticals,
Inc., a company duly organized and existing under the laws of Delaware with
offices at 00 Xxxxxx Xxxxxx, Xxxxxxxxx XX 00000, Xxxxxx Xxxxxx of America
("Millennium"), and Solvay, Societe Anonyme, a Belgian corporation with its
principal offices at 00, xxx xx Xxxxxx Xxxxxx, X-0000 Xxxxxxxxx, Xxxxxxx
("Solvay"), each on behalf of itself and its Affiliates. Millennium and Solvay
are sometimes referred to herein individually as a "Party" and collectively as
the "Parties" and references to "Millennium" and "Solvay" shall include their
respective Affiliates.
WHEREAS,
Millennium and Solvay are parties to a certain License and Supply
Agreement dated 27 July 1994 ("the License Agreement");
Millennium and Solvay are also parties to a certain Long Term Supply
Agreement dated 28 September 1995, amended as per the First Amendment dated 1
April 1997 and assigned to Millennium as per the Assignment Agreement dated 12
February 2002 (the "Long Term Supply Agreement");
Millennium and Solvay wish to cancel the Long Term Supply Agreement and
to replace it with this Agreement;
NOW, THEREFORE, Millennium and Solvay agree as follows:
1 - CERTAIN DEFINITIONS
1.1 "AFFILIATES" shall mean any entity or person which controls, is
controlled by or is under common control with either Party. For purposes
of this Article 1.1, "control" shall mean (a) in the case of corporate
entities, the direct or indirect ownership of at least one-half of the
stock or participating shares entitled to vote for the election of
directors, and (b) in the case of a partnership, the power to direct the
management and policies of such partnership. Without limitation on the
foregoing and for purposes of this Agreement, Peptisyntha, Societe
Anonyme ("Peptisyntha"), which is a fully owned subsidiary of Solvay and
a corporation existing under the laws of Belgium and having its
principal offices at 000, xxx xx Xxxxxxxx, X-0000 Xxxxxxxxx, Xxxxxxx, is
deemed an Affiliate of Solvay.
1.2 "BULK PRODUCT" shall mean a bulk peptide product which contains
eptifibatide, is produced by the Licensed Process (as defined in the
License Agreement) and is intended to undergo further processing,
formulation and/or vialing and packaging.
1.3 "BULK PRODUCT INTERMEDIATES" shall mean [**] used to manufacture Bulk
Product which have been partially processed.
1.4 "DELIVERY SCHEDULE" shall mean the delivery schedule agreed upon
according to the provisions of Article 4.4 for delivery of Bulk Product
to Millennium hereunder which may be reviewed according to the
provisions of Article 9.8(b).
1.5 "DELIVERY SHORTFALL" shall mean the difference in grams, calculated at a
given date of any year between
(a) the total quantity of Bulk Product which Solvay is committed to
supply before said given date according to the Delivery Schedule
for such year, and
(b) the total quantity of Bulk Product complying with the
requirements of Article 8.2 delivered to Millennium during such
year before said given date.
A Delivery Shortfall shall be [**].
1.6 "EPTIFIBATIDE" shall refer to a specific peptide designated by
Millennium and known as eptifibatide, which same peptide was known
previously as Integrilin or Integrelin, the chemical structure of which
is known to Solvay because of the prior business relationship between
Millennium and Solvay.
1.7 "KEY RAW MATERIALS" shall mean the [**] reasonably required for the
production of Bulk Product or Bulk Product Intermediates [**].
1.8 "MINIMUM ORDER" shall mean [**] kilograms of Bulk Product.
1.9 "ORDER SHORTFALL" shall mean the difference between the Minimum Order
and the quantity ordered by Millennium for supply in any given year
below the Minimum Order, expressed in grams.
1.10 "ORDER SURPLUS" shall mean the lesser of (i) the amount ordered by
Millennium for supply in any given year in excess of the Minimum Order
or (ii) [**] kilograms, expressed in grams.
1.11 "PRODUCTION CAPACITY" shall mean Solvay's capacity for manufacturing
Bulk Product measured in kilograms of Bulk Product per year referred to
in Article 2.1.
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1.12 "PURCHASE ORDER" shall mean a purchase order or supplementary purchase
order
(a) placed by Millennium according to the provisions of Article 4.4
for production of Bulk Product by Solvay and supply thereof to
Millennium according to the Delivery Schedule,
(b) acknowledged by Solvay according to the provisions of Article
4.5, and
(c) which may be reviewed according to the provisions of Article
9.8(b).
1.13 "REQUIREMENTS FORECASTS" shall mean the estimates of future requirements
for Bulk Product to be manufactured by Solvay that are prepared by
Millennium pursuant to Article 3.1.
1.14 "SPECIFICATION" shall mean the specification for Bulk Product as
contained in Appendix C hereto and as may thereafter be amended in
writing from time to time to reflect changes in such specifications.
Unless otherwise defined herein, other capitalized terms used herein shall have
the meaning specified in the License Agreement, as may be amended from time to
time. For convenience, this Agreement may refer to specific provisions or
appendices of the License Agreement. Defined terms may be used in their singular
or plural forms. Unless otherwise indicated, "year" shall mean a calendar year.
2 - PRODUCTION CAPACITY
2.1 CURRENT PRODUCTION CAPACITY. Solvay represents that its Production
Capacity dedicated to the production of eptifibatide is [**] kilograms
unless notified differently according to Articles 2.2 or 3.2.
2.2 PRODUCTION CAPACITY INCREASE. Solvay represents and Millennium
acknowledges that decisions regarding substantial increase of the
Production Capacity beyond the levels represented in Article 2.1 above
need to be made [**]before the increase is effective. Therefore, on a
timely basis, the Parties shall discuss the Requirements Forecasts and
the implication of these forecasts on the need for increasing the
Production Capacity. Solvay may however make incremental increases to
such capacity [**] provided Millennium agrees to collaborate for
handling some regulatory aspects. Should Solvay succeed in implementing
such incremental capacity increase, it shall notify Millennium thereof
and the current production capacity referred to in Article 2.1 would be
updated accordingly.
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3 - PRODUCTION PLANNING AND FORECASTS
3.1 REQUIREMENTS FORECASTS. Millennium shall provide Solvay with forecasts
of its expected requirements for Bulk Product in accordance with Section
2.2 of the License Agreement that are prepared in good faith and to the
best of Millennium's knowledge at the time they are prepared. The
Requirements Forecasts shall be consistent with the forecasts made by
Millennium for requirements for eptifibatide worldwide, including sales
to third parties, research quantities and appropriate inventory levels,
and will cover [**]. The Requirements Forecasts [**] are appended hereto
as Appendix A. Subsequent Requirements Forecasts shall be provided to
Solvay on [**] of each year during the term of this Agreement, but
Millennium may elect to provide such Requirements Forecasts more
frequently. The Requirements Forecasts are provided for the purpose of
programming, are not to be construed as Purchase Orders, and are not
binding on Millennium or Solvay.
3.2 CHANGES TO THE SPECIFICATION. In the event that Millennium notifies
Solvay of requested changes to the Specification, Solvay shall
acknowledge receipt of such notice within a reasonable time, but in any
event no later than [**], and Solvay will indicate the effect of such
requested changes on Production Capacity and shall [**], as the case may
be. After Millennium receives Solvay's response, if Millennium so
requests, the Parties shall negotiate in good faith on such requested
change to the Specification, which shall be subject to the mutual
written agreement of both Parties, such agreement not to be unreasonably
withheld or delayed.
3.3 PERSONNE DE CONFIANCE. Solvay agrees that Millennium may designate a
"Personne de Confiance", who will be a Millennium employee or Millennium
consultant. He or she shall have the mission to improve communication
between Solvay and Millennium and to identify issues and facilitate
their prompt resolution. Such mission shall consist of the following
activities :
- Review of planned and actual production and delivery schedules and
activities
- Review of planned and actual Bulk Product Intermediates purchasing
from suppliers
- Review of planned and actual inventories of Bulk Product Intermediates
and Bulk Product
- Review of status of technology transfer to the Secondary Source and
potential additional sources
- Review of issues affecting production and regulatory compliance
- Review of plans for and status of plant expansion.
Any additional activity is subject to Solvay's approval.
Under appropriate confidentiality arrangements with Solvay, the
"Personne de Confiance" will have access to the same information that
could be communicated to any other Millennium personnel, except
technology transfer agents (also referred to by the Parties as TTAs).
However, the "Personne de Confiance" shall not have the power to make
contractual commitments on behalf of Millennium, amend this Agreement or
any other
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agreements between Millennium and Solvay or enter into any other
agreements on behalf of Millennium without specific written
authorization from Millennium.
Millennium may change its designated "Personne de Confiance" as
necessary, provided he or she signs a confidentiality agreement in
substantially similar form to that signed by [**] dated October 10, 1996
(a copy of which is attached hereto as Appendix D).
4 - PURCHASE ORDERS
4.1 PURCHASE COMMITMENT. Millennium agrees to purchase from Solvay and
Solvay agrees to manufacture and supply to Millennium an amount of Bulk
Product through Purchase Orders.
4.2 MINIMUM PURCHASE COMMITMENT. Millennium shall order from Solvay the
Minimum Order of Bulk Product for delivery in the years 2004 and
following during the term of this Agreement. In the event that
Millennium orders less than such Minimum Order for delivery in any given
year (referred to as the "Given Year" hereinafter in this Article 4.2),
Millennium shall pay a penalty calculated by multiplying the Order
Shortfall by [**] percent ([**]%) and by [**] for delivery in such Given
Year calculated as set forth in Appendix B hereto taking paragraph (a)
thereof as the reference price.
Such penalty, which is subject to waiver in case of the occurrence of a
Delivery Shortfall during the Given Year as provided for in the
provisions of Article 9.8(c), shall be paid in [**] of said Given Year.
Such penalty shall be Millennium's exclusive liability and Solvay's sole
remedy for Millennium not ordering the Minimum Order.
Notwithstanding the foregoing, the Order Shortfall shall be, for the
purpose of calculating the penalty payment referenced above, reduced by
the sum of:
(a) if Millennium has ordered more than the Minimum Order for
delivery in the year preceding said Given Year (referred to as
the "Previous Year" hereinafter in this Article 4.2), the Order
Surplus for delivery in such Previous Year, and
(b) if the total quantity of Bulk Product delivered by Solvay at the
end of the Previous Year is lower than the quantity ordered by
Millennium for delivery in such Previous Year (such ordered
quantity is not being subject to the deduction foreseen under
Article 9.8(b)),
(i) if the total quantity of Bulk Product delivered by Solvay
at the end of said Previous Year is equal to or greater
than [**] grams, [**] grams, or
(ii) if the total quantity of Bulk Product delivered by Solvay
at the end of said Previous Year is lower than [**])
grams, [**] percent ([**]%) of the difference between [**]
and the total quantity of Bulk Product delivered by Solvay
accrued at the end of the Previous Year, expressed in
grams.
The Parties acknowledge that, according to the above, the said Order
Shortfall may be reduced to [**] but not below [**]. Any quantity taken
into account to reduce said Order
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Shortfall for the purpose of calculating the penalty payment referenced
above shall accordingly in no event exceed such Order Shortfall.
In addition, Millennium agrees to pay to Solvay an amount in United
States Dollars computed by multiplying that part of the Order Surplus
which has been taken into account to reduce the Order Shortfall
(expressed in grams) by the difference between
- the unit price applicable [**] for quantities [**] kilograms
calculated as set forth in Appendix B hereto taking paragraph (a)
thereof as the reference price, and
- the unit price applicable for [**] kilograms calculated as set
forth in Appendix B hereto taking paragraph (b) thereof as the
reference price.
The said amount shall be paid by Millennium to Solvay [**].
4.3 SUPPLY COMMITMENT. Solvay shall accept purchase orders placed according
to the provisions of Article 4.4 provided that the total amount of Bulk
Product ordered for any year does not exceed its Production Capacity and
shall supply such amount to Millennium according to the Delivery
Schedule.
4.4 TIMING OF PURCHASE ORDERS AND DELIVERY SCHEDULE. [**] during the term of
this Agreement, Millennium shall provide Solvay with a purchase order
specifying the amount of Bulk Product that Millennium is ordering for
the following year.
For the sake of clarification, Millennium has no obligation hereunder to
place orders for delivery beyond the term of this Agreement and Solvay
has no obligation hereunder to accept Purchase Orders for delivery
beyond the term of this Agreement.
Promptly after receipt of such purchase order, Solvay shall provide
Millennium with a delivery schedule specifying the dates at which Bulk
Product shall be delivered. Each delivery shall consist, to the extent
possible, [**] of approximately [**] kilograms. The Parties shall
discuss in good faith for adjusting the delivery dates according to
their own specific requirements, including the limitations resulting
from the operation and maintenance of Solvay's currently existing
manufacturing facilities, and such delivery schedule will be finalized
and agreed upon in good faith.
Millennium may elect to increase the amount it has ordered for a year by
providing Solvay with a supplemental purchase order [**], which increase
Solvay shall accept provided that the total amount does not exceed the
lesser of (i) the Production Capacity or (ii) [**] percent ([**]%) of
the amount of the Purchase Order placed [**].
Upon receipt of such supplemental purchase order, the Parties shall
discuss in good faith for reviewing the delivery schedule established
earlier in the year according to their own specific requirements,
including the limitations resulting from the operation and maintenance
of Solvay's currently existing manufacturing facilities, and such
delivery schedule will be finalized and agreed upon in good faith.
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4.5 ACKNOWLEDGEMENT. Promptly after the Delivery Schedule is finalized
according to the provisions of Article 4.4 [**], Solvay shall
acknowledge in writing acceptance of a purchase order and supplemental
purchase order placed by Millennium. The Delivery Schedule shall be
attached to the acknowledgement document sent to Millennium.
5 - INVENTORIES AND STORAGE OF RAW MATERIALS AND BULK PRODUCT INTERMEDIATES
5.1 RAW MATERIALS INVENTORY. In addition to having available the amounts of
Key Raw Materials required to accomplish the manufacture of the specific
quantities of Bulk Products ordered by Millennium for each year during
the term of this Agreement, Solvay will maintain an inventory of Key Raw
Materials of not less than the amount necessary to meet [**] percent
([**]%) of the production scheduled for that year. The inventory will be
maintained at a facility [**]. Such inventory shall be rotated first in,
first out.
5.2 SUBCONTRACTING. Solvay may contract to [**], the manufacture of certain
Bulk Product Intermediates provided however, that Solvay shall remain
responsible and be guarantor of the performance by [**] and shall cause
[**] to comply with the provisions of this Agreement in connection with
such performance, including but not limited to the provisions of Article
11.
5.3 BULK PRODUCT INTERMEDIATES INVENTORY. During the term of this Agreement,
Solvay will maintain in inventory Bulk Product Intermediates
manufactured up through certain manufacturing steps. To the extent
possible, such inventory shall be rotated on a first in, first out
basis, with Bulk Product Intermediates subsequently manufactured and
scheduled for production through to final Bulk Product. Solvay shall
retain samples of lots of each Bulk Product Intermediate to be used in
the manufacture of Bulk Product until such Bulk Product has been
manufactured, shipped to and accepted by Millennium. Millennium will be
informed in writing by Solvay at least twice quarterly on the level of
inventories of all Bulk Product Intermediates and on the scheduled
production of Bulk Product Intermediates.
5.4 BULK PRODUCT INVENTORY. Solvay shall notify Millennium of the completion
of the manufacture of each lot of final, purified Bulk Product.
5.5 DELIVERY. Subject to Article 6, Solvay shall make deliveries of Bulk
Product to Millennium or Millennium's designee at the dates agreed upon
in the Delivery Schedule of any Purchase Order according to the shipping
procedures described in Article 8.1. Delay in delivery which may occur
hereunder shall be subject to the provisions of Article 9.8.
5.6 POSTPONEMENT OF DELIVERY. Millennium shall have the right to request
that the delivery of bulk product foreseen under Article 5.5 is
postponed for a
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period [**]. in such event, Solvay shall put such undelivered bulk
product into inventory at a facility [**] until it is delivered. such
inventory shall be stored pursuant to Appendix C. [**] pursuant to
[**] under this Article [**].
6 - QUALITY CONTROL AND REGULATORY MATTERS
6.1 SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture Bulk Product
under this Agreement in conformity with the Specification, in a duly
licensed facility as required by the United States Food and Drug
Administration and equivalent European Union regulatory agencies, and in
compliance with applicable laws and regulations and Good Manufacturing
Practices, as prescribed from time to time by these appropriate
regulatory agencies. Each shipment of Bulk Product hereunder shall have
been subjected to a quality control inspection by Solvay in accordance
with the Specification and with Solvay's then current quality control
standards and systems, which shall be at least as stringent as those
agreed in writing between Millennium and Solvay. Solvay shall not make
any change to its manufacturing process for the Bulk Product (as it
exists as of the Effective Date) which would affect the regulatory
approvals for the Bulk Product in the United States or the European
Union (and to the extent applicable, of Member States of the European
Union) without first obtaining the prior written approval of Millennium.
Solvay shall number each shipment with a vendor lot number that is
traceable to Key Raw Materials, Bulk Product Intermediates and/or other
components used to manufacture such Bulk Product and shall maintain all
appropriate validation documentation as reasonably specified by
Millennium and agreed by Solvay, or as required by appropriate
regulatory authorities. Such manufacturing and validation information
shall be communicated to Millennium pursuant to Section 3.4 of the
License Agreement. Solvay shall permit Millennium and/or representatives
of appropriate regulatory agencies to review periodically Solvay's Bulk
Product manufacturing facilities and testing procedures at reasonable
times with a Solvay representative present, and to obtain copies of
batch records for Bulk Product in order to assure compliance with the
requirements of this Article 6.1.
6.2 COMPLIANCE WITH LAW. Solvay shall be responsible for complying with all
applicable regulatory requirements of the United States, the European
Union, and to the extent applicable, of Member States of the European
Union, for the manufacture, importation and shipment of the Bulk Product
supplied hereunder. Solvay shall give Millennium prompt written notice
of any impending inspections by a governmental agency of the facility
used for or processes involved in the manufacture of Bulk Product or
Bulk Product Intermediates, and provide Millennium an opportunity to
observe such inspection. Each Party shall promptly notify the other in
writing of new instructions or specifications of which it becomes aware
and governmental inspection reports which are relevant to the
manufacture of Bulk Product or Bulk Product Intermediates under this
Agreement and which are required by the United States Food and Drug
Administration, equivalent European Union regulatory agencies, or other
applicable laws or governmental regulations and shall confer with each
other with respect to the best means to comply with such requirements.
Solvay shall assist Millennium in obtaining and maintaining all
approvals
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and authorizations of any governmental agencies necessary for the use,
sale or distribution of eptifibatide products, and will notify
Millennium [**] of any comments, responses or notices received from any
governmental authorities which relate to the regulatory status of
eptifibatide. These actions by Solvay shall not be construed as an
admission that Solvay is doing business in the United States.
6.3 NOTIFICATION OF ISSUES. Solvay shall notify Millennium in writing [**]
of any issue related to manufacturing or raw material supply, or other
information relating to Solvay or the site(s) of manufacture which may
affect the regulatory status of eptifibatide or the ability of Solvay to
supply Bulk Product.
7 - SHIPPING AND ACCEPTANCE OF PRODUCT
7.1 PRODUCT SHIPPING PROCEDURES. Any shipment made hereunder shall be made
with the proper identification on the packaging as required by
applicable authorities and by this Agreement. Bulk Product will be
labeled and packaged according to the Specification. Notwithstanding
contrary provisions in the Specification, however, Bulk Product shall be
packaged in a shipping container approved by Millennium [**]. Solvay
shall [**]. In the event that Millennium specifies that the Bulk Product
be shipped to a location other than Millennium's offices in South San
Francisco (e.g., to a different location for product fill and finish),
or in the event that Millennium's shipping request requires that the
Bulk Product be placed into inventory [**], then upon Millennium's
request, Solvay shall ship a quality control sample to Millennium's
offices indicated above (or such other place as Millennium may
designate) in advance of or not later than concurrently with the
shipment of the Bulk Product or the placing of the Bulk Product into
inventory. Except as provided herein with respect to non-conforming
product or Bulk Product placed into inventory, title and risk of loss as
to all Bulk Product shipped shall pass to Millennium or Millennium's
designee [**]. In the event that, upon Millennium's request pursuant to
Article 6, shipment of a lot of Bulk Product is not made promptly after
the completion of manufacture of such lot and therefore such lot is
placed into inventory, title shall pass to Millennium or Millennium's
designee upon the delivery to inventory, but risk of loss shall remain
with Solvay until such Bulk Product is delivered [**]. Solvay shall
assist Millennium in arranging any desired insurance (in amounts that
Millennium shall determine) and transportation [**], as the case may be.
All customs, duties, costs, taxes, insurance premiums, and other
expenses of such transportation and delivery (whether shipment of Bulk
Product is made promptly after completion of manufacture or such Bulk
Product is placed into inventory at Millennium's request), [**]. Solvay
shall provide a packing list and a certificate of analysis to Millennium
for every shipment and for every placing of the Bulk Product into
inventory.
7.2 NON-CONFORMING AND NON-COMPLYING PRODUCT. Bulk Product supplied
hereunder shall be produced by Solvay in compliance with all applicable
laws and regulations of the United States, the European Union, and to
the extent applicable, of Member States of the European Union, including
without limitation current Good
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Manufacturing Practices as set forth in the United States Code of
Federal Regulations, and in conformance with the Specification.
Millennium may reject any shipment of Bulk Product which
(a) does not conform with the Specification or is not in compliance
with such applicable laws and regulations, or
(b) is adulterated or misbranded within the meaning of the United
States Federal Food, Drug and Cosmetic Act, equivalent European
Union regulatory agency requirements, or other applicable laws or
governmental regulations. Any notice of rejection of
non-conforming product or notice that the product is adulterated
or misbranded must be submitted to Solvay [**] after receipt by
Millennium or its designee at the shipment destination designated
by Millennium (and for the sake of clarification, when Bulk
Product is placed in inventory, the Parties agree that such
inventory is not a shipment destination designated by Millennium
for the purposes of this Article 7.2), accompanied by a report of
analysis (including a product sample from the lot analyzed)
prepared according to the Specification. If no such notice of
rejection of non-conforming product is submitted, Millennium
shall be deemed to have accepted such delivery of the product.
Product may be rejected as non-conforming based on analysis of a
product sample shipped in advance of or concurrently with the
full lot.
7.3 PROCEDURES AFTER NOTICE OF REJECTION. After notice of rejection of
product is given in accordance with Article 7.2 above, Millennium shall
cooperate with Solvay in determining whether rejection is necessary or
justified. Solvay shall notify Millennium promptly whether or not it
accepts Millennium's basis for any rejection. If Solvay disagrees with
Millennium's determination that a certain product does not meet the
requirements of Article 7.2 above, such product shall be submitted to a
mutually acceptable third party laboratory; the fees and expenses of
such laboratory testing shall be borne entirely by the Party against
whom such findings are made. Such third party laboratory shall determine
whether such product meets the requirements of Article 7.2 above and the
Parties agree that such laboratory's determination shall be final and
determinative. Whether or not Solvay accepts Millennium's basis for
rejection, promptly on receipt of a notice of rejection of product,
Solvay shall, at Millennium's request, use its best efforts to replace
such rejected product. In the event that the rejected lot is determined
to not meet the requirements of Article 7.2 above, any moneys paid for
the rejected lot shall be returned to Millennium [**] after such
rejection, unless the Parties agree on a schedule pursuant to which
Solvay shall deliver a replacement lot. Bulk Product may only be
reprocessed in accordance with validated reprocessing procedures
described in the drug master file, as agreed by the Parties.
Unless Solvay requests the destruction of rejected Bulk Product [**] of
receipt of Millennium's notice of rejection of such Bulk Product,
Millennium shall promptly return such Bulk Product to Solvay, [**], and
according to shipping instructions in the Specification. Millennium
shall, upon receipt of a request for destruction of the material,
destroy such Bulk Product promptly, properly and at Solvay's expense,
and provide Solvay with certification of such destruction. In the event
the Bulk Product is rejected by
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Millennium on the basis of analysis of a product sample, Solvay shall
retain the relevant lot of Bulk Product and treat it in the same fashion
provided above.
7.4 GOVERNING TERMS. All sales hereunder shall be subject to the provisions
hereof (including the Specification) and shall not be subject to the
terms and conditions contained on any shipping request of Millennium or
confirmation of Solvay, except insofar as any such shipping request or
confirmation establishes :
(a) the quantity of any Bulk Product to be shipped;
(b) the agreed delivery date as set forth in the Delivery Schedule;
(c) the shipment route and destination; or
(d) the carrier.
8 - PRICE AND PAYMENTS
8.1 PRICES. Millennium agrees to pay to Solvay the prices for the
manufacture of Bulk Product set forth in Appendix B. Applicable pricing
shall be determined [**] in a particular year.
8.2 PRICE COMPUTATION. The payments to be made by Millennium to Solvay for
the quantity of Bulk Product stated in a Purchase Order shall be
computed by [**] such quantity by the [**] identified in Appendix B.
8.3 INVOICING AND PAYMENT. Payment for Bulk Product shall be made in the
following increments :
(a) before the [**] of each year for Purchase Orders placed during
that year, [**] percent ([**]%) of the applicable Bulk Product
price specified in Appendix B multiplied by [**] stated in the
applicable Purchase Order;
(b) within [**] of receipt of Solvay's written certification of the
completion of the manufacture and delivery to Solvay's inventory
of a lot of Bulk Product (if upon Millennium's request pursuant
to Article 5.6 shipment is not made promptly after completion of
the manufacture), or within[**] of receipt of Solvay's written
certification of the completion of the manufacture and shipment
of a lot of Bulk Product to Millennium or Millennium's designee,
[**] percent ([**]%) of the applicable Bulk Product price
specified in Appendix B multiplied by the [**] in that lot.
However, in the event that [**], payment for Bulk Product shall be made
in the following increments instead of the above:
(a) before [**] of each year for Purchase Orders placed during that
year, [**] percent ([**]%) of the applicable Bulk Product price
specified in Appendix B multiplied by [**] stated in the
applicable Purchase Order, and
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(b) within [**] of receipt of Solvay's written certification of the
completion of the manufacture and delivery to Solvay's inventory
of a lot of Bulk Product (if upon Millennium's request pursuant
to Article 6 shipment is not made promptly after completion of
the manufacture), or within [**] of receipt of Solvay's written
certification of the completion of the manufacture and shipment
of a lot of Bulk Product to Millennium or Millennium's designee,
[**] percent ([**]%) of the applicable Bulk Product price
specified in Appendix B multiplied by [**] in that lot.
8.4 METHOD OF PAYMENT. All payment shall be made in United States Dollars by
wire transfer to the bank account of Solvay-CICC S.A. No. [**], or to
such account of Solvay in such bank as Solvay may from time to time
designate by notice to Millennium.
8.5 TAXES. Solvay shall be responsible for all value added taxes, property
taxes, sales tax or any other such tax resulting from sales of Bulk
Product to Millennium from Solvay or production of Bulk Product or
purchase of any raw materials.
8.6 MILLENNIUM'S RIGHT TO VERIFY MANUFACTURE CERTIFICATION. Millennium shall
have the right at its own expense to have an independent third party,
acceptable to Solvay, audit Solvay's production records, during normal
business hours and upon reasonable notice, for the purpose of verifying
the manufacture of Bulk Product in accordance with this Agreement as
certified pursuant to Article 7.2. Solvay's acceptance of the
independent third party shall not be unreasonably withheld.
8.7 OVERDUE PAYMENT. Payments provided for in this Article 8, when overdue,
shall bear interest at a rate per annum equal to two percentage points
(2%) in excess of the one-year LIBOR effective at the date such payment
is due, and for the time period until payment is made by Millennium.
8.8 DELIVERY SHORTFALL. In recognition of the fact that long term supply
disruptions will affect the commercial viability of Millennium and
eptifibatide, in the event that the Delivery Shortfall at any time
during a given year (referred to as the "Given Year" hereinafter in this
Article 8.8) is greater than [**] kilograms, or in the event that the
Delivery Shortfall at the end of said Given Year is greater than [**]
kilograms, the Parties shall discuss in good faith for setting up
alternatives to remedy such Delivery Shortfall. If no alternative is
deemed acceptable by Millennium, then
(a) Millennium shall have the right to have a quantity of Bulk
Product up to the said Delivery Shortfall [**] and purchase such
quantity (referred to as the "Quantity" hereinafter in this
Article 8.8 and in Article 8.9) [**] of the License Agreement,
(b) the said Delivery Shortfall shall be deducted from the quantity
of Bulk Product ordered by Millennium in the Purchase Order for
delivery in said Given Year and the Delivery Schedule of said
Purchase Order shall be amended by withdrawing the deliveries
which Solvay was unable to make,
- 12 -
(c) if Millennium has ordered less than the Minimum Order for
delivery in such Given Year, the penalty due by Millennium
pursuant to Article 4.2 by reason of occurrence of an Order
Shortfall for such Given Year shall be [**]; in the event that
Millennium has already paid installments for such penalty during
said Given Year, such installment payments shall be credited
against future amounts due to Solvay hereunder except for the
last year of the term of this Agreement for which Solvay shall
reimburse Millennium in cash for such installment payments, and
(d) should Millennium exercise its right under paragraph 8.8(a) the
Quantity purchased [**] shall not be taken into account to
calculate for said Given Year (or for the [**], if such Quantity
is delivered to Millennium [**]) the minimum [**]percent ([**]%)
share of Millennium's total requirements of Bulk Product which
Millennium is bound to purchase from Solvay pursuant to Section
2.2 of the License Agreement.
8.9 [**]. For any year of the term of this Agreement for which Millennium
orders from Solvay at least the Minimum Order and orders [**] Bulk
Product [**], the royalty of [**] percent ([**]%) to be paid by
Millennium to Solvay pursuant to Section 4.2 (a) and 4.2 (b) of the
License Agreement shall be [**] percent ([**]%).
8.10 NOTIFICATION. [**] at any time during the term of this Agreement,
Millennium shall immediately notify Solvay in writing thereof.
9 - TERM AND TERMINATION
9.1 TERM. This Agreement shall become effective as of 1 January 2003 in
relation with the Bulk Product ordered for year 2004 and will continue
subject to the provisions of Article 9.2 until 31 December 2007. This
Agreement shall automatically renew thereafter [**]s unless either Party
gives written notice to the other Party at least [**] prior to the
beginning of such a renewal period that it does not wish to renew.
9.2 TERMINATION. This Agreement may be terminated:
(a) upon mutual written agreement between the Parties
(b) by either Party as a result of a material breach or default in
the performance of any obligation, condition or covenant of this
Agreement by the other Party, if such default or noncompliance
shall not have been remedied, or steps initiated to remedy the
same to the non-defaulting Party's reasonable satisfaction,
within ninety (90) days after receipt by the defaulting Party of
a notice thereof from the other Party, or
(c) by Millennium on notice of its receipt of a notice from a
regulatory authority in the Unites States of America that
eptifibatide is no longer approved for commercial sale, provided
that such notice is delivered to Solvay at least twelve (12)
months before termination becomes effective.
- 13 -
9.3 The termination of this Agreement shall not relieve the Parties from any
of their obligations until the time of their fulfillment hereunder to
the extent such obligations apply to Bulk Product ordered in a Purchase
Order acknowledged by Solvay according to the provisions of Article 4.5
or revised according to the provisions of Article 8.8(b) prior to the
effective date of such termination, including but not limited to
(a) the obligation in Solvay to deliver said Bulk Product,
(b) the obligation in Millennium to accept and, upon acceptance, pay
for any of said Bulk Product, and
(c) any other such obligation of either Party under Articles 6, 7,
8, 9.3, 9.4, 10, 11, 12, and 13,
Millennium's further payment of penalties, if any, pursuant to Article
4.2 above for not meeting the minimum purchase commitments in such
Article 4.2 for the year in which this Agreement is terminated in
accordance with Section 9.2(c) above shall be reduced on a pro-rata
basis to reflect the exact date of termination during such year.
Termination shall not limit Millennium's right to sell eptifibatide
produced from Bulk Product in its possession or delivered to it after
such termination. Termination of this Agreement shall not affect the
License Agreement except as provided for in Article 9.4(a).
9.4 In the event that SOLVAY exercises its right under Article 9.1 to
terminate the automatic renewal of this Agreement after its initial
term,
(a) the [**] percent ([**]%) share of Millennium's total, worldwide
requirements of Bulk Product which Millennium is required to
purchase from Solvay under Section 2.2 of the License Agreement
shall be reduced to [**] percent ([**]%), and
(b) both Parties shall negotiate in good faith another agreement for
supply of Bulk Product by Solvay to Millennium [**] under the
Long Term Supply Agreement dated 28 September 1995 before its
termination.
10 - INDEMNIFICATION, LIABILITY AND RECALLS
10.1 MILLENNIUM INDEMNIFICATION. Millennium shall indemnify, defend and hold
Solvay and Solvay Affiliates harmless from and against all costs,
claims, suits, expenses (including reasonable attorneys' fees) and
damages arising out of or resulting from :
(a) the use by or administration to any person of eptifibatide
(except where such cost, claim, suit, expense or damage arose or
resulted from Solvay's negligence or willful misconduct, or an
event specified in Article 10.2); or
(b) infringement of any third party intellectual property rights
relating to eptifibatide but not to the manufacture of Bulk
Product;
provided that Solvay gives prompt notice in writing to Millennium of any
such claim or action, gives Millennium sole control and authority with
respect to the defense and
- 14 -
settlement of such claim or action to Millennium, assists Millennium if
requested by Millennium at Millennium's expense in defending such claim
or action and does not compromise or settle such claim or action without
Millennium's prior written consent. Millennium shall not accept any
settlement which imposes liability on Solvay not covered by this
indemnification or restrictions on Solvay without Solvay's prior written
consent, which consent shall not be unreasonably withheld or delayed.
10.2 SOLVAY INDEMNIFICATION. Solvay shall indemnify, defend and hold
Millennium harmless from and against all costs, claims, suits, expenses
(including reasonable attorneys' fees) and damages arising out of or
resulting from :
(a) any failure of the Bulk Product supplied by Solvay under this
Agreement to meet the Specification;
(b) any failure of Solvay to manufacture the Bulk Product in
accordance with Good Manufacturing Practices or any other
applicable government law or regulation; and
(c) infringement of any third party intellectual property right
relating to the manufacture, use or sale of Bulk Product but not
to eptifibatide independent of its manufacture;
provided that Millennium gives prompt notice to Solvay of any such claim
or action, offers to give Solvay sole control and authority with respect
to the defense and settlement of such claim or action to Solvay, assists
Solvay if requested by Solvay at Solvay's expense in defending such
claim or action, and does not compromise or settle such claim or action
without Solvay's prior written consent. Solvay shall not accept any
settlement which imposes liability on Millennium not covered by this
indemnification or restrictions on Millennium without Millennium's prior
written consent, which consent shall not be unreasonably withheld or
delayed.
10.3 LIMITATION OF LIABILITY. Subject to Solvay's obligations under Articles
10.2(c) and 10.4 and other than for fraudulent misrepresentation, death
or personal injury caused by Solvay's negligent or willful acts,
Solvay's liability to Millennium under this Agreement shall be limited
to the free (to Millennium) replacement of Bulk Product within a
reasonable time, or the value thereof, provided that the information
Solvay originally submitted to Millennium about the batch of Bulk
Product and the manufacture of same was accurate. Neither Party shall be
liable to the other for indirect, incidental or consequential damages
arising out of any of the terms or conditions of this Agreement or with
respect to its performance.
10.4 RECALLS. Solvay will indemnify and hold Millennium harmless from the
costs of Bulk Product recalled and up to [**] U.S. dollars ($ [**] U.S.)
for any out-of-pocket expense relating to implementation of a recall of
any batch of Bulk Product supplied by Solvay due to failure to meet the
warranties set forth in Article 11.1 below. For purposes of this
Agreement, the expenses of recall shall be the expenses of notification
and destruction or return of the recalled Bulk Product, and any costs
directly associated with the distribution
- 15 -
of replacement Bulk Product. Millennium shall have the right to control
the arrangement of any recall, and the Parties will cooperate with each
other in implementing such recall.
11 - WARRANTIES
11.1 SOLVAY WARRANTIES. Solvay warrants :
(a) that it will comply with all manufacturing instructions and the
Specification, including quality control standards provided in
accordance with this Agreement;
(b) that Bulk Product will be produced in accordance with such
instructions and specifications and with Good Manufacturing
Practices and other applicable laws, rules and regulations of the
United States, the European Union, and to the extent applicable,
of European Union Member States; and
(c) that, upon delivery of Bulk Product [**], Bulk Product will be in
conformity with the Specification and with the United States
Food, Drug and Cosmetic Act, providing , inter alia, that the
Bulk Product shall not be adulterated or misbranded or otherwise
of a nature which may not be introduced into United States
interstate commerce.
11.2 NO OTHER WARRANTIES. THE EXPRESS WARRANTIES MADE IN THIS AGREEMENT AND
THE LICENSE AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
12 - GENERAL PROVISIONS
12.1 COMPLAINTS. Solvay will report to Millennium in writing any complaints
and any information that it may receive relating to eptifibatide.
12.2 NOTICES. All notices and demands required or permitted to be given or
made pursuant to this Agreement shall be in writing and shall be deemed
given if delivered personally or be given by facsimile transmission
(receipt verified), mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service
(receipt verified), properly addressed to the address of the Party to be
notified as shown below :
IF TO SOLVAY :
The General Manager of Solvay Peptides
SOLVAY S.A.
000, xxx xx Xxxxxxxx
- 00 -
X - 0000 Xxxxxxxxx, Belgium
Facsimile: 00-0-000-0000
IF TO MILLENNIUM :
Millennium Pharmaceuticals, Inc.
Vice President of Commercial Manufacturing
Xxx Xxxxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Xxxxxx Xxxxxx of America
Facsimile: 0-000-000-0000
With a copy to :
Millennium Pharmaceuticals, Inc.
General Counsel
Xxx Xxxxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Xxxxxx Xxxxxx of America
Facsimile : 0-000-000-0000
or to such other address as to which either Party may notify the other.
Any notice sent by facsimile transmission shall be followed within
twenty-four (24) hours by a signed notice sent by first class mail,
postage prepaid.
12.3 ASSIGNMENT AND DELEGATION. Solvay may not assign its rights and/or
delegate its obligations under this Agreement to any third party without
the prior written consent of Millennium, such consent not to be
unreasonably withheld, except in connection with the sale, merger or
transfer of substantially all of the stock or assets of Solvay or the
sale, merger or transfer of substantially all of the interests in or the
assets of Peptisyntha to any party who meets financial and ethical
standards generally acceptable within the pharmaceutical industry,
providing that such assignee or delegatee agrees to be bound by the
terms of this Agreement, in which case the consent of Millennium is not
required. Millennium may assign its rights hereunder in whole or part,
or delegate any of its obligations hereunder to any party who meets
financial and ethical standards generally acceptable within the
pharmaceutical industry, except without such requirement of standards in
connection with the sale, merger or transfer of all or substantially all
of the assets of Millennium relating to eptifibatide, provided such
assignee or delegatee agrees to be bound by the terms of this Agreement.
12.4 PERFORMANCE BY AFFILIATES. The Parties recognize that each may perform
some or all of its obligations under this Agreement through Affiliates
as specified in this Agreement, provided however, that each Party shall
remain responsible and be guarantor of the performance by its Affiliates
and shall cause its Affiliates to comply with the provisions of this
Agreement in connection with such performance.
- 17 -
12.5 PERFORMANCE BY THIRD PARTIES. The Parties recognize that Solvay may
perform some or all of its manufacture and storage obligations under
this Agreement through a third party, with the prior written consent of
Millennium, such consent not to be unreasonably withheld. [**]. Solvay
shall remain responsible and be guarantor of the performance by third
parties performing its obligations hereunder and shall cause such third
parties to comply with the provisions of this Agreement in connection
with such performance.
12.6 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of England; excluding: (i) its conflicts of
laws principles; and (ii) the United Nations Convention on Contracts for
the International Sale of Goods. Solvay and Millennium submit
irrevocably to the exclusive jurisdiction and venue of the English
courts.
12.7 FORCE MAJEURE. Neither Party shall be liable to the other for loss or
damage, or, except as provided herein, have any right to terminate this
Agreement by virtue of an occurrence which prevents, delays or
interferes with the performance by a Party of any of its obligations
hereunder, if such occurs by reason of any Act of God, flood, fire,
explosion, casualty or accident, or war, revolution, civil commotion,
acts of public enemies, blockage or embargo, or any law, order or
proclamation of any government, strike or other labor trouble, failure
of suppliers to deliver materials, equipment or machinery, interruption
of or delay in transportation, or any other cause whatsoever, whether
similar or dissimilar to those above enumerated, beyond the reasonable
control of such Party, if, and only if, the Party affected shall have
used its best efforts to avoid such occurrence ; PROVIDED, HOWEVER, that
the occurrence of a force majeure event shall [**]. In such an event,
the Party affected shall notify the other and shall attempt to perform
its obligations as soon as possible.
12.8 ENTIRE AGREEMENT. With respect to the manufacture and supply of Bulk
Product for year 2004 and thereafter, this Agreement together with the
License Agreement is the entire agreement between the Parties and shall
terminate and supersede any prior written or oral promises or
representations between the Parties not incorporated herein including
the Long Term Supply Agreement dated September 28, 1995. For the sake of
clarification, the Parties acknowledge that the termination of such Long
Term Supply Agreement does not relieve the Parties from those of their
obligations which survive such termination as provided for in Article
9.3 thereof, including but not limited to
(a) the obligation in Solvay to deliver Bulk Product ordered by
Millennium in the purchase orders here below which were placed
before said termination
(i) purchase order N DEG. 1077633 ([**] kg) from Millennium
dated [**], and
(ii) purchase order N DEG. P20395 ([**] kg) from Cor
Therapeutics [**], and
(b) the obligation in Millennium to pay for Bulk Product delivered by
Solvay.
In addition, Solvay agrees to deliver to Millennium an amount of [**]
kilograms of Bulk Product in 2003 in addition to the quantities ordered
in the purchase orders referred to here above, [**].
- 18 -
In the event of conflict between this Agreement and the License
Agreement, the terms of the License Agreement shall control except for
the provisions of Article 8.8(a), 8.8(d), 8.9 and 9.4(a) which shall
prevail, and such provisions shall be deemed to supplement and amend the
License Agreement for the period for which such provisions are in force
hereunder. No amendment or modification of the terms of this Agreement
shall be binding on either Party unless reduced to writing and signed by
the respective authorized officers of the Parties.
12.9 SEVERABILITY. If any provision of this Agreement is determined to be
illegal or unenforceable by any court of law or any competent
governmental or other authority, the remaining provisions shall be
severable and enforceable in accordance with their terms so long as this
Agreement with such terms or provisions does not fail of its essential
purpose. The Parties shall negotiate in good faith to replace any such
illegal or unenforceable provisions with suitable substitute provisions
which will maintain as far as possible the purposes and the effect of
this Agreement.
12.10 RELATIONSHIP OF THE PARTIES. 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 extent, if at all, specifically provided herein.
No right, express or implied, is granted by this Agreement to either
Party to use in any manner the name of the other or any other trade name
or trade xxxx of the other in connection with the performance of this
Agreement. Solvay shall not, without first obtaining the written consent
of Millennium, in any manner disclose or publish the terms of this
Agreement.
12.11 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 hereof, at that
point in time or in the future.
12.12 HEADINGS. All headings, titles and captions in this Agreement are for
convenience only and shall not be of any force or substance.
12.13 COUNTERPARTS. This Agreement may be executed in multiple counterparts,
each of which shall be an original, but all of which shall constitute
but one agreement.
13 - INSURANCE
13.1 INSURANCE REQUIREMENTS. Solvay shall secure and maintain in full force
and effect throughout the term of this Agreement and for at least three
(3) years thereafter, public and private insurance with coverage and
minimum policy limits set forth as follows :
- 19 -
(a) WORKER'S COMPENSATION, including coverage for occupational
disease, with benefits determined by statute, in at least the
amounts required by applicable law.
(b) COMPREHENSIVE GENERAL LIABILITY, PERSONAL/ADVERTISING INJURY and
PRODUCT LIABILITY, including coverage for contractual liability
assumed by Solvay and coverage for Solvay's independent
contractor(s), with an aggregate limit of at least twenty million
U.S. dollars ($ 20,000,000 U.S.).
(b) COMPREHENSIVE AUTOMOBILE LIABILITY, including coverage for owned,
hired, and non-owned automobiles in at least the amounts required
by applicable law.
(d) "ALL RISK" property policy, valued at replacement cost, covering
loss or damage to manufacturing facilities engaged in the
manufacture of Bulk Product or Bulk Product Intermediates under
this Agreement and Millennium's property and materials in the
care, custody, and control of Solvay.
13.2 PROOF OF INSURANCE. Solvay shall furnish to Millennium a certificate
from an insurance carrier (having a minimum Standards & Poor's rating of
A) demonstrating the amounts of insurance set forth above have been
satisfied as of the date of such certificate. The insurance certificate
shall confirm each of the following:
(a) excluding Solvay's Worker's Compensation policy, Millennium is
named as an additional insured with respect to matters arising
from this Agreement;
(b) such insurance is primary and non-contributing to any liability
insurance carried by Millennium; and
(c) thirty (30) days prior written notice shall be given to
Millennium in the event of cancellation or any material change in
the policies or in the matters covered in Sections 13.2(a) and
13.2(b) above.
13.3 INSPECTIONS. Solvay shall comply, at Millennium's expense, with
reasonable requests for information made by Millennium's insurance
provider representative(s) by permitting such representative(s) to
inspect manufacturing facilities engaged in the manufacture of Bulk
Product or Bulk Product Intermediates under this Agreement during
operational hours with a minimum one month prior notice to Solvay. In
regard to such inspections, the representative(s) shall adhere to such
guidelines and policies pertaining to safety and non-disclosure as
Solvay may require.
- 20 -
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement to be
effective on the date first set forth above.
MILLENNIUM SOLVAY S.A.
PHARMACEUTICALS INC.
BY : /s/ Xxxx X. Xxxxxxx BY : /s/ Xxxxxx Xxxxxxxxxx
------------------------- --------------------------
TITLE : V.P. MANUFACTURING TITLE : GENERAL MANAGER SOLVAY PEPTIDES
XXXXXXX X. XXXXX, CFO /s/ Xxxxxx Xxxxx, DIRECTOR AND MEMBER OF
THE EXECUTIVE COMMITTEE; GENERAL MANAGER
PHARMACEUTICALS SECTOR SOLVAY
DATE : 19 December 2002 DATE : 18 December 2002
------------------------- -----------------------
Appendix A : Requirements Forecasts
Appendix B : Bulk Product Price
Appendix C : Bulk Product Specification (with letter from Peptisyntha dated
December 10, 2002 attached)
Appendix D : Confidentiality Agreement signed by [**] dated 10 October 1996
- 21 -
APPENDIX A : REQUIREMENTS FORECASTS
[**] [**] [**]
- 22 -
APPENDIX B : BULK PRODUCT PRICE
The reference price for Bulk Product at the Specification, [**], as the case may
be, shall be :
(a) for quantities ordered in any given year up to and including [**]
United States Dollars (USD [**])
(b) for quantities ordered in any given year in excess of [**] United
States Dollars (USD [**])
The unit price for Bulk Product shall be computed by multiplying the
above-specified reference price by two corrective factors determined in the
following manner:
(i) [**] corrective factor: divide the value of [**] as of the date
of the relevant Purchase Order by [**] from that ratio, [**], and
then [**] to that product to identify the factor.
(ii) [**] corrective factor: [**] as of the date of the Purchase
Order, [**], and then [**] to that product to identify the
factor.
[**], as of the date of the Purchase Order, [**].
- 23 -
SOLVAY
--------------------------------------------------------------------------------
DIRECTION CENTRALE RECHERCHE & TECHNOLOGIE
From: X. Xxxxxxxxxx
Xx. Xxxx Xxxxxxx
MILLENNIUM Pharmaceuticals Inc.
Xxx Xxxxxxxx
XXX - XXXXXXXXX, XX 00000
Xxxxxx Xxxxxx of America
PEPTI - PBY/CCI Brussels, December 10, 2002
BY DHL
Dear Xxxx,
In relation with our discussions on the New
Long Term Supply Agreement, with the
Specifications attached as Appendix C, [**].
I herewith confirm that [**] in the final Bulk Product.
Best regards,
For SOLVAY S.A.
/s/ Xxxxxx Xxxxxxxxxx
Xxxxxx XXXXXXXXXX
General Manager Solvay Peptides
- 24 -
APPENDIX C
Bulk Product Specification
I - BULK PRODUCT CONTENT AND TESTING
TEST LOT TEST SPECIFICATION METHOD
-------- ---- ------------- ------
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
-------------------------
1 [**].
2 [**].
3 [**].
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
- 25 -
II - SHIPPING SPECIFICATION FOR SHIPMENT OF BULK PRODUCT TO MILLENNIUM
[**] containing Bulk Product will be packed in a molded (Styrofoam) container
along with dry ice inside a cardboard shipper. The outside of the cardboard
shipper will be labeled "Refrigerate Upon Arrival". Shipments will be made [**]
The commercial invoice and certificate of analysis will accompany the shipment.
The commercial invoice will specify the harmonized code : 2934.99.3000 "Drugs".
Shipments should be made via [**](in San Francisco) or their local agent in
Brussels. Before the shipment is sent, Solvay will telefax the commercial
invoice and details of the impending shipment to MILLENNIUM and to [**]. The
Bulk Product will be shipped such that the Port-of-Entry into the United States
is San Francisco. The shipment will be sent to :
MILLENNIUM Pharmaceuticals
Attention QA/QC
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 - USA
- 26 -
III - DESCRIPTION OF THE METHODS
The table below lists the Peptisyntha Test Procedure numbers for the analytical
methods that will be used for the release of Eptifibatide Bulk Product. The
method numbers referenced below and their respective procedures may only be
changed by mutual agreement of MILLENNIUM and Solvay.
METHOD PEPTISYNTHA METHOD NUMBER
------ -------------------------
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
[**] [**]
IV - REFERENCE STANDARDS
For the purpose of Eptifibatide Bulk Product release testing. Peptisyntha will
use a reference standard that has been either provided by MILLENNIUM.
- 27 -
APPENDIX D
CONFIDENTIALITY AGREEMENT
This Agreement is entered into effective as of October 10, 1996 among:
SOLVAY, SOCIETE ANONYME ("SOLVAY"), a Belgian corporation, with its principal
offices at 00, xxx xx Xxxxxx Xxxxxx, 0000 Xxxxxxxx, Xxxxxxx, on behalf of itself
and its Affiliates; and
COR THERAPEUTICS, INC. ("COR"), a Delaware corporation, with its principal
offices at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, XXX, on
behalf of itself and its Affiliates; and
[**] ("RECIPIENT"), a designee of COR with an address at [**].
WITNESSETH
WHEREAS, COR owns certain patent rights, trademarks and know-how relating to a
product called INTEGRILIN(TM),
WHEREAS, SOLVAY has developed a unique and valuable patented and proprietary
process useful for the manufacture of peptides, and is practicing the said
process for the manufacture of bulk peptide products containing INTEGRILIN sold
to COR pursuant to several Agreements entered into between SOLVAY and COR.
WHEREAS, SOLVAY has agreed to disclose confidential information to the RECIPIENT
who has been duly appointed as "Homme de Confiance" by COR with responsibility
for coordination of certain communications between COR and PEPTISYNTHA, an
Affiliate of SOLVAY, such
- 28 -
mission being described in the APPENDIX hereof and being subject to updating
from time to time by SOLVAY and COR.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the parties agree as follows:
1.0 - CERTAIN DEFINITIONS
For the purposes of this Agreement, the following terms shall have the following
meanings:
1.1 "AFFILIATES" shall mean any entity or person which controls, is
controlled by or is under common control with either Party. For purposes
of this section 1.1., "control" shall mean:
(a) in the case of corporate entities, the direct or indirect
ownership of at least one-half of the stock or participating
shares entitled to vote for the election of directors, and
(b) in the case of a partnership, the power to direct the management
and policies of such partnership.
Without limitation on the foregoing and for purposes of this Agreement,
PEPTISYNTHA & Cie, Societe en Nom Collectif ("PEPTISYNTHA"), which is a
fully owned subsidiary of SOLVAY and an entity existing under the laws
of Belgium and having its principal offices at 000, xxx xx Xxxxxxxx,
0000 Xxxxxxxx, Xxxxxxx, is deemed an Affiliate of SOLVAY.
1.2 "AGREEMENT PURPOSE" shall. mean the fulfillment by RECIPIENT of the
mission of "Homme de Confiance" he has been entrusted with and which is
described in the APPENDIX hereof.
1.3 "SOLVAY CONFIDENTIAL INFORMATION" shall mean any or all information
disclosed by SOLVAY to RECIPIENT in order to enable him to fulfill the
Agreement Purpose as well as any and all information that RECIPIENT may
learn or have access to, due to his presence in SOLVAY's or
PEPTISYNTHA's facilities, relating to SOLVAY's or PEPTISYNTHA's business
or technology.
1.4 "EFFECTIVE DATE" shall mean October 10, 1996.
1.5 "INTEGRILIN" shall mean a specific peptide designated by COR and known
as INTEGRILINtm, the chemical structure of which is known to RECIPIENT
pursuant to the terms of separate agreements entered into with COR.
- 29 -
1.6 "PARTY" shall mean SOLVAY, COR or RECIPIENT.
2 - DISCLOSURE OF SOLVAY CONFIDENTIAL INFORMATION
2.1 SOLVAY shall disclose to RECIPIENT SOLVAY Confidential Information
sufficient to enable RECIPIENT to fulfill the Agreement Purpose.
2.2 SOLVAY Confidential Information disclosed under paragraph 2.1 hereabove
maybe disclosed in tangible form, such as in writing and marked
"Confidential", or provided orally.
3 - CONFIDENTIALITY AND EXCEPTIONS
3.1 RECIPIENT hereby agrees, regarding SOLVAY Confidential Information
disclosed to him by SOLVAY under the terms of Article 2 hereof that he
shall
(a) make no use of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person, except to
COR's employees duly appointed to receive it;
(c) not disclose to any party or person either the existence of this
Agreement or its underlying discussions except for the Agreement
Purpose;
(d) take the same steps to protect said information as he takes to
protect the proprietary and confidential information of COR.
3.2 RECIPIENT hereby agrees, regarding SOLVAY Confidential Information he
may learn or have access to due to his presence in SOLVAY's or
PEPTISYNTHA's facilities and which is not comprised in the Confidential
Information referred to in Article 2 hereof; that he shall:
(a) make no use, of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person;
(c) not disclose to any party or person either the existence of this
Agreement or its underlying discussions except for the Agreement
Purpose;
(d) take the same steps to protect said information as he takes to
protect the proprietary and confidential information of COR.
- 30 -
3.3 The obligations under paragraph 3.1 and 3.2 hereabove shall not,
however, apply to any SOLVAY Confidential Information which:
(a) RECIPIENT can prove is at the time of disclosure or thereafter
becomes public knowledge through no fault or negligence of
RECIPIENT, or
(b) RECIPIENT can prove was known to him, prior to the receipt of
such Confidential Information from SOLVAY, or
(c) is lawfully obtained by RECIPIENT from any party not bound by a
secrecy obligation towards SOLVAY relating to the Confidential
Information.
For the purposes of this paragraph 3.3, information shall not be deemed
to be public , knowledge or known on the ground only that
(i) the general principle is public knowledge or known to
RECIPIENT if the particular practice is not itself public
knowledge or so known, or
(ii) it constitutes a combination of or is drawn from
information which is public knowledge or known to
RECIPIENT unless the combination itself and its principle
and mode of operation is also public knowledge or known
to the RECIPIENT.
4.0 - DOCUMENTS DELIVERY OR DESTRUCTION
Upon the written request of SOLVAY, RECIPIENT undertakes to promptly deliver it,
or destroy if so instructed by it, all documents furnished by SOLVAY to
RECIPIENT and constituting Confidential Information, as well as all copies
thereof which might be in his possession.
5.0 - NO IMPLIED LICENSE
Nothing in this Agreement shall be construed as to grant RECIPIENT any title or
right or license to own or use at any time the SOLVAY Confidential Information,
except as expressly set forth herein.
6.0 - COR'S RESPONSIBILITY
COR shall guarantee the performance of this Agreement by RECIPIENT.
- 31 -
7.0 - TERM
This Agreement shall become effective on the Effective Date and shall remain in
effect until terminated by any Party. The provisions of Article 3 shall however
survive until the thirty-first day of December 2030.
8.0 - GENERAL PROVISIONS
8.1 NOTICES
All notices and demands required or permitted to be given or made pursuant to
this Agreement shall be in writing and shall be deemed given if delivered
personally or by given facsimile transmission (receipt verified), telexed,
mailed by registered or certified mail (return receipt requested), postage
prepaid, or sent by express courier service, properly addressed to the address
of the Party to be notified as shown below:
If to SOLVAY
SOLVAY S.A.
DCR-LC
000, xxx xx Xxxxxxxx
X - 0000 Xxxxxxxx, Xxxxxxx
ATTENTION: GENERAL MANAGER RESEARCH AND DEVELOPMENT
If to COR
President, COR Therapeutics, Inc.
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, XXX
If to RECIPIENT
[**]
or to such other address as to which any Party may notify the others. Any notice
sent by facsimile transmission or telex shall be followed within twenty-four
(24) hours by a signed notice sent by first class mail, postage prepaid.
8.2 ASSIGNMENT AND DELEGATION
RECIPIENT may not assign his rights and/or delegate his obligations under this
Agreement to any third party without the prior consent of SOLVAY and COR.
8.3 AMENDMENT
- 32 -
No amendment or modification of the terms of this Agreement shall be binding on
any Party unless reduced to writing and signed by the respective authorised
officers of SOLVAY and COR and by RECIPIENT.
8.4 PUBLICITY
The Parties agree that, except as may otherwise be required by applicable laws,
regulations, rules or orders, no information concerning this Agreement and the
transactions contemplated herein shall be made public by any Party without the
prior written consent of the others.
8.5 WAIVER
Failure of any 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 hereof, at that point in time or in the future.
8.6 COUNTERPARTS
This Agreement may be executed in multiple counterparts, each of which shall be
an original, but all of which shall constitute but one agreement.
8.7 GOVERNING LAW
This Agreement shall be governed by the laws of
England. SOLVAY, COR and
RECIPIENT consent to the exclusive jurisdiction and venue of the Courts of
England.
IN WITNESS THEREOF, the parties hereto have executed this Agreement, in three
original copies.
SOLVAY S.A. COR THERAPEUTICS, INC.
By: /s/ A. Hoffait By: /s/ Xxxx X. Xxxxxx
----------------------------- -----------------------------
A. Hoffait Xxxx X. Xxxxxx
Title: General Manager, Research and Title: Executive Vice President,
Development Commercial Operations
RECIPIENT
/s/ [**]
----------------
[**]
APPENDIX: Mission of the "Homme de Confiance"
- 33 -
APPENDIX
MISSION OF THE "HOMME DE CONFIANCE"
The mission of the "Homme de Confiance" aims at improving communications between
SOLVAY and COR and at facilitating prompt resolution of issues between them.
The mission will include the following activities
- Review of production and delivery schedules and activities;
- Review of Intermediates purchasing from suppliers and Intermediates and
Bulk Products inventories;
- Review of status of technology transfer to the Secondary Source and
potential additional sources;
- Review of outstanding issues affecting production and regulatory
compliance;
- Review of plans for and status of Plant Expansion.
Any additional activity, within the scope of COR's letter dated October 6, 1996
attached, is subject to SOLVAY's approval.
---
- 34 -
[COR LOGO]
COR THERAPEUTICS, INC.
000 X. Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx
Xxxxxxxxxx 00000
000 0000000
Fax 000 000 0000
October 6, 1996
Mr. Alfred Hoffait
General Manager, Research & Development Solvay, X.X.
Xxx xx Xxxxxxxx 000
X-0000 Xxxxxxxx, Xxxxxxx
Dear Xxxxxx:
This letter serves to clarify any issues regarding [**] level of confidentiality
and access to information from COR's perspective. As "homme de confiance", COR
views [**] as a COR representative in frequent attendance at Solvay, and as
such, we would like him to have access to the same information that could be
communicated to any other COR personnel.
[**] has entered into a confidentiality arrangement with COR, and therefore this
letter specifically authorizes you to show [**] confidential COR information
that may be in your files, and to discuss with him any issues regarding the
relationship between COR and Solvay.
It is our hope that involving [**] in COR/Solvay issues on a regular basis will
improve communications between our companies and facilitate prompt resolution of
issues. However, you understand that [**] is not COR's general agent and he does
not have the power to commit COR or enter into agreements on behalf of COR
without specific instructions from COR.
We appreciate your willingness to include [**] as a representative of COR.
Regards,
/s/Xxxx X. Xxxxxx
Xxxx X. Xxxxxx
Executive Vice President, Commercial Operations
- 35 -
AMENDMENT NO. 5 TO THE LICENSE AND SUPPLY AGREEMENT
This Amendment, effective as of the thirty first (31st) day of December
2002, is by and between
SOLVAY S.A., a company duly organized and existing under the laws of
Belgium with offices at 00, xxx xx Xxxxxx Xxxxxx, X-0000 Xxxxxxxxx, Xxxxxxx,
acting on behalf of itself and its AFFILIATES (as hereinafter defined),
hereinafter globally referred to as "SOLVAY",
and
MILLENNIUM Pharmaceuticals, Inc., a company duly organized and existing
under the laws of Delaware with offices at 00 Xxxxxx Xxxxxx, Xxxxxxxxx, XX
000000, hereinafter referred to as "MILLENNIUM."
RECITALS
COR (AS HEREINAFTER DEFINED) AND SOLVAY ARE THE PARTIES TO A CERTAIN LICENSE
AND SUPPLY AGREEMENT.
COR HAS ASSIGNED TO MILLENNIUM SAID LICENSE AND SUPPLY AGREEMENT PER THE
ASSIGNMENT AGREEMENT DATED 12 FEBRUARY 2002.
SOLVAY AND MILLENNIUM ARE WILLING TO MODIFY A PROVISION OF SAID LICENSE AND
SUPPLY AGREEMENT.
OPERATIVE PROVISIONS
ARTICLE 1. DEFINITIONS
1.1 Whenever used in this Agreement, the following terms written
in capital letters shall have the following meaning:
a) AFFILIATES shall have the same meaning as in the LICENSE
AGREEMENT.
b) COR shall mean COR THERAPEUTICS, Inc., a company duly
organized and existing under the laws of Delaware with offices at
000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, XXX
00000.
c) LICENSE AGREEMENT shall mean the License and Supply
Agreement dated 27 July 1994 entered into between SOLVAY and COR
and amended as per
(i) the First Amendment dated 13 March 1995,
(ii) the Second Amendment dated 1 June 1995,
(iii) the Third amendment dated 5 September 1995, and
(iv) the Fourth Amendment dated 1 April 1997.
1.2 Unless the indicated otherwise, references to Sub-Clauses
shall mean references to Sub-Clauses of this Agreement.
ARTICLE 2. - AMENDMENT
2.1 Section 2.2 of the LICENSE AGREEMENT shall be deleted and
replaced by the following Section 2.2:
SECONDARY SUPPLY.
-----------------
COR shall have the right to establish a Secondary Source for the
manufacture of Bulk Product by the Licensed Process for COR The
Secondary Source shall be selected from the list of specific potential
secondary sources acceptable to COR and to Solvay which is attached
hereto as Exhibit C; this list may be amended from time to time upon
agreement of COR and Solvay, such agreement not to be unreasonably
withheld, and without any additional fee. COR and Solvay agree that a
potential corporate partner, such as one of those exemplified in Exhibit
C, would be acceptable as the Secondary Source. COR will notify Solvay
of the establishment of the Secondary Source. In the event COR
terminates a supply arrangement with a Secondary Source, COR may
establish an alternate Secondary Source. COR shall notify Solvay [**] of
such a termination of supply arrangements with a Secondary Source.
Further, after the Secondary Source is established, COR may use [**] for
the manufacture of Bulk Product starting from Step One Intermediates
supplied by Solvay to [**]. COR's future requirements for Bulk Product
cannot be ascertained with certainty at the present time, however, COR
wants to entertain certain minimum purchase obligations. Therefore,
after the Secondary Source is established, COR shall be required to
purchase from Solvay a share of at least [**] percent ([**]%) of its
total, worldwide requirements for Bulk Product on a year-to-year basis
(to the extent that such share does not exceed the manufacturing
capacity planned by Solvay to produce Bulk Product) for the time period
during which royalties are payable under this Agreement, except to the
extent the parties have agreed otherwise in writing. For purposes of the
preceding sentence, such planned capacity shall be determined for a
particular calendar year X on the [**]. Notwithstanding the above
however, COR may purchase from such Secondary Source and/or [**] percent
([**]%) of its requirements in the event of any breach or default of
Solvay of any supply arrangement between COR and Solvay for so long as
the breach or default remains uncured. In the event Solvay assigns or
transfers to a third party the Licensed Process, this Agreement, the
Supply Agreement or the
Long Term Supply Agreement, inconsistently with
the terms of these Agreements, COR may establish and additional,
"Back-up" Secondary Source for the manufacture of Bulk Product. In the
event that COR wishes to establish COR itself either as the
2
Secondary Source or the Back-up Secondary Source, then COR and Solvay
shall negotiate in good faith, before establishing COR in such capacity,
a method for establishing [**].
b) All the other provisions of the LICENSE AGREEMENT shall remain
unchanged and in full force and effect.
c) The present amendment shall be effective as of the first date
here above written.
IN WITNESS HEREOF, the parties have caused this Agreement to be executed
in two original copies by their duly authorized representatives, as of the date
first above written.
SOLVAY S.A.
MILLENNIUM PHARMACEUTICALS INC.
Name: /s/ Xxxxxx Xxxxx Name: /s/ Xxxx X. Xxxxxxx
--------------------- -------------------------
Title: Director and Member of Title: VP - Manufacturing
the Executive Committee
General Manager Pharmaceuticals Sector
SOLVAY
Xxxxxx Xxxxxxxxxx
General Manager
Solvay Peptides
Date: 18 December 2002 Date: 19 December 2002 8:18 AM EST
---------------- -----------------------------
Sign: Sign:
----------------------------- ------------------------------
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