EXHIBIT 10.3
AMENDMENT TO ARTICLE 5 OF
COLLABORATION AGREEMENT
THIS AMENDMENT TO ARTICLE 5 OF COLLABORATION AGREEMENT, effective this
1st day of January, 2004 (the "Effective Date") is made by and between Genzyme
Corporation, with its place of business located at 15 Pleasant Street Connector,
Framingham, MA 01701 ("Genzyme") and Sankyo Pharma Inc. a Delaware Corporation,
Two Hilton Court, Parsipanny, New Jersey 07054 (hereinafter referred to as
"Sankyo") (the "Amendment").
WHEREAS, Sankyo and Genzyme are parties to a certain Collaboration
Agreement, dated December 23, 1999, as amended, by and between GelTex
Pharmaceuticals, Inc., Genzyme's predecessor in interest, and Sankyo (the
"Agreement").
WHEREAS, Sankyo, and Genzyme wish to modify the terms of the Agreement
to provide for the storage of certain of the Drug Substance (as defined in the
Agreement) at the Manufacturing Facilities (as defined in the Agreement) upon
its release by Genzyme, to Sankyo;
NOW THEREFORE, Genzyme and Sankyo agree that Section 5 of the Agreement
will be amended as set forth below:
The terms used in this Amendment shall have the meanings assigned to
them in the Agreement, except that the parties explicitly acknowledge and agree
that Genzyme is the successor in interest to GelTex, that GelTex no longer
exists, and that Genzyme and GelTex shall be considered the same party with
respect to the rights and obligations set forth in this Amendment and the
Collaboration Agreement regardless of which name is used o refer to that party.
Genzyme as the successor shall have all the rights and obligations belonging to
that party regardless of whether they are set forth in reference to GelTex or to
Genzyme.
Section 5.1.7 of the Agreement shall be deleted in its entirety and
replaced in full with the following:
5.1.7 PURCHASE ORDERS. The terms of Section 5.1.3 hereof shall serve as
the firm purchase order for the initial 80 tons of Drug Substance to be
delivered during the 80-ton delivery period. For all quantities of Drug
Substance thereafter, the following terms shall apply.
a.) By October 1, 2000 (for deliveries commencing February 1,
2001), and thereafter, not less than ninety (90) days prior to
the first day of each calendar quarter during the Term, Sankyo
shall provide Genzyme with a
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the commission.
firm purchase order setting forth the quantities of Drug
Substance ordered for each month of that calendar quarter, the
delivery dates for such quantities and the locations to which
such quantities shall be delivered ("Purchase Order"). The
Purchase Order shall also indicate whether the Drug Substance
shall be delivered for shipment to the Finisher/Packager
pursuant to Section 5.1.8 or retained at the Manufacturing
Facilities as "Sankyo Material" (as defined in Section 5.1.9
below).
b) Upon receipt of the Purchase Order and after the Drug
Substance is ready for shipment pursuant to Section 5.1.8,
Genzyme shall issue a Sales Order to Sankyo referencing the
lot numbers and quantities of the Drug Substance and
confirming Sankyo's instruction as to whether the specific
lots of Drug Substance will be delivered to the carrier for
shipment pursuant to Section 5.1.8 or stored at the
Manufacturing Facilities ("Sales Order").
c) Sankyo acknowledges and agrees that any Drug Substance that is
retained at the Manufacturing Facilities after a Sales Order
is issued by Genzyme shall be owned by Sankyo as described in
Section 5.1.9 below and will be stored pursuant to the Amended
Warehousing Agreement between Genzyme and Powdersize, Inc.
("warehousing Agreement"), a copy of which is attached hereto
as Exhibit A. Sankyo agrees to fully abide by the terms of the
Warehousing Agreement and to confine the quantity of Sankyo
Material that it directs be retained at the Manufacturing
Facilities and stored pursuant to the Warehousing Agreement to
what is explicitly allowed therein. Sankyo agrees to accept
immediate, full and unqualified responsibility for any Sankyo
Material that exceeds the allowed storage amount of 2
truckloads as specified in the Warehousing Agreement and
agrees that neither Genzyme nor Powdersize, Inc. shall have
any further responsibility for any such Sankyo Material.
Sankyo agrees to fully reimburse Genzyme for all fees and
other costs associated with the retention, storage and/or
handling of Sankyo Material under the Warehousing Agreement.
d) All Purchase Orders for the Drug Substance shall be for a
minimum batch size quantities reasonably agreed to by the
parties. In addition, Genzyme is not obligated to accept a
Purchase Order (i) for purchase orders which will be filled
during the first two quarters of any calendar year unless the
amount ordered under the Purchase order is equal to at least
[**] of the total amount of the firm commitment made to
Genzyme under section 5.1.4 with respect to the Delivery
period to which the Purchase Order relates, and (ii) for all
Purchase Orders, the amount ordered under the Purchase Order
does not require production at a rate in excess of [**]. If
Sankyo determines that it will require an increase in the
production of Drug Substance such that Drug Substance is
manufactured at a rate in excess of [**], Sankyo shall provide
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the commission.
Genzyme with at least [**] notice and the parties shall
discuss the terms under such additional capacity can be met.
Section 5.1.9 of the Agreement shall be deleted in its entirety and
replaced in full with the following:
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the commission.
5.1.9 TITLE AND RISK OF LOSS. Title to and risk of loss of all Drug
Substance ordered under Purchase Orders shall remain with Genzyme, or
its Manufacturer, until the Drug Substance is referenced in and made
subject to a Sales Order issued by Genzyme to Sankyo. As of the date of
a Sales Order is issued by Genzyme to Sankyo referencing a quantity of
Drug Substance, Sankyo shall own such Drug Substance ("Sankyo
Material"). Sankyo shall have title to and risk of loss in respect of
all Drug Substance that is Sankyo Material regardless of whether or not
it is shipped to the Finisher/Packager or retained at the Manufacturing
Facilities. Sankyo shall be fully responsible for any and all costs,
including storage costs, associated with all Sankyo Material, including
that retained at the Manufacturing Facilities pursuant to Section 5.1.7
and this Section 5.1.9. Genzyme shall have no further responsibility
for any Sankyo Material, regardless of whether or not it is shipped to
the Finisher/Packager or retained at the Manufacturing Facilities,
except that Genzyme shall be responsible for insuring the Sankyo
Material during delivery to the Finisher/Packager and shall designate
Sankyo as the loss payee with respect to such insurance and shall pay
for shipping costs under Section 5.1.8. Sankyo agrees to defend,
indemnify and hold Genzyme, its affiliates and their respective
directors, officers, employees and agents harmless from all claims,
losses, damages or expenses arising out of or relating to any delay in
the shipment of any Sankyo Material to the Finisher/Packager and or the
retention, storage, or handling of any Sankyo Material at the
Manufacturing Facilities. To the extent this indemnity provision
conflicts with Article 12 of the Collaboration Agreement, this
provision shall govern.
Section 5.1.11 of the Agreement shall be deleted in its entirety and
replaced in full with the following:
5.1.11 INVOICES.
a) Genzyme shall invoice Sankyo for all shipments of Drug
Substance ordered by Sankyo pursuant to Purchase Orders.
b) Genzyme shall separately invoice Sankyo for all fees and other
costs associated with any Sankyo Material retained at the
Manufacturing Facilities and stored pursuant to the
Warehousing Agreement Exhibit A, including but not limited to
a storage fee of Sixty Dollars ($60.00) per lot for each month
of storage, after the date of the Sales Order referencing such
Sankyo Drug Substance, pursuant to Sankyo's request under
section 5.1.7.
c) Sankyo shall pay each invoice within thirty (30) days after
Sankyo's receipt of Genzyme's invoice in accordance with the
terms of Section 9.3. Invoices shall be dated no earlier than
the date of the Sales Order issues by Genzyme with respect to
the Drug Substance.
[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the commission.
This Amendment constitutes the entire agreement of the parties with
regard to the subject matter hereof. To the extent not expressly modified by
this Amendment, the Agreement as previously amended, shall remain unaltered and
in full force and effect.
IN WITNESS WHEREOF, the parties hereto have caused these presents to be executed
in duplicate as of the day and year first above written.
GENZYME CORPORATION SANKYO PHARMA INC.
By: /s/ Mark Bamforth By: /s/ Joseph Pieroni
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Name: Mark Bamforth Name: Joseph Pieroni
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Title: Senior Vice President Title: President
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Date: July 21, 2004 Date: June 25, 2004
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[**] = Portions of this exhibit have been omitted pursuant to a confidential
treatment request. An unredacted version of this exhibit has been filed
separately with the commission.