Exhibit 10.67
CONFIDENTIAL TREATMENT
AMENDMENT NO. 2
to the
MANUFACTURING AND SUPPLY AGREEMENT
entered into as of September 30, 2001
by and between
ACS DOBFAR, SPA AND CUBIST PHARMACEUTICALS, INC.
This AMENDMENT NO. 2 ("AMENDMENT NO. 2"), to that certain Manufacturing
and Supply Agreement (the "AGREEMENT") entered into as of September 30, 2001, is
made this 12th day of February, 2003, by and between ACS Dobfar, SpA, an Italian
corporation ("ACSD") and Cubist Pharmaceuticals, Inc., a Delaware corporation
("CUBIST"). Unless otherwise defined herein, capitalized terms used but not
defined herein shall have the meaning set forth in the Agreement, and the
Agreement shall be amended to incorporate any additional definitions provided
for in this Amendment No. 1, including definitions in the preamble and recitals
hereto.
WHEREAS, Cubist and ACSD desire to amend the Agreement as set forth in
this Amendment No. 1;
NOW, THEREFORE, in consideration of the foregoing and the mutual
promises made herein, and for other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, the parties hereto agree to
amend the Agreement as follows:
1. AMENDMENT OF SECTION 2.1. The Agreement is hereby amended by
deleting Section 2.1 thereof in its entirety and replacing it with the following
Section 2.1:
2.1 FACILITY CONSTRUCTION AND TIMETABLE
(a) By [*] (the FACILITY COMPLETION TARGET DATE), ACSD will
construct, equip, test and qualify (IQ/OQ/PQ) and make operational the
Facility in accordance with current Good Manufacturing Practices.
ACSD's obligations hereunder include, but are not limited to:
(i) [*] necessary to perform the Process in a dedicated
Facility;
(ii) provision of [*] for [*] of [*];
(iii) the [*] of all required [*] for the [*] of Product
and [*]: and
(iv) [*] to manufacture Product.
Subject to adjustment in accordance with Section 2.2, ACSD will
complete all activities and to meet all dates set forth in this
Agreement. ACSD agrees that the following events (the "Targets") shall
occur by [*]: (i) ACSD shall produce [*] full [*] of the Facility; (ii)
[*] thereto shall be completed and ready for [*]; (iii) ACSD shall
commence [*]; and (iv) ACSD will be prepared in all respects for a [*].
The target date for [*] of the NDA Manufacturing Supplement for [*] is
[*]. In addition, ACSD shall (i) complete [*] and validation of [*] by
[*]; and (ii) complete
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theconsistency batches, the IQ/OQ/PQ, and the [*] validation batches
for the purification process by [*]. ACSD agrees that time is of the
essence in completing the tasks set forth in this Section 2.1 in order
to comply with ACSD's obligation to supply Product in [*]. In
connection with ACSD completing all activities required to meet the
aforementioned dates, Cubist shall remit to ACSD [*] of [*] on each of
(i) the date of execution by both parties of this Amendment No. 2 (the
"February Payment"); (ii)May 1, 2003 (the "May Payment"); and (iii)
August 1, 2003 (the "August Payment").
(b) By Xxxxx 0, 0000, XXXX and Cubist shall mutually agree
upon a schedule for all tasks [*] set forth in section 2.1(a) above
(the "Schedule"). In the event that, in Cubist's sole discretion,
Cubist determines that the Schedule will not enable [*], the May and
August Payments shall not be payable to ACSD and ACSD shall promptly
refund to Cubist the February Payment.
2. AMENDMENT OF SECTION 3.2. The Agreement is hereby amended by
deleting Section 3.2 thereof in its entirety and replacing it with the following
Section 3.2:
3.2 PROCESS VALIDATION
ACSD will [*] a validation process at the Facility in accordance with
EXHIBIT D herein, and at ACSD expense. [*] and limits for the process
must span the [*] and limits [*] during the manufacture of [*] at [*].
No Process changes will be made during the period beginning on [*] and
ending on the [*]. All post-validation process changes must be approved
by Cubist in writing. Cubist will provide [*] and [*] as such reports
become available. ACSD will provide Cubist with a [*]* for the Facility
and Process.
3. AMENDMENT OF SECTION 3.3. The Agreement is hereby amended by
deleting Section 3.3 thereof in its entirety and replacing it with the following
Section 3.3:
3.3 PROCESS IMPROVEMENTS
Following the [*] of the date of the Facility Approval, ACSD may
continue operating [*] Process improvements [*]. No Process
improvements will be made during the period beginning on [*] and ending
on the [*]. [*] for the purpose of [*] will be entirely at [*]. ACSD
will reimburse Cubist for any additional Cubist expenses [*]. All [*]
related to the [*] will be implemented only after [*]. The
authorization will be obtained in writing following a successful and
complete [*] outlined in the [*].
4. AMENDMENT OF SECTION 3. The Agreement is hereby amended by adding
the following Section 3.5 immediately following the end of Section 3.4 of the
Agreement
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3.5 Q.A. DIRECTOR
In order to ensure and maintain consistent quality assurance with
respect to the Product and the process, on or before April 1, 2003 ACSD
shall have hired, with the approval of Cubist (which approval shall not
be unreasonably withheld), a full-time Quality Assurance Director and
shall engage an independent validation consultant, each with
significant experience in the process of manufacturing and supply of
pharmaceutical products.
5. AMENDMENT OF SECTION 5.1. The Agreement is hereby amended by
deleting Section 5.1 thereof in its entirety and replacing it with the following
Section 5.1:
5.1 PURCHASE COMMITMENT
Contingent upon the [*], Cubist will purchase a [*] kilograms of
Product during the term of this Agreement, [*] and further subject to
the [*]. In the event that the [*], or the [*], Cubist shall not be
required to purchase [*] kg of Product [*] or in any other year during
the term of the Agreement. Notwithstanding anything to the contrary
herein, ACSD will [*] to be delivered in the year [*] and, if longer,
the [*], in accordance with the commercial Process specified in the
Exhibits B-1, C-1 and D herein which may be modified in writing by
Cubist from time to time. To the extent that there is any conflict
between the [*] set forth in Exhibit C-1 and those set forth in Exhibit
B-1, the [*] set forth in Exhibit C-1 shall supersede in all respects.
During the period prior to the receipt of Product Approvals, Cubist [*]
in accordance with EXHIBITS B-1, C-1, and D herein. Any such Product
purchases shall count toward the [*] kilograms of Product that Cubist
is required to purchase. Subject to the conditions of this Agreement,
Cubist agrees to make the following yearly purchases:
YEAR PURCHASE MINIMUM(KG)
2004 [*]
2005 [*]
2006 [*]
2007 [*]
2008 [*]
2009 [*]
2010 [*]
[*]
The above schedule will be extended for any delays caused by ACSD.
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6. AMENDMENT OF SECTION 5.6. The Agreement is hereby amended by deleting Section
5.6(a) in its entirety and replacing it with the following Section 5.6(a)
5.6 OBLIGATION TO SUPPLY
(a) [*] for Product submitted by Cubist [*], provided that such
request is delivered to ACSD at least [*] days prior to the
beginning of the corresponding quarter. ACSD shall not be in
breach of this Section 5.6 if [*]. Delivery dates will be set
independently from Product release and invoice dates as described
in Section 5.7;
7. AMENDMENT OF SECTION 6.1. The Agreement is hereby amended by
deleting Section 6.1 thereof in its entirety and replacing it with the following
Section 6.1:
6.1 PRODUCT PRICE
(a) Subject to the provisions of Sections 5, 6 and 7,
Cubist will [*], including the additional [*] kg
required to be purchased by Cubist in [*], at a price
of [*] per kilogram (USD [*]/kg);
8. AMENDMENT OF SECTION 6.2. The Agreement is hereby amended by
deleting Section 6.2 thereof in its entirety and replacing it with the following
Section 6.2:
6.2 PRODUCT PRICE [*]
Cubist will pay ACSD [*] per kilogram (USD [*]) on the [*] purchased
over the life of the contract other than the [*] kgs of Product [*] in
[*] until cumulative [*] payments equal [*] (USD [*]). Once the
cumulative [*] payments have accrued to [*](USD [*]), Cubist will
immediately stop paying the [*] and will pay [*] per kilogram (USD
[*]/kg) of Product, as provided in Section 6.1 herein.
YEAR PURCHASE MINIMUM [*]
2005 [*] [*]
2006 [*] [*]
2007 [*] [*]
2008 [*] [*]
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2009 [*] [*]
2010 [*] [*]
[*]
The above schedule will be [*]. In the event that Cubist [*] as
provided in Section 5.1, Cubist will pay [*] corresponding to the [*]
in the year specified in this Section 6.2. Any delays [*] (including,
but not limited, to [*]) will extend [*].
9. AMENDMENT OF SECTION 7. The Agreement is hereby amended by deleting
Section 7 thereof in its entirety and replacing it with the following Section 7:
7. EXCLUSIVITY
ACSD covenants that it will not promote, sell, deliver or provide any
Product or Daptomycin to any third party without the prior written
consent of Cubist, or produce any product, bulk drug substance or
active pharmaceutical ingredient [*] other than the Product.
Notwithstanding the foregoing, ACSD shall be permitted to produce
vancomycin (the "Competing Product") in the Facility for Xxx Xxxxx &
Company, provided that the following conditions have been and continue
to be met at all times:
(i) ACSD [*] and as well as [*];
(ii) ACSD [*] in accordance with the [*] in Cubist's Purchase Orders;
(iii) ACSD, [*] in accordance with [*]; and
(iv) At Cubist's request, [*], dedicated [*].
In the event that any of conditions (i) through (iv) are not met, ACSD
shall lose its right to produce the Competing Product and shall cease
production thereof upon receipt of written notice from Cubist.
10. AMENDMENT OF SECTION 12.1. The Agreement is hereby amended by
deleting Section 12.1 thereof in its entirety and replacing it with the
following Section 12.1:
12.1 TERM
This Agreement shall take effect as of the Effective Date and shall
remain in effect until the seventh anniversary of Facility Approval or
until ACSD has received all payments due under Section 6.2 unless
sooner terminated in accordance with Section 12.2 or extended in
accordance with this Section 12.1. Thereafter, this Agreement shall
automatically renew for additional two-year terms. Not later than the
sixth (6h) anniversary of the Effective Date, Cubist shall notify ACSD
in writing whether Cubist desires to extend the Agreement for an
additional two years. All
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applicable terms and conditions of this Agreement shall remain in
effect during such extension term, unless expressly amended in writing
by the parties. Cubist may renew this Agreement for additional two-year
extension terms by providing written renewal notice to ACSD not later
than twelve (12) months prior to the expiration of the then current
extension term.
11. AMENDMENT OF SECTION 12.2. The Agreement is hereby amended by
adding the following Section 12.2(c) immediately following Section 12.2(b) of
the Agreement:
(c) In the event that any current Cubist supplier of Product
purchases substantially all of the stock or assets relating to that portion of
ACSD's business that is related to the subject of this Agreement, all payments
hereunder shall be promptly returned to Cubist and Cubist shall have the right
to modify any Purchase Requirements set forth herein. Cubist shall also have the
right to pursue an alternative source of supply for the Product.
12. AMENDMENT TO EXHIBITS B AND C AND ADDITION OF NEW EXHIBIT F. The
Agreement is hereby amended by replacing Exhibits B (In-Process Testing
Procedures and Specifications) and C (Product Release Test Methods and
Specifications) with Exhibits B-1 (CMC section of the Cubist U.S. NDA filing)
and C-1 (Master Product Specifications) attached hereto. To the extent that
there is any conflict between the specifications set forth in Exhibit C-1 and
those set forth in Exhibit B-1, the specifications set forth in Exhibit C-1
shall supersede in all respects.
13. NO OTHER AMENDMENTS. Except to the extent amended hereby, all of
the definitions, terms, provisions and conditions set forth in the Agreement are
hereby ratified and confirmed and shall remain in full force and effect. The
terms and conditions herein and subject matter hereof shall at all times be
considered Confidential Information of Cubist, as defined in the Agreement. The
Agreement and this Amendment No. 2 shall be read and construed together as a
single agreement and the term "Agreement" shall be deemed a reference to the
Agreement as amended by this Amendment No. 2. This Amendment No. 2 may be signed
in any number of counterparts, each of which shall be deemed to be an original
and all of which together shall constitute but one and the same instrument. In
making proof of this Amendment No. 2 it shall not be necessary to produce or
account for more than one such counterpart.
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IN WITNESS WHEREOF, this Amendment No. 2 has been executed under seal
by the parties hereto as of the day and year first above written.
ACS DOBFAR SpA
By: /s/ XXXXX XXXXXXXXX
-------------------------------------
Title: President
Date: 02/20/03
CUBIST PHARMACEUTICALS, INC.
By: /s/ XXXXXXX X. XXXXXX
-------------------------------------
Title: President/COO
Date: 2/13/03
