Exhibit 10.1


 


CONFIDENTIAL TREATMENT


 


AMENDMENT
NO. 1


to the


MANUFACTURING AND SUPPLY
AGREEMENT


entered into as of June 22, 2000


by and between


DSM Capua, S.p.A. and Cubist
Pharmaceuticals, Inc.


 


This AMENDMENT
NO. 1 (“Amendment No. 1”)
to that certain Manufacturing and Supply Agreement entered into as of June 22,
2000 (the “Agreement”) is made this 9th day of September, 2005, by and
between DSM Capua, S.p.A., an Italian corporation (“DSM”) 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 DSM 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.                                      Definitions. 
Article 1 of the
Agreement is hereby amended by:


 


a.               Adding the following definition:


 


Business Day means any day other than Saturday,
Sunday or any day banks are authorized or required to be closed in the
Commonwealth of Massachusetts, USA.


 


b.              Adding the following definition:


 


Deliver means shipment of Product to Cubist, FCA
Capua.  Delivery and
Delivered shall be interpreted
accordingly.


 


c.                                       Deleting the
definition for FOB in its entirety
and replacing it with the
following definition:


 


FCA means “Free Carrier” as defined in Incoterms 2000, LCIA Publishing S.A.


 


d.              Adding the following definition:


 


Furnish means DSM making Product and the
Manufacturing Documentation available to Cubist for Delivery or storage at DSM
in accordance with this Agreement


 










*Confidential Treatment Requested. 
Omitted portions filed with the Commission.


 





















 


following DSM’s release of
such Product.  Furnished and
Furnishing shall be interpreted
accordingly.


 


e.               Adding the following definition:


 


Latent
Defect means a
Product defect that is not detected and could not have been detected using
Cubist’s or its agents’ standard product inspection procedures within the [ ]*
period described in Section 3.11(a) below. For the purpose of this
definition, a Product defect shall mean a non conformance of Product with the
representations and warranties contained in Section 6.2 of this Agreement.


 


f.                                         Deleting the definition for Specifications
in its entirety and replacing it with the following definition:


 


Specifications
means the
specifications for the Product attached to this Agreement as Exhibit D-1.
Such specifications may be modified from time to time to reflect improvements
(if any) by mutual agreement of the parties. 
Such specifications may also be modified at Cubist’s request (provided, that Cubist is responsible for all reasonable
costs associated with such modifications) as required by any regulatory
authority, for safety purposes or for any other commercially reasonable
purpose. Copies of such modified specifications shall be maintained by both
parties, and shall become a part of this Agreement as if incorporated herein.


 


g.                                      Adding the
following defined terms and section references to the list of terms under Other Defined Terms:


 


	
  Initial 2005 Quantity

  	
   

  	
  Section 3.2

  
	
  Initial 2006 Quantity

  	
   

  	
  Section 3.2

  
	
  Manufacturing Documentation

  	
   

  	
  Section 3.8

  
	
  Remaining 2005 Quantity

  	
   

  	
  Section 3.2

  
	
  Remaining 2006 Quantity

  	
   

  	
  Section 3.2

  
	
  Storage Limit

  	
   

  	
  Section 3.3

  
	
  Total 2005 Quantity

  	
   

  	
  Section 3.2

  
	
  Total 2006 Quantity

  	
   

  	
  Section 3.2

  
	
  Total 2007 Quantity

  	
   

  	
  Section 3.2

  



 


2.                                      Volume and Pricing.  The
Agreement is hereby amended by deleting Section 3.2 thereof in its
entirety and replacing it with the following new Section 3.2:


 


3.2                               Purchase and Pricing Commitment;
Furnishing and Delivery


 


a.                                       2005.  During calendar year 2005, and
subject to the following terms, Cubist shall purchase and DSM shall sell [ ]*
(the “Total 2005 Quantity”) at [ ]*, each in
accordance with this Section 3.2(a). 
DSM shall not Furnish more than the Total 2005 Quantity in 2005.


 










*Confidential Treatment Requested. 
Omitted portions filed with the Commission.


 


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i.                              The first [ ]* of the Total 2005 Quantity
(the “Initial 2005 Quantity”) shall be
Furnished to Cubist as produced by DSM in 2005; provided,
that the Initial 2005 Quantity shall be Delivered to Cubist only
pursuant to orders submitted by Cubist in accordance with Section 3.4
below, and any Product Furnished but not Delivered shall be stored by DSM until
the date of Delivery specified in a purchase order, subject to Section 3.3
below; provided, further, that if DSM fails to
Furnish at least [ ]* in the third and fourth calendar quarters of 2005, the
difference between [ ]* and the amount actually Furnished by DSM in such
quarter(s) shall be subtracted from the Initial 2005 Quantity and the Total
2005 Quantity.


 


ii.                           The remaining [ ]* of the Total 2005 Quantity
(the “Remaining 2005 Quantity”) shall be Furnished on or before December 28, 2005, at
Cubist’s discretion as specified in purchase orders submitted in accordance
with Section 3.4 below.  The
Remaining 2005 Quantity shall not otherwise be Furnished to Cubist prior to the
date specified in Cubist’s purchase orders; provided, that
DSM shall deliver the Manufacturing Documentation for one batch of the
Remaining 2005 Quantity at a time and shall not deliver such documents for
another batch until [ ]* have expired since Cubist’s receipt of all such
pertinent documents for the prior batch,
and DSM shall not deliver the Manufacturing Documentation to Cubist for the
final batch of the Remaining 2005 Quantity more than [ ]* prior to the date
specified in Cubist’s purchase order for such final batch.  The Remaining 2005 Quantity shall be
Delivered to Cubist only pursuant to orders submitted by Cubist in accordance
with Section 3.4 below, and any Product Furnished but not Delivered shall
be stored by DSM until the date of Delivery specified in a purchase order.


 


b.                                      2006.                     During calendar year 2006, and subject to the
following terms, Cubist shall purchase and DSM shall supply [ ]* of Product
(the “Total 2006 Quantity”) at [ ]* for the first [ ]* and at [ ]* for the remaining [
]*.  DSM shall not Furnish more than the
Total 2006 Quantity in 2006.  The prices
stated in this Section 3.2(b) shall apply to any Product Furnished in
2006, regardless of whether DSM Furnished the entire Total 2005 Quantity in
2005.


 


i.                              The first [ ]* of the Total 2006 Quantity
(the “Initial 2006 Quantity”) shall be
Furnished to Cubist as produced by DSM in 2006; provided,
that the Initial 2006 Quantity shall be Delivered to Cubist only
pursuant to orders submitted by Cubist in accordance with Section 3.4
below, and any Product Furnished but not Delivered shall be stored by DSM until
the date of Delivery specified in a purchase order, subject to Section 3.3
below; provided, further, that if DSM fails to
Furnish at least [ ]* in any calendar quarter during 2006, the difference
between [ ]* and the amount actually Furnished by DSM in such quarter shall be
subtracted from Initial 2006 Quantity and the Total 2006 Quantity.


 


ii.                           The remaining [ ]* of the Total 2006 Quantity
(the “Remaining 2006 Quantity”) shall be Furnished on or before December 28, 2006, at
Cubist’s discretion as specified in purchase orders submitted in accordance
with Section 3.4 below.  The
Remaining 2006 Quantity shall not otherwise be Furnished to Cubist prior to the
date specified in Cubist’s purchase orders; provided, that
DSM shall deliver the Manufacturing Documentation for one batch of the
Remaining 2006 Quantity at a time and shall not deliver such documents for
another batch until [ ]* have expired since Cubist’s receipt of all such
pertinent documents for the prior


 










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batch, and DSM
shall not deliver the Manufacturing Documentation to Cubist for the final batch
of the Remaining 2006 Quantity more than [ ]* prior to the date specified in
Cubist’s purchase order for such final batch. 
The Remaining 2006 Quantity shall be Delivered to Cubist only pursuant
to orders submitted by Cubist in accordance with Section 3.4 below, and
any Product Furnished but not Delivered shall be stored by DSM until the date
of Delivery specified in a purchase order.


 


c.                                       2007.  During 2007, Cubist shall
purchase and DSM shall supply [ ]* of Product (the “Total 2007
Quantity”) at [ ]*.  The price stated in this Section 3.2(c) shall
apply to any Product Furnished in 2007, regardless of whether DSM Furnished the
entire Total 2006 Quantity in 2006.  DSM
shall Furnish such Product to Cubist as specified in Cubist’s purchase orders
submitted in accordance with Section 3.4 below, which shall be submitted
in order to allow title to pass on or before March 31, 2007, at Cubist’s
discretion, in accordance with the terms of Section 3.8 below; provided, that DSM shall deliver the Manufacturing
Documentation for one batch of the Total 2007 Quantity at a time and shall not
deliver such documents for another batch until [ ]* have expired since Cubist’s
receipt of all such pertinent documents for the prior batch, and DSM shall not deliver the Manufacturing
Documentation to Cubist for the final batch of the Total 2006 Quantity more
than [ ]* prior to the date specified in Cubist’s purchase order for such final
batch.  The Total 2007 Quantity shall be
Delivered to Cubist only pursuant to orders submitted by Cubist in accordance
with Section 3.4 below, and any Product Furnished but not Delivered shall
be stored by DSM until the date of Delivery specified in a purchase order.


 


3.                                      Storage.  The
Agreement is hereby amended by deleting Section 3.3 thereof in its
entirety and replacing it with the following new Section 3.3:


 


3.3                               Storage.  DSM
shall store Product that is produced by DSM hereunder prior to the Delivery
date specified in Cubist’s purchase order therefore; provided, that,
except as provided in this Section 3.3, in no event will DSM be required
to store more than [ ]* (the “Storage Limit”)
in their cold room at any one time.  The
Storage Limit shall not apply to any portions of the Remaining 2005 Quantity or
the Remaining 2006 Quantity.  Any Product
stored by DSM shall be stored in accordance with cGMPs, Cubist’s reasonable
instructions and all other applicable laws, statutes, rules and
regulations.


 


4.                                      Purchase Orders.  The
Agreement is hereby amended by deleting Section 3.4 thereof in its
entirety and replacing it with the following new Section 3.4:


 


3.4                               Purchase Orders. 
Cubist shall submit written purchase orders by mail or facsimile, or by
other means agreed upon by the parties, for Delivery and/or Furnishing of Product
consistent with Section 3.2 above. 
Each purchase order for Delivery shall specify the date of Delivery of
Product ordered. Purchase orders for Furnishing of Product shall be submitted
by Cubist at the latest as follows:


 


•                  Purchase orders relating to Total 2005
Quantity; as soon as possible after signing of this Amendment No. 1;


 










*Confidential Treatment Requested. 
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•                  Purchase orders relating to all other amounts
covered by this Agreement shall be submitted on a monthly basis at least [ ]*
in advance of the date of the requested Furnishing of the Product covered by
the purchase order.


 


In
addition, purchase orders for the Furnishing of Product relating to the
Remaining 2005 Quantity and the Remaining 2006 Quantity, as the case may be,
shall specify the date that the Product shall be Furnished on or before December 28
of the applicable year. DSM may reject only the amounts covered by a purchase
order for the Initial 2006 Quantity that exceed [ ]* to be Delivered or
Furnished during any calendar month, and DSM must so reject such amounts within
[ ]* following receipt of the applicable purchase order.  DSM may not reject any other purchase
orders.  DSM shall Furnish or Deliver the
Product ordered under each such accepted purchase order in accordance with Section 3.2
above It is agreed by the parties that the standard printed terms of
purchase/sale of Cubist and DSM shall not be applicable.


 


5.                                      Deletion of Section.  The
Agreement is hereby amended by deleting Section 3.5 thereof in its
entirety and replacing it with the following:


 


3.5                               [Reserved].


 


6.                                      Transfer of Title.  The
Agreement is hereby amended by deleting Section 3.8 thereof in its
entirety and replacing it with the following new Section 3.8:


 


3.8                               Transfer of Title. 
Title to and risk of loss in the Product shall pass to Cubist upon the
earlier of:


 


(a)          Delivery of Product to
Cubist pursuant to Cubist’s purchase orders;


 


(b)         release of product by
Cubist; or


 


(c)          [ ]* after receipt by
Cubist of complete and accurate certificates of analysis, certified batch
manufacturing records, certificates of manufacturing compliance and all other
pertinent documents required by the quality agreement between the parties or
otherwise demonstrating, as determined by Cubist, for
each batch of Product, the Product’s compliance with the Specifications, GMP,
and any other regulatory or Cubist’s reasonable requirements, which have been
communicated to DSM (the “Manufacturing Documentation”);
provided that, DSM shall deliver the
Manufacturing Documentation for one batch at a time and shall not deliver the
Manufacturing Documentation for another batch until [ ]* have expired since
Cubist’s receipt of all Manufacturing Documentation for the prior batch, unless
otherwise agreed to by the parties.


 


7.                                      Invoicing and Payment.  The
Agreement is hereby amended by replacing the heading and the first sentence of Section 3.9
with the following heading and three sentences:


 










*Confidential Treatment Requested. 
Omitted portions filed with the Commission.


 


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3.9                               Invoicing and Payment.  DSM
may invoice Cubist for the [ ]* of Product included in the Initial 2005
Quantity, the Initial 2006 Quantity and the Total 2007 Quantity upon DSM’s
release of such Product and Cubist’s receipt of the Manufacturing Documentation
for such Product.  DSM may not invoice
Cubist for the [ ]* of such Product until the transfer of title in such Product
to Cubist in accordance with Section 3.8 above.  DSM may not invoice Cubist for the price of
Product included in the Remaining 2005 Quantity and the Remaining 2006 Quantity
prior to December 28 of each such year, unless Cubist’s purchase orders
specify a date of Furnishing or Delivery for any such Product prior to December 28.  For any such Product for which Cubist has
specified an earlier date of Furnishing, DSM may invoice Cubist upon the
transfer of title in such Product to Cubist in accordance with Section 3.8
above, but no earlier than [ ]* after the date of Furnishing specified by
Cubist.  For any such Product for which
Cubist has specified an earlier date of Delivery, DSM may invoice Cubist upon
Delivery.   Cubist shall pay each
undisputed invoice within [ ]* of Cubist’s receipt thereof.  Any amounts paid by Cubist hereunder for
Product that Cubist has rejected due to nonconformance with the Specifications
and Product Approvals pursuant to Section 3.11(a), or for which complete
and accurate Manufacturing Documentation has not been provided by DSM, shall be
refunded to Cubist or, at Cubist’s option, applied towards additional payments
that become due from Cubist to DSM under this Agreement.


 


8.                                      Cost Reduction and Technical
Reviews.  The Agreement is hereby amended by deleting Section 3.10
thereof in its entirety and replacing it with the following new Section 3.10:


 


3.10                        Cost
Reduction Assistance and Technical Reviews.


 


(a)                                  DSM and Cubist agree to conduct periodic
technical review meetings as well as a periodic process change reviews and a
quarterly production review.


 


(b)                                 Cubist agrees to use commercially reasonable
efforts to help DSM reduce DSM’s direct costs to manufacture Product during the
term of the agreement, including by supporting DSM in process changes and
improvements and new supplier approvals.; provided, that
such commercially reasonable efforts shall not include any out-of-pocket
payments by Cubist.


 


9.                                      Manufacturing Documentation.  The Agreement is hereby amended by:


 


(a)                                  Adding at the end
of the first sentence of Section 3.11(a) thereof the following: “,
including, without limitation, all applicable Manufacturing Documentation.”


 


(b)                                 Adding
at the end of the first sentence of Section 3.11(b) thereof the
following: “, including, without limitation, for failure to supply complete and
accurate Manufacturing Documentation.”


 










*Confidential Treatment Requested. 
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10.                               Latent Defects. The Agreement is hereby amended by adding
at the end of the last sentence of Section 3.11(a) thereof the
following:


 


“, unless Cubist discovers a
Latent Defect, in which case Cubist shall notify DSM of such Latent Defect
within [ ]* from the day on which such Latent Defect was discovered and confirmed,
but in any event no later than [ ]* after the expiry of the shelf life of the
relevant unit of filled and finished drug product, in the absence of which
Cubist shall be deemed to have waived all claims in this respect.
Notwithstanding anything herein to the contrary, in the event that Cubist
discovers a Latent Defect in accordance with the terms and conditions hereof,
Cubist shall be entitled to receive a refund of all payments made for the
entire batch of Product from which the Latent Defect is discovered, and Cubist’s
purchase requirements as set forth in Section 3.2 herein shall be waived
until such time that DSM is able to produce Product that is free from the
Latent Defect.


 


11.                               Replacing “delivery” with “Furnishing”. The Agreement is hereby amended by
replacing the word “delivery” in each place that it occurs in Section 4.2
thereof with the word “Furnishing.”


 


12.                               Certificates of
Manufacturing Compliance.  The
Agreement is hereby amended by adding after “the current Good Manufacturing
Practices of the FDA” in the first sentence of Section 4.3 thereof the
following: “and EU regulatory authorities.”


 


13.                               Replacing “delivery” with “Delivery”.  The
Agreement is hereby amended by replacing the word “delivery” in each place that
it occurs in Sections 6.2 and 6.3 thereof with the word “Delivery.”


 


14.                               Term.  The
Agreement is hereby amended by:


 


a.               deleting Section 8.1 thereof in its
entirety and replacing it with the following new Section 8.1:


 


8.1 Term.  This Agreement shall take
effect on the Effective Date and shall remain in effect, unless otherwise
terminated in accordance with the provisions herein, until December 31,
2005, with up to [ ]*.


 


b.              deleting Section 8.2(b) thereof in
its entirety and replacing it with the following new Section 8.2(b):


 


(b) Notwithstanding
anything herein to the contrary, Cubist may terminate this Agreement by
providing DSM with [ ]* prior written notice at any time after June 30,
2005.  Along with such notice of
termination, Cubist shall provide DSM with purchase orders indicating the
Product to be Delivered to Cubist prior to the effective date of termination.


 


c.               deleting Section 8.3(a)(ii) thereof
in its entirety and replacing it with the following new Section 8.3(a)(ii):


 










*Confidential Treatment Requested. 
Omitted portions filed with the Commission.


 


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(ii) Cubist shall have
no obligation to purchase Product beyond the quantity of Product that, pursuant
to Cubist’s purchase orders, is scheduled for Furnishing or Delivery on or
before the effective date of the termination or expiration of the Agreement.


 


15.                               Designated Contacts.  The
Agreement is hereby amended by replacing the name Alan Watson in Section 9.1(a) thereof
with Lindon Fellows, and replacing the name Michel Deinum with Rolf Douwenga.


 


16.                               Notices. 
The Agreement is
hereby amended by deleting the information set forth under the captions “If to
Cubist:” and “If to DSM:” in Section 10.6 thereof and replacing it with
the following:


 


Cubist
Pharmaceuticals, Inc.


65
Hayden Avenue


Lexington,
MA 02421


Attention:  Senior Vice President, Technical Operations


Facsimile
No: +1-781-860-0566


Telephone
No: +1-781-860-8660


With a copy to:             General Counsel


Facsimile
No:  +1-781-860-1407


 


DSM
Capua S.p.A.


Strada
Statale Appia 46 –48


Capua,
Italy


Attention:
Managing Director


Facsimile
No: +39-


Telephone
No:+39-


With
a copy to DPC General Counsel


Facsimile
No. +31-464770437


 


17.                               Exhibits.  The Agreement is hereby amended by replacing Exhibit C
(Process) and Exhibit D (Specifications) with Exhibit C-1 and Exhibit D-1
attached hereto and by replacing Exhibit F with Exhibit F-1 attached
hereto in which the language “and supporting Analytical forms and equipment
logs and tags” has been replaced with the following: “supporting Analytical
forms and associated deviations and investigations.”  


 


18.                               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. 1 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. 1. 
This Amendment No. 1 may be signed in any number of counterparts,
each of which shall be deemed to be an original and all of which together shall


 










*Confidential Treatment Requested. 
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constitute but one and the same
instrument.  In making proof of this
Amendment No. 1 it shall not be necessary to produce or account for more
than one such counterpart.


 


IN
WITNESS WHEREOF, this
Amendment No. 1 has been executed under seal by the parties hereto as of
the day and year first above written.


 


	
   

  	
  DSM CAPUA S.P.A.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
  CUBIST PHARMACEUTICALS,
  INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  
	
   

  	
   

  
	
   

  	
  Title:

  



 










*Confidential Treatment Requested. 
Omitted portions filed with the Commission.


 


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EXHIBIT C-1


[ ]*


 










*Confidential Treatment Requested. 
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EXHIBIT D-1


[ ]*


 










*Confidential Treatment Requested. 
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EXHIBIT E-1


[ ]*


 










*Confidential Treatment Requested. 
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