Exhibit 10.58


 


CONFIDENTIAL TREATMENT


 


AMENDMENT NO. 5


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. 5 (“Amendment No. 5”), to that certain
Manufacturing and Supply Agreement (as amended to date pursuant to Amendments
Nos. 1, 2, 3 and 4, the “Agreement”) entered into as of September 30,
2001, is made this 17th day of November, 2009 (“Amendment No. 5
Effective Date”), 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. 5, including definitions in the preamble and recitals
hereto.


 


WHEREAS, Cubist and ACSD desire to amend the Agreement as set
forth in this Amendment No. 5;


 


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


 


(a) Capacity Improvements. ACSD
and Cubist have agreed on the project plan attached hereto at Exhibit G
for the process and associated plant improvements to the Facility that are
intended to increase the capacity of the Facility to produce Product (the “Capacity
Improvements”).  The Parties shall
work together diligently to implement the Capacity Improvements as rapidly as
reasonably possible after the Amendment No. 5 Effective Date.  Cubist shall be responsible for the
agreed-upon []* necessary to []* the Capacity Improvements; provided that, ACSD shall be prohibited from using such
capital equipment for any other activities other than activities in support of
Cubist, and such prohibition shall survive the expiration or termination of
this Agreement.  ACSD shall purchase the
capital equipment, and Cubist shall issue a purchase order to ACSD for capital
expenditure contribution for []*.  ACSD
shall be responsible for all other ACSD costs related to the Capacity
Improvements, including without limitation the costs of []*.


 


(b) Additional
Improvements.  Cubist and ACSD shall
each have the right to propose additional process and associated plant
improvements for the production of Product to be implemented at the Facility
that are intended to improve the quality of, and the efficiency of the process
for producing, Product (“Additional Improvements”); provided
that, Cubist shall have final decision-making authority on what
Additional Improvements are implemented. 
ACSD shall agree to all reasonable Additional Improvement proposals by
Cubist and shall implement the Additional Improvements as rapidly as possible; provided that, both Cubist and ACSD agree that


 






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it is possible for the Additional Improvement
to achieve regulatory approval, if necessary, and that Cubist and ACSD agree to
a project implementation plan for such Additional Improvement. A failure by
ACSD to agree to a reasonable Additional Improvement in accordance with all
Italian regulations and law or to implement such Additional Improvement as
rapidly as possible shall constitute a breach by ACSD of a material obligation
under Section 12.2(a)(i) of this Agreement if the delay or the
failure will cause relevant damage to Cubist. 
Cubist shall be responsible for the agreed-upon []* necessary to []* the
Additional Improvements; provided that,
ACSD shall be prohibited from using such capital for any other activities other
than activities in support of Cubist, and such prohibition shall survive the
expiration or termination of this Agreement. 
ACSD shall be responsible for all other ACSD costs related to the
Additional Improvements, including without limitation the costs of []*.  ACSD shall not implement any process
improvements for the production of Product on its own without the express prior
written consent of Cubist.


 


2.  Amendment of Section 5.1.  The Agreement is hereby amended by deleting
the text of Section 5.1 thereof in its entirety and replacing it with the
following:


 


Provided that ACSD maintains the staff appropriate to operate the Facility in order to
satisfy Cubist’s purchase orders, including, but not limited to, at least  []* full time employees (“FTEs”) dedicated to the manufacture and supply of
Product to Cubist hereunder consistent with the organizational chart and
parameters set forth in Exhibit F, Cubist shall order from
ACSD at least []* percent ([]*%) of Cubist’s requirements of Product each
calendar year during the Term; provided that,
ACSD is fully committed to supply 100% of Cubist’s requirements.


 


3. Amendments of Section 5.6.  The Agreement is hereby amended by inserting
the following two sentences at the beginning of Section 5.6(a) thereof:


 


ACSD shall be obligated to accept Cubist
Purchase Forecasts and purchase orders for each calendar year up to the anticipated
annual capacity of the Facility. A failure by ACSD to so accept a Cubist
Purchase Forecast or purchase order shall constitute a breach by ACSD of a
material obligation under Section 12.2(a)(i) of the Agreement.


 


The Agreement is hereby further amended by adding the following
subsection (d) at the end of Section 5.6 of the Agreement:


 


(d) If ACSD fails to
deliver any Product ordered by Cubist in any calendar year in accordance with
Sections 5.1, 5.3 and 5.4 hereof, Cubist, at its sole discretion, may add the
amount of the shortfall to the Product that it intends to order for the
following calendar year, and the price that Cubist shall pay for Product the
following year shall be the price pursuant to Section 6.1 based on the
total volume ordered for that year, including the shortfall from the previous
year. For the avoidance of doubt, Cubist shall pay for Product delivered in the
calendar year in which the shortfall occurred using the price pursuant to Section 6.1
for the amount of Product ordered in such year, not the amount actually
delivered.


 






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4. 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


 


Provided that ACSD maintains the staff appropriate to
operate the Facility in order to satisfy Cubist’s purchase orders, including,
but not limited to, at least []*
FTEs dedicated to the manufacture and supply of Product to Cubist hereunder
consistent with the organizational chart and parameters set forth in Exhibit F,
Cubist shall pay the following amounts for Product hereunder:


 


(a) For all Product
ordered by Cubist for delivery in 2009, Cubist shall pay to ACSD USD $[]* per
kilogram.


 


(b) For all Product
ordered by Cubist for delivery on or after January 1, 2010 and until
implementation and validation of the first Additional Improvement, Cubist shall
pay for Product in Euros according to the Product Price Schedule attached
hereto at Exhibit H.


 


(c) In connection with
the implementation of any Additional Improvement, Cubist and ACSD shall agree
on a new Product Price Schedule, which shall be appended to the Agreement in
replacement of the Product Price Schedule attached hereto at Exhibit H.  The prices on the new Product Price Schedule
will be calculated []*, such calculation to be based on []*. The prices on the
new Product Price Schedule will reflect []*. 
For the avoidance of doubt, the prices on the new Product Price Schedule
shall in no instance be higher than the prices on the Product Price Schedule
attached at Exhibit H hereto.


 


(d) The appropriate price from the Product Price
Schedule (including any new Product Price Schedule) shall be determined using
the number of kgs of Product forecast by Cubist to be delivered during the
relevant calendar year in accordance with Section 5.3.  At the end of each calendar year, if the
actual number of kgs of Product ordered to be delivered during such calendar
year would cause the price per kg according to the Product Price Schedule to be
different than previously paid by Cubist, then, no later than March 31st of the
following calendar year, Cubist shall pay to ACSD the additional amount if
Cubist paid too little; or ACSD shall pay to Cubist the amount Cubist overpaid
if Cubist paid too much.


 


5. Amendment of Section 6.2.  The Agreement is hereby amended by deleting
the text of Section 6.2 thereof in its entirety and replacing it with, “[Reserved].”


 


6. Addition of Exhibits.  The Agreement is hereby amended by adding as
exhibits thereto Exhibit G and Exhibit H attached
hereto.


 


7. 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. 5 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. 5. 
This Amendment No. 5 may be signed in any number of counterparts,
each of which shall be deemed to be an original and all of 


 






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which together
shall constitute but one and the same instrument.  In making proof of this Amendment No. 5
it shall not be necessary to produce or account for more than one such
counterpart.


 


IN WITNESS WHEREOF, this Amendment No. 5 has been executed under
seal by the parties hereto to be effective as of the day and year first above
written.


 


 


	
   

  	
  ACS DOBFAR SpA

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Falciani
  Marco

  
	
   

  	
   

  
	
   

  	
  Name: Falciani
  Marco

  
	
   

  	
   

  
	
   

  	
  Title: President

  
	
   

  	
   

  
	
   

  	
  Date:
  November 17, 2009

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  CUBIST
  PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Lindon M.
  Fellows

  
	
   

  	
   

  
	
   

  	
  Name: Lindon M.
  Fellows

  
	
   

  	
   

  
	
   

  	
  Title: SVP,
  Technical Operations

  
	
   

  	
   

  
	
   

  	
  Date: 17
  November 2009

  



 






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EXHIBIT G


 


ACSD Capacity Expansion Plan


 


[attached]


 






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ACSD Capacity Expansion Plan


November 11th, 2009


 


Cubist’s
production requirements to meet demand are expected to increase to about []* kg
annually. In order to meet expected future demand, ACSD and Cubist have agreed
to expand the API capacity in Anagni. Cubist will be responsible for the agreed
upon []*, and ACSD will be responsible for []* and any other agreed upon costs.
ACSD and Cubist personnel will collaborate closely during all phases of the
capacity expansion project. Cubist must agree to all significant decisions in
writing, including equipment design and specifications, suppliers, key
contractors including engineering companies and consultants, building layout,
and any changes of the manufacturing process. Cubist shall have final say over
any decisions for the project.


 


The
key milestones for the capacity expansion project, and the projected time for
completion for each milestone are described below.


 


Project Milestones


 


1. Agreement on conceptual design
and project approach


· ACSD and Cubist shall agree conceptually
to changes of the manufacturing process, and the manufacturing facility,
including equipment changes, target date []*


 


2.  Long-lead-time items


· ACSD and Cubist shall identify long lead
time items which are expected to have a delivery time of 4 months or longer,
target date []*


· ACSD and Cubist shall agree on
suppliers, design, and price of long lead time items, target date []*


· ACSD orders long lead time items, target
date []*


· Cubist shall owe ACSD []*% of the total
amount invoiced solely for such equipment by the third party vendor(s) to
ACSD upon completion of such long lead time equipment orders, []*% upon
delivery, and []*% after completion of installation and qualification


· Within 3 business days of the event
triggering the payment owed, ACSD shall invoice Cubist for such amounts owed,
and shall attach to such invoices copies of any third party invoices upon which
ACSD’s invoice is based, and Cubist shall pay such invoice within 30 days of
Cubist’s receipt thereof


 


3. Detailed Project Plan


· ACS and Cubist shall agree upon and sign
a detailed project plan, including project scope, project team, equipment list,
suppliers for key equipment, facility layout, basic design drawings and project
schedule, target date []*


 


4. Third party contractors,
engineering companies, consultants


· ACSD and Cubist shall agree upon third
party contractors, engineering companies, and consultants, including scope of
external services, documentation standards, price of services, target date []*


 


5. Detailed design review


· ACSD and Cubist shall agree and sign off
on detailed design package, including facility layout, detailed design drawings
of buildings, detailed specifications and drawings of new or changed equipment,
detailed drawings of piping and instrumentation, description of automation,
target date []*


· Cubist shall owe ACSD []*% of ACSD’s
external costs invoiced by a third party directly related to completion of the
detailed design package upon Cubist’s sign off


· Within 3 business days of Cubist’s sign
off, ACSD shall invoice Cubist for such amounts owed, and shall attach to such
invoice copies of any third party invoices upon which ACSD’s invoice is based,
and Cubist shall pay such invoice within 30 days of Cubist’s receipt thereof


 






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6. Process Equipment (other than
long lead time items)


· ACSD and Cubist shall agree on
suppliers, design, and price of all equipment, target date []*


· Cubist shall owe ACSD []*% of the total
amount invoiced solely for such equipment by the third party vendor(s) to
ACSD upon completion of such other equipment orders, []*% upon delivery, and []*%
after completion of installation and qualification of all other equipment


· Within 3 business days of the event
triggering the payment owed, ACSD shall invoice Cubist for such amounts owed,
and shall attach to such invoices copies of the third party invoices upon which
ACSD’s invoice is based, and Cubist shall pay such invoice within 30 days of
Cubist’s receipt thereof


 


7. Process materials, i.e. resins


· ACSD and Cubist shall agree on
suppliers, design, price, and the distribution of costs for process materials
between ACSD and Cubist, target date []*


· Cubist shall owe ACSD []*% of the agreed
upon Cubist share of the total amount invoiced solely for such process
materials by the third party vendor(s) to ACSD upon completion of all
process material orders, []*% upon delivery, and []*% after completion of
installation and qualification of the process materials


· Within 3 business days of the event
triggering the payment owed, ACSD shall invoice Cubist for such amounts owed,
and shall attach to such invoices copies of any third party invoices upon which
ACSD’s invoice is based, and Cubist shall pay such invoice within 30 days of
Cubist’s receipt thereof


 


8. Utility Infrastructure


· ACSD and Cubist shall agree on changes
to utilities and related equipment required to support the capacity expansion
project, and the distribution of utility related costs between ACSD and Cubist,
target date []*


 


9. Buildings and building
modifications


· ACSD and Cubist shall agree on all
building additions and modifications, including buildings design, materials,
contractors, and prices, target date []*


· Cubist shall owe ACSD []*% of the total
amount invoiced by the third party vendor(s) to ACSD for such agreed upon
building additions and modifications after completion of such additions and
modifications to Cubist’s satisfaction in accordance with the detailed project
plan


 


10. Process changes and
validation


· ACSD and Cubist shall agree on all
process changes, including implementation schedules and validations protocols.


 


11. Final validation of equipment
and processes at the increased capacity


· Upon successful completion of the final
validation of a process in the modified facility which is capable of producing
at an annual capacity of []* kg or higher, such capability determined by the
number of kg produced and the time it takes to produce any 3 consecutive
batches that are released for commercial use, Cubist shall owe half of the
remaining []*% of project costs which Cubist is responsible for according to
the agreement of amendment No. 5, this project plan, the detailed project
plan referred to above, and any other agreements between ACSD and Cubist.  Within 3 business days of release for
commercial use of the third such batch, ACSD shall invoice Cubist for such
amounts owed, and shall attach to such invoice copies of any third party
invoices upon which ACSD’s invoice is based, and Cubist shall pay such invoice
within 30 days of Cubist’s receipt thereof


 


· Upon successful completion of the final
validation of a process in the modified facility which is capable of producing
at an annual capacity of []* kg or higher, such capability determined by the
number of kg produced and the time it takes to produce any 3 consecutive
batches that are released for commercial use, Cubist will pay the  remaining []*% of project costs which Cubist
is responsible for according to the agreement of amendment No. 5, this
project plan, the detailed project plan referred to above, and any other
agreements between ACSD and Cubist. 
Within 3 business days of release for commercial use of 


 






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the third such batch,
ACSD shall invoice Cubist for such amounts owed, and shall attach to such invoice
copies of any third party invoices upon which ACSD’s invoice is based, and
Cubist shall pay such invoice within 30 days of Cubist’s receipt thereof


 


ACSD shall pay all third
party vendors on a timely basis and shall use best efforts to ensure delivery and
performance by such third party vendors. In addition to Cubist’s right to
monitor under the Agreement, Cubist shall have the right to audit all original
invoices from any third party vendor(s) and any other documents
demonstrating delivery and performance by such third party vendors relating to
the project. ACSD shall inform Cubist of any deviations from the agreed upon
project plan, including but not limited to project costs and timelines.


 






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EXHIBIT H


 


Product Price Schedule


 


	
  Kgs Ordered/

  	
   

  	
  Price

  	
   

  
	
  Calendar Year

  	
   

  	
  (beginning 2010)

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  
	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  €

  	
  []

  	
  *

  



 






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