EXHIBIT 10.63
CONFIDENTIAL TREATMENT
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement (AGREEMENT) IS entered into as of
September 30, 2001 (EFFECTIVE DATE) by and between ACS Dobfar, SpA, an Italian
corporation (ACSD) and Cubist Pharmaceuticals, Inc., a Delaware corporation
(CUBIST).
BACKGROUND
Cubist is a drug company focused on the development and commercialization of
daptomycin antibiotic drug. Cubist has commenced Phase III clinical trials of
daptomycin and intends to obtain approval to market and sell the drug for the
treatment of serious and life threatening infections in humans.
ACSD has expertise in the manufacture of drugs on a contract basis. ACSD wishes
to provide scale-up services and to construct a production facility dedicated to
the manufacturing of daptomycin for Cubist, and to sell bulk daptomycin
exclusively to Cubist. Cubist desires to have ACSD construct a production
facility, and manufacture and supply Cubist with daptomycin for marketing and
sale in all jurisdictions. This Agreement sets forth the terms under which ACSD
will construct a dedicated production facility and manufacture and supply
daptomycin to Cubist.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, ACSD and Cubist agree as follows:
1. DEFINITIONS
Capitalized terms used in this Agreement and not otherwise defined herein shall
have the meaning set forth below.
AFFILIATE means with respect to either party, any entity that, directly or
indirectly, is controlled by, controls or is under common control with such
party. For purposes of this Agreement, control means, with respect to any party,
the direct or indirect ownership of more than fifty percent (50%) of the voting
or income interest in such party or the possession otherwise, directly or
indirectly, of the power to direct the management or policies of such party.
BATCH RECORD means a record of the procedures followed by ACS with respect to
the manufacture, handling and storage of Product. The Batch Record consists of
[ * ], such as [ * ].
[ * ]
CERTIFICATE OF ANALYSIS (COA) means a document which is generated for each batch
of Product and which certifies that Product was manufactured in a cGMP compliant
facility and meets the filed regulatory release testing specifications.
CHANGE ORDER is defined in Section 2.4 herein.
CHANGE ORDER REQUEST is defined in Section 2.4 herein.
CONFIDENTIAL INFORMATION means all data, specifications, training and any other
know-how related to the design, development, manufacture, or performance of the
Product, as well as all other information and data provided by either party to
the other party pursuant to this Agreement in written or other tangible
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medium and marked as confidential, or if disclosed orally or displayed,
confirmed in writing within [ * ] days after disclosure, except any portion
thereof which:
(a) is known to the receiving party, as evidenced by the receiving
party's written records, before receipt thereof under this
Agreement;
(b) is disclosed to the receiving party by a third person who is
under no obligation of confidentiality to the disclosing party
hereunder with respect to such information and who otherwise has
a right to make such disclosure;
(c) is or becomes generally known in the trade through no fault of
the receiving party; or
(d) is independently developed by the receiving party without access
to such information, as evidenced by the receiving party's
written records.
CONTRACT YEAR means each twelve (12) month period during the term of this
Agreement beginning on the Effective Date.
CONTRACTOR means any manufacturer, packager, or other Product support service
provider who performs processing and/or packaging of a Product or any
intermediate step of manufacture, or other Product support service.
CRITICAL EQUIPMENT means any equipment that comes into contact with Product or
is essential to the manufacturing process or is designed to assure that Product
has the identity, strength, quality and purity that it is represented to
possess.
CUBIST TECHNOLOGY means individually and collectively the:
(a) intellectual property rights embodied or disclosed in:
(i) Cubist patent application(s) and patents,
(ii) any patent application filed as a continuation, division,
or continuation-in-part of the application(s) described in
clause (a)(i), patents issuing therefrom and reissues,
reexaminations and extensions of such patents; and
(iii) any foreign counterpart to the application(s) described in
clauses (a)(i)-(ii) (including divisions, continuations,
confirmations, additions, renewals or
continuations-in-part of such patent applications),
patents issuing therefrom and extensions thereof, and
(b) all other Confidential Information, discoveries, inventions,
know-how, techniques, methodologies, modifications, improvements,
works of authorship, designs and data (whether or not protectable
under patent, copyright, trade secrecy or similar laws) that are
conceived, discovered, developed, created or reduced to practice
or tangible medium of expression by consultants (other than those
consultants that are also affiliated with ACSD in connection with
the transactions contemplated by this Agreement) or employees of
Cubist at any time, concurrent with or related to the
transactions contemplated by the Development and Facility
Construction Timetable, or based on the results of the
transactions contemplated by the Timetable and Facility
Construction Plan. Cubist Technology specifically includes, but
is not limited to, all process development technology developed
for Cubist as part of the Materials Transfer & Confidentiality
Agreement between Cubist and ACSD dated February 11, 1998.
CGMP means Current Good Manufacturing Practices and is further defined in
Section 3.1 herein.
DAPTOMYCIN means the compound daptomycin the chemical structure of which is
detailed in Exhibit A or a pharmaceutically acceptable salt thereof or a
pharmaceutically acceptable formulation thereof.
DEVIATION means documented evidence of an excursion from operating,
manufacturing, testing instructions or procedures. A Deviation does not
permanently change an existing procedure, it is intended to be a specific or one
time excursion.
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DRUG MASTER FILE (DMF) is a submission to the FDA that provides detailed
information about the Facility, Process and Materials used in the manufacture of
Product, and that is used to support an NDA and other regulatory submissions.
FACILITY means the cGMP drug production facility in Anagni, Italy constructed
and equipped by ACSD exclusively for the manufacture of Product.
FACILITY APPROVAL means the FDA approval of the NDA Manufacturing Supplement for
the Facility.
FACILITY APPROVAL TARGET DATE is defined in Section 2.1 herein.
FACILITY COMPLETION means the construction, equipment, testing, and
qualification of the Facility according to the terms of this Agreement.
FACILITY COMPLETION TARGET DATE is defined in Section 2.1 herein
FDA means the United States Food and Drug Administration or any successor entity
thereto or any equivalent U.S. or foreign governmental regulatory agency with
jurisdiction to grant Product Approvals.
FORCE MAJEURE means any event beyond the control of the parties, including, but
not limited to, fire, earthquakes, flood, riots, epidemics, war, or embargoes.
FORMAL INVESTIGATION means a written report detailing the specifics of an
investigation resulting from an exceptional event, and which includes a
description of the incident, investigation, conclusions and corrective action or
action plan, if applicable.
IN-PROCESS SPECIFICATIONS mean the chemical, physical, biological and microbial
testing methods and results required for the commercial manufacture of Product
in accordance with Process, and which are listed in Exhibit B herein, provided
that such specifications shall at all times comply with the relevant regulations
of the FDA or other regulatory agency in the country of sale, and provided that
such specifications may be modified from time to time in accordance with this
Agreement.
LOT NUMBER means a controlled number used to identify a specific lot or batch of
Product or Material.
MATERIAL means any actives, excipients, or components, which are used in the
manufacture of Product.
NONCONFORMING MATERIALS REPORT means a document used to describe the disposition
of Product or Material that fails to meet established specifications.
MANUFACTURING COMPLIANCE REPORT is defined in Section 8.3 herein.
MATERIAL REVIEW BOARD (MRB) means a Cubist multidisciplinary committee
responsible for the review, evaluation and disposition of non-conforming
materials and Product.
NDA means a new drug application filed with the FDA to obtain marketing approval
for Product in the United States or any comparable application fled with the
regulatory authorities of a country other than the United States to obtain
marketing approval for Product in that country.
NDA MANUFACTURING SUPPLEMENT means an application filed with the FDA, or any
comparable application filed with the regulatory authorities of a country other
than the United States, to obtain approval to manufacture Product at the
Facility.
PROCESS means the commercial process employing the [ * ].
PRODUCT means Daptomycin bulk drug substance that meets Product Specifications
and is manufactured for Cubist in accordance with Sections 2 and 3 and Exhibits
B, C and D of this Agreement.
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PRODUCT APPROVAL means those regulatory or other approvals required for the
manufacture, importation, promotion, pricing, marketing and sale of the Product
in any particular country.
PRODUCT PRICE PREMIUM is defined in Section 6.2 herein.
PRODUCT SPECIFICATIONS mean the chemical, physical, biological and microbial
testing methods and results required for the release of Product and listed in
Exhibit C herein, provided that such specifications shall at all times comply
with the relevant regulations of the FDA or other regulatory agency in the
country of sale, and provided that such specifications may be modified from time
to time in accordance with this Agreement.
PURCHASE FORECAST is defined in Section 5.3 herein.
REPROCESSING means duplication of a step or steps in a manufacturing process in
order to bring Product into conformance with Product Specifications without
altering the safety, identity, strength, quality, or purity of Product beyond
established requirements.
RMA means Return Material Authorization and is further defined in Section 6.5(b)
herein.
SOP means standard operating procedure.
SPECIFICATION REVIEW COMMITTEE (SRC) means a Cubist multidisciplinary committee
responsible for the review and approval of new specifications and changes to
existing specifications as they relate to Product or Process.
STABILITY REVIEW GROUP (SRG) means a Cubist multidisciplinary committee
responsible for the review and approval of new stability protocols and changes
to existing stability protocols as they relate to Product. In addition it is
responsible for the routine review of stability data and evaluation of any
trends that are noted.
USD means United States Dollars.
VIALED DRUG PRODUCT means Product that has been filled into single dosage vials,
lyophilized, and released according to Cubist's secondary manufacturing process
specifications.
2. CONSTRUCTION OF PRODUCTION FACILITY IN ANAGNI
2.1 FACILITY CONSTRUCTION AND TIMETABLE
By [ * ] (the FACILITY COMPLETION TARGET DATE), ACSD will [ * ] and make [ * ]
in accordance with current Good Manufacturing Practices. ACSD's obligations
hereunder include, but are not limited to:
(a) construction of [ * ] to perform the Process in a dedicated
Facility;
(b) provision of [ * ] of Product;
(c) the installation of all [ * ] and [ * ]; and
(d) obtaining approval from the [ * ].
Subject to adjustment in accordance with Section 2.2, ACSD will make its best
efforts to complete all activities and to meet all dates set forth in this
Agreement. The performance of [ * ] of the Facility is expected no later than
[ * ] with all data and reports [ * ] by [ * ]. The target date for [ * ] for
the ACSD facility (the FACILITY APPROVAL TARGET DATE) is [ * ].
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2.2 DATE ADJUSTMENTS
Cubist and ACSD each agree to perform the tasks assigned to each in this
Agreement. Each party acknowledges that delays in performance by either party
may cause delays in performance by the other party. If [ * ] fails to meet its
obligations under this Agreement in a timely manner so as to cause a [ * ] delay
in [ * ] performance, all dependent dates shall be adjusted day-for-day to
account for the delay caused by [ * ]. If [ * ] failure is due to additional
written requirements from [ * ], then such dates may be adjusted by mutual
written agreement.
2.3 INSPECTION
Cubist will have the right to observe and inspect the progress of work at the
Facility at all reasonable times, both during the construction process and at
any time thereafter, and to confer with ACSD regarding compliance with the dates
set forth in Section 2.1 above, Product Specifications, In-Process
Specifications, cGMP, and other legal, regulatory or contractual requirements.
2.4 CHANGE PROCEDURES
(a) ACSD will notify and consult with Cubist immediately concerning
any potential delay in completion or validation of the Facility.
ACSD acknowledges that time is of the essence for this Agreement,
and that significant delays in the completion of the Facility may
cause Cubist material harm. Cubist and ACSD will, from time to
time during the construction process, confer regarding the
quality standards for materials and layout of operations within
the Facility. [ * ]. Cubist may request amendments to the
building, equipment, or Process to:
(i) effect [ * ] in the Facility,
(ii) to [ * ], or
(iii) to accommodate [ * ].
(b) If Cubist wishes to make a change it shall notify ACSD of the
requested change in writing, specifying the change with
sufficient details to [ * ] (each, a CHANGE ORDER REQUEST).
Within [ * ] business days following the date of ACSD's receipt
of a Change Order Request, ACSD shall deliver a document that:
(i) assesses the impact of the change on the total cost of the
Timetable and Facility Construction Plan, and
(ii) incorporates a description of the requested change and its
proposed cost (a CHANGE ORDER).
If Cubist accepts the Change Order in writing, then the
provisions of this Agreement shall be deemed amended to
incorporate such Change Order. The cost stated in the Change
Order shall be deemed an adjustment to the charges specified in
this Agreement.
It is the expectation of both parties that the dates and
milestones set forth in this Agreement has been defined broadly
enough to accomplish both parties' goals and that no Change
Orders will be required.
2.5 ACSD CAPITAL INVESTMENT
Subject to Section 4 below, the [ * ]. Any increases in capital expenditures
required by Cubist will be specified in writing and will be [ * ].
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3. PRODUCTION
3.1 MANUFACTURING QUALITY
ACSD shall manufacture Product for Cubist in accordance with Exhibit D of this
Agreement and under Current Good Manufacturing Practices (cGMPs) as required by
the FDA and set forth in Title 21 Code of Federal Regulations Parts 210 and 211
(section.section.210.1-211.204 et. seq.), with particular emphasis on 211.22,
211.25 and 211.28 or the equivalents thereto pertaining to the responsibilities
of a quality unit, personnel qualifications and personnel responsibilities
respectively.
According to the provisions of Exhibit D, ACSD will develop a cGMP-compliant
quality unit at the Facility. This quality unit will follow and implement
policies and procedures mutually authorized by ACSD and Cubist. Compliance with
this Agreement is dependent upon, among other factors, ACSD hiring or training a
full-time senior level quality manager reasonably acceptable to Cubist dedicated
to, and located at, the Facility, to establish and lead the cGMP-compliant
quality unit.
ACSD will develop a cGMP compliant quality control test laboratory for the
testing and release of Product.
3.2 PROCESS VALIDATION
ACSD will develop and complete a validation process at the Facility in
accordance with Exhibit D herein, and [ * ]. Validation parameters and limits
for the process must span the actual process parameters and limits developed and
documented during the manufacture of consistency batches at commercial scale.
All post-validation process changes [ * ]. Cubist will provide test method
validation reports and small-scale purification validation studies as such
reports become available. ACSD will provide Cubist with a master validation plan
for the Facility and Process.
3.3 PROCESS IMPROVEMENTS
Following Facility Approval, ACSD may continue operating [ * ] with the [ * ].
Development undertaken for the purpose of [ * ] will be [ * ]. ACSD will [ * ].
All modifications in raw materials, conditions or processing related to the
manufacture of Product will be implemented [ * ]. The [ * ] following a
successful and complete cGMP change control process outlined in the [ * ].
3.4 STABILITY PROGRAM BATCHES
ACSD will supply Cubist with samples from the first [ * ] validation batches of
Product to be placed on stability as defined by Cubist's approved stability
protocols. In addition, ACSD will supply Cubist with samples from a minimum of
[ * ] commercial batch per year. Cubist will be responsible for conducting all
stability testing. ACSD agrees to ship stability samples under defined storage
conditions to either Cubist or a site designated by Cubist.
4. CUBIST INVESTMENT
According to the provisions of this Section 4, Cubist will contribute to ACSD
[ * ] in equity, milestones, Product Price Premiums, resin investment, process
development, quality systems and facility qualification support as specified
below.
4.1 EQUITY CONTRIBUTION
Within [ * ] days of execution of this Agreement Cubist will transfer to ACSD
[ * ] with an aggregate value of [ * ]. This equity contribution will comply
with terms and conditions specified in Exhibit E.
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4.2 MILESTONES
cubist will pay to ACSD:
- [ * ] upon [ * ] and [ * ]; and
- [ * ] upon [ * ].
4.3 PRODUCT PRICE PREMIUMS
Cubist will pay to ACSD [ * ] through a [ * ] specified in Section 6.2.
4.4 RESIN INVESTMENT
ACSD expects to spend [ * ]. In the event that Product is not approved for
commercial sale by [ * ].
4.5 PROCESS DEVELOPMENT, QUALITY SYSTEMS, FACILITY QUALIFICATION SUPPORT
Cubist will contribute such expertise, training, and support staff and services,
[ * ], as is reasonably necessary to assist ACSD in the [ * ].
5. PURCHASE OF PRODUCT
5.1 PURCHASE COMMITMENT
Contingent upon the receipt of the necessary Product and Facility Approvals,
Cubist will purchase [ * ] of Product during the term of this Agreement. During
the period prior to the receipt of Product Approvals, Cubist may, but is not
obligated to, purchase Product produced using commercial Process in accordance
with Exhibits B, C and D herein. Any such Product purchases [ * ] 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 [ * ](KG)
---- ------------------
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
[ * ]
The above schedule will be extended for any delays caused by ACSD.
5.2 DELAY IN PURCHASES / PAYMENT OF PRODUCT PRICE PREMIUMS
In the event that Facility Approval is received, but Cubist does not choose to
purchase [ * ], Cubist may defer the purchase and the payment for Product until
the following year, [ * ].
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Any delays caused by ACSD (including, but not limited to delays in construction,
validation, qualification, documentation, regulatory approvals and other ACSD
activities under this Agreement) will extend the Cubist purchase commitment
schedule, as described in Section 5.1 herein, on a day for day basis to account
for such ACSD delays.
5.3 PURCHASE FORECASTS
During the term of this Agreement, Cubist shall provide to ACSD, within the
first [ * ] business days of each quarter, on a quarterly basis, a rolling
forecast for orders of Product with respect to the following [ * ] quarters
(PURCHASE FORECAST). Cubist shall be [ * ] of the amount of Product forecast for
the [ * ] of any Purchase Forecast, and shall execute a binding purchase order
to that effect. The forecast for the remaining [ * ] of any Purchase Forecast
shall be non-binding.
5.4 PRODUCT ORDERS
Orders for Product shall be placed by written purchase order and submitted by
mail or facsimile, or by other means agreed upon by the parties. Due to the
expected variance in Product yield, an exact purchase amount may not be possible
and the Cubist purchase orders will accordingly include a [ * ]. Amounts in
excess of the stated [ * ]. No order shall be binding upon ACSD until it has
been accepted by ACSD in writing. ACSD shall accept or reject all orders within
[ * ] days following receipt of same and shall deliver all orders that are
accepted within [ * ] days of the projected delivery date.
5.5 CHANGED PURCHASE ORDERS
In the event that Cubist cancels, reschedules or otherwise reduces a purchase
order less than [ * ] days in advance of the scheduled batch initiation, Cubist
shall [ * ] of the price of the Product that [ * ]. Cubist may not [ * ] less
than [ * ] days in [ * ]. Cubist may [ * ] days in [ * ].
5.6 OBLIGATION TO SUPPLY
(a) ACSD shall use best efforts to accept and fill each order for
Product submitted by Cubist including orders that exceed the
Purchase Forecast by [ * ], provided that such request is
delivered to ACSD [ * ] days prior to [ * ]. ACSD shall not be in
breach of this Section 5.6 if ACSD's failure to supply Product is
due to a Force Majeure event or if ACSD's failure is limited to
[ * ]. Delivery dates will be set independently from Product
release and invoice dates as described in Section 5.7;
(b) If ACSD is unable to supply the Product ordered by Cubist in
accordance with the terms of this Agreement, then ACSD shall
[ * ], and any such [ * ]. If ACSD is unable to [ * ] days after
its initial failure to supply, then ACSD shall consult with
Cubist and the parties shall work together to remedy the problem.
In such an event, Cubist may, at its option, and upon notice to
ACSD:
(i) [ * ] and/or
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(ii) in the event that the parties agree that Cubist will
[ * ];
(c) In order to minimize adverse consequences from any interruption
in ACSD's ability to supply Cubist with Product, ACSD shall
maintain a back-up supply of raw materials sufficient to support
Cubist's forecasted production needs for a period of [ * ] months
following any failure of ACSD to timely supply Cubist with
Product. The costs of purchasing and maintaining this back-up
supply of raw materials will be borne by [* ]. Upon removal of
any units of raw materials from the back-up supply, [ * ], in
accordance with cGMP First-To-Expire-First-Out rules, so that an
adequate back-up supply is maintained at all times. The parties
shall confer [ * ] to review their aggregate requirements for raw
material and will adjust the size of the back-up supply of raw
materials in order to maintain at least [ * ] month supply of raw
material [ * ] shall also increase the size of the back-up supply
from time to time as warranted by commercially prudent risk
management practices.
5.7 PRODUCT WAREHOUSING AND PAYMENT SCHEDULE
Storage of Product after release by ACSD will be the responsibility of [ * ] for
a quantity amounting to the greater of [ * ] supply or [ * ] of Product as
[ * ]. Delivery of Product to finish/fill organizations will be scheduled and
mutually agreed upon by Cubist and ACSD. Cubist will be invoiced at the time
[ * ]. The payment for released Product that is warehoused at ACSD or contract
freezer warehouse facilities will follow promptly behind the invoicing of
material that is ready for shipment provided that a Certificate of Analysis is
sent to Cubist, and such Certificate of Analysis is reviewed and accepted by
Cubist. In addition, a batch payment becomes due upon review and approval of the
Batch Record and batch Certificate of Analysis by Cubist.
5.8 THIRD PARTY SUPPLY
If Cubist notifies ACSD that Cubist will obtain the Product through a third
party [ * ] then Cubist may purchase Product from a [ * ]. Cubist may continue
to exercise [ * ] and substantiates such claim to Cubist's reasonable
satisfaction. [ * ], Cubist shall commence purchasing Product from ACSD,
provided that:
(a) Cubist shall [ * ] and
(b) ACSD shall [ * ].
6.0 TERMS OF SALE
6.1 PRODUCT PRICE
(a) Subject to the provisions of Sections 5, 6 and 7, Cubist will
purchase Product from ACSD at a price of [ * ].
(b) Subject to [ * ], Cubist and ACSD agree to re-evaluate the
cost structure of Product manufacturing [ * ] days after the
[ * ] anniversary of the Facility Approval, and to negotiate in
good faith an appropriate adjustment to the price of the
Product specified in Section 6.1 (a).
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6.2 PRODUCT PRICE PREMIUMS
Cubist will pay ACSD a [ * ] on the price of Product (PRODUCT PRICE PREMIUM)
purchased over [ * ]. Once the [ * ] have accrued to [ * ], Cubist will
immediately stop paying the Product Price Premiums and will pay [ * ] of
Product, as provided in Section 6.1 herein.
YEAR PURCHASE [ * ] PRODUCT PRICE PREMIUM
---- ------------- ---------------------
[ * ] [ * ] $[ * ]
[ * ] [ * ] $[ * ]
[ * ] [ * ] $[ * ]
[ * ] [ * ] $[ * ]
[ * ] [ * ] $[ * ]
[ * ] [ * ] $[ * ]
$[ * ]
The above schedule [ * ]. In the event that Cubist [ * ]. Any delays caused by
ACSD (including, but not limited, to delays in construction, validation,
qualification, documentation and other ACSD activities under this Agreement)
will extend Cubist's obligation to pay the Product Price Premiums.
6.3 PAYMENT
(a) Cubist shall pay for Product within [ * ] days after the date of
receipt by Cubist of ACSD's invoice, Certificate of Analysis,
Batch Records, and Manufacturing Compliance Reports as required
by Exhibit D with respect to such Product. [ * ], all taxes and
charges that may be imposed by any government taxing authority on
the amounts paid by [ * ]. In the event and to the extent that
[ * ], Cubist may [ * ].
(b) Cubist shall make payments required under this Section 6.3 by
wire transfer to a bank identified by ACSD in writing. All
payments shall be calculated, invoiced, stated and paid in United
States Dollars (USD).
6.4 SHIPPING
ACSD shall arrange for shipment of the Product ordered by Cubist via common
carrier of Cubist's choice, [ * ] to the port of entry specified by Cubist.
[ * ] shall pay all shipping, insurance, customs, duties and other governmental
charges relating to the importation and sale of the Product, if any, and shall
have all responsibility for storing and clearing the Product through all customs
and importation requirements. ACSD acknowledges that validation of shipping
procedures by Cubist will require ACSD to prepare shipments that comply with
validation parameters, comply with cGMP regulations related to shipping and
conform to relevant SOPs.
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6.5 QUALITY, DOCUMENTATION, FACILITY EXPECTATION AND ACCEPTANCE
(a) Each shipment of Product from ACSD shall contain Certificates of
Analysis for the Product being shipped as are necessary to show
that the Product is in conformity with the Product Specifications
and Product Approval. Cubist shall have reviewed and approved
Batch Records and quality control records for all Products to be
shipped prior to shipment. Cubist shall notify ACSD within [ * ]
days of the receipt of a shipment of the Product of any apparent
non-conformity of the Product to the Product Specifications;
provided that with respect to obvious nonconformities, Cubist
will promptly notify ACSD in order that ACSD may notify its
shipper and insurer. If Cubist fails to so notify ACSD, it will
be deemed to have accepted the Product; provided that ACSD's
obligations under Sections 10.2 and 11.1 herein shall survive
acceptance of the Product by Cubist. [ * ].
(b) Cubist shall not be required to pay ACSD for any Product which
has been properly rejected or for which unresolved Deviations
remain. [ * ]. Samples of all defective units of the Product
shall be returned to ACSD using the procedure specified in this
Section 6.5(b). Cubist shall notify ACSD in writing of its
rejection of Product under Section 6.5(a), and shall request a
Return Material Authorization (RMA) number, which ACSD shall
issue promptly. Within [ * ] days of receipt of such RMA number
Cubist shall return rejected Product to ACSD freight prepaid and
properly insured, along with a reasonably detailed statement of
the claimed defect and proof of date of purchase. In the event
ACSD determines that the returned Product is defective and
Product has been properly rejected by Cubist, ACSD shall replace
such defective Product free of charge. ACSD shall return to
Cubist, freight prepaid, all replaced Product, along with
reimbursement of the shipment charges for return of the
nonconforming Product if ACSD requires said nonconforming Product
to be returned. In the event, that ACSD determines that the
returned Product is not defective and the parties are unable to
resolve such dispute to their mutual satisfaction within [ * ]
business days of ACSD's determination, ACSD shall submit a sample
of such returned Product to an independent laboratory reasonably
acceptable to Cubist for testing against the Product
Specifications and the test results obtained by such laboratory
shall be final and controlling as between Cubist and ACSD. The
fees and expenses of such laboratory testing shall be borne
entirely by the party against whom such laboratory's findings are
made. In the event the test results indicate that the Product in
question does not conform to the Product Specifications, ACSD
shall replace such Product at no additional cost to Cubist within
[ * ] business days after receipt of such results if replacement
Product stock is available, and in any case as soon as possible
after receipt of such results.
7. EXCLUSIVITY
ACSD covenants that it will not
(a) promote, sell or deliver any Product or Daptomycin or
(b) provide Product or Daptomycin to any third party except as
specifically designated by Cubist in writing.
8. REGULATORY ACTIVITIES
8.1 GENERAL AND PERMANENT CONDITIONS
(a) ACSD shall cooperate with Cubist to
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(i) obtain all necessary regulatory approvals, including but
not limited to, DMF and Facility Approvals,
(ii) maintain all such Facility approvals in effect throughout
the term of this Agreement.
(b) ACSD shall obtain approval to manufacture Product from the
Italian Ministry of Health and other applicable local authorities
as required by law or regulation;
(c) Provide Cubist with all necessary documentation to support Cubist
regulatory filings.
8.2 CERTIFICATES OF ANALYSIS
ACSD shall perform, or cause to be performed, sample tests on each lot of
Product to be purchased pursuant to this Agreement before delivery to Cubist.
Each test report shall set forth the items tested, In-Process Specifications,
Product Specifications and test results in a Certificate of Analysis, containing
the types of information which shall have been requested by Cubist, for each lot
delivered. ACSD shall send or cause to be sent such certificates to Cubist prior
to shipment of each lot. The Certificate of Analysis will be accompanied by a
certified Batch Record signed by ACSD's quality assurance department and
co-signed by the technical director of the Facility. Review of the production
documents including, but not limited to, Certificates of Analysis by a Cubist
representative on site will be permitted under mutually agreed conditions.
8.3 MANUFACTURING COMPLIANCE REPORTS
ACSD shall provide or cause to be provided, for each lot of Product purchased
pursuant to this Agreement, a manufacturing compliance report, which
(a) outlines the process sub-lots and the processing organization
used for the formation of the batch; and
(b) contains Deviation reports, investigations, resolved
discrepancies and other information, memos and other
documentation concerning the quality of each batch of Product as
requested by Cubist; and
(c) includes a certification that the lot of Product was manufactured
in accordance with the In-Process and Product Specifications and
the then current Good Manufacturing Practices of the FDA,
including without limitation practices and procedures listed in
Exhibit D.
In the event the FDA or other governmental regulatory agency notifies ACSD that
it intends to visit or inspect the Facility, ACSD shall immediately provide
notice of such visit or inspection to Cubist and Cubist shall have the right to
participate in such visit or inspection. ACSD shall advise Cubist immediately if
an authorized agent of the FDA or other governmental regulatory agency visits
the Facility without prior notice. ACSD shall furnish to Cubist the report by
such agency of such visit within [ * ] business days of ACSD's receipt of such
report. ACSD shall not respond in writing to any regulatory agency without the
prior review and written approval of such response by Cubist. In the event ACSD
fails to meet the cGMPs, ACSD will be responsible, at ACSD's expense, for
(a) conducting an investigation to define the probable causes for the
failure,
(b) providing an acceptable cGMP investigation report to Cubist for
review and written approval and
(c) achieving compliance with cGMPs.
Additionally, ACSD will provide adequate staffing and training for manufacturing
and quality control for the production of Product. In addition, a functional
quality unit responsible for quality requirements described in Exhibit D must
operate in the Facility for the issuance of document change control, cGMP
policies, verification, compliance demonstration and cGMP documentation of all
manufacturing operations including but not limited to Product impact parameters
such as environmental monitoring, cleaning, process validation, preventative
maintenance, calibration and similar support functions outlined in the ICH and
FDA guidelines for the safe and efficacious production of pharmaceutical
products. This
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 12 of 37
documentation will include all Deviations and investigations performed as part
of the Product release procedure that will be mutually developed by the parties.
8.4 ACCESS TO FACILITY; CUBIST'S RIGHT TO MONITOR
(a) Cubist shall at all times upon reasonable notice and during
normal business hours have the right to inspect the Facility to
ascertain compliance with cGMPs. In addition, Cubist shall have
the right to designate a Cubist employee or an independent
consultant to monitor the Process at the Facility at Cubist's
sole expense.
(b) ACSD shall not change the specified raw materials or the Process
for the manufacture of Product without the prior written consent
of Cubist; Cubist may require ACSD to make changes in raw
materials or the Process subject to mutually agreed price
adjustments; ACSD will not use the Facility for any purpose
except the manufacture of Product and will not supply Product to
any party except Cubist.
8.5 PRODUCT RECALLS
If (a) any regulatory authority withdraws the approval to sell the
Product in such country or issues a directive or requests that
the Product be recalled from the market for Product safety
reasons or
(b) any regulatory authority or court of competent jurisdiction
issues a request, directive or order that the Product be
recalled, or
(c) Cubist shall reasonably determine that the Product should be
recalled
then the parties shall take all appropriate corrective actions, and shall
cooperate in any governmental investigations surrounding the recall.
In the event that such recall results from any cause or event arising from
defective manufacture, storage or handling of the Product by ACSD (excluding
defects relating to packaging or labeling supplied by or prepared at the
direction of Cubist), then ACSD shall be responsible for all expenses of the
recall. ACSD shall, at Cubist's option, either refund the purchase price for
recalled Product PLUS the cost of vialing the Product (not to exceed [ * ] per
vial of Product (in vialed form) with a maximum liability of [ * ] per batch of
Product (in vialed form)) or replace recalled Product held by Cubist or its
customers, including in each case Product embodied in vialed form consistent
with directions received from the appropriate governmental authority within a
reasonable time at ACSD expense, including freight and applicable duties, unless
the recall is due to an act or omission of Cubist or its agents. [ * ]. For the
purposes of this Agreement, the expenses of recall shall include, without
limitation, the expenses of notification and destruction or return of the
recalled Product and all other costs incurred in connection with such recall,
but shall not include [ * ].
In the event a regulatory authority orders the withdrawal of Product from any
country, Cubist shall not be obligated to purchase the Product or sell the
Product in such country from the date of such withdrawal until Cubist is again
authorized to sell Product in such country. ACSD shall not be obligated to
supply the Product to Cubist in such country for such period. If such a
withdrawal decision is final and not appealable, this Agreement shall terminate
with respect to such country.
8.6 COMPLIANCE WITH LAWS
ACSD and Cubist will comply with all applicable laws and regulations pertaining
to the manufacture use or sale of the Product and performance of their
respective duties under this Agreement. The compliance obligations of each party
shall include but not be limited to regulatory compliance in the areas of
safety, health and the environment.
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 13 of 37
9. CONFIDENTIALITY; PROPRIETARY RIGHTS
9.1. PUBLICITY
The parties shall:
(a) keep the material terms of this Agreement confidential,
(b) agree upon the text and the exact timing of an initial public
announcement relating to the transactions contemplated by this
Agreement as soon as possible after the Effective Date (such
agreement not to be unreasonably withheld by either party), and
(c) agree on the text and the timing of any subsequent public
announcements regarding this Agreement or the transactions
contemplated herein.
Neither party shall use the name of the other party or any director, officer or
employee of the other party or any adaptation thereof in any advertising,
promotional or sales literature or publicity without the prior written approval
of the other party. If this Agreement is required to be filed by either Party
with the Securities and Exchange Commission or another applicable securities
regulatory authority, to the extent reasonable, such party shall request
confidential treatment for any provisions of this Agreement that the other party
believes would disclose trade secrets, confidential commercial or financial
information that would impair the value of the contractual rights represented by
this Agreement or provide detailed commercial and financial information to
competitors or third parties.
9.2. CONFIDENTIALITY
It is contemplated that in the course of the performance of this Agreement each
party may, from time to time, disclose Confidential Information to the other.
Each party agrees that any Confidential Information disclosed by either party in
accordance with this Agreement shall be maintained in secrecy and each will use
all reasonable diligence to prevent disclosure except to personnel and
consultants, provided that disclosure to such personnel or consultants is
necessary in order to accomplish the purposes for which the Information was
disclosed to the receiving party and provided further that such personnel and
consultants agree to be bound by the Confidentiality provision of the Agreement.
Each party agrees that it will protect and maintain the confidentiality of the
Confidential Information that it receives from the other with at least the same
degree of care as it uses to protect its own confidential information. Each
party hereby further agrees that it will not use the Information for any purpose
other than as contemplated by this Agreement.
Any and all Confidential Information received by either party from the other,
upon request shall be promptly returned, [ * ].
It is understood that no patent right or license is hereby granted by this
Agreement and that the disclosure of Confidential Information does not result in
any obligation to grant either party any right in and to such Information.
9.3 PROPRIETARY RIGHTS.
(a) This Agreement does not convey to ACSD any rights in the Cubist
Technology by implication, estoppel or otherwise except for the
rights expressly granted under this Agreement. Title to the
Cubist Technology, Process, and Product (and the intellectual
property rights embodied in the Product) shall at all times
remain vested in Cubist.
(b) ACSD will implement and conduct the Process but will not
research, modify or enhance the Process without authorization
from Cubist; provided that in the event Process improvements are
realized in implementing and running the Process then ACSD will
take all necessary steps to assign, free of charge, ownership of
the improvements specific to the Product in Cubist.
* Confidential Treatment Requested. Omitted portions filed with the Commission.
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(c) Subject to the terms and conditions of this Agreement, Cubist
hereby grants to ACSD, and ACSD hereby accepts, a non-exclusive,
royalty-free right and license, excluding the right to grant
sublicenses, to practice the Process and to make, have made,
export and sell Product exclusively to Cubist.
9.4 PROPRIETARY RIGHTS NOTICES
ACSD shall ▇▇▇▇ or have marked all containers or packages of Product in
accordance with the patent marking laws of the jurisdiction in which such units
of Product are manufactured or sold.
10. REPRESENTATIONS AND WARRANTIES
10.1 AUTHORIZATION; ENFORCEABILITY
Each of ACSD and Cubist represent and warrant to the other that:
(a) it is a corporation duly organized, validly existing and in good
standing under the laws of its incorporating jurisdiction;
(b) it has all requisite corporate power and authority to enter into
this Agreement;
(c) it is duly authorized to execute and deliver this Agreement and
to perform its obligations hereunder and consummate the
transactions contemplated hereby; and
(d) this Agreement is a valid and binding obligation of such party
enforceable in accordance with its terms.
10.2 PRODUCT WARRANTY
ACSD represents and warrants to Cubist that all Product supplied to Cubist
hereunder shall:
(a) conform to the Product Specifications; and
(b) be manufactured, labeled, packaged and tested (while in the
possession or control of ACSD) in accordance with the In-Process
Specifications, the applicable cGMPs, and the applicable laws and
regulations in the United States and the EU relating to the
manufacture, labeling, packaging and testing of the Product,
including all FDA and EU standards as defined by regulations,
guidelines and International Conference on Harmonization advisory
documents.
THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY ACSD WITH
RESPECT TO THE PRODUCT, AND ACSD GIVES AND MAKES NO REPRESENTATIONS OR
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR MEDICAL PURPOSE AND IMPLIED MEDICAL
WARRANTIES ARISING UNDER TRADE USAGE OR CUSTOM OR ANY EXPRESS OR IMPLIED
WARRANTIES OF PATENT VALIDITY OR FREEDOM TO PRACTICE OR FROM PATENT
INFRINGEMENT.
11. RISK ALLOCATION
11.1 ACSD INDEMNIFICATION
ACSD, which as used herein shall include its directors, employees,
representatives and Affiliates, shall defend, indemnify and hold harmless
Cubist, its directors, employees and consultants from and against any and all
losses (including reasonable attorney's fees) arising from or related to:
(a) any material breach of this Agreement, including but not limited
to, ACSD's representations and warranties herein;
(b) any negligence, recklessness or intentional misconduct by ACSD in
performing its obligations under this Agreement or with respect
to the manufacture, storage, handling or delivery of the Product;
or
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 15 of 37
(c) any failure of the Product or failure of the Product to comply
with Product Specifications, but in each case only if such defect
or failure did not arise or result from the improper use,
administration, storage or handling of the Product by a third
party.
The foregoing indemnification action shall not apply in the event and to the
extent that a court of competent jurisdiction determines that such losses arose
as a result of Cubist's negligence, intentional misconduct or breach of this
Agreement.
11.2 CUBIST INDEMNIFICATION
Cubist, which as used herein shall include its directors, employees,
representatives and Affiliates, shall defend, indemnify and hold harmless ACSD
from and against any and all losses arising from or related to:
(a) any material breach of Cubist's representations and warranties
under this Agreement;
(b) any negligence, recklessness or intentional misconduct by Cubist
in performing its obligations under this Agreement or with
respect to its storage, handling, shipping, use, marketing,
distribution or sale of the Product;
(c) any representation or warranty made by Cubist to its customers or
users with respect to the Product other than representations or
warranties that
(i) the Product conforms to the Product Specifications or
(ii) the Product is not, at the time of delivery by ACSD to
Cubist, adulterated within the meaning of the FDA
regulations;
(d) any packaging or labeling of any Product to the extent that such
packaging or labeling has been supplied by or at the direction of
Cubist and applied in accordance with instructions from Cubist;
(e) an inherent defect in the Product, including such a claim arising
from an injury to a person resulting from proper use,
administration, storage and handling of the Product in accordance
with the Product instructions, but only if such defect or failure
did not arise or result from the improper use, administration,
storage or handling of the Product by a person other than the
Indemnifying Party; or
(f) an allegation that the Product infringes or misappropriates any
intellectual property right of any third party (including without
limitation, any patent, copyright, trade secret or trademark);
provided that Cubist will not be obligated to indemnify ACSD
pursuant to Section 11.2(f) in the event and to the extent that
the alleged infringement is caused by:
(i) ACSD's misuse or modification of the Product; or
(ii) ACSD's use of the Product in combination with any products
or materials not provided by Cubist (except for products
and materials with which the Product is designed to be
used, as provided in the In-Process or Product
Specifications).
The foregoing indemnification obligation shall not apply in the event and to the
extent that a court of competent jurisdiction determines that such losses arose
as a result of ACSD's negligence, intentional misconduct or breach of this
Agreement.
11.3 INSURANCE
(a) ACSD shall purchase and maintain in force during the term of this
Agreement and at its expense:
(i) premises liability insurance and all-risk property
insurance including boiler and machinery coverage, written
at replacement cost value and with replacement cost
endorsement and
(ii) workmen's compensation or similar insurance in form and
amounts required by law and employer's liability
insurance, covering employees of ACSD having coverage
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 16 of 37
limits at least equal to those covering similar types of
ACSD employees at other locations. Certificates of such
insurance shall be provided to Cubist upon the execution
of this Agreement. The insurance policies specified in
clause 11.3(a)(i) shall name Cubist as an additional named
insured;
(b) Each party shall purchase and maintain insurance or
self-insurance adequate to cover its obligations hereunder and
which are consistent with normal business practices of prudent
companies similarly situated at all times during this Agreement.
It is understood that such insurance shall not be construed to
create a limit of either party's liability with respect to its
indemnification obligations under this Section 11;
(c) Each party shall provide the other with written evidence of the
insurance required under Sections 11.3(a) and 11.3(b) (or
financial information that describes the amounts available under
any self-insurance facility) upon request. Each party shall
provide the other with written notice at least [ * ] days prior
to the cancellation, non-renewal or material change in such
insurance or self-insurance which materially adversely affects
the rights of the other party hereunder. If such party does not
obtain replacement insurance or take other measures that allow it
to provide comparable coverage within such [ * ] day period, the
other party shall have the right to terminate this Agreement
effective at the end of such [ * ] day period without notice or
any additional waiting periods.
12. TERM AND TERMINATION
12.1 TERM
This Agreement shall take effect as of the Effective Date and shall remain in
effect until the sixth 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 [ * ] of the Effective Date, Cubist shall notify ACSD
in writing whether Cubist desires to extend the Agreement for an additional two
years. All 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 [ * ] prior to the
expiration of the then current extension term.
12.2 TERMINATION
(a) Either party may terminate this Agreement at any time:
(i) upon [ * ] days written notice to the other party in the
event that the other party shall have breached any of its
material obligations hereunder and shall not have cured
such default prior to the expiration of the [ * ] day
period; or
(ii) upon written notice to the other party in the event that
any bankruptcy, insolvency or receivership proceeding or
the like (including out-of-court arrangements involving a
party that cannot pay its debts as they mature) is
commenced by or against the other party unless, in the
case of an involuntary proceeding, it is dismissed within
[ * ] days;
(b) Cubist may terminate this Agreement with notice to ACSD
(i) in the event that ACSD fails to achieve its obligations
under Section 2.1 within [ * ] days of the Facility
Completion Target Date or
(ii) in the event that Facility Approval is not received within
[ * ] days of the Facility Approval Target Date due to
ACSD failure by to meet its obligations under this
Agreement.
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Page 17 of 37
Prior to Cubist terminating this Agreement under this Paragraph 12.2(b), but no
later than [ * ] days from the applicable Target Date, ACSD will be given
reasonable opportunity to present to Cubist a plan of corrective action. If
Cubist and ACSD mutually agree on the plan in writing, ACSD will be provided an
additional period of time, specified and agreed to in writing by both parties,
to remedy the delay in meeting its obligations;
(c) Cubist may terminate this Agreement upon [ * ] days notice to
ACSD if Cubist or an affiliate or sublicensee terminates the
manufacture or sale of the Product;
(d) Cubist may terminate this Agreement in the event that the FDA
does not approve the Product within [ * ];
(e) The parties may also terminate this Agreement at any time with
[ * ] days notice upon mutual written agreement between Cubist
and ACSD.
12.3 EFFECT OF TERMINATION
(a) Upon any termination (including expiration) of this Agreement:
(i) ACSD and Cubist will terminate all tasks being performed
pursuant to Section 3 in an orderly manner, as soon as
practical and in accordance with a written schedule agreed
to by Cubist and ACSD to minimize disruption to customers
for the Product;
(ii) All licenses from Cubist to ACSD shall terminate with the
exception of those necessary to fulfill ACSD's obligations
to Cubist in accordance with this Section 12.3;
(iii) Each party will return to the other party or certify in
writing to the other party that it has destroyed all
documents and other tangible items it or its employees or
agents have received or created pursuant to this Agreement
pertaining, referring or relating to the Confidential
Information of the other party, [ * ]; and
(iv) ACSD shall promptly notify Cubist of the quantity of
Product in inventory and in production and [ * ] or, in
the alternative, to [ * ]. In addition, ACSD will accept
orders from Cubist on a C.O.D. basis for additional
Product that Cubist is, as of the date of termination
notice, contractually obligated to furnish to its
customers, if Cubist does not have sufficient Product in
its inventory to fulfill such obligations, provided Cubist
notifies ACSD of any and all such transactions in writing
within [ * ] days of the termination date;
(b) If this Agreement is terminated by Cubist pursuant to Section
12.2(a) or Section 12.2(b), ACSD shall reimburse Cubist for the
Premium within [ * ] days following termination. In all other
cases, if termination occurs after the receipt of Product
Approvals and Cubist has not recovered the Premium as of the date
of termination, [ * ];
(c) Termination of this Agreement shall not affect rights and
obligations of either party that may have accrued prior to the
effective date of termination or any obligation specifically
stated to survive termination. The provisions of Sections [ * ]
shall survive any expiration or termination of this Agreement.
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 18 of 37
13. DISPUTE RESOLUTION
In the event that any dispute arises relating to this Agreement, ACSD and Cubist
shall each designate a representative to meet and attempt to resolve the dispute
through good faith discussions. If the representatives are unable to resolve
such dispute to their mutual satisfaction within [ * ] days after they commence
discussions, then either party may seek alternate resolution or legal or
equitable relief.
14. GENERAL PROVISIONS
14.1 GOVERNING LAW
This Agreement shall be governed and construed in accordance with the laws of
Massachusetts, to the exclusion of both its rules on conflicts of laws and the
provisions of the "United Nations Convention on Contracts for the International
Sale of Goods".
14.2 AMENDMENT AND WAIVER
No provision of or right under this Agreement shall be deemed to have been
waived by any act or acquiescence on the part of either party, its agents or
employees, but only by an instrument in writing signed by an authorized officer
of each party. No waiver by either party of any breach of this Agreement by the
other party shall be effective as to any other breach, whether of the same or
any other term or condition and whether occurring before or after the date of
such waiver.
14.3 INDEPENDENT CONTRACTORS
Each party represents that it is acting on its own behalf as an independent
contractor and is not acting as an agent for or on behalf of any third party.
This Agreement and the relations hereby established by and between ACSD and
Cubist do not constitute a partnership, joint venture, franchise, agency or
contract of employment. Cubist is not granted, and shall not exercise, the right
or authority to assume or create any obligation or responsibility on behalf of
or in the name of ACSD or its Affiliates.
14.4 ASSIGNMENT
Neither party may assign this Agreement or any of such party's rights and
obligations hereunder to any third party without the prior written consent of
the other party, which consent shall not be unreasonably withheld. Either party
may assign this Agreement, and such party's rights and obligations hereunder, to
an Affiliate (including a subsidiary) which controls, is controlled by, or is
under common control with a party so long as the assigning party remains
primarily liable for its obligations hereunder. In addition, either party may
assign this Agreement, and its rights and obligations hereunder, to any third
party that purchases substantially all of the assigning party's stock or assets
relating to that portion of such party's business that is related to the subject
of this Agreement. Any attempted assignment, delegation or transfer in
contravention of this Agreement shall be null and void.
14.5 SUCCESSORS AND ASSIGNS
This Agreement shall bind and inure to the benefit of the parties hereto and
their respective successors and permitted assigns.
14.6 NOTICES
Unless otherwise provided herein, any notice, report, payment or document to be
given by one party to the other shall be in writing and shall be deemed given
when received:
If to ACSD:
ACS Dobfar, SpA
20067 Tribiano (Milan)
▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇/▇/▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Phone: 0113902-90693218
Fax: 0113902-90693204
* Confidential Treatment Requested. Omitted portions filed with the Commission.
Page 19 of 37
If to Cubist:
Cubist Pharmaceuticals, Inc.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ U.S.A.
Attention: ▇▇▇▇ ▇▇▇▇▇▇
Telefax No.: (▇▇▇) ▇▇▇-▇▇▇▇
Telephone No.: (▇▇▇) ▇▇▇-▇▇▇▇
or to such other place as either party may designate as to itself by written
notice to the other party.
14.7 SEVERABILITY
In the event any provision of this Agreement shall for any reason be held to be
invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof. The
parties agree that they will negotiate in good faith or will permit a court or
arbitrator to replace any provision hereof so held invalid, illegal or
unenforceable with a valid provision which is as similar as possible in
substance to the invalid, illegal or unenforceable provision.
14.8 CONFLICT OR INCONSISTENCY
In the event of any conflict or inconsistency between the terms and conditions
hereof and any terms or conditions set forth in any purchase order or other
document relating to the transactions contemplated by this Agreement, the terms
and conditions set forth in this Agreement shall prevail.
14.9 ENTIRE AGREEMENT
The terms and provisions contained in this Agreement (including the Exhibits)
constitute the entire understanding of the parties with respect to the
transactions and matters contemplated hereby and supersede all previous
communications, representations, agreements and understandings relating to the
subject matter hereof. No representations, inducements, promises or agreements,
whether oral or otherwise, between the parties not contained in this Agreement
or incorporated by reference in this Agreement shall be of any force or effect.
No agreement or understanding extending this Agreement or varying its terms
(including any inconsistent terms in any purchase order, acknowledgment or
similar form) shall be binding upon either party unless it is in a writing
specifically referring to this Agreement and signed by the duly authorized
representative of the applicable party.
14.10 RULES OF CONSTRUCTION
The parties agree that they have participated equally in the formation of this
Agreement and that the language and terms of this Agreement shall not be
construed against either party by reason of the extent to which such party or
its professional advisors participated in the preparation of this Agreement.
14.11 FORCE MAJEURE
Except as otherwise provided in this Agreement, in the event that a delay or
failure of a party to comply with any obligation created by this Agreement is
caused by a Force Majeure condition, that obligation shall be suspended during
the continuance of the Force Majeure condition.
14.12 FURTHER ASSURANCES
Each party covenants and agrees that, subsequent to the execution and delivery
of this Agreement and without any additional consideration, it will execute and
deliver any further legal instruments and perform any acts which are or may
become reasonably necessary to effectuate the purposes of this Agreement.
* Confidential Treatment Requested. Omitted portions filed with the Commission.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their respective duly authorized officers, and have duly delivered and
executed this Agreement under seal as of the date first set forth above.
ACS DOBFAR SpA
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇
----------------------------------
Title: President
Date: November 13, 2001
CUBIST PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
----------------------------------
Title: Chairman and CEO
Date: 9/28/01
Page 21 of 37
