Exhibit 10.1
[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
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COMMISSION.]
DEVELOPMENT AND TOLL
MANUFACTURING AGREEMENT
between
JAVELIN PHARMACEUTICALS, INC.
and
BAXTER HEALTHCARE CORPORATION

 

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COMMISSION.]
TABLE OF CONTENTS

             
1.
  DEFINITIONS     1  
2.
  BAXTER OBLIGATIONS FOR SUPPLY AND FUTURE DEVELOPMENT WORK     5  
3.
  API, NOVEL EXCIPIENT AND MATERIALS     6  
4.
  MANUFACTURE     7  
5.
  PRODUCT SPECIFICATIONS; CERTIFICATE OF ANALYSIS     8  
6
  LABELING AND PACKAGING     9  
7.
  FORECASTS     9  
8.
  PURCHASE ORDERS     9  
9.
  DELIVERY     11  
10.
  PRICE AND PAYMENTS     11  
11.
  INSPECTION OF PRODUCT     12  
12.
  ACCESS TO MANUFACTURING FACILITY AND RECORDS     12  
13.
  REPRESENTATIONS AND WARRANTIES; DISCLAIMERS; LIMITATION OF LIABILITY     14  
14.
  INDEMNIFICATION     16  
15.
  RECALLS     17  
16.
  TERM AND TERMINATION     18  
17.
  CONFIDENTIALITY     19  
18.
  INSURANCE     21  
19.
  MISCELLANEOUS     21   SCHEDULE 1.9     25   SCHEDULE 1.27     26   SCHEDULE
1.29     27   SCHEDULE 1.31     28   SCHEDULE 1.31A     29   SCHEDULE 2.1     30
  SCHEDULE 10.1     31  

 

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COMMISSION.]
DEVELOPMENT AND TOLL MANUFACTURING AGREEMENT
          This Development and Toll Manufacturing Agreement (this “Agreement”)
is entered into as of this 30th day of July, 2008 (the “Effective Date”) by and
between Javelin Pharmaceuticals, Inc., a Delaware corporation, having its
principal place of business at 125 Cambridge Park Drive, Cambridge, MA 02140
(“Purchaser”), and Baxter Healthcare Corporation, a Delaware corporation, having
a place of business at 2 Esterbrook Lane, Cherry Hill, NJ 08003 (“Supplier”).
          WHEREAS, Supplier manufactures certain pharmaceutical products;
          WHEREAS, Purchaser intends to distribute and market finished dosage
pharmaceutical products, including, without limitation, a certain intravenous
dosage product sometimes currently known as “Diclofenac Sodium Injection (the
“Product”); and
          WHEREAS, Supplier and Purchaser have entered into a Development and
Toll Manufacturing Agreement, dated April 25, 2007, (“US Agreement”) for
activities related to Product to be sold in the United States, and the parties
now want to enter into an agreement for activities related to Product to be sold
in certain other European countries (as defined herein), and
          NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein, and intending to be legally bound hereby, the parties agree as
follows:
1.       DEFINITIONS. As used in this Agreement, the following terms shall have
the following respective meanings:

  1.1   “Acceptable Product” has the meaning assigned thereto in Section 11.1.  
  1.2   “Activities” has the meaning assigned thereto in Section 4.3.     1.3  
“Affiliate” means any individual or entity directly or indirectly controlling,
controlled by, or under common control with a party. For purposes of this
definition, “control” means the direct or indirect ownership of at least fifty
percent (50%) of the outstanding voting securities of a party, or the right to
control the policy decisions of such party. Notwithstanding the foregoing, the
term “Affiliate” does not include subsidiaries in which a party or its
Affiliates owns a majority of the ordinary voting power to elect a majority of
the board of directors, but is restricted from electing such majority by
contract or otherwise, until such time as such restrictions are no longer in
effect.

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  1.4   “Alternate Presentation” means any alternative configuration of the
Product other than in two (2) mL vials with one (1) or two (2) mL fill volumes
and packaged in either a ten (10) or twenty-five (25) unit Baxter standard vial
packaging configuration.     1.5   “Alternative Source Period” has the meaning
assigned thereto in Section 8.7.     1.6   “Annual Period” means a period of
twelve (12) calendar months, beginning on (i) the date of the First Regulatory
Approval in one of the Member States for the Product manufactured at the
Manufacturing. Facility, or (ii) the date of Regulatory Approval of the Product
in Germany, whichever is later, and each 12-month period thereafter during the
Term.     1.7   “API” means the active pharmaceutical ingredient diclofenac
sodium USP/Ph.Eur.     1.8   “API Specifications” means the specifications for
or concerning the manufacturing, testing, and packaging of bulk API set forth in
Schedule 1.88 attached hereto, as the same may be amended from time to time upon
written agreement of the parties.     1.9   “Binding Forecast” has the meaning
assigned thereto in Section 7.2.     1.10   “Calendar Year” means a period of
twelve (12) calendar months, beginning each January 1 and ending on the
subsequent December 31 during the Term.     1.11   “Certificate of Analysis” has
the meaning assigned thereto in Section 5.2.     1.12   “Claim” has the meaning
assigned thereto in Section 14.3.     1.13   “Commercially Reasonable Efforts”
means efforts and resources normally used by a party for a compound or product
owned by it or to which it has rights, which is of similar market potential at a
similar stage in its product life, taking into account the competitiveness of
the marketplace, the proprietary position of the compound or product, the
regulatory structure involved, the profitability of the applicable product, and
other relevant factors.     1.14   “Confidential Information” means all
proprietary and confidential information of a party, including, without
limitation, trade secrets, technical information, business information, sales
information, customer and potential customer lists and identities, product sales
plans, license and sublicense agreements, inventions, developments, discoveries,
know-how, methods, techniques, formulae, data, processes, and other proprietary
ideas, whether or not protectable under patent,

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      trademark, copyright, or other legal principles, that the other party has
access to or receives, but does not include information that (a) is or becomes
publicly available through no breach of this Agreement by the receiving party;
(b) was already known to the receiving party at the time it was disclosed to the
receiving party hereunder; (c) is independently developed by employees of the
receiving party without the aid, use, or application of Confidential Information
received from the disclosing party hereunder; or (d) is received from a Third
Party which is under no obligation of confidentiality to the disclosing party.  
  1.15   “Directives” means the European Medicines Agency (EMEA) Directives as
the same may be amended from time to time, and rules and regulations promulgated
there under.     1.16   “EMEA” means the European Medicines Agency or any
successor entity.     1.17   “Force Majeure Event” has the meaning assigned
thereto in Section 19.7.     1.18   “Full Lot” means Baxter’s prevailing batch
size with the same intermediate packaging, single language product insert and
labeling per lot.     1.19   “GMP” means good manufacturing practice promulgated
by the MHRA or EMEA, including, without limitation, Directive 2003/94/EC,
Directive 2004/27/EC, Directive 91/412/EEC and all applicable directives, rules
and regulations, policies and guidelines in effect at a given time.     1.20  
“Indemnitee” has the meaning assigned thereto in Section 14.3.     1.21  
“Indemnitor” has the meaning assigned thereto in Section 14.3.     1.22  
“Manufacturing Facility’” means Supplier’s facility located at 2 Esterbrook
Lane, Cherry Hill, New Jersey 08003.     1.23   “Materials” means any or all
chemical substances, inactive ingredients, excipients other than the Novel
Excipient, components, labels, packaging materials, and other consumable
materials used in the manufacture of the Product; provided, however, that the
term “Materials” shall not include any equipment used in the manufacture of the
Product.     1.24   “Member States” means France, Germany, United Kingdom, Spain
and Italy.     1.25   “MHRA” means the Medicines and Healthcare products
Regulatory Agency, or any successor entity.     1.26   “Novel Excipient” means
hydroxypropylbetadex.

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COMMISSION.]

  1.27   “Novel Excipient Specifications” means the specifications for or
concerning the manufacturing, testing, and packaging of the Novel Excipient set
forth in Schedule 1.27 attached hereto, as the same may be amended from time to
time upon written agreement of the parties.     1.28   “Product” means the
pharmaceutical product currently known as Diclofenac Sodium Injection or
Dyloject® containing the API.     1.29   “Product Specifications” means the
specifications for or concerning the manufacturing, testing, and packaging of
Product set forth in Schedule 1.29 attached hereto, as the same may be amended
from time to time upon written agreement of the parties.     1.30   “Proposed
Response” has the meaning assigned thereto in Section 12.2.     1.31   “Quality
Agreement” means the applicable agreement, dated as of the date hereof, between
Supplier and Purchaser, in the form of Schedule 1.31 attached hereto relating to
the Product manufactured at the Manufacturing Facility.     1.32   “Reasonable
Steps” has the meaning assigned thereto in Section 17.1.     1.33   “Recall”
means any action by Purchaser and its Affiliates, or Supplier and its
Affiliates, to recover title or possession or halt distribution, prescription,
or consumption of Product sold or shipped to Third Parties. The term “Recall”
also applies to Product that would have been subject to recall if it had been
shipped.     1.34   “Regulations” means the MHRA Regulations as the same maybe
amended from time to time, and rules and regulations promulgated there under.  
  1.35   “Regulatory Approvals” means all authorizations by the appropriate
Regulatory Authorities that are required for the manufacture (other than
manufacturing facility licenses, approvals, or authorizations), marketing,
promotion, pricing, and sale of the Product in the Member States.     1.36  
“Regulatory Authority” means any national, supra-national, regional, state, or
local regulatory agency, department, bureau, commission, council, or other
governmental entity in the Member States involved in the granting of Regulatory
Approval for the Product, including, without limitation, the MHRA or EMEA.    
1.37   “Rolling Forecast” has the meaning assigned thereto in Article 7.    
1.38   “Seizure” means any action by the MHRA or EMEA to detain or destroy
Product or prevent the distribution, prescription, consumption, or release of
Product.

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DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

  1.39   “Technical Coordinator” has the meaning assigned thereto in Section
2.2.1 hereof.     1.40   “Term” has the meaning assigned thereto in
Section 16.1.     1.41   “Third Party” means any person or entity other than
Supplier, Purchaser, and their respective Affiliates.     1.42   “Unit” means
each two (2) mL vial with a one (1) or two (2) mL fill volume.

2.   BAXTER OBLIGATIONS FOR SUPPLY AND FUTURE DEVELOPMENT WORK

  2.1   Process or Development Tasks. Supplier is providing development work in
accordance with the provisions of Schedule 2.1 to the US Agreement. The parties
anticipate the development work under the US Agreement will also be used for
this Agreement. Supplier shall provide Purchaser with the Marketing
Authorization Application documentation for the Product.     2.2   Development
Work and Budget. If any events occur necessitating additional process or
development work, the parties will meet and develop a schedule to define the
additional work and the additional costs. Purchaser shall make payments to
Supplier for its performance of the additional work in accordance with the
budget and payment schedule (the “Budget”) established with respect to the
additional work, as described in the Development Plan within [***] days of the
later to occur of (i) completion of the relevant portion of the additional work
triggering such payment pursuant to the Budget, to Purchaser’s reasonable
satisfaction, and (ii) receipt of a detailed invoice with respect to same.    
2.3   Obligation to Supply Product. During the Term, Supplier shall manufacture
and supply Product to Purchaser, and Purchaser shall purchase Product from
Supplier, pursuant to the provisions of this Agreement.     2.4   Technical
Coordinator.

  (a)   Appointment. Purchaser shall appoint an authorized technical
representative and a back-up technical representative by providing written
notice of such representatives to Supplier (each, a “Technical Coordinator”).
Purchaser may replace either of its Technical Coordinators at any time, with or
without cause, by providing written notice thereof to Supplier.     (b)  
Responsibilities of Technical Coordinators. The Technical Coordinators shall be
responsible for communications, other than legal notices, between the parties in
matters of quality, manufacturing, project management, and

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COMMISSION.]

      compliance with respect to the Product. The Technical Coordinators shall
be available on a regular basis for consultation during the Term regarding
Supplier’s performance under this Agreement, and compliance with applicable
Specifications, Purchaser’s quality requirements, the quality requirements of
applicable laws or Regulatory Authorities having jurisdiction over the
manufacture of Product hereunder, GMPs, and all other applicable regulatory
requirements.

  2.5   Notification. Supplier shall immediately notify Purchaser of any event
that is reasonably likely to cause a breach by Supplier of its obligations under
this Agreement or of any issue that might result in a supply interruption of any
duration.     2.6   [***]     2.7   Right of First Refusal for Additional
European Union Member States. Purchaser also grants to Supplier, under similar
terms and conditions listed herein, and as may need to be modified by mutual
agreement of the parties (including pricing), the right of first refusal to
produce the Product, in the current presentation or in alternate presentations
for distribution and sale in countries in Europe in additional to the Member
States.

3.   API, NOVEL EXCIPIENT AND MATERIALS.

  3.1   Supply of API and Materials. Purchaser has chosen those suppliers of
API, Novel Excipient and Materials identified in Purchaser’s regulatory filing
for the Product. During the Term, Supplier shall purchase API, Novel Excipient
and Materials, from those companies included in the regulatory filing for
Product, for use by Supplier in the manufacture of Product to be supplied to
Purchaser under this Agreement.     3.2   Purchaser is responsible for
certifying and auditing all Product-related suppliers. At Purchasers request,
Supplier will supply Purchaser with a statement regarding supplier compliance
for common suppliers used and audited by Supplier. Supplier makes no guarantee
of continued maintenance of supplier audits on a routine basis.     3.3  
Testing of API and Novel Excipient. Supplier shall test API and Novel Excipient,
in accordance with the procedures identified in Schedules 1.8 and 1.27 to verify
that the API meets the API Specifications and that the Novel Excipient meets the
Novel Excipient Specifications.

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DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
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COMMISSION.]

  3.4   Failure to Meet API Specifications or Novel Excipient Specifications. If
the API provided by the API supplier fails to meet the API Specifications, or
the Novel Excipient provided by the Novel Excipient supplier fails to meet the
Novel Excipient Specifications, Supplier agrees to notify Purchaser immediately
in writing, which notice shall state with particularity the reasons such APT
fails to meet the API Specifications or such Novel Excipient fails to meet the
Novel Excipient Specifications, and shall include copies of any documentation in
support of Supplier’s conclusion. Purchaser shall timely cooperate with Supplier
in addressing the failure, and if such failure cannot be remedied, in
identifying and qualifying an alternate API supplier or Novel Excipient
supplier. Such qualification shall be at Purchaser’s expense.     3.5   Change
Controls. Purchaser shall require that suppliers-provide notice of any proposed
change to the API, Novel Excipient or Materials, including process
specifications, validation and/or controls, as well as the manufacturing and/or
packaging of the API, Novel Excipient or Materials. Supplier shall not be
responsible for any failure by any supplier to provide such notice.

4.   MANUFACTURE.

  4.1   Manufacturing Facility. Supplier shall manufacture all Product supplied
to Purchaser pursuant to this Agreement at the Manufacturing Facility.     4.2  
Manufacture of Product. Supplier agrees to manufacture and supply the Product in
accordance with (a) the Product Specifications, (b) the applicable Regulatory
Approvals, as the same may be amended from time to time, (c) GMP requirements,
and (d) all other applicable laws, rules, regulations and internal
specifications. Upon either Party becoming aware of any proposed changes in the
Regulatory Approvals, it shall promptly notify the other Party and shall consult
with the other party regarding the proposed changes and activities. Supplier
shall not have the right to decline to implement any change in the Regulatory
Approvals.     4.3   Manufacturing Changes. The Product Specifications shall be
amended as (a) reasonably requested by Purchaser or (b) necessary to conform
such Product Specifications to the regulatory requirements necessary to obtain
and maintain Regulatory Approvals with respect to the Product in the reasonable
discretion of Purchaser. If any change in the Product Specifications, or if any
change in the Regulatory Approvals, applicable laws, rules, or regulations or
sources of Materials requires either (a) a change in the Product manufacturing
process, or (b) Supplier to conduct development, testing, or other activities
(e.g., process development, stability testing, validation of new specifications)
(collectively, “Activities”) in addition to those activities Supplier conducted
or is required to

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      conduct in its manufacture of the Product prior to such change being
requested or required, Purchaser shall reimburse Supplier for all commercially
reasonable documented costs incurred by Supplier in connection with such change.
If Supplier requires regulatory changes to support improved process or yield
improvements, then Purchaser, in consultation with Supplier, agrees to submit
such changes to the EMEA or MHRA, as required, and Supplier shall pay for such
changes. Changes implemented to support improved process or yield improvements
shall not result in interruption in the supply or quality of the Product.    
4.4   Procurement of Materials. Supplier shall timely procure and maintain
adequate inventories of all API, Novel Excipient and Materials necessary for the
production of Product. Title to all such Materials shall reside in Supplier.    
4.5   Regulatory Filings. Each party shall provide the other, as applicable,
with all Regulatory Approval submissions, annual reports, and correspondence to
the EMEA or MHRA on issues reasonably related to the performance of Supplier’s
obligations as set forth in this Agreement.     4.6   Compliance with Laws and
Regulations. While the Product is in its possession or under its control,
Supplier shall comply with all applicable laws, Regulations, and directives,
including EMEA or MHRA requirements, regarding the manufacture, handling, and
storage of the Product.

5.   PRODUCT SPECIFICATIONS; CERTIFICATE OF ANALYSIS.

  5.1   Product Specifications and Release Testing. As of the time of delivery
by Supplier, each batch of Product shall conform to the Product Specifications.
Supplier shall perform release testing according to the testing methods set
forth in the Product Specifications, to release the Product from the
Manufacturing Facility. Purchaser shall be responsible for all additional
release testing.

  5.2   Certificate of Analysis. Supplier shall provide to Purchaser a
Certificate of Analysis with each shipment of Product to Purchaser or its
designated recipient stating that the Product conforms to the Product
Specifications. The Certificate of Analysis shall be in a format agreed upon by
Supplier and Purchaser, and such Certificate of Analysis shall include the
results of release testing conducted by Supplier on the Product. Supplier shall
also provide Purchaser with a copy of the manufacturing and controls information
for the applicable batch(es) delivered. Additional copies of the manufacturing
and controls documentation for the applicable batch(es) shall be provided at
Purchaser’s expense, ([***] per page).

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COMMISSION.]

6. LABELING AND PACKAGING. All Product shipped and delivered by Supplier to
Purchaser, under this Agreement shall be packaged and labeled in accordance with
this Agreement, the then-current packaging and labeling specifications provided
by Purchaser, and GMPs. Prior to the Effective Date, Purchaser supplied Supplier
with labeling for the Product (including the EAN number(s) for the Product).
Supplier shall print, either directly or through a Third Party, labels and other
printed material to be included as part of the Product. From time to time,
Purchaser may provide Supplier with modified labeling and upon receipt thereof,
Supplier shall use its Commercially Reasonable Efforts to incorporate such new
labeling on the Product in accordance with Purchaser’s requested schedule
therefore. Purchaser shall provide Supplier with any modifications to the
labeling for the Product as promptly as possible in order to ensure compliance
with any and all applicable regulations. Purchaser shall reimburse Supplier for
all pre-approved commercially reasonable costs incurred by Supplier in making
modifications to labeling, branding, or imprinting packaging and/or
manufacturing processes to accommodate Purchaser’s new labeling or to
accommodate any other changes requested by Purchaser and agreed to by Supplier.
Such reimbursement shall be made pursuant to invoices submitted by Supplier to
Purchaser, which invoices shall be payable within [***] days after Purchaser’s
receipt thereof Upon Purchaser’s request, Supplier shall promptly enter into a
separate written label agreement with Purchaser, setting forth Supplier’s
obligations relating to the labeling of Product hereunder.
7. FORECASTS. Throughout the Term, Purchaser, shall provide Supplier with a
rolling one (1) year forecast by calendar month (the “Rolling Forecast”) of its
expected purchases of Product as follows:

  7.1   Forecasts. On or before each [***] during the Term, Purchaser shall
provide Supplier with a written forecast of Purchaser’s expected purchases of
Product for a period of [***] calendar months beginning on the date of such
forecast. [***] percent of the forecast for the [***] calendar months and [***]
percent of the forecast for the [***] calendar months shall be binding on
Purchaser, subject to Section 8.3, and the forecast for the [***] calendar
months shall not be binding on Purchaser. As soon as commercially reasonable,
Purchaser shall supply an initial forecast.     7.2   Binding Forecasts. The
portion of each Rolling Forecast that is binding on Purchaser as provided in
Section 7.1 shall be a “Binding Forecast.” The portion of each Rolling Forecast
that is not binding on Purchaser as provided in Section 7.1 shall be used by
Supplier and Purchaser solely for planning purposes.

8.   PURCHASE ORDERS.

  8.1   Placement of Purchase Orders. From time to time during the Term,
Purchaser shall place purchase orders with Supplier, in a format chosen by
Purchaser,

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      specifying the quantity of Product desired in Full Lots, and the place(s)
to which and the manner and dates by which delivery is to be made; said delivery
dates to be no earlier than [***] calendar days after the purchase order date.
All purchase orders shall be sent by Purchaser to the following address or via
electronic exchange:

Baxter Healthcare Corporation
2 Esterbrook Lane
Chevy Hill, New Jersey 08003
Attn.: Director of Logistics
Tel.: 856-489-2114
Fax: 856-424-2592

      or to such other addresses as Supplier may notify Purchaser from time to
time.     8.2   Acceptance of Purchase Orders. Purchase orders made in
accordance with this Article 8 shall be deemed to be accepted by Supplier if
Supplier has not rejected said purchase orders within [***] business days after
receipt of the same; provided, however, that Supplier shall not reject any
purchase order specifying quantities which purchase orders are otherwise in
accordance with the provisions of this Article 8.     8.3   Quantity
Limitations. Supplier shall execute all accepted purchase orders for quantities
of Product ordered up to and including [***] percent of the quantity of Product
set forth in the applicable Binding Forecast for each calendar month. Supplier
shall use its Commercially Reasonable Efforts to fulfill orders for quantities
of Product greater than [***] percent of the quantity set forth in the
applicable Binding Forecast for each calendar month.     8.4   Minimum Purchase
Requirements. Following receipt of Regulatory Approval for the Product,
Purchaser shall purchase a Minimum of [***] Units in the first Annual Period and
[***] Units during each Annual Period thereafter. In any Annual Period in which
Purchaser does not purchase the Minimum Units, Purchaser shall pay to Supplier
[***].     8.5   Conflict. In the event of any conflict between the provisions
of this Agreement and any purchase order, the provisions of this Agreement shall
control.     8.6   Failure to Supply. In the event (i) Supplier cannot or does
not properly satisfy all of Purchaser’s Orders for Product on a timely basis in
accordance with this Section 8 for a period of [***] days, and such failure is
not attributable to a failure to properly supply API, Novel Excipient or
Materials by the suppliers, or (ii) any facility involved in the manufacture or
storage of Product hereunder is prohibited

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COMMISSION.]

      from, or materially adversely affected in its ability to, produce, store,
or otherwise be involved in the provision of Product to Purchaser under this
Agreement by the appropriate regulatory authorities, and such material adverse
event is not a Force Majeure Event, Purchaser can qualify an alternate
manufacturing source and purchase Product from such alternate source until such
time as Supplier can resume manufacture of the Products (the “Alternate Source
Period”). Supplier shall, as requested by Purchaser and at Supplier’s expense,
provide the technical transfer package for the Product to Purchaser and/or third
parties designated by Purchaser to manufacture Product in accordance with all
legal and regulatory requirements as quickly as possible. [***].

9. DELIVERY. Supplier shall execute all accepted purchase orders by delivering
the appropriate quantity of Product to Supplier’s designated mutually agreeable
carrier(s) at the Manufacturing Facility no later than the delivery dates
provided in the applicable purchase order. Title and risk of loss shall pass to
Purchaser when each order of Product is delivered to the designated carrier at
the Manufacturing Facility. Supplier shall instruct the designated carrier to
deliver the Product to such address as Purchaser may provide to Supplier from
time to time. All shipments shall be accompanied by temperature monitoring
devices or other indicators, at Purchaser’s expense.

10.   PRICE AND PAYMENTS.

  10.1   Price. Purchaser shall purchase from Supplier, and Supplier shall sell
to Purchaser, Product at the purchase price set forth in Schedule 10.1 attached.
The pricing may be adjusted [***], beginning on [***] and [***] thereafter
during the Initial Term, as defined in Section 16. 1, and any renewals, by a
percentage equal to the percentage change in the [***] during the [***]-month
period ending the preceding [***] (or if discontinued such equivalent index as
is mutually agreed to by the parties). [***].     10.2   Freight, Insurance, and
Taxes. Purchaser shall pay all actual freight, insurance, and government sales
tax imposed on purchasers for resale, and duties and other fees (except tax on
income to Supplier) incurred in connection with the sale and shipment of Product
to Purchaser.     10.3   Payment. Payments to Supplier for the purchase price of
Product, as well as any other payment due from Purchaser to Supplier pursuant to
this Agreement, shall be made by Purchaser within [***] days after the later of
the date of invoice or the product ship date from the Manufacturing Facility,
except as to orders for Product that are rejected by Purchaser in accordance
with the procedures set forth in Article 11 or that the parties dispute are in
conformance with the Specifications. In the event that Product is rejected by
Purchaser, but is determined to be Acceptable Product pursuant to Section 11.2,
the payment for such Product shall

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      be due and payable within [***] business days after the determination with
respect to such Product is made in accordance with Section 11.2 hereof.

11.   INSPECTION OF PRODUCT.

  11.1   Inspection, Rejection of Product. Purchaser may analyze representative
samples of each lot of Product delivered hereunder for purposes of determining
whether the same meets the Specifications and was manufactured in accordance
with GMP (“Acceptable Product”), and, if performed, shall do so within [***]
days from the date of shipment (or, in the case of a latent defect, within [***]
days after discovery of such latent defect). Purchaser shall notify Supplier in
writing within said [***] days of rejection of any of the Product that Purchaser
is rejecting said Product because it is not Acceptable Product.     11.2   Third
Party Analysis. If Supplier, after good faith consultation with Purchaser,
disputes any finding by Purchaser that Product is not Acceptable Product,
representative samples of such Product shall be forwarded to a Third Party
jointly selected by Supplier and Purchaser for analysis, which analysis shall be
performed in compliance with applicable MHRA Regulations for retesting of
pharmaceutical products. The findings of such Third Party regarding whether the
Product was Acceptable Product shall be binding upon Supplier and Purchaser. The
cost of such analysis by such Third Party shall be borne by the party whose
findings differed from those generated by such Third Party.     11.3  
Replacement of Product. Unless any nonconformity is caused by a negligent or
wrongful act or omission by Purchaser or its agents, Supplier shall, at no cost
to Purchaser, and at Purchaser’s election: (a) replace any Product order, or
portion thereof, that is not Acceptable Product within [***] days; or (b) cancel
any order or portion of an order for which non-Acceptable Product was delivered.
    11.4   Disposition of Rejected Product. Supplier shall instruct Purchaser as
to the disposition of any Product order or portion thereof determined not to be
Acceptable Product. At the sole option of Supplier, said Product may be returned
to Supplier, at Supplier’s expense, including shipping costs, or destroyed in an
environmentally acceptable manner, at Supplier’s expense.     11.5   Qualified
Persons Requirements. The costs of services or audits provided by an EMEA
Qualified Person(s) will be borne by Purchaser.

12.   ACCESS TO MANUFACTURING FACILITY AND RECORDS.

  12.1   Inspection b Regulatory Authorities. Upon the request of the MHRA, EMEA
or other Regulatory Authority, such Regulatory Authority shall have access to

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      observe and inspect the Manufacturing Facility and procedures used for the
manufacture, testing, labeling, packaging and/or warehousing of the Product and
to audit such facilities for compliance with GMP and/or other applicable
regulatory standards.     12.2   Notification of Injuries and Inspections.
Supplier shall notify Purchaser within two (2) business days of any written or
oral inquiries, notifications, observations or inspection activity by the MHRA,
EMEA or other Regulatory Authority in regard to any Product. Supplier shall
provide a complete description of any such governmental inquiries,
notifications, inspections or observations promptly after such visit or inquiry.
Supplier shall furnish to Purchaser (a) within two (2) business days after
receipt, any report or correspondence issued by the MHRA, EMEA or other
Regulatory Authority in connection with such visit or inquiry, including, but
not limited to, any EMEA or MHRA observations, that pertain to the Product in
the Member States, and (b) not later than five (5) business days prior to the
time it provides to the MHRA, EMEA or other Regulatory Authority, copies of
proposed responses or explanations relating to items set forth above (each, a
“Proposed Response”), in each case redacted of trade secrets or other
confidential or proprietary information of Supplier that are unrelated to its
obligations under this Agreement or to Product. Supplier shall discuss with
Purchaser and consider in good faith any comments provided by Purchaser on the
Proposed Response. After the filing of a response with the Regulatory Authority,
Supplier shall notify Purchaser and provide Purchaser with copies of any further
contacts with such agency relating to the subject matter of the response.    
12.3   Inspection by Purchaser. Supplier shall permit Purchaser or Purchaser’s
mutually agreed upon designee to inspect once annually that portion of the
Manufacturing Facility where Product is manufactured (including those sections
of the manufacturing, packaging, laboratory and warehousing facilities utilized
in the manufacture, packaging, storage, testing, shipping or receiving of
Products. Such inspections may include Active Ingredients, the work in process
and Products as well as all batch records). Such right shall also include the
right to review such documents as is reasonably necessary for the purpose of
assessing Supplier’s compliance with the Product Specifications and applicable
regulations. Such inspection and document review shall be conducted upon
reasonable prior notice by Purchaser, but not less than thirty (30) days prior
to the proposed inspection, at a time and date mutually agreeable to Supplier
and Purchaser, and shall be coordinated by the Technical Coordinators. Purchaser
shall also have a right to inspect the Manufacturing Facility as set forth in
this Section 12.3 at any time during the Term if (i) Purchaser has reasonable
cause to be concerned with whether the Manufacturing Facility complies with
applicable regulations, or (ii) in the event an audit results in adverse
findings in which case Purchaser shall be

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      entitled to re-audit the Manufacturing Facility, until the adverse
findings are resolved, without reference to the once annual limitation.

13.   REPRESENTATIONS AND WARRANTIES; DISCLAIMERS; LIMITATION OF LIABILITY.

  13.1   Representations and Warranties by Supplier. Supplier hereby represents,
warrants and covenants that:

  (a)   it is a corporation or entity duly organized and validly existing under
the laws of the state of its incorporation;     (b)   the execution, delivery,
and performance of this Agreement by Supplier has been duly authorized by all
requisite corporate action and does not require any shareholder action or
approval,     (c)   it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;     (d)   the execution,
delivery, and performance by Supplier of this Agreement and its compliance with
the provisions of this Agreement does not and shall not conflict with or result
in a breach of any of the terms and provisions of or constitute a default under
(i) any other Agreement to which it is a party; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any order, writ, injunction,
or decree of any court or governmental authority entered against it or by which
any of its property is bound;     (e)   it shall at all times comply with all
applicable material laws and regulations relating to its activities under this
Agreement;     (f)   all Product supplied hereunder conforms to the Product
Specifications and any manufacturing, packaging, labeling or storage
specifications provided by Purchaser to Supplier, has been and shall be
manufactured, packaged, labeled and stored in accordance with the applicable
Regulatory Approvals and GMP, and was not adulterated or misbranded while in
Supplier’s possession or at any time prior to delivery of such Product by
Supplier hereunder.

  13.2   Representations and Warranties by Purchaser. Purchaser hereby
represents, warrants and covenants that:

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

  (a)   it is a corporation or entity duly organized and validly existing under
the laws of the state of its incorporation;     (b)   the execution, delivery,
and performance of this Agreement by Purchaser has been duly authorized by all
requisite corporate action and does not require any shareholder action or
approval;     (c)   it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;     (d)   the execution,
delivery, and performance by Purchaser of this Agreement and its compliance with
the provisions of this Agreement does not and shall not conflict with or result
in a breach of any of the terms and provisions of or constitute a default under
(i) any other Agreement to which it is a party; (ii) the provisions of its
charter or operative documents or bylaws; or (iii) any order, writ, injunction,
or decree of any court or governmental authority entered against it or by which
any of its property is bound; and     (e)   it shall at all times comply with
all applicable material laws and regulations relating to its activities under
this Agreement.

  13.3   Disclaimer of Warranties by Supplier. EXCEPT AS EXPRESSLY SET FORTH IN
THIS AGREEMENT, SUPPLIER HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS, IMPLIED, OR
STATUTORY, WITHRESPECT TO THE PRODUCT AND THE MANUFACTURING FACILITY, INCLUDING,
BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT.     13.4   Disclaimer of
Warranties by Purchaser. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
PURCHASER EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY,
WITH RESPECT TO THE API OR PRODUCT, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND
NONINFRINGEMENT.     13.5   Limitation of Liability. EXCEPT IN CONNECTION WITH A
BREACH BY EITHER PARTY OF ARTICLE 17, THE INDEMNIFICATION OBLIGATION OF SUPPLIER
UNDER SECTION 14.1, AND THE INDEMNIFICATION OBLIGATION OF PURCHASER UNDER
SECTION 14.2, NEITHER SUPPLIER NOR PURCHASER SHALL BE LIABLE FOR ANY SPECIAL,
INDIRECT, CONSEQUENTIAL, EXEMPLARY, OR INCIDENTAL

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DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOSS OF REVENUE, LOSS OF PROFITS,
COST OF REPLACEMENT, OR COMMERCIAL LOSS) ARISING OUT OF OR RELATED TO THIS
AGREEMENT, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY (INCLUDING, WITHOUT
LIMITATION, NEGLIGENCE), EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES.

14.   INDEMNIFICATION.

  14.1   Indemnification by Supplier. Supplier shall indemnify and hold harmless
Purchaser, its Affiliates, and its and their officers, directors, employees, and
agents from and against any and all losses, claims, damages, liabilities,
obligations, penalties, judgments, awards, costs, expenses, and disbursements,
including, without limitation, the costs, expenses, and disbursements, as and
when incurred, of investigating, preparing, or defending any action, suit,
proceeding, or investigation asserted by a Third Party (including, without
limitation, reasonable attorneys’ fees and expenses), caused by, relating to,
based upon, arising out of, or in connection with (a) any failure of Product
supplied hereunder to conform to the Product Specifications; (b) any failure of
Product supplied hereunder to be manufactured in accordance with applicable
Regulatory Approvals and GMP; (c) any adulteration of Product supplied hereunder
while in Supplier’s possession; (d) breach of any of Supplier’s representations,
warranties, or covenants under this Agreement; or (e) Supplier’s willful
misconduct or negligence.     14.2   Indemnification by Purchaser. Purchaser
shall indemnify and hold harmless Supplier and its officers, directors,
employees, and agents from and against any and all losses, claims, damages,
liabilities, obligations, penalties, judgments, awards, costs, expenses, and
disbursements, including, without limitation, the costs, expenses, and
disbursements, as and when incurred, of investigating, preparing, or defending
any action, suit, proceeding, or investigation asserted by a Third Party
(including, without limitation, reasonable attorneys’ fees and expenses), caused
by, relating to, based upon, arising out of, or in connection with (a) breach of
any of Purchaser’s representations, warranties, or covenants under this
Agreement; or (b) Purchaser’s willful misconduct or negligence.     14.3  
Procedure for Indemnification. Each party seeking to be reimbursed, indemnified,
defended, and/or held harmless under Sections 14.1 or 14.2 (each, an
“Indemnitee”) shall (a) provide the party obligated to indemnify such Indemnitee
(the “Indemnitor”) with prompt, written notice of any claim, suit, demand, or
other action for which such Indemnitee seeks to be reimbursed, indemnified,
defended, and/or held harmless (each, a “Claim”), which notice shall include a
reasonable identification of the alleged facts giving rise to such Claim;
(b) grant such party reasonable authority and control over the defense and
settlement of any

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      such Claim; and (c) reasonably cooperate with such party and its agents in
defense of any such Claim, at the Indemnitor’s expense. Each Indemnitee shall
have the right to participate in the defense of any Claim for which Indemnitee
seeks to be reimbursed, indemnified, defended, or held harmless, by using
attorneys of such Indemnitee’s choice, at such Indemnitee’s expense. Any
settlement of a Claim for which any Indemnitee seeks to be reimbursed,
indemnified, defended, and/or held harmless under this Article 14 shall be
subject to the prior written approval of such Indemnitee, which approval shall
not be unreasonably withheld, conditioned, or delayed.

15.   RECALLS.

  15.1   Recall. In the event of an actual or threatened Recall of API or
Product required or recommended by a Regulatory Authority of competent
jurisdiction within the Member States, or if Recall of API or Product is
reasonably deemed advisable by Purchaser in its sole discretion, such Recall
shall be promptly implemented and administered by Purchaser in a manner which is
appropriate and reasonable under the circumstances and in conformity with
accepted trade practices. Supplier shall assist Purchaser as requested by
Purchaser to ensure a timely, accurate, and complete Recall. The costs of any
such Recall shall be borne by the party or parties whose actions or omissions
caused the Recall to be necessary. Supplier shall have no obligation to pay
costs of Recalls of API. Supplier shall have no obligation to pay costs of
Recalls of Product to the extent such recalls are (a) caused by actions of Third
Parties occurring after such Product is sold by Purchaser; (b) due to design
defects in the specifications, packaging or labeling not attributable to
Supplier’s execution of its responsibilities under this Agreement; or (c) due to
any other breach by Purchaser of its duties under this Agreement, unless such
Recall is due to a breach by both Purchaser and Supplier of their duties under
this Agreement.     15.2   Duty to Inform. Each party shall keep the other party
fully and promptly informed of any notification, event, or other information,
whether received directly or indirectly, which might affect the marketability,
safety, or effectiveness of Product or might result in a Recall or Seizure of
API or Product by the MHRA, EMEA or other Regulatory Authority.     15.3  
Recall Due to Supplier Breach. In the event of any Recall or Seizure arising out
of or resulting from Supplier’s breach of this Agreement, Supplier shall, at the
election of Purchaser, either:

  (a)   supply Product, without charge to Purchaser, in an amount sufficient to
replace the amount of Product Recalled or Seized; or

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COMMISSION.]

  (b)   refund to Purchaser, or give credit to Purchaser against outstanding
receivables due from Purchaser, against the price of Product to be delivered to
Purchaser in the future, in amounts equal to the price paid by Purchaser to
Supplier for Product so Recalled or Seized plus the reasonable transportation
costs incurred by Purchaser and not otherwise recovered by Purchaser in respect
of such Recalled or Seized Product.

      Supplier shall also pay to Purchaser Purchaser’s reasonable out-of-pocket
expenses incurred in connection with such Recall or Seizure.     15.4   Recall
Not Due to Supplier Breach. In the event of any Recall or Seizure not arising
out of or resulting from Supplier’s breach of this Agreement, Purchaser shall
pay to Supplier Supplier’s reasonable out-of-pocket expenses incurred in
connection with such Recall or Seizure.

16.   TERM AND TERMINATION.

  16.1   Term and Renewal. This Agreement shall begin on the Effective Date and
shall continue for three (3) years from the date of the first Regulatory
Approval in a Member State for Product manufactured at the Manufacturing
Facility (the “Initial Term”). There after, the Agreement will be automatically
extended for consecutive [***] year terms unless either party notifies the other
party in writing [***] months in advance of its desire not to extend the
Agreement.     16.2   Termination for Breach. Either party may terminate this
Agreement immediately by giving notice to the other party in the event that the
other party commits a breach of any material provision of this Agreement that is
not cured within [***] days after notice thereof by the non-breaching party.    
16.3   Termination for Insolvency. Either party may terminate this Agreement
immediately in the event that the other party becomes the subject of a voluntary
or involuntary proceeding relating to insolvency, receivership, liquidation, or
composition for the benefit of creditors.     16.4   Termination for Failure to
Acquire MHRA or EMEA Approval. Either party may terminate this Agreement if the
MHRA or EMEA has not approved the Product as manufactured in the Manufacturing
Facility by [***]. However, prior to exercising this termination right, if the
Product is still under review by the MHRA or EMEA on [***], the parties will
negotiate in good faith to continue the Agreement.     16.5   Upon Expiration or
Termination.

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COMMISSION.]

  16.5.1   Confidential Information. Upon expiration or termination of this
Agreement, all Confidential Information shall be returned to the disclosing
party or destroyed unless otherwise specified or permitted elsewhere under this
Agreement. The parties may retain one (1) copy of Confidential Information for
archival purposes only.     16.5.2   Materials. Upon expiration or termination
of this Agreement, Supplier shall deliver all Materials purchased by Supplier in
anticipation of manufacture of Product hereunder in accordance with the Rolling
Forecasts, at Purchaser’s expense. Supplier shall submit an invoice to Purchaser
for the reasonable cost of such Materials, and Purchaser shall pay such invoice
within [***] days after the invoice date.     16.5.3   Survival. The following
provisions shall survive termination or expiration of this Agreement: Articles
13-15, this Section 16.5.3, Articles 17-19, any payment obligations of the
parties accruing hereunder prior to the expiration or termination of this
Agreement, and any other provision that is necessary to interpret the respective
rights and obligations of the parties hereunder.

  16.6   Termination at Will. Following the start of the first Annual Period,
Purchaser shall have the right to terminate this Agreement at any time during
the Term for any reason by giving Supplier no less than twenty-four (24) months
prior written Notice.

17.   CONFIDENTIALITY.

  17.1   Confidentiality Obligations. Except as permitted elsewhere under this
Agreement, during the Term and thereafter until the third (3rd) anniversary of
the effective date of termination or expiration of this Agreement, each party
agrees to take Reasonable Steps (as defined in this Section 17.1) (a) to receive
and maintain the Confidential Information of the other party in confidence,
(b) not to disclose such Confidential Information to any third party, and (c) to
promptly notify the disclosing party upon learning of any law, rule, regulation,
or court order that purports to compel disclosure of any Confidential
Information of the disclosing party and to reasonably cooperate with the
disclosing party, at the disclosing party’s expense, in the exercise of the
disclosing party’s right to protect the confidentiality of such Confidential
Information. Neither party hereto shall use all or any part of the Confidential
Information of the other party for any purpose other than to perform its
obligations under this Agreement. The parties shall take Reasonable Steps (as
defined in this Section 17.1) to ensure that their employees, representatives,
and agents comply with this provision, and shall be responsible for any breach
by such employees, representatives, and agents. As used herein,

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      “Reasonable Steps” means at least the same degree of care that the
receiving party uses to protect its own Confidential Information, and in, no
event, no less than reasonable care.     17.2   Exclusions. Nothing contained
herein shall prevent a party from disclosing Confidential Information pursuant
to any applicable law, rule, regulation, or court order; provided, however, that
such party complies with the notice provisions of Section 17.1(c) to the extent
permissible under applicable laws, rules, regulations, or court orders. Such
disclosure shall not alter the status of such information hereunder for all
other purposes as Confidential Information. In addition, nothing contained
herein shall prevent a party from disclosing Confidential Information that:

  (a)   is generally known to the public at the time of disclosure or becomes
generally known through no wrongful act on the part of the Recipient;     (b)  
can be shown by writing to have been in the Recipient’s possession at the time
of disclosure otherwise than as a result of any prior confidential disclosure by
the Disclosing Party or another party or the Recipient’s breach of any legal
obligation;     (c)   becomes known to the Recipient through disclosure by
sources other than the Disclosing Party having no duty of confidentiality with
respect to such Confidential Information, whether to the Disclosing Party or
another party, and having the legal right to disclose such Confidential
Information; or     (d)   is independently developed by the Recipient without
reference to or reliance upon the Confidential Information.

  17.3   Remedies. Each party acknowledges and agrees that the provisions of
this Article 17 are reasonable and necessary to protect the other party’s
interests in its Confidential Information, that any breach of the provisions of
this Article 17 may result in irreparable harm to such other party, and that the
remedy at law for such breach may be inadequate. Accordingly, in the event of
any breach or threatened breach of the provisions of this Article 17 by a party
hereto, the other party, in addition to any other relief available to it under
this Agreement, at law, in equity, or otherwise, shall be entitled to seek
temporary and permanent injunctive relief restraining the breaching party from
engaging in and/or continuing any conduct that would constitute a breach of this
Article 17, without the necessity of proving actual damages or posting a bond or
other security.

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ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

18.   INSURANCE.

  18.1   Each party shall obtain and keep in force during the term of this
Agreement, general comprehensive liability insurance and product liability
insurance covering occurrence of bodily injury and property damage in an amount
of not less than $[***] combined single limit; provided, however, that Supplier
may self-insure for this type of coverage.     18.2   Each party shall carry the
insurance coverage set forth herein during the term of this Agreement and
through the later of [***] years following termination of this Agreement or
[***] following the expiration of the last to expire Product made in accordance
with this Agreement. Each party shall have the right to request from the other
party certificates of insurance and shall require at least thirty (30) days
written notice to such party prior to any cancellation, nonrenewal or reduction
in coverage below the minimum pursuant to Section 18.1.

19.   MISCELLANEOUS

  19.1   Assignment. During the term of this Agreement the rights of either
party under this Agreement shall not be assigned, nor shall the performance of
either party’s duties be delegated without the other party’s prior written
consent, such consent to not be unreasonably withheld, except either party may
assign this agreement to an Affiliate, a purchaser or o licensee of all or
substantially all of such party’s business related to the sales of the Product
in the Member States. Notice of assignment shall be given to other party at
least thirty (30) days prior to the effective date of said assignment.     19.2
  Entire Agreement. This Agreement, together with the referenced schedules,
embodies and shall constitute the entire agreement and understanding of the
parties relating to the subject matter of this Agreement and shall supersede all
prior oral or written agreements, contracts, understandings, representations, or
arrangements, whether oral or written, between them, relating to the subject
matter of this Agreement.     19.3   Modification. No change or addition may be
made to this Agreement or any schedule attached hereto except in writing, signed
by a duly authorized representative of each party, and expressly stating that it
is a modification of this Agreement.     19.4   Notices. All communications
between the parties with respect to any of the provisions of this Agreement
shall be sent to the addresses set forth below, or to such other addresses as
designated by one party to the other party by notice pursuant to this
Section 19.4, by nationally recognized courier or by prepaid certified mail, or
by facsimile transmission or other electronic means of communications, with
confirmation by letter given by the close of business on or

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COMMISSION.]

      before the next following business day. All notices provided hereunder
shall be effective upon receipt.         If to Purchaser, to:

Javelin Pharmaceuticals, Inc.
125 Cambridge Park Drive
Cambridge, MA 02140
Attn: VP - Clinical & Commercial Manufacturing
Tel.: 212-554-4362
Fax: 212-554-4554
with a copy, which copy shall not constitute notice, to:
Javelin Pharmaceuticals, Inc.
125 Cambridge Park Drive
Cambridge, MA 02140
Attn: General Counsel
Tel.: 617-349-4512
Fax: 617-349-4505
If to Supplier, to:
Baxter Healthcare Corporation
2 Esterbrook Lane
Cherry Hill, New Jersey 08003-4099
Attn.: Plant Manager
Tel.: 856-489-2189
Fax: 856-424-8747
with a copy, which copy shall not constitute notice, to:
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
Attn.: General Counsel
Tel.: 847-948-2600
Fax: 847-948-2450

  19.5   Severability. If any provision of this Agreement is held to be void or
unenforceable by a court of competent jurisdiction, such finding(s) shall not be
construed to render any other provision of this Agreement either void or

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      unenforceable, and all other provisions shall remain in full force and
effect. Upon any such determination, the parties shall make such amendments to
this Agreement as necessary to remove the invalid or unenforceable part of any
such provision, but otherwise achieve to the maximum extent permissible, the
economic, legal, and commercial intent and objectives of the original provision.
    19.6   Waiver. Failure or delay by either party in exercising or enforcing
any provision, right, or remedy under this Agreement, or waiver of any remedy
hereunder, in whole or in part, shall not be deemed a waiver thereof, or prevent
the subsequent exercise of that or any other rights or remedy.     19.7   Force
Majeure. Neither Purchaser nor Supplier shall be in breach of this Agreement if
there is any failure of performance under this Agreement occasioned by any act
of God, fire, act of government or state, war, civil commotion, insurrection,
embargo, prevention from or hindrance in obtaining energy or other utilities,
labor disputes of whatever nature, failure by a supplier to supply API, Novel
Excipient or Materials or any other reason beyond the control and without the
fault or negligence of the party affected thereby (a “Force Majeure Event”).
Such excuse shall continue as long as the Force Majeure Event continues. Upon
cessation of such Force Majeure Event, the affected party shall promptly resume
performance hereunder. Each party agrees to give the other party prompt written
notice of the occurrence of any Force Majeure Event, the nature thereof, and the
extent to which the affected party will be unable fully to perform its
obligations hereunder. Each party further agrees to use reasonable efforts to
correct the Force Majeure Event as quickly as possible and to give the other
party prompt written notice when it is again fully able to perform such
obligations. In the event any Force Majeure event prevents Supplier from
supplying Product for a period longer than one hundred twenty (120) days,
Purchaser shall have the right to source the Product from Third Parties or to
appoint another supplier of the Product.     19.8   Headings. The headings and
captions used in this Agreement are solely for the convenience of reference and
shall not affect its interpretation.     19.9   Independent Contractors. The
parties acknowledge, agree and declare that the relationship hereby established
between them is solely that of provider and recipient of manufacturing services
and that each party hereto is an independent contractor with respect to the
other.     19.10   Maintenance of Agreement. Supplier shall keep a copy of this
Agreement and any amendments hereto at the Manufacturing Facility, and at any
other location permitted in accordance with this Agreement where the Product is
packaged or labeled, during the Term and for a period of two (2) years following
the date of

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]

      the final shipment of Product from such facility or location. Supplier
shall make such copy of the Agreement and any amendments hereto available for
inspection at any reasonable hour to any officer or employee of the MHRA or EMEA
who requests such copy in the course of performing his or her duties for the
MHRA or EMEA     19.11   Choice of Law, Jurisdiction. The provisions of this
Agreement shall be governed by and construed in accordance with the laws of the
State of Delaware, without regard to conflict of laws principles. Any and all
disputes between the parties arising out of or related to this Agreement shall
be heard in the state and federal courts located in the State of Delaware, and
the parties hereby consent and submit to the jurisdiction of such courts.    
19.12   Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall constitute together the same document.

          IN WITNESS WHEREOF, the parties hereto, by their authorized officers,
have executed this Agreement as of the Effective Date.

                      JAVELIN PHARMACEUTICALS, INC.       BAXTER HEALTHCARE
CORPORATION    
 
                   
By:
  /s/ Martin Driscoll       By:   /s/ Peter J. Arduini    
 
  Name: Martin Driscoll           Name: Peter J. Arduini    
 
  Title: Chief Executive Officer           Title: Corporate Vice President and  
 
 
                       President, Medication Delivery    

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 1.9
API SPECIFICATIONS
See attached specifications.
To be added by the parties upon filing of the Marketing Authorization
Application with the Regulatory Authorities.

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 1.27
NOVEL EXCIPIENT SPECIFICATIONS
See attached specifications.
To be added by the parties upon filing of the Marketing Authorization
Application with the Regulatory Authorities.

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 1.29
PRODUCT SPECIFICATIONS
[***]

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 1.31
QUALITY (TECHNICAL) AGREEMENT
[***]

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 1.31A
LIST OF CONTACTS
[***]

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 2.1
PACKAGING DEVELOPMENT

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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN
ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
SCHEDULE 10.1
PRICING
[***]

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