EX-10.1






Exhibit 10.1



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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED
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DEVELOPMENT AND TOLL

MANUFACTURING AGREEMENT




between




JAVELIN PHARMACEUTICALS, INC.




and




BAXTER HEALTHCARE CORPORATION




 









 





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




	 	 	 	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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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE 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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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN 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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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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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN 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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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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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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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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SEPARATELY WITH THE SECURITIES AND EXCHANGE 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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SEPARATELY WITH THE SECURITIES AND EXCHANGE 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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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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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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PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE 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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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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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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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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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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SCHEDULE 1.29




PRODUCT SPECIFICATIONS




[***]




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SCHEDULE 1.31




QUALITY (TECHNICAL) AGREEMENT




[***]




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SCHEDULE 1.31A




LIST OF CONTACTS




[***]





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SCHEDULE 2.1




PACKAGING DEVELOPMENT




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SCHEDULE 10.1




PRICING




[***]





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