EX-10.1



 




Exhibit 10.1

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DEVELOPMENT AND TOLL

MANUFACTURING AGREEMENT




between




JAVELIN PHARMACEUTICALS




and




BAXTER HEALTHCARE CORPORATION




 









 




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TABLE OF CONTENTS




	 	 	 	 	 
	1. DEFINITIONS
	 	 	3	 
	 
	 	 	 	 
	2. SUPPLY
	 	 	6	 
	 
	 	 	 	 
	3. SUPPLY OF API
	 	 	8	 
	 
	 	 	 	 
	4. MANUFACTURE
	 	 	9	 
	 
	 	 	 	 
	5. PRODUCT SPECIFICATIONS; CERTIFICATE OF ANALYSIS
	 	 	10	 
	 
	 	 	 	 
	6. LABELING AND PACKAGING
	 	 	10	 
	 
	 	 	 	 
	7. FORECASTS
	 	 	11	 
	 
	 	 	 	 
	8. PURCHASE ORDERS
	 	 	11	 
	 
	 	 	 	 
	9. DELIVERY
	 	 	13	 
	 
	 	 	 	 
	10. PRICE AND PAYMENTS
	 	 	13	 
	 
	 	 	 	 
	11. INSPECTION OF PRODUCT
	 	 	14	 
	 
	 	 	 	 
	12. ACCESS TO MANUFACTURING FACILITY AND RECORDS
	 	 	15	 
	 
	 	 	 	 
	13. REPRESENTATIONS AND WARRANTIES; DISCLAMERS;
	 	 	 	 
	 
	 	 	 	 
	LIMITATION OF LIABILITY
	 	 	16	 
	 
	 	 	 	 
	14. INDEMNIFICATION
	 	 	18	 
	 
	 	 	 	 
	15. RECALLS
	 	 	19	 
	 
	 	 	 	 
	16. TERM AND TERMINATION
	 	 	20	 
	 
	 	 	 	 
	17. CONFIDENTIALITY
	 	 	21	 
	 
	 	 	 	 
	18. INSURANCE
	 	 	23	 
	 
	 	 	 	 
	19. MISCELLANEOUS
	 	 	23	 







 









 







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	SCHEDULE 1.9

	 	API SPECIFICATIONS
	 
	 	 
	SCHEDULE 1.24

	 	NOVEL EXCIPIENT SPECIFICATIONS
	 
	 	 
	SCHEDULE 1.26

	 	PRODUCT SPECIFICATIONS
	 
	 	 
	SCHEDULE 1.28

	 	QUALITY AGREEMENT
	 
	 	 
	SCHEDULE 2.1

	 	DEVELOPMENT PLAN
	 
	 	 
	SCHEDULE 2.2

	 	PRODUCT DEVELOPMENT WORK AND BUDGET
	 
	 	 
	SCHEDULE 10.1

	 	PRICING






 









 





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DEVELOPMENT AND TOLL MANUFACTURING AGREEMENT




     This Development and Toll Manufacturing Agreement (this “Agreement”) is entered into as of
this 25 day of April, 2007 (the “Effective Date”) by and between Javelin Pharmaceuticals, a
Delaware corporation, having its principal place of business at 125 CambridgePark Drive, Cambridge,
MA 02140 (“Purchaser”), and Baxter Healthcare Corporation, a Delaware corporation, having a place
of business at 95 Spring Street, New Providence, NJ 07974 (“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, Purchaser wishes to procure from Supplier, and Supplier wishes to provide certain
product development support and to supply to Purchaser, certain quantities of the Product in vials
on the terms and conditions set forth in this Agreement.



     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	 	“Act” means the United States Food, Drug, and Cosmetic Act, as the same may be
amended from time to time, and rules and regulations promulgated there under.
	 
	 	1.3	 	“Activities” has the meaning assigned thereto in Section 4.3.
	 
	 	1.4	 	“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




 









 










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	 	 	 	directors, but is restricted from electing such majority by contract or otherwise,
until such time as such restrictions are no longer in effect.
	 
	 	1.5	 	“Alternate Presentation” means any injectible pharmaceutical other than
two mL of Product in a two mL vial.
	 
	 	1.6	 	“Alternative Source Period” has the meaning assigned thereto in Section
8.7.
	 
	 	1.7	 	“Annual Period” means a period of twelve (12) calendar months beginning
on the date of the Regulatory Approval by the FDA for the Product, and each 12-month
period thereafter during the Term.
	 
	 	1.8	 	“API” means the active pharmaceutical ingredient diclofenac sodium USP.
	 
	 	1.9	 	“API Specifications” means the specifications for or concerning the
manufacturing, testing, and packaging of bulk API set forth in Schedule 1.9 attached
hereto, as the same may be amended from time to time upon written agreement of the
parties.
	 
	 	1.10	 	“Binding Forecast” has the meaning assigned thereto in Section 7.2.
	 
	 	1.11	 	“Calendar Year” means a period of twelve (12) calendar months,
beginning each January 1 and ending on the subsequent December 31 during the Term.
	 
	 	1.12	 	“Certificate of Analysis” has the meaning assigned thereto in Section
5.2.
	 
	 	1.13	 	“cGMP” means current good manufacturing practice promulgated by the
FDA, including, without limitation, the Act, 21 C.F.R. Parts 210 and 211, and all
applicable FDA rules, regulations, policies and guidelines in effect at a given time.
	 
	 	1.14	 	“Claim” has the meaning assigned thereto in Section 14.3.
	 
	 	1.15	 	“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.
	 
	 	1.16	 	“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




 









 










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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,
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.



1.17 “FDA” means the United States Food and Drug Administration, or any
successor entity.



1.18 “Force Majeure Event” has the meaning assigned thereto in Section 19.7.





1.19 “Indemnitee” has the meaning assigned thereto in Section 14.3.





1.20 “Indemnitor” has the meaning assigned thereto in Section 14.3.



1.21 “Manufacturing Facility” means Supplier’s facility located at 2
Esterbrook Lane, Cherry Hill, New Jersey 08003.



1.22 “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.



1.23 “Novel Excipient” means Kleptose(r) HPB (hydroxypropylbetadex).



1.24 “Novel Excipient Specifications” means the specifications for or
concerning the manufacturing, testing, and packaging of the Novel Excipient set forth
in Schedule 1.24 attached hereto, as the same may be amended from time to time upon
written agreement of the parties.



1.25 “Product” means the pharmaceutical product currently known as
Diclofenac Sodium Injection or Dyloject(r) containing the API.



1.26 “Product Specifications” means the specifications for or concerning the
manufacturing, testing, and packaging of Product set forth in Schedule 1.26




 









 







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	 	 	 	attached hereto, as the same may be amended from time to time upon written agreement
of the parties.
	 
	 	1.27	 	“Proposed Response” has the meaning assigned thereto in Section 12.2.
	 
	 	1.28	 	“Quality Agreement” means the applicable agreement, dated as of the
date hereof, between Supplier and Purchaser, in the form of Schedule 1.28 attached
hereto relating to the Product manufactured at Cherry Hill, New Jersey.
	 
	 	1.29	 	“Reasonable Steps” has the meaning assigned thereto in Section 17.1.
	 
	 	1.30	 	“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.
	 
	 	1.31	 	“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 Territory.
	 
	 	1.32	 	“Regulatory Authority” means any national, supra-national, regional,
state, or local regulatory agency, department, bureau, commission, council, or other
governmental entity in the Territory involved in the granting of Regulatory Approval
for the Product, including, without limitation, the FDA.
	 
	 	1.33	 	“Rolling Forecast” has the meaning assigned thereto in Article 7.
	 
	 	1.34	 	“Seizure” means any action by the FDA to detain or destroy Product or
prevent the distribution, prescription, consumption, or release of Product.
	 
	 	1.35	 	“Technical Coordinator” has the meaning assigned thereto in Section
2.2.1 hereof.
	 
	 	1.36	 	“Term” has the meaning assigned thereto in Section 16.1.
	 
	 	1.37	 	“Territory” means the United States and its commonwealths and
territories (including, without limitation, Puerto Rico).
	 
	 	1.38	 	“Third Party” means any person or entity other than Supplier,
Purchaser, and their respective Affiliates.
	 
	 	1.39	 	“Unit” means each two mL vial.





 









 




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2. BAXTER OBLIGATIONS FOR DEVELOPMENT AND SUPPLY.





	 	2.1	 	Process or Development Tasks. Supplier shall provide Purchaser with a
timeline, milestones and FDA submission documentation that support internal product and
process development tasks described in the development plan set forth in Schedule 2.1
(“Development Plan”). Purchaser and Supplier will agree upon those tasks that each will
perform and the associated timelines. Supplier will develop price estimates for each
major milestone. Purchaser will provide purchase orders to cover Supplier’s pricing for
each major milestone.
	 
	 	2.2	 	Development Work and Budget. Supplier shall perform the development
and scale-up work described in the Development Plan (“Product Development Work”).
Purchaser shall make payments to Supplier for its performance of the Product
Development Work in accordance with the budget and payment schedule (the “Budget”)
established with respect to the Product Development Work, as described in the
Development Plan within [***] days of the later to occur of (i) completion of the
relevant portion of the Product Development 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.
	 
	 	2.4.1	 	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.
	 
	 	2.4.2	 	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 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, cGMPs, and all other
applicable regulatory requirements.




 









 










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	 	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 Territories. 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 outside the Territory.





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 it 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	 	Testing of API and Novel Excipient. Supplier shall test API and Novel
Excipient, in accordance with the procedures identified in Schedules 1.9 and 1.26 to
verify that the API meets the API Specifications and that the Novel Excipient meets
the Novel Excipient Specifications.
	 
	 	3.3	 	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 API 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






 









 








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	 	 	 	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.
	 
	 	3.4	 	Audit of API, Novel Excipient and Material suppliers. Supplier shall
conduct routine audits, at Supplier’s expense, of all suppliers of API, Novel
Excipient and Materials, as required to comply with the provisions of the Act. Major
findings will be remediated or alternate suppliers will be identified by Purchaser and
will be qualified at Purchaser’s expense. Any additional non-routine audits will be
conducted by Supplier at Purchaser’s expense.
	 
	 	3.5	 	Change Controls. Supplier shall require that API supplier, Novel
Excipient supplier and suppliers of Materials will 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. Purchaser shall cooperate with Supplier in addressing
the failure, and if it cannot be remedied, in identifying and qualifying an alternate
supplier. Such qualification shall be at Purchaser’s expense.





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) cGMP
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




 









 










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	 	 	 	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
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 FDA,
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
FDA 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 federal,
state, and local statutory and regulatory 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.
	 
	 	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. At Purchaser’s expense, ([***] per page)
Supplier shall also provide Purchaser with a copy of the manufacturing and controls
information for the applicable batch(es) delivered.




 









 










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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 cGMPs. Prior to
the Effective Date, Purchaser supplied Supplier with labeling for the Product {including the
NDC 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 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 January 1, April 1, July 1, and October 1
during the Term after Purchaser receives Regulatory Approval for the Product from the
FDA, 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.
	 
	 	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.




 








 










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	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,
specifying the quantity of Product desired (in full lots of Product), 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:




Baxter Healthcare Corporation

2 Esterbrook Lane

Cherry Hill, New Jersey 08003

Attn.: Lawrence Katz

Tel.: 856-489-2243

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 from the FDA, 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 [***].




 








 










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	 	8.5	 	Pre-Approval Manufacturing. Purchaser may, at its own financial risk,
place purchase orders for commercial launch quantities prior to Purchaser’s final FDA
drug approval, subject to Supplier’s acceptance of such order, which acceptance shall
not be unreasonably withheld or delayed. Such pre-approval purchase orders shall have
a delivery date at least [***] days from the date of the purchase order. Product will
not ship from the Supplier’s manufacturing site or Supplier’s distribution centers
until a copy of the final FDA drag approval letter is delivered to the Supplier.
Payment for pre-approval purchase orders actually manufactured and fulfilled by
Supplier will become due [***] days after the scheduled delivery date, whether or not
Regulatory Approval from the FDA has been received.
	 
	 	8.6	 	Conflict. In the event of any conflict between the provisions of this
Agreement and any purchase order, the provisions of this Agreement shall control.
	 
	 	8.7	 	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 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 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




 









 










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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.]





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.




	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 annually, beginning on [***] and each [***] 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 12-
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 receipt of the Product covered by such invoice, 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 be due and
payable within [***] days after the determination with respect to such Product is made
in accordance with Section 11.2 hereof.




 









 










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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.]





	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 cGMP
(“Acceptable Product”), and, if performed, shall do so within [***] days from the date
of delivery of such Product to the designated carrier (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 FDA regulations for re-testing 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.






	12.	 	ACCESS TO MANUFACTURING FACILITY AND RECORDS.






	 	12.1	 	Inspection by Regulatory Authorities. Upon the request of the FDA or
other Regulatory Authority, such Regulatory Authority shall have access to 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 cGMP and/or other applicable regulatory standards.




 









 










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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.]





	 	12.2	 	Notification of Inquiries and Inspections. Supplier shall notify
Purchaser within two (2) business days of any written or oral inquiries,
notifications, or inspection activity by the FDA or other regulatory agency in regard
to any Product. Supplier shall provide a complete description of any such governmental
inquiries, notifications or inspections 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 FDA or other governmental agency in connection with
such visit or inquiry, including, but not limited to, any FDA Form 483 (list of
Inspectional Observations) or applicable portions of any FDA Warning Letters that
pertain to the Product in the Territory, and (b) not later than five (5) business days
prior to the time it provides to the FDA or other regulatory agency, 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 FDA or other regulatory agency, 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
designee to inspect once annually that portion of the Manufacturing Facility where
Product is manufactured and 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 Purchaser has reasonable cause to be concerned with whether
the Manufacturing Facility complies with applicable regulations.






	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;




 









 










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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.]





	 	(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 cGMP, and was not adulterated or misbranded while in
Supplier’s possession or at any time prior to delivery of such Product by
Supplier hereunder; and
	 
	 	(g)	 	it has not and shall not use in any capacity the services of
any persons debarred or convicted under 21 U.S.C. § 335(a) or 335(b) in
connection with the manufacture of the Product,






	 	13.2	 	Representations and Warranties by Purchaser. Purchaser 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
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;




 









 










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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.]





	 	(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 arty 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, WITH RESPECT 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
NON-INFRINGEMENT.
	 
	 	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 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.




 









 










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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.]





	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 cGMP; (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 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




 









 










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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.]





	 	 	 	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 governmental agency or authority of competent
jurisdiction within the Territory, or if Recall of API or Product is reasonably deemed
advisable by Purchaser, or jointly deemed advisable by Purchaser and Supplier, 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 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 FDA.
	 
	 	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
	 
	 	(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.




 









 










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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]





	 	 	 	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 final FDA drug approval letter
for the Product (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 FDA Approval. Either party may
terminate this Agreement if the FDA has not approved the Product by [***]. However,
prior to exercising this termination right, if the Product is still under review by
the FDA on [***], the parties will negotiate in good faith to continue the Agreement.
	 
	 	16.5	 	Upon Expiration or Termination.
	 
	 	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.




 









 










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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.]





	 	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.






	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, “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:




 









 










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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]





	 	(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.






	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




 









 










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	 	 	 	thirty (30) days written notice to such party prior to any cancellation, nonrenewal
or material change in coverage.






	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 or a purchaser of all or substantially all of such party’s business.
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 supercede 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 before the next following
business day. All notices provided hereunder shall be effective upon receipt.




If to Purchaser, to:



Javelin Pharmaceuticals

125 CambridgePark Drive

Cambridge, MA 02140

Attn: VP — Clinical & Commercial Manufacturing

Tel: 212-554-4362

Fax: 212-554-4554




 









 







[*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.]



with a copy, which copy shall not constitute notice, to:



Javelin Pharmaceuticals

125 CambridgePark 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.: Managing Director

Tel: 856-489-2100

Fax: 856-424-8747



with a copy, which copy shall not constitute notice, to:



Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, II 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
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




 









 










[*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.]





	 	 	 	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 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 FDA who requests such copy in the course of
performing his or her duties for the FDA.
	 
	 	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.




 









 










[*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.]





	 	19.12	 	Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall constitute together the same document.





[SIGNATURE PAGE FOLLOWS]




 









 





[*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.]




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



	 	 	 	 	 	 	 
	JAVELIN PHARMACEUTICALS	 	BAXTER HEALTHCARE CORPORATION
	 
	 	 	 	 	 	 
	By:

	 	/s/ Daniel B. Carr	 	By:	 	/s/ Daniel Tasse 
	 

	 	 
	 	 	 	 
	Name:

	 	Daniel B. Carr, M.D. 	 	Name:	 	Daniel Tasse
	 

	 	 
	 	 	 	 
	Title:

	 	CEO/CMD 	 	Title:	 	GM-BPT 
	 

	 	 
	 	 	 	 






 









 




[*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 completion of the Regulatory Services work under Schedule 2.2.




 









 




[*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 1.24




NOVEL EXCIPIENT SPECIFICATIONS



See attached specifications.



To be added by the Parties upon completion of the Regulatory Services work under Schedule 2.2.




 









 




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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.]




SCHEDULE 1.26




PRODUCT 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.]




SCHEDULE 1.28




QUALITY AGREEMENT




[***]




 









 




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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.]




SCHEDULE 2.1




DEVELOPMENT PLAN




[***]




 









 




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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.]




SCHEDULE 2.2




PRODUCT DEVELOPMENT WORK AND BUDGET*




[***]




 









 




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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.]




SCHEDULE 10.1




PRICING




[***]