Document:

Exhibit 10.14

 

EXHIBIT 10.14

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.

 

 

 

CLINICAL SUPPLY AGREEMENT

between

LAWRENCE LABORATORIES

and

CADENCE PHARMACEUTICALS, INC.

dated as of February 21, 2006

 

 

 

 

TABLE OF CONTENTS

	 	 	 	 	 	 	 
	 	 	 	 	Page
	 
	 	 	 	 	 	 
	ARTICLE 1

	 
	 	 	 	 	 	 
	DEFINITIONS

	 
	 	 	 	 	 	 
	1.1

	 	Defined Terms
	 	 	2	 
	 
	 	 	 	 	 	 
	ARTICLE 2

	 
	 	 	 	 	 	 
	SUPPLY OF CLINICAL TESTING PRODUCTS

	 
	 	 	 	 	 	 
	2.1

	 	Supply and Purchase
	 	 	5	 
	2.2

	 	Purchase Price of Clinical Testing Products
	 	 	6	 
	2.3

	 	Limitation to Clinical Use
	 	 	6	 
	 
	 	 	 	 	 	 
	ARTICLE 3

	 
	 	 	 	 	 	 
	TERMS AND CONDITIONS OF PURCHASE AND SALE

	 
	 	 	 	 	 	 
	3.1

	 	Forecasts
	 	 	6	 
	3.2

	 	Ordering
	 	 	7	 
	3.3

	 	Shipping Document
	 	 	7	 
	3.4

	 	Delivery, Title, and Shipping
	 	 	7	 
	3.5

	 	Invoicing and Payment
	 	 	9	 
	3.6

	 	Inspection; Non-Conforming Product
	 	 	9	 
	3.7

	 	Obsolescence Charge
	 	 	10	 
	3.8

	 	Quality Control
	 	 	11	 
	3.9

	 	Change of Supplier or Facility
	 	 	11	 
	3.10

	 	Recalls
	 	 	11	 
	3.11

	 	Representations, Warranties and Covenants
	 	 	12	 
	3.12

	 	Force Majeure
	 	 	13	 
	 
	 	 	 	 	 	 
	ARTICLE 4

	 
	 	 	 	 	 	 
	REGULATORY MATTERS

	 
	 	 	 	 	 	 
	4.1

	 	Record Retention
	 	 	13	 
	5.2

	 	Regulatory Matters
	 	 	13	 
	 
	 	 	 	 	 	 
	ARTICLE 5

	 
	 	 	 	 	 	 
	CONFIDENTIALITY

	 
	 	 	 	 	 	 
	5.1

	 	Confidentiality
	 	 	14	 

-i-

 

	 	 	 	 	 	 	 
	 	 	 	 	Page
	ARTICLE 6

	 
	 	 	 	 	 	 
	INDEMNIFICATION

	 
	 	 	 	 	 	 
	6.1

	 	By BMS
	 	 	14	 
	6.2

	 	By Cadence
	 	 	14	 
	6.3

	 	Conditions to Indemnification
	 	 	15	 
	6.4

	 	Limitation of Liability
	 	 	15	 
	 
	 	 	 	 	 	 
	ARTICLE 7

	 
	 	 	 	 	 	 
	DISPUTE RESOLUTION

	 
	 	 	 	 	 	 
	7.1

	 	Arbitration
	 	 	16	 
	 
	 	 	 	 	 	 
	ARTICLE 8

	 
	 	 	 	 	 	 
	TERM; TERMINATION

	 
	 	 	 	 	 	 
	8.1

	 	Term; Termination
	 	 	17	 
	8.2

	 	Consequences of Termination
	 	 	17	 
	 
	 	 	 	 	 	 
	ARTICLE 9

	 
	 	 	 	 	 	 
	MISCELLANEOUS

	 
	 	 	 	 	 	 
	9.1

	 	Notices
	 	 	17	 
	9.2

	 	Governing Law
	 	 	18	 
	9.3

	 	Equitable Relief
	 	 	19	 
	9.4

	 	Headings
	 	 	19	 
	9.5

	 	No Third Party Beneficiaries
	 	 	19	 
	9.6

	 	Severability
	 	 	19	 
	9.7

	 	Assignment and Subcontracting
	 	 	19	 
	9.8

	 	Consents
	 	 	20	 
	9.9

	 	Entire Agreement
	 	 	20	 
	9.10

	 	Exhibits
	 	 	20	 
	9.11

	 	Waivers and Amendments
	 	 	20	 
	9.12

	 	No Partnership or Joint Venture
	 	 	20	 
	9.13

	 	Absence of Presumption
	 	 	21	 
	9.14

	 	Counterparts; Facsimile Execution
	 	 	21	 
	9.15

	 	Guarantee
	 	 	21	 

-ii-

 

EXHIBITS

	 	 	 
	Exhibit A:

	 	Specifications
	Exhibit B:

	 	Initial Forecast
	Exhibit C:

	 	Quality Agreement

-iii-

 

INDEX OF DEFINED TERMS

	 	 	 	 	 
	Term	 	Section Where Defined

	 
	$ 

	 	1.1
	Affiliate

	 	1.1
	Agreement

	 	Introductory Paragraph

	Applicable Law

	 	1.1
	BMS

	 	Introductory Paragraph

	BMS Party

	 	6.2
	Business Day

	 	1.1
	Cadence

	 	Introductory Paragraph

	Cadence Party

	 	6.1
	cGMP

	 	1.1
	Claim

	 	1.1
	Clinical Testing Product

	 	1.1
	Clinical Use

	 	1.1
	Confidential Information

	 	1.1
	Control

	 	1.1
	Controlled

	 	1.1
	Controlling

	 	1.1
	Demand

	 	7.1
	Dispute

	 	7.1
	Dollar

	 	1.1
	Drug Regulatory Authority

	 	1.1
	Effective Date

	 	Introductory Paragraph

	EMEA

	 	1.1
	Execution Date

	 	Introductory Paragraph

	Facility

	 	3.9
	FDA

	 	1.1
	FDCA

	 	1.1
	Firm Order

	 	3.2(a)
	Force Majeure

	 	1.1
	Forecast

	 	3.1
	Indemnified Party

	 	6.3
	Indemnifying Party

	 	6.3
	IV APAP Agreement

	 	Recitals

	NDA

	 	1.1
	Parent

	 	Introductory Paragraph

	Parenteral Acetaminophen Product

	 	1.1
	Parties

	 	Introductory Paragraph

	Party

	 	Introductory Paragraph

	Person

	 	1.1
	Pharmatop License Agreement

	 	Recitals

	Placebo

	 	1.1
	Quality Agreement

	 	3.8
	Regulatory Approval

	 	1.1
	Specifications

	 	1.1
	Supply Price

	 	2.2
	Supply Term

	 	1.1
	Technology

	 	1.1
	Territory

	 	1.1
	Third Party

	 	1.1

-iv-

 

CLINICAL SUPPLY AGREEMENT

          This Clinical Supply Agreement (the “Agreement”) is entered into as of February 21,
2006 (the “Execution Date”) by and among Lawrence Laboratories, an indirect wholly-owned
subsidiary of Parent (as defined below) and a corporation organized under the laws of Ireland with
its registered office at Unit 12, Distribution Centre, Shannon Industrial Estate, Shannon, County
Clare, Ireland (“BMS” ), Cadence Pharmaceuticals, Inc., a Delaware corporation having an
address at 12730 High Bluff Drive, San Diego, California 92130 (“Cadence” ), and, solely
for the purposes of Section 9.15 hereof, Bristol-Myers Squibb Company, a Delaware corporation
having an address at 345 Park Avenue, New York, New York 10154 (“Parent”) and is effective
as of March 29, 2006 (the “Effective Date” ). BMS and Cadence are sometimes collectively
referred to herein collectively as the “Parties” and each individually as a
“Party.”

RECITALS

          WHEREAS, Cadence holds certain license rights in intellectual property relating to Parenteral
Acetaminophen Products (as defined below) in the United States and Canada pursuant to that certain
IV APAP Agreement dated February 21, 2006, between Parent and Cadence (the “IV APAP
Agreement”), which sublicenses to Cadence certain intellectual property rights with respect to
the United States and Canada under that certain License Agreement dated December 23, 2002 between
SCR Pharmatop, a civil law partnership organized under the laws of France, having its head office’s
address at 10, Square St. Florentin, 78150 Le Chesnay, France, recorded with the Register of
Commerce and Companies of Versailles under No. 407552702, and Parent (the “Pharmatop License
Agreement” ) and licenses to Cadence certain rights to use patents and know-how of Parent in
the same jurisdictions;

          WHEREAS, BMS has arrangements for one of its Affiliates located in Italy to manufacture
Clinical Testing Products (as defined below) for supply to Cadence pursuant to this Agreement;

          WHEREAS, BMS or its Affiliate holds certain license rights in intellectual property relating
to Parenteral Acetaminophen Products (as defined below) in Italy entitling BMS or its Affiliate to
use such intellectual property to manufacture Parenteral Acetaminophen Products in Italy for supply
to Cadence pursuant to this Agreement;

          WHEREAS, BMS or its Affiliates have expertise in manufacturing Parenteral Acetaminophen
Products for use in clinical trials and related Placebos (as defined below); and

          WHEREAS, Cadence desires to purchase, and BMS desires to supply from its Affiliate’s facility
in Italy (or such other facility as BMS may determine in accordance with this Agreement), Cadence’s
requirements for the Clinical Testing Products for use in clinical trials in support of applications for Regulatory Approvals (as defined below) for Parenteral
Acetaminophen Products in the Territory.

 

2

AGREEMENT

          THEREFORE, the Parties, intending to be legally bound, agree as follows:

ARTICLE 1

DEFINITIONS

     1.1 Defined Terms. As used in this Agreement, the following terms shall have the
following meanings:

          “Affiliate” of a Party means any corporation, firm, partnership or other entity
that directly or indirectly Controls, is Controlled by or is under common Control with such
Party.

          “Agreement” has the meaning set forth in the Introductory Paragraph.

          “Applicable Law” means any applicable federal, state, local or foreign statute,
law, ordinance, rule or regulation, judicial order or industry standard imposed by
regulation or law, including without limitation the laws of, and regulations promulgated
under, the FDCA or the Canadian equivalent of the FDCA.

          “BMS” has the meaning set forth in the Introductory Paragraph.

          “BMS Party” has the meaning set forth in Section 6.2.

          “Business Day” means any day other than a Saturday, a Sunday or a United States
Federal, EU, Irish or Italian holiday.

          “Cadence” has the meaning set forth in the Introductory Paragraph.

          “Cadence Party” has the meaning set forth in Section 6.1.

          “cGMP” means all current good manufacturing practices under 21 C.F.R. 210, as
amended from time to time or any successor regulation.

          “Claim” means any claim (including without limitation, product liability
claims, strict liability or tort claims and intellectual property infringement claims),
action, suit, governmental investigation or other proceedings made or brought by or on
behalf of a Third Party against any Cadence Party or any BMS Party, as the case may be,
including without limitation enforcement actions by the FDA or other
applicable Drug Regulatory Authorities and claims for infringement of intellectual
property and for bodily injury, death or property damage.

 

3

          “Clinical Testing Product” means any Parenteral Acetaminophen Products and any
related Placebo used in clinical trials to support Regulatory Approval in the Territory of
any such Parenteral Acetaminophen Product.

          “Clinical Use” means the non-commercial use of any Clinical Testing Product in
clinical trials or otherwise, in each case solely to support Regulatory Approval of any
Parenteral Acetaminophen Product in the Territory.

          “Confidential Information” has the meaning set forth in the IV APAP Agreement.

          “Control” means (a) with respect to Technology or technical information, the
possession by a Party of the ability to grant a license or sublicense of such Technology or
technical information as provided herein without violating the terms of, or requiring a
consent under, any agreement or arrangement between such Party and any Third Party and (b)
when used with respect to any Person means the power to direct the management and policies
of such Person, directly or indirectly, whether through the ownership of voting securities,
by contract, or otherwise. “Controlled” and “Controlling” shall have
correlative meanings.

          “Demand” has the meaning set forth in Section 7.1.

          “Dispute” has the meaning set forth in Section 7.1.

          “Dollar” or “$” means United States dollars, the lawful currency of the
United States.

          “Drug Regulatory Authority” means any governmental authority or instrumentality
with responsibility for granting any licenses, approvals, authorizations (e.g., NDAs) or
granting pricing and/or reimbursement approvals necessary for the marketing and sale of
pharmaceutical products in any regulatory jurisdiction.

          “Effective Date” has the meaning set forth in the Introductory Paragraph.

          “EMEA” means the European Agency for the Evaluation of Medicinal Products, or
any successor agency.

          “Execution Date” has the meaning set forth in the Introductory Paragraph.

          “Facility” has the meaning set forth in Section 3.9.

          “FDA” means the United States Food and Drug Administration or any successor
agency.

          “FDCA” means the Federal Food, Drug & Cosmetics Act, 21 U.S.C. 321 et seq., any
amendments or supplements thereto, or any regulations promulgated or adopted
thereunder.

 

4

          “Firm Order” has the meaning set forth in Section 3.2(a).

          “Force Majeure” means any circumstances that are not within the reasonable
control of the Person affected thereby, including without limitation an act of God,
terrorist attack, war, insurrection, riot, strike or labor dispute, shortage of materials,
fire, explosion, flood, government requisition or allocation, breakdown of or damage to
plant, equipment or facilities (to the extent that, in the event of a breakdown only, such
plant, equipment or facilities were reasonably maintained), interruption or delay in
transportation, fuel supplies or electrical power, embargo, boycott, order or act of civil
or military authority.

          “Forecast” has the meaning set forth in Section 3.1.

          “Indemnified Party” has the meaning set forth in Section 6.3.

          “Indemnifying Party” has the meaning set forth in Section 6.3.

          “IV APAP Agreement” has the meaning set forth in the Recitals.

          “NDA” means a new drug application or an abbreviated new drug application,
including any amendments or supplements thereto, filed with the FDA pursuant to the FDCA or
any comparable filing with any Drug Regulatory Authority in Canada and includes any Common
Technical Document for the Registration of Pharmaceuticals for Human Use filed with the FDA
or any other Drug Regulatory Authority in the Territory.

          “Parent” has the meaning set forth in the Introductory Paragraph.

          “Parenteral Acetaminophen Product” means the currently validated parenterally
administered dosage form of paracetamol: APAP for injection [***] as more particularly set
forth in the Specifications.

          “Parties” has the meaning set forth in the Introductory Paragraph.

          “Party” has the meaning set forth in the Introductory Paragraph.

          “Person” means any individual, firm, corporation, partnership, limited
liability company, trust, joint venture, governmental authority or other entity.

          “Pharmatop License Agreement” has the meaning set forth in the Recitals.

          “Placebo” means the currently validated placebo to be used for clinical trials
of Parenteral Acetaminophen Products: Placebo APAP for injection [***] as more particularly
set forth in the Specifications.

          “Quality Agreement” has the meaning set forth in Section 3.8.

 

			
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          “Regulatory Approval” means with respect to any Parenteral Acetaminophen
Products in any regulatory jurisdiction in the Territory, approval from the applicable Drug
Regulatory Authority sufficient to market and sell such Parenteral Acetaminophen Products in
such jurisdiction.

          “Specifications” means with respect to Parenteral Acetaminophen Products and
Placebo the specifications set forth on Exhibit A.

          “Supply Price” has the meaning set forth in Section 2.2.

          “Supply Term” means the period beginning on the Effective Date and terminating
on the earlier of (i) the date Cadence receives Regulatory Approval from any Drug Regulatory
Authority in any jurisdiction in the Territory; or (ii) the close of business on December
31, 2008.

          “Technology” means and includes all inventions, discoveries, improvements,
trade secrets, know-how, processes, procedures, research records, records of inventions,
test information, formulae, drawings, specifications, instructions, techniques, data, market
surveys and other similar proprietary methods, materials or property, whether or not
patentable, relating to Parenteral Acetaminophen Products and/or the Placebo, including but
not limited to (a) samples of, methods of production or use of, and structural and
functional information pertaining to, chemical compounds, proteins or other biological
substances, (b) data, formulations, techniques and know-how, and (c) rights under patents,
patent applications, and copyrights.

          “Territory” means the United States (including Puerto Rico and all U.S.
possessions and territories) and Canada.

          “Third Party” means a Person who or which is neither a Party nor an Affiliate
of a Party.

ARTICLE 2

SUPPLY OF CLINICAL TESTING PRODUCTS

     2.1 Supply and Purchase. (a) During the Supply Term and upon the terms and
conditions set forth in this Agreement, BMS shall, or shall cause its Affiliates to, manufacture,
or cause the manufacture of, and supply to Cadence Clinical Testing Products for Clinical Use,
ordered pursuant to Firm Orders hereunder, subject to variations permitted by Section 3.2. Cadence
shall purchase from BMS and its Affiliates all of the Clinical Testing Products ordered by Cadence
pursuant to Firm Orders hereunder. BMS and its Affiliates shall not have any obligation to supply
Clinical Testing Products for commercial sale, and following the expiration of the Supply Term, BMS
and its Affiliates shall not have any obligation to supply Clinical Testing Products hereunder,
except that if BMS does not timely deliver at the designated port of departure in accordance with Section 3.4 any Clinical Testing
Products it is obligated to supply hereunder or if any portion of such Clinical Testing Products is
properly rejected in accordance

 

6

with Section 3.6, BMS’s obligation to supply such quantity of Clinical Testing Products shall
remain in effect until conforming Clinical Testing Products are placed at the disposal of Cadence’s
carrier at the designated port of departure in accordance with this Agreement. BMS’s obligation to
manufacture, supply and deliver the Clinical Testing Products is conditioned on the execution and
delivery of the Quality Agreement contemplated by Section 3.8 not less than four (4) months prior
to the scheduled date for placement of the Clinical Testing Products at the disposal of Cadence’s
carrier, and BMS shall have no obligation to accept any Firm Order that calls for the delivery of
any Clinical Testing Product following the end of the Supply Term. BMS shall not be obligated to
supply more than [***] each of Parenteral Acetaminophen Products or Placebo over the term of this
Agreement.

     (b) The Clinical Testing Products shall be in finished dosage forms (in vials in bulk without
commercial or clinical labeling) as specified in the Specifications. Cadence shall be responsible
for labeling the Clinical Testing Products for Clinical Use.

     (c) So that BMS shall be aware of the date of the expiration of the Supply Term, Cadence shall
(i) keep BMS informed as to the expected date of any Regulatory Approval with respect to Parenteral
Acetaminophen Products in the Territory, (ii) notify BMS within three (3) Business Days after
Cadence receives written notice of any such Regulatory Approval and (iii) promptly notify BMS of
any determination by Cadence to permanently cease all Clinical Use of the Parenteral Acetaminophen
Products in the Territory.

     2.2 Purchase Price of Clinical Testing Products. The purchase price to be paid by
Cadence for Clinical Testing Products (the “Supply Price”) shall be $[***] for the
Parenteral Acetaminophen Products and $[***] for the Placebo, in each case as such prices are
adjusted as provided below. Such purchase prices shall be adjusted (i) as of the first day of each
calendar year to reflect any increase during the [***] period ending on November 30 of the
preceding calendar year in the [***] as published by Eurostat or any successor agency that assumes
responsibility for the preparation and publication of such index and (ii) from time to time to
reflect any increase exceeding [***] percent ([***]%) in the aggregate in the cost of raw materials
or supplies.

     2.3 Limitation to Clinical Use. Neither Cadence nor any of its Affiliates shall (i)
label or relabel (or cause to be labeled or relabeled) any of the Clinical Testing Products for
commercial sale or for any use or purpose other than Clinical Use, (ii) sell to any Third Party any
Clinical Testing Products supplied hereunder or (iii) use any Clinical Testing Products for any
purpose other than Clinical Use.

ARTICLE 3

TERMS AND CONDITIONS OF PURCHASE AND SALE

     3.1 Forecasts. Attached as Exhibit B is Cadence’s initial non-binding
forecast of its requirements for each Parenteral Acetaminophen Product and Placebo for Clinical Use
that Cadence expects to order for delivery during the [***] ([***]) [***] following the anticipated

 

			
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7

Effective Date. Prior to the first day of each calendar quarter during the Supply Term, Cadence
shall deliver to BMS an updated non-binding forecast setting forth its requirements for each
Parenteral Acetaminophen Product and Placebo for Clinical Use that Cadence expects to order for
delivery during the [***] ([***]) month period beginning on the first day of such calendar quarter.
Each such forecast is referred to herein as, a “Forecast”.

     3.2 Ordering. (a) Cadence shall submit to BMS a written irrevocable firm purchase
order for all Clinical Testing Products to be purchased by it not later than [***] ([***]) [***]
prior to the requested shipping date of such Clinical Testing Products (each, a “Firm
Order”). Each such Firm Order shall include the quantity of each Clinical Testing Product and
the desired time and manner of shipment and the shipping destination. Any Firm Order for any
Clinical Testing Product must be for a quantity equal to the minimum batch size for such Clinical
Testing Product as in effect from time to time or an integral multiple thereof. The minimum batch
size in effect as of the date of this Agreement is [***] of Parenteral Acetaminophen Product and
[***] of Placebo. The Parties agree that the actual number of vials successfully manufactured by
BMS for any batch of the Clinical Testing Products may be within a range of plus or minus [***]
percent (+/-[***]%) of the minimum batch size or of the actual number of vials ordered by Cadence
pursuant to a Firm Order. The number of vials of Clinical Testing Products supplied by BMS pursuant
to a Firm Order may vary from the amount actually ordered by Cadence within such limits, and BMS
may ship to Cadence, and Cadence shall purchase, such greater or lesser number of vials in full
satisfaction of such Firm Order, provided that Cadence shall only be required to purchase
such number of vials actually supplied to Cadence. BMS shall provide to Cadence no less than [***]
([***]) [***] prior written notice of any change in the minimum batch size. BMS shall not be
obligated to fill more than one order for, or to make more than one delivery of, Placebo. If
Cadence has submitted to BMS, and BMS has accepted, a Firm Order prior to the Effective Date, the
fulfillment of such Firm Order by BMS shall be subject to the execution of the Quality Agreement,
and BMS shall not be obligated to place any Clinical Testing Products at the disposal of Cadence’s
carrier prior to the expiration of [***] ([***]) [***] after the execution of the Quality
Agreement.

     (b) No terms and conditions contained in any purchase order, acknowledgment, invoice, bill of
lading, acceptance or other preprinted form issued by either Party shall be effective to the extent
they are inconsistent with or modify the terms and conditions contained herein.

     3.3 Shipping Document. Each shipment of Clinical Testing Products shall include a
certificate of analysis and a packing slip that describes the Clinical Testing Products, the date
of manufacture, traceable lot or batch number(s), quantities, shipment date and destination and
such additional information as the Parties may agree in writing from time to time.

     3.4 Delivery, Title, and Shipping. (a) Delivery of Clinical Testing Products shall
be [***] the designated port of departure (Incoterms 2000) in Italy, which port of departure
(maritime or air) shall be specified by Cadence. BMS shall arrange for shipping and insurance in the manner customarily arranged for
its own products from the point of manufacture to the port of departure and shall arrange for
Italian export clearances, but Cadence shall bear the cost of such shipping and insurance, any
special packing expenses and export or customs agents, all of

 

			
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8

which shall be included in BMS’s invoice and paid by Cadence in accordance with Section 3.5.
Cadence shall arrange for loading, shipment, insurance from the port of departure to the ultimate
destination and import customs clearances at the destination country, and Cadence shall be
responsible for all loading charges, freight, insurance, import customs clearances and other
shipping expenses from such port of departure to the ultimate destination. Title to the Clinical
Testing Products and risk of loss, delay or damage in transit for Clinical Testing Products
purchased by Cadence shall pass to Cadence when the Clinical Testing Products are placed at the
disposal of Cadence’s carrier at the port of departure. Cadence shall cause its carrier to inspect
all Clinical Testing Products for physical damage prior to shipment, and Cadence shall promptly
notify BMS of any such physical damage. Cadence shall bear the cost of all such pre-shipment
inspection. BMS and its Affiliates shall not have any responsibility for any loss or damage to any
Clinical Testing Products after BMS or its export or customs agent places the Clinical Testing
Products at the disposal of Cadence’s carrier, nor shall any loss or damage to any Clinical Testing
Products following such placement at the disposal of Cadence’s carrier obviate Cadence’s obligation
to purchase and pay for such Clinical Testing Products. Without limiting BMS’s right to recover
the full invoiced amount for the Clinical Testing Products and as partial security therefor,
Cadence shall cause each shipment of Clinical Testing Products to be insured for the full invoiced
amount of each shipment. Cadence shall provide to BMS proof, satisfactory to BMS, of such
insurance.

     The ultimate destination country of each shipment hereunder shall be in the Territory. In the
event Cadence desires to use any of the Clinical Testing Products for clinical trials in the
Clinical Study Countries (as defined in the IV APAP Agreement) in accordance with Section 3.6 of
the IV APAP Agreement, Cadence shall ship such Clinical Testing Products to the Territory and
Cadence shall be solely responsible for shipping such Clinical Testing Products for the Territory
to an appropriate destination in the applicable Clinical Study Country.

     (b) BMS shall place the Clinical Testing Products at the disposal of Cadence’s carrier at port
of departure (maritime or air) for shipment to Cadence or its designee, appropriately labeled with
a traceable lot or batch number and packaged for shipping in the standard commercial packaging
materials customarily used by BMS not later than the later of (i) [***] ([***]) [***] following the
receipt of Cadence’s Firm Order or (ii) the shipping date requested by Cadence in its Firm Order.
If Cadence requests a shipping date that is less than [***] ([***]) [***] after the delivery to BMS
of the applicable Firm Order, BMS shall use reasonable commercial efforts to meet such earlier
delivery date, but BMS shall not be in breach of this Agreement for failing to meet such earlier
delivery date. If BMS or its Affiliate is unable to place any shipment at the disposal of
Cadence’s carrier by the date described in the first sentence of this paragraph, in addition to any
other remedies available to Cadence pursuant to this Agreement, BMS shall provide Cadence with
updated delivery information (including estimated delivery date(s)) in writing on a weekly basis
until such shipment has been made available to Cadence’s carrier.[***](c) Cadence shall make
arrangements with a carrier to pick up each shipment of Clinical Testing Products at the designated
port of departure (maritime or air) and to transport such shipment of Clinical Testing Products to
Cadence or its designee. Cadence shall notify BMS in advance in writing of the name of the carrier
and shall provide such other information as may be necessary for BMS to place the Clinical Testing Products at the disposal
of such carrier

 

			
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9

at the port of departure. Cadence shall have sole responsibility for the import of the Clinical
Testing Products into the Territory and for obtaining all import and import-related customs permits
and clearances.[***](d) In the event of any shortage of supply of Clinical Testing Products due to
Force Majeure, BMS shall allocate its available supply of Clinical Testing Products between it and
its Affiliates, its and its Affiliates’ other customers and Cadence on a pro rata basis based on
the aggregate back orders of Clinical Testing Products, which allocation shall be determined by BMS
in good faith.

     3.5 Invoicing and Payment. (a) BMS shall invoice Cadence for the Clinical Testing
Products in Dollars at the time of shipment. Each invoice shall include the invoice number, the
Firm Order number (if any), unit price and total price of the Clinical Testing Products contained
in the shipment.

     (b) Cadence shall pay BMS within [***] ([***]) [***] after the receipt of any invoice. All
payments to be made hereunder to BMS shall be made in Dollars by wire transfer of immediately
available funds to such bank account as may be designated by BMS in writing from time to time,
unless the Parties agree to settle such payments through other means. In the event Cadence
disputes any invoice, Cadence shall pay any undisputed amount as and when due hereunder and shall
pay the additional amount, if any, owed with respect to such invoice not later than [***] ([***]
[***] following the resolution of such dispute, together with interest from the original due date
of such invoice at the rate specified in Section 3.5(c).

     (c) Any payment not made as and when due shall bear interest at the rate of [***] percent
([***]%) per annum, compounded daily, from the due date to the date of payment. In addition to but
without limiting the preceding sentence, BMS shall have the right to suspend future shipments of
Clinical Testing Products to Cadence if BMS does not receive payment within [***] ([***]) [***]
after the date of any invoice, other than invoices subject to a bona fide dispute. BMS shall
resume shipments of Clinical Testing Products upon receiving such late payment and, if requested by
BMS, reasonable assurances as to payment of future invoices.

     3.6 Inspection; Non-Conforming Product. (a) Cadence shall promptly inspect or cause
to be inspected all shipments of Clinical Testing Products hereunder and shall test, or cause to be
tested, all Clinical Testing Products received by it or its designee within [***] ([***]) [***]
after receipt of such shipment at the shipping destination. Within [***] ([***]) [***]s after
receipt by Cadence of any shipment of Clinical Testing Products, Cadence may reject any lot or
portion thereof that failed to conform to the Specifications or the terms of this Agreement at the
time BMS placed the Clinical Testing Products at the disposal of Cadence’s carrier by sending BMS
notice of the lot or batch numbers of the rejected Clinical Testing Products, together with an
indication of the specific basis for rejection and a sample of the rejected goods. Notwithstanding
the foregoing, if the discovery of the non-conformity of any Clinical Testing Product could not
reasonably have been discovered until after such [***] ([***]) [***] period, Cadence shall notify
BMS of such non-conformity promptly (and in any event not less than [***] ([***]) [***]) following
the discovery thereof. Cadence shall not be entitled to reject any shipment or any portion thereof
on account of damage incurred following the time that BMS

 

			
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placed the Clinical Testing Products at the disposal of Cadence’s carrier, and Cadence’s sole
remedy shall be against the carrier or under any applicable insurance. BMS shall have the right to
examine and test any Clinical Testing Product that Cadence claims to be non-conforming. If it is
determined that there is any such failure to conform to Specifications at the time that BMS placed
the Clinical Testing Products at the disposal of Cadence’s carrier, BMS and Cadence shall cooperate
to determine the cause of the non-conformity.

     (b) In the event that BMS and Cadence do not resolve such issue within [***] ([***]) Business
Days after BMS notifies Cadence that BMS disagrees with Cadence’s belief as to the non-conformity
of any Clinical Testing Product at the time that BMS places the Clinical Testing Products at the
disposal of Cadence’s carrier, such Parties shall submit a sample of the disputed Clinical Testing
Product to an independent laboratory, mutually selected by the Parties, for testing, and the
results of such testing shall be binding upon the Parties, absent manifest error. The Party whose
assertion as to the conformity or nonconformity of the Clinical Testing Product in question is not
supported by the results of the testing of the independent laboratory shall bear all costs and
expenses of such testing. If the results of such testing by such independent laboratory are
inconclusive, then (i) all costs and expenses of such testing shall be borne by the Parties in
equal shares and (ii) the Parties shall share the Supply Price of such Clinical Testing Products
and the freight, insurance and other shipping expenses, fees, duties, taxes and levies incurred by
the Parties in connection therewith, and Cadence shall pay to BMS one-half of such Supply Price and
other items within [***] ([***]) [***] after the receipt of such inconclusive results; and (iii)
BMS shall promptly replace any such Clinical Testing Products and deliver FCA in accordance with
Section 3.4 replacement conforming Clinical Testing Products (even if such replacement entails
shipping Clinical Testing Products subsequent to the Supply Term), which shall be purchased and
paid for by Cadence in accordance with Article 2 and Section 3.5 of this Agreement.

     (c) Cadence shall, as requested by BMS in its sole discretion: (i) return promptly to BMS at
BMS’s expense all properly rejected Clinical Testing Products or (ii) destroy such non-conforming
Clinical Testing Products in accordance with FDA guidelines or send such non-conforming Clinical
Testing Products to a destruction facility of BMS’s choice for destruction at BMS’s expense.
Cadence shall not be required to pay BMS for any Clinical Testing Product that has been properly
rejected, and BMS shall reimburse or credit Cadence for the freight, insurance and other shipping
expenses, fees, duties, taxes and levies for any shipment of Clinical Testing Products that is
properly rejected. BMS shall promptly replace any properly rejected Clinical Testing Products and
supply to Cadence conforming Clinical Testing Products (even if such replacement entails shipping
Clinical Testing Products subsequent to the Supply Term). Cadence shall pay the Supply Price and
all shipping costs (which shall include the cost of returning the Clinical Testing Products to BMS
and reshipping such Clinical Testing Products to Cadence or its designee) for any Clinical Testing
Products improperly rejected.

     3.7 Obsolescence Charge. To the extent that BMS purchases inventories of raw
materials, components or other supplies to meet Cadence’s Forecast, Cadence shall reimburse BMS for
any such inventories that were purchased but unused and cannot reasonably be used by BMS.

 

			
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     3.8 Quality Control. Not later than [***] ([***]) [***] after the Execution Date, BMS
(and/or one of its Affiliates) and Cadence shall enter into a quality agreement (the “Quality
Agreement”) containing quality terms consistent with Applicable Law and such other terms as are
mutually satisfactory to the Parties and not inconsistent with this Agreement. When the Quality
Agreement is finalized and executed, a copy of the definitive Quality Agreement shall be attached
hereto as Exhibit C to this Agreement. In the event of any conflict between the terms of
this Agreement and the Quality Agreement, the terms of the Quality Agreement shall control.

     3.9 Change of Supplier or Facility. BMS may in its sole discretion upon [***] ([***])
[***] written notice to Cadence change the manufacturing facility used in the manufacturing of the
Clinical Testing Products (the “Facility” ).

     3.10 Recalls. Each Party shall notify the other by telephone within [***] ([***])
[***] after receiving any information, request or directive giving rise to a good faith belief that
a recall of any Clinical Testing Product is required under Applicable Law or is otherwise necessary
to avoid risk of injury or liability. In the event that a Drug Regulatory Authority in the
Territory issues or requests a recall or takes similar action in connection with the Clinical
Testing Products, or in the event that either Party in good faith, believes that a recall is
required under Applicable Law or is otherwise necessary to avoid risk of injury or liability, it
may initiate a recall by providing written notice thereof to the other Party specifying in
reasonable detail, the nature of the recall and the affected products. Within [***] ([***])
Business Days following such written notification (or sooner if exigent circumstances exist or
otherwise are required in order to comply with Applicable Law), the Parties shall discuss the
circumstances giving rise to such notification and the content of such notification, and, if so
required, the timing and breadth of the recall, the customers to which the recall shall extend, the
strategies and notifications to be used, and other related issues. BMS and Cadence each shall
maintain such traceability records as are sufficient and as may be necessary to permit a recall,
product withdrawal or field correction of any Clinical Testing Product. Each Party shall provide
full cooperation and assistance to the other Party in connection with any recall as may be
reasonably requested by the other Party. In the event that the Parties cannot agree on any such
decision regarding the manner of a recall and such recall relates solely to a failure of BMS and
its Affiliates to manufacture the Clinical Testing Product in accordance with Applicable Law or the
Specifications, the issue shall be resolved by BMS in good faith. In the event that the Parties
cannot agree on any such decision regarding the manner of a recall and such recall relates to a
matter other than a failure of BMS and its Affiliates to manufacture the Clinical Testing Product
in accordance with Applicable Law or the Specifications, the issue shall be resolved by Cadence in
good faith. Cadence shall be responsible for collecting and shipping any recalled Clinical Testing
Product to a location determined by BMS. BMS shall be responsible for disposing of any recalled
Clinical Testing Product in accordance with Applicable Law. The costs of the recall (including all
costs of collecting, shipping and disposing of the recalled Clinical Testing Product) shall be
borne by Cadence, except that such costs shall be borne by BMS to the extent it results from a
breach of any of BMS’s representations, warranties or covenants under this Agreement.

 

			
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     3.11 Representations, Warranties and Covenants.

     (a) BMS represents, warrants and covenants that the Clinical Testing Products when delivered
FCA at the designated port of departure (Incoterms 2000) in accordance with Section 3.4 shall (i)
conform to the Specifications; (ii) be manufactured, packaged, tested, stored and handled by it and
its Affiliates in compliance with the Specifications, the Quality Agreement, cGMP and any
Applicable Laws; and (iii) at the time of that BMS places the Clinical Testing Products at the
disposal of Cadence’s carrier, not be adulterated or misbranded within the meaning of the FDCA.
Notwithstanding the foregoing, BMS does not represent, warrant or covenant against any Clinical
Testing Product becoming adulterated or misbranded within the meaning of the FDCA or ceasing to
conform to the Specifications as a result of an act or omission or damage caused by Cadence or any
Third Party (including any carrier of Cadence) after placement of the Clinical Testing Products at
the disposal of Cadence’s carrier pursuant to Section 3.4. BMS represents, warrants and covenants
that BMS or its Affiliate shall transfer to Cadence good and marketable title to the Clinical
Testing Products free from any and all liens, mortgages or encumbrances of any kind created by BMS
and its Affiliates and its and their suppliers and creditors.

     (b) BMS represents, warrants and covenants that it and its Affiliates hold and will continue
to hold during the Supply Term sufficient rights in all manufacturing processes and Technology
necessary for the manufacture and supply of the Clinical Testing Products.

     (c) BMS represents, warrants and covenants that as of the date hereof it has not received
written notice of any pending or threatened Claim that would interfere with BMS’s performance under
this Agreement or that materially and adversely affects the rights and interests of Cadence
hereunder.

     (d) Each Party represents, warrants and covenants that the execution and delivery of this
Agreement and the performance of its obligations hereunder: (i) has been authorized to enter into
this Agreement by all necessary corporate action on the part of it and its shareholders, (ii) does
not conflict with or violate any requirement of Applicable Law or any of its charter documents and
(iii) does not conflict with, violate or breach or constitute a default or require any consent
(which has not been obtained) under, any contractual obligation, license or court or administrative
order by which it is bound.

     (e) EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION 3.11, NEITHER BMS NOR ANY OF ITS AFFILIATES
MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, STATUTORY OR
OTHERWISE WITH RESPECT TO THE CLINICAL TESTING PRODUCTS (WHETHER USED ALONE OR IN COMBINATION WITH
OTHER SUBSTANCES) OR ANY MANUFACTURING PROCESS USED TO MANUFACTURE ANY CLINICAL TESTING PRODUCTS,
INCLUDING WITHOUT LIMITATION (i) ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE; (ii) ANY IMPLIED WARRANTIES ARISING FROM COURSE OF PERFORMANCE, COURSE OF
DEALING OR USAGE IN THE TRADE; (iii) ANY WARRANTIES OF DESIGN OR DESCRIPTION OR ANY WARRANTY OTHERWISE
CREATED BY ANY AFFIRMATION OF FACT OR

 

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PROMISE OR SAMPLE OR MODEL; AND ALL SUCH REPRESENTATIONS AND WARRANTIES WHETHER IN CONTRACT,
WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARE HEREBY DISCLAIMED.

     3.12 Force Majeure. No Party shall be considered to be in breach of, nor shall any
Party be liable for any failure to perform its obligations under, this Agreement (other than
obligations to make payments of money) by reason of Force Majeure. A Party affected by Force
Majeure shall give the other Party prompt notice of any interruption of performance on account of
Force Majeure, and of the resumption of such performance, and shall keep the other Party informed
on a current basis as to the steps being taken to remove, and the anticipated time of removal of,
the circumstances resulting in such Force Majeure. The time for performance of any obligation
hereunder that is affected by Force Majeure shall be extended by the actual time of delay caused by
such Force Majeure, provided that the Party affected by such Force Majeure uses commercially
reasonable efforts to mitigate any such delay. Notwithstanding the foregoing, nothing in this
Section 3.12 shall excuse or suspend the obligation to make any payment due under this Agreement in
the manner and at the time provided herein.

ARTICLE 4

REGULATORY MATTERS

     4.1 Record Retention. Any books and records relating to the receipt, manufacture,
storage, handling or testing of any Clinical Testing Product shall be maintained under this
Agreement by a Party or its Affiliates in accordance with Applicable Law.

     4.2 Regulatory Matters. At all times during the Term, BMS shall maintain the
production facility, equipment and processes (including, without limitation, the process used in
producing the Clinical Testing Products and in performing BMS’s other obligations under this
Agreement in compliance with all Applicable Laws (including, without limitation, cGMP, the FDA and,
to the extent applicable, the EMEA guidelines, employment and labor law requirements, electrical,
fire and safety at work codes and regulations and guidelines issued by any applicable Drug
Regulatory Authorities in the Territory. BMS shall make available for inspection, upon the request
of Cadence, all documentation relating to such compliance. Upon reasonable prior notice and
subject to BMS’s customary rules and restrictions with respect to site visits by non-BMS personnel,
BMS shall permit representatives of Cadence to conduct inspections at all Facilities utilized by
BMS and its Affiliates hereunder, pursuant to the Quality Agreement, to confirm such compliance;
provided that such inspections may not be made more than once in any twelve-month period (not
including Cadence’s initial visit to the Facility, to be made prior to February 28, 2006) and each
such inspection shall be limited to no more than [***] ([***]) [***]; provided,
further, that if material corrective measure are necessary, Cadence may conduct an
additional inspection to verify the implementation of such corrective measures, which additional
inspection shall be limited to [***] ([***]) [***]. BMS shall promptly provide to Cadence copies
of all material communications received from and sent to any Drug Regulatory Authority which relate solely to
the Clinical Testing Products and which is reasonably likely to cause BMS to be unable to make
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Agreement. BMS shall consult with Cadence regarding its response to any such communication
from a Drug Regulatory Authority. Cadence understands and agrees that any inspection, other than
inspections to verify corrective measures, will be charged against the time allocated for tech
transfer pursuant to Section 2.12 of the IV APAP Agreement. Cadence’s initial preparatory tour of
BMS’s Facility, which shall take place prior to February 28, 2006, and shall last not more than one
(1) Business Day, shall not be charged against such time allocated for tech transfer and shall not
be counted as Cadence’s annual visit.

ARTICLE 5

CONFIDENTIALITY

     5.1 Confidentiality. Any Confidential Information of the Parties exchanged hereunder
shall be governed by, and shall be maintained in confidence pursuant to, the confidentiality
provisions set forth in Section 5.2 and Section 5.3 of the IV APAP Agreement.

ARTICLE 6

INDEMNIFICATION

     6.1 By BMS. BMS shall indemnify, defend and hold harmless Cadence, its Affiliates and
its and their employees, subcontractors, agents, officers and directors (each a “Cadence
Party” ) from and against all losses, liabilities, damages, fees (including, until such time as
BMS assumes control of a given Claim, reasonable attorneys’ fees and costs of litigation pertaining
to such Claim), and expenses paid or payable by a Cadence Party to a Third Party that result from
or arise out of any Claim against a Cadence Party to the extent such Claim or any losses,
liabilities, damages or fees, cost and expenses in connection therewith is alleged to be or is in
fact caused by, or is alleged to or in fact arises from or is based on the breach of any warranty
of BMS contained in Section 3.11 or any material breach of BMS’s covenants contained elsewhere in
this Agreement; provided, however, that BMS shall not be obligated to indemnify a
Cadence Party under this Agreement for any losses, liabilities, damages, fees or expenses incurred
by such Cadence Party to the extent attributable to (i) any breach of this Agreement or the Quality
Agreement by Cadence or a Cadence Party or (ii) negligence, gross negligence or willful misconduct
on the part of Cadence or a Cadence Party.

     6.2 By Cadence. Cadence shall indemnify, defend and hold harmless BMS, its Affiliates
and its and their employees, subcontractors, agents, officers and directors (each, a “BMS
Party”), from and against all losses, liabilities, damages, fees (including, until such time as
Cadence assumes control of a given Claim, reasonable attorneys’ fees and costs of litigation pertaining to such Claim), and
expenses paid or payable by a BMS Party to a Third Party that result from or arise out of any Claim
against a BMS Party to the extent such Claim or any losses, liabilities, damages or fees, cost and
expenses in connection therewith is alleged to be or is in fact caused by, or is alleged to or in
fact arises from or is based on (i) infringement of a Third Party’s intellectual property in
connection with the use or sale of the Clinical Testing Products or

 

 

15

(ii) any handling, storage, consumption, administration, injection, infusion, ingestion or other
use or misuse of or exposure to the Clinical Testing Products after the placement thereof at the
disposal of Cadence’s carrier at the designated port of departure, except to the extent that the
Claim or any losses, liabilities, damages or fees, cost and expenses in connection therewith
results from or arises out of (A) a failure of the Clinical Testing Products to conform to the
Specifications when placed at the disposal of Cadence’s carrier in accordance with Section 3.4; (B)
any breach of this Agreement or the Quality Agreement by BMS; (C) the negligence, gross negligence
or willful misconduct on the part of BMS; or (D) any other matter for which BMS is expressly
obligated to indemnify Cadence pursuant to Section 6.1. Cadence shall be solely responsible for
any handling, storage, consumption, administration, injection, infusion, ingestion or other use or
misuse of or exposure to, the Clinical Testing Products after placement at the disposal of
Cadence’s carrier, except as provided in the immediately preceding sentence.

     6.3 Conditions to Indemnification. A Party seeking indemnification under this Article
6 (the “Indemnified Party”) shall give prompt notice of the Claim to the other Party (the
“Indemnifying Party”) and, provided that the Indemnifying Party is not contesting the
indemnity obligation, shall permit the Indemnifying Party to control and assume the defense of any
litigation relating to such Claim and disposition of any such Claim unless the Indemnifying Party
is also a party (or likely to be named a party) to the proceeding in which such Claim is made and
the Indemnified Party gives notice to the Indemnifying Party that it may have defenses to such
Claim or proceeding that are in conflict with the interests of the Indemnifying Party, in which
case the Indemnifying Party shall not be so entitled to assume the defense of the case. If the
Indemnifying Party does assume the defense of any Claim or proceeding, it (i) shall act diligently
and in good faith with respect to all matters relating to the settlement or disposition of any
Claim as the settlement or disposition relates to Parties being indemnified under this Article 6,
(ii) shall cause such defense to be conducted by counsel reasonably acceptable to the Indemnified
Party, or (iii) shall not settle or otherwise resolve any Claim without prior notice to the
Indemnified Party and the consent of the Indemnified Party (which consent shall not be unreasonably
withheld, conditioned or delayed) if such settlement involves anything other than the payment of
money by the Indemnifying Party. The Indemnified Party shall cooperate with the Indemnifying Party
in its defense of any Claim for which the Indemnifying Party has assumed the defense in accordance
with this Section 6.3, and shall have the right (at its own expense) to be present in person or
through counsel at all legal proceedings giving rise to the right of indemnification.

     6.4 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES
OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY FOR, NOR SHALL ANY INDEMNIFIED PARTY HAVE THE RIGHT
TO RECOVER, ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES (INCLUDING LOST
PROFITS OR DAMAGES FOR LOST OPPORTUNITIES), WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT
LIABILITY OR OTHERWISE (WHETHER IN ANY CLAIM FOR INDEMNIFICATION PURSUANT TO THIS ARTICLE 6 OR
OTHERWISE), ARISING (x) OUT OF THE MANUFACTURE, USE OR SALE OF ANY CLINICAL TESTING PRODUCT SOLD
HEREUNDER OR (y) OUT OF ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT OR (z) ANY REPRESENTATION OR
WARRANTY CONTAINED IN OR MADE PURSUANT TO THIS AGREEMENT, EXCEPT THAT SUCH LIMITATION SHALL

 

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NOT APPLY TO PUNITIVE OR CONSEQUENTIAL DAMAGES PAID OR PAYABLE TO A THIRD PARTY BY AN INDEMNIFIED PARTY
FOR WHICH THE INDEMNIFIED PARTY IS ENTITLED TO INDEMNIFICATION HEREUNDER.

ARTICLE 7

DISPUTE RESOLUTION

     7.1 Arbitration. Except as otherwise provided in this Agreement, any dispute,
difference or question arising between the Parties or any of their Affiliates or Indemnified
Parties in connection with this Agreement or the Quality Agreement, the formation, interpretation,
construction thereof or the rights, duties or liabilities of any Party or any of its Affiliates (a
“Dispute”) shall be resolved by binding arbitration in accordance with this Section 7.1.
Any Party or any such Affiliate or Indemnified Party may require resolution of any such Dispute by
arbitration hereunder by sending a written notice to the other Party demanding arbitration of the
Dispute (the “Demand”). In that event, the Dispute shall be finally resolved by
arbitration in accordance with the United States Arbitration Act and the Commercial Arbitration
Rules of the American Arbitration Association. The venue for the arbitration shall be New York,
New York. The arbitration shall be conducted in the English language before a panel of three (3)
arbitrators. Each Party shall name one arbitrator, and the two so named shall name the third
arbitrator, who shall act as chairman. If the two party arbitrators cannot agree on a third
arbitrator within thirty (30) days after the Demand, then at the request of either Party the
President of the Association of the Bar of the City of New York shall appoint the third arbitrator.
The arbitrators shall promptly meet, fix the time, date and place of the hearing and notify the
Parties. All documents, exhibits, testimony or other information that is not in the English
language shall be translated into the English language at the expense of the Party proffering the
evidence requiring translation. The decision of the arbitrators may (depending on the equities of
the case) include an award of legal fees, costs of arbitration and interest. The panel of
arbitrators shall promptly transmit an executed copy of its decision to the Parties. The decision
of the arbitrators shall be final, binding and conclusive upon the Parties. Judgment on the award
rendered by the arbitrators may be entered in any court having jurisdiction thereof. Each Party
retains the right to seek from a court any interim or provisional relief that may be necessary to
protect the rights or property of that Party as permitted by Section 9.3 hereof pending the
establishment of the arbitrators’ determination of the merits of the controversy, and any such
action shall not be deemed incompatible with this Agreement to arbitrate or a waiver of the right
to arbitration. The obligations of the Parties under this Section are specifically enforceable and
shall survive any termination of this Agreement. Unless the decision of the arbitrators provides
otherwise, the Parties shall bear their own costs in preparing for the arbitration and the costs of
the arbitrators shall be equally divided between the Parties.

 

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ARTICLE 8

TERM; TERMINATION

     8.1 Term; Termination. (a) This Agreement shall commence on the Effective Date and
shall continue for the Supply Term and until BMS has supplied in accordance with this Agreement all
the Clinical Testing Products ordered by Cadence pursuant to Firm Orders prior to the end of the
Supply Term that BMS is obligated to supply under this Agreement unless earlier terminated as
provided below. This Agreement shall terminate upon the occurrence of any of the following events:

     (i) the written consent of each of BMS and Cadence to terminate this Agreement;

     (ii) Cadence’s permanent cessation of the Clinical Use of the Parenteral Acetaminophen
Products in the Territory;

     (iii) the termination of the IV APAP Agreement; or

     (iv) the dissolution or termination of Cadence, other than in connection with or
following an assignment of this Agreement in accordance with Section 9.7.

          (b) Either Party may, by written notice to the other Party, terminate this Agreement in the
event of a material breach of this Agreement by the other Party, which remains uncured by such
other Party for a period of sixty (60) days.

     8.2 Consequences of Termination. Termination of this Agreement pursuant to this
Article 8 shall be without prejudice to any rights which shall have accrued to the benefit of any
Party prior to such termination. Such termination shall not relieve any Party from its obligations
which are expressly indicated to survive the termination of this Agreement. All of the Parties’
rights and obligations under the immediately proceeding sentence and under Sections 2.3, 3.6, 3.7,
3.10, 3.11 and 8.2 and Articles 4, 5, 6, 7and 9 hereof shall survive such termination for the
applicable period. In the event of the termination or expiration of this Agreement (other than for
an uncured material breach by BMS), Cadence will reimburse BMS and its Affiliates for the cost of
any inventory of Placebos or the inventory of raw materials and supplies purchased by BMS for
producing the Placebos to the extent (i) BMS or its Affiliates reasonably acquired and held such
inventory consistent with Cadence’s Forecasts, (ii) BMS and its Affiliate that holds such
inventory is unable reasonably to utilize such inventory for other customers or for itself or any
other BMS Affiliate and (iii) BMS delivers such inventory to Cadence.

ARTICLE 9

MISCELLANEOUS

     9.1 Notices. All notices, consents, requests, demands and other communications
required or permitted under this Agreement: (a) shall be in writing in the English language;

 

18

(b) shall be sent by messenger, a reliable express delivery service or facsimile (with a copy sent by
one of the foregoing means), charges prepaid as applicable, to the appropriate address(es) or
number(s) set forth below; and (c) shall be deemed to have been given on the date of receipt by the
addressee (or, if the date of receipt is not a Business Day, on the first Business Day after the
date of receipt), as evidenced by (i) a receipt executed by the addressee (or a responsible person
in his or her office), the records of the Person delivering such communication or a notice to the
effect that such addressee refused to claim or accept such communication, if sent by messenger or
express delivery service, or (ii) a receipt generated by the sender’s fax machine showing that such
communication was sent to the appropriate number on a specified date, if sent by facsimile. All
such communications shall be sent to the following addresses or numbers, or to such other addresses
or numbers as any Party may inform the others by giving five Business Days’ prior notice:

	 	 	 
	If to Cadence:
	 	With a copy to:
	 
	 	 
	Cadence Pharmaceuticals, Inc.
	 	Cadence Pharmaceuticals, Inc.
	12730 High Bluff Drive, Suite 410
	 	12730 High Bluff Drive, Suite 410
	San Diego, CA 92130
	 	San Diego, CA  92130
	Attn: President & CEO
	 	Attn:  VP of Business Development
	Fax No.: (858) 436-1401
	 	Fax No.:  (858) 436-1401
	 
	 	 
	If to BMS:
	 	With a copy to:
	 
	 	 
	Lawrence Laboratories
	 	Bristol-Myers Squibb Company
	Unit 12 Distribution Centre
	 	1 Squibb Drive
	Shannon Industrial Estate
	 	New Brunswick, NJ
	County Clare
	 	Attn:  Senior Counsel Technical Operations
	Ireland
	 	Fax No.:  732-227-3874
	Attn: General Manager
	 	 
	Fax No.: 011-35-3-61-47-1396
	 	 
	 
	 	 
	If to Parent:
	 	With a copy to:
	 
	 	 
	Bristol-Myers Squibb Company
	 	Bristol-Myers Squibb Company
	1 Squibb Drive
	 	1 Squibb Drive
	New Brunswick, NJ
	 	New Brunswick, NJ
	Attn: Director, Contract Manufacturing
	 	Attn:  Senior Counsel Technical Operations
	Fax No.: 732-227-3960
	 	Fax No.:  732-227-3874

     9.2 Governing Law. This Agreement is a contract under the laws of the State of New
York and for all purposes shall be governed by, and construed and enforced in accordance with, the
laws of said State, without giving effect to any conflict of law rules.

 

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     9.3 Equitable Relief. The Parties acknowledge and agree that each would be
irreparably damaged in the event that any provision of this Agreement is not performed by the other
in accordance with its specific terms or is otherwise breached. Accordingly, it is agreed that
each Party is entitled to an injunction or injunctions to prevent breaches of this Agreement by the
other and shall have the right to specifically enforce this Agreement and the terms and provisions
hereof against the other without the posting of any bond or other security, in addition to any
other remedy to which such aggrieved Party may be entitled at law or in equity; provided,
however, that the powers of the arbitrators under Section 7.1 shall be limited to enforcing
the obligations provided for in this Agreement as drafted.

     9.4 Headings. All titles or captions contained in this Agreement are for convenience
of reference only and shall not limit or affect in any way the meaning or interpretation of this
Agreement.

     9.5 No Third Party Beneficiaries. This Agreement shall be binding upon, and inure
solely to the benefit of, the Parties and their permitted assigns, and nothing herein, express or
implied, is intended to, or shall confer upon, any other Person any legal or equitable right,
benefit or remedy of any nature whatsoever.

     9.6 Severability. If any term or other provision of this Agreement is held to be
invalid, illegal or incapable of being enforced by any Applicable Law or public policy, all other
terms and provisions of this Agreement shall nevertheless remain in full force and effect so long
as the economic or legal substance of the transactions contemplated hereby is not affected in any
manner materially adverse to any Party. Upon such determination that any term or other provision
is invalid, illegal or incapable of being enforced, the Parties shall negotiate in good faith to
modify this Agreement so as to effect the original intent of the Parties as closely as possible in
an acceptable manner in order that the transactions contemplated hereby are consummated as
originally contemplated to the greatest extent possible.

     9.7 Assignment and Subcontracting. (a) Except as set forth below in this Section 9.7
neither this Agreement, nor any right, interest or obligation hereunder, may be assigned, pledged
or otherwise transferred by any Party, whether by operation of law or otherwise, without the prior
consent of the other Party, except that BMS may assign any of its rights or delegate any of its
obligations hereunder to any of its Affiliates, provided, that BMS shall provide Cadence
with written notice of any such assignment or delegation. Cadence acknowledges that BMS will
delegate the manufacturing of the Clinical Testing Products to its Affiliate, Bristol-Myers Squibb
S.R.L., in Italy and that delegation to such Affiliate shall not require any further notice to
Cadence.

     (b) Either Party may assign or transfer all of its rights and obligations hereunder without
the prior consent of the other Party to a successor in interest by reason of merger,
consolidation or sale of substantially all of the assets of the assigning Party (and so long
as such assignment or transfer includes, without limitation, all Approvals, all manufacturing
assets relating to the IV APAP Agreement, and all rights and obligations under the IV APAP
Agreement); provided, that such successor in interest shall have agreed prior to such
assignment or transfer to be bound by the terms of this Agreement in a writing provided to the
other Party.

 

20

     (c) BMS may subcontract any or all of its obligations under this Agreement to a Third Party,
with the prior written consent of Cadence, which shall not be unreasonably withheld, delayed, or
conditioned.

     (d) Not withstanding anything to the contrary herein, any assignment, delegation or
subcontracting by a Party of any of its rights or obligations under this Agreement shall not
relieve such Party from any of its obligations hereunder.

     (e) Any assignment or transfer in violation of the foregoing shall be null and void and wholly
invalid, the assignee or transferee in any such assignment or transfer shall acquire no rights
whatsoever, and the non-assigning non-transferring Party shall not be required to recognize, such
assignment or transfer.

     (f) Subject to the foregoing, this Agreement shall inure to the benefit of and be binding on
the Parties’ successors and permitted assigns.

     9.8 Consents. Any consent or approval to any act or matter required under this
Agreement shall be in writing and shall apply only with respect to the particular act or matter to
which such consent or approval is given, and shall not relieve any Party from the obligation to
obtain the consent or approval, as applicable, wherever required under this Agreement to any other
act or matter.

     9.9 Entire Agreement. This Agreement contains the entire agreement of the Parties
with respect to the subject matter of this Agreement and supersedes all prior written and oral
agreements, and all contemporaneous oral agreements, relating to such subject matter.

     9.10 Exhibits. The Exhibits attached to this Agreement are an integral part hereof
and all references to this Agreement include such Exhibits.

     9.11 Waivers and Amendments. No modification of or amendment to this Agreement shall
be valid unless in a writing signed by all Parties referring specifically to this Agreement and
stating the Parties’ intention to modify or amend the same. Any waiver of any term or condition of
this Agreement shall be in a writing signed by the Party sought to be charged with such waiver
referring specifically to the term or condition to be waived, and no such waiver shall be deemed to
constitute the waiver of any other breach of the same or of any other provision hereof.

     9.12 No Partnership or Joint Venture. This Agreement is not intended to create, and
nothing contained herein shall be construed to create, an association, joint venture, trust or
partnership, or to impose a trust or partnership covenant, obligation or liability on or with
regard to the other Party. Each Party shall be severally responsible for its own covenants, obligations and liabilities as herein
provided. No Party shall be under the control of, or shall be deemed to control any other Party;
no Party is the legal representative, agent, joint venturer or employee of the other Party with
respect to this Agreement for any purpose whatsoever; no Party shall have the right or power to
bind the other Party; and no Party has the right or authority to assume or create any obligations
of any kind or to make any representation or warranty on behalf of any other Party, whether express
or implied, or to bind any other Party in any respect whatsoever.

 

21

The provisions of this Agreement
are intended only for the regulation of relations between the Parties.

     9.13 Absence of Presumption. With regard to each and every term and condition of this
Agreement and any and all agreements and instruments subject to the terms hereof, the Parties
hereto understand and agree that the same have or has been mutually negotiated, prepared and
drafted, and if at any time the Parties hereto desire or are required to interpret or construe any
such term or condition or any agreement or instrument subject hereto, no consideration shall be
given to the issue of which Party hereto actually prepared, drafted or requested any term or
condition of this Agreement or any agreement or instrument subject hereto.

     9.14 Counterparts; Facsimile Execution. This Agreement may be executed in any number
of counterparts, and by each of the Parties on separate counterparts, each of which, when so
executed, shall be deemed an original, but all of which shall constitute but one and the same
instrument. Delivery of an executed counterpart of this Agreement by facsimile shall be equally as
effective as delivery of a manually executed counterpart of this Agreement.

     9.15 Guarantee. In consideration for Cadence entering into this Agreement and for
other good and valuable consideration the sufficiency of which is hereby acknowledged, Parent
hereby absolutely and unconditionally guarantees to Cadence the timely performance of each and all
of the obligations (including, without limitation, any obligation to make payments under this
Agreement) of BMS (or any of its permitted assignees), subject to the terms and conditions of this
Agreement. Parent agrees that its guarantee is a continuing obligation which shall not be
terminated unless and until all of the obligations hereunder of BMS (or any of its permitted
assignees) are fully performed and that Cadence may enforce this guarantee without exhausting any
and all remedies available against BMS (or any of its permitted assignees).

 

 

SIGNATURE PAGE TO CLINICAL SUPPLY AGREEMENT

          IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the day and year first
above written.

	 	 	 	 	 
	 	LAWRENCE LABORATORIES

 	 
	 	By:  	/s/ Barry Sexton
 	 
	 	 	Name:  	Barry Sexton 	 
	 	 	Title:  	General Manager 	 
	 
	 	CADENCE PHARMACEUTICALS, INC.

 	 
	 	By:  	/s/ Theodore R. Schroeder
 	 
	 	 	Name:  	Theodore R. Schroeder 	 
	 	 	Title:  	President and CEO 	 
	 
	 	And with respect to Section 9.15 only:

BRISTOL-MYERS SQUIBB COMPANY

 	 
	 	By:  	/s/ Bernard F. Leclere
 	 
	 	 	Name:  	Bernard F. Lecler 	 
	 	 	Title:  	VP Supply Chain 	 

 

 

	 	 	 	 	 

EXHIBIT A

SPECIFICATIONS

Specifications for Parenteral Acetaminophen Products

The Specifications are the same as those for BMS’s currently marketed product, which are set forth
below, except that the Specifications for the Clinical Testing Products do not include a trade
name. The Clinical Testing Products will be provided in vials in bulk, without commercial or
clinical labeling.

 

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

[***]

 

*** Certain information on this
page has been omitted and filed separately with the Commission.
Confidential treatment has been requested with respect to the omitted
portions.

 

EXHIBIT B

INITIAL FORECAST

For the first [***] period after the Effective Date:

     [***] (at minimum batch size) of Parenteral Acetaminophen Product

     [***] (at minimum batch size) of Placebo

in each case to be placed at the disposal of Cadence’s carrier not later than the later of (i)
[***] ([***]) [***] after the Effective Date or (ii) [***] ([***]) months after the execution of
the Quality Agreement.

 

			
	***	 	Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

EXHIBIT C

QUALITY AGREEMENT

 

 

Bristol-Myers Squibb Company

Cadence Pharmaceuticals

QUALITY AGREEMENT — Intravenous Acetaminophen

Parties to this Agreement:

	 	 	 	 	 
	Cadence Pharmaceuticals (the Contracting Company)

	 	-
	 	Company A
	Bristol-Myers Squibb Srl, BMS Anagni (the Contract Acceptor)

	 	-
	 	Company B

1. GUIDING PRINCIPLES

This quality agreement (written in accordance with the principles defined in Chapter 7 of the
EU/PIC Guide to Good Manufacturing Practice and the US Food and Drug Administration regulations 21
CFR part 211) specifies the relationship between the quality organizations of Cadence
Pharmaceuticals and Bristol-Myers Squibb Srl BMS Anagni, for the Products listed in Appendix A.
These Products are manufactured and/or packaged and QC tested by BMS Anagni Company B (hereafter
referred to as BMS Anagni) and released and used for clinical trials by Cadence Pharmaceuticals
Company A (hereafter referred to as Cadence).

The abbreviation “BMS Anagni” is used throughout the remainder of this document to refer to
“Bristol-Myers Squibb Srl located in Anagni, Italy” represented by its affiliates or agents who are
signatories to this document. The abbreviation “BMS” refers to Bristol-Myers Squibb Company.

Quality contacts are listed in Appendix B.

A glossary of terms used in this document is shown in Appendix C.

2. PRIMARY RESPONSIBILITIES

	2.1	 	The Cadence Pharmaceuticals Pharmaceutical Development and Quality Assurance Departments have
the responsibility to provide sufficient information to BMS Anagni to ensure that Products can
be manufactured, packaged and tested in accordance with cGMPs, the Product specifications and
Cadence requirements. The governing document for these requirements shall be the US
Investigational New Application (IND) number 58,362 which has been transferred from BMS to
Cadence Pharmaceuticals. Cadence will provide the manufacturing, specification and quality
sections of IND 58,362 directly to BMS Anagni with a letter authorizing the use of these
documents as the governing compliance document. The letter will be sent from the Vice
President of Regulatory Affairs and Quality Assurance at Cadence within 30 days of receipt of
the full IND from BMS. All manufacturing procedures, QC testing and release specifications
shall be in conformance with this IND application.

 

 

	2.2	 	Lawerence Laboratories, a Bristol-Myers Squibb Company wholly-owned subsidiary located in
Shannon, Ireland, has the responsibility to purchase and to ship to BMS Anagni, the API,
acetaminophen.
	 
	2.2	 	BMS Anagni has the responsibility to purchase, test and release material, perform sampling,
maintain in-process controls and to ensure that the Products are manufactured, packaged, QC
tested and released for shipment in compliance with cGMPs and the Product registrations.
Anagni has also the responsibility to, test and release the API sent by Lawrence Laboratories
	 
	2.3	 	Final certification and release of the bulk packaged Product to Cadence is the responsibility
of a BMS Anagni Qualified Person who will ensure that the Products have been manufactured,
packaged, and QC tested and in compliance with cGMPs and the IND application requirements.
	 
	2.4	 	Final certification and release of the final labeled Product to clinical sites is the
responsibility of a Cadence Authorized Person who will ensure that the Products have been
handled, labelled and released to clinical sites in compliance with cGMPs and the IND
application requirements.
	 
	2.5	 	Changes to the manufacturing process, QC testing, release specifications or stability testing
requirements as outlined in IND 58,362 shall be approved by Cadence Quality Assurance and
Pharmacetical Development groups prior to implementation for any clinical batch of Product
intended for use by Cadence in clinical trials.
	 
	2.6	 	A summary of responsibilities is included in Appendix D.

3. CHANGE CONTROL

All changes will be completed in accordance with standard BMS Anagni procedures. This will
ensure that all the parties to this agreement are notified and their approval obtained, as
required, prior to the execution of the change. A change is defined as any alteration from the
process, QC testing, Specifications or other cGMP requirements outlined in IND 58,362. These
changes require approval by Cadence Quality Assurance and Pharmaceutical Development prior to
implementation.

4. MATERIAL RELEASE PROCEDURES

	4.1	 	Starting Materials
	 
	 	 	API is supplied by Laurence Labs to BMS Anagni. BMS Anagni is responsible for inspecting
and testing starting materials according to approved in-house procedures and technical
specifications, which are in compliance with IND 58,362.

 

 

	4.2	 	Bulk Product / Bulk Nested Product / Finished Product
	 
	4.2.1	 	Product testing, batch record review and batch release of Product will be performed by BMS
Anagni to ensure the Product meets specification listed in Attachment E, and was manufactured
in compliance with cGMPs, the Product IND 58,362 and other BMS, Anagi or Cadence requirements.
	 
	4.2.2	 	For each batch of Product, BMS Anagni will send Cadence a Certificate of Analysis, a copy of
the Product Batch Record, a copy of all deviation reports and conclusions, a copy of any
out-of-specification reports and conclusions, other investigations conducted as a result of
deviations from production requirements and a Certificate of Conformance/Manufacture (CoC/M).
The CoC/M will include a statement that the batch has been manufactured and packaged according
to the master production documents in compliance with cGMPs and IND 58,362 and that any
deviations have been investigated as per BMS Anagni Standard Operating Procedures. In
addition, it will include the following information:

	 	•	 	Product name, lot number, date of manufacture and expiry date (bulk nested
Products/Finished Products only)
	 
	 	•	 	Total quantity of bulk Product released (Number of units)
	 
	 	•	 	Notification if and when the batch was reprocessed or reworked using a validated procedure
	 
	 	•	 	Signature of BMS Anagni Product Release Authority

	4.3	 	Final certification and release of Product to clinical sites will be the responsibility of
Cadence Quality Assurance, who will act in accordance with applicable regulations and filings.

5. BATCH RECORD RETENTION

	5.1	 	Originals of all batch and laboratory documentation (including raw data) will be retained by
BMS Anagni according to regulatory and BMS Anagni requirements.
	 
	5.2	 	BMS Anagni will provide a copy of the complete batch documents to Cadence Quality Assurance.

6. RETAIN SAMPLES

This requirement applies to bulk nested Product or Finished Product only. Bulk nested
Products are indicated by the abbreviation (BN) in Appendix A; Finished Products are
indicated by (FP) and bulk Product by (B).

BMS Anagni will ensure that retain samples of Product are kept under proper storage
conditions, as required to comply with retain sample requirements and/or registration
commitments. However, in no case should the number of retained samples be less than the
amount needed to perform twice the necessary tests for Finished Product release, with the
exception of sterility and bacterial endotoxin testing for which only one complete retest
quantity need be retained. Testing of retain samples may be initiated with approval of
Cadence Quality Assurance. Retain samples will be visually inspected on an annual basis as
per cGMP and BMS Anagni, requirements. Any issues will be immediately notified to Cadence
Quality Assurance.

7. STABILITY FOR FINISHED PRODUCT AND PLACEBO

This requirement applies to bulk nested Product and placebo or Finished Product and placebo
only. Bulk nested Products are indicated by the abbreviation (BN) in Appendix A; Finished
Products are indicated by (FP) and bulk Product by (B).

 

 

	7.1	 	BMS Anagni will ensure the completion of appropriate stability studies on Products and
placebo in their primary packaging containers according to the stability protocol outlined in
IND 58,362, Attachment E, that will conform to current ICH and cGMP guidelines.
	 
	7.2	 	For each lot of Product or placebo, representative samples must be collected for stability
testing according to the stability protocols. Stability to be performed on the clinical trial
lots according to the approved stability protocols, Attachment E.
	 
	7.3	 	If a confirmed result indicates a Product or placebo lot has failed to remain within
specifications, BMS Anagni is required to notify the Cadence Quality Assurance representatives
immediately.
	 
	7.4	 	In all cases BMS Anagni must investigate any confirmed out-of-specification result and
forward a copy of the completed investigation report within 30 days to Cadence Quality
Assurance.

8. COMPLAINTS

	8.1	 	Product complaint reports received by BMS Anagni from its customers will be handled in
accordance with standard BMS Anagni policies and guidelines.
	 
	8.2	 	When requested, BMS Anagni will investigate all Product complaints and provide Cadence
Quality Assurance with a written report within thirty (30) days after receipt of the complaint
or complaint sample as appropriate.

9. RECALL

Recalls will be handled in accordance with applicable regulations and standard BMS Anagni
guidelines. The designated group that manages Product recalls is responsible for making all
Product recall decisions. Within certain jurisdictions, this group must include an
Authorized Person from Cadence Quality Assurance.

10. ANNUAL PRODUCT REVIEW — Not Applicable

11. AUDITS

Audits of BMS Anagni will be performed by Cadence auditors prior to release of the first
clinical production lot by Cadence (only one audit is anticipated) and audit reports will be
available to the Anagni Quality group upon request.

12. VENDOR QUALIFICATION

This will be completed in accordance with appropriate Regulatory requirement and standard
BMS Anagni policies and guidelines.

 

 

13. STORAGE

BMS Anagni will ensure that pharmaceutical Products (bulk Product, bulk nested Product or
Finished Product) are stored within the Product label storage range defined in IND 58,362.
Excursions in temperature and/or relative humidity (if applicable) during storage must be
investigated. Any such excursion impacting on Product quality will be reported to the Authorized
Person.

14. SUBCONTRACTING

Where BMS Anagni proposes to subcontract any services related to the Products supplied, BMS
Anagni change control procedures will apply. Cadence Pharmaceutical Development and
Quality Assurance shall be notified of any intention to subcontract manufacturing or testing
activities to gain agreement prior to implementing any transfer activities.

15. MICROBIOLOGICAL MONITORING

BMS Anagni will maintain an appropriate microbiological monitoring program to ensure
acceptable microbiological quality and compliance with applicable regulations.

16. TRAINING

Each person engaged in the manufacturing, processing, packaging, testing or holding of a
drug Product shall have education, training, and experience, or any combination thereof, to
enable that person to perform the assigned functions. Training shall be in the particular
operations that the employee performs and in current applicable manufacturing regulations as
they relate to the employee’s functions. Training in applicable manufacturing regulations
shall be conducted by qualified individuals on a continuing basis and with sufficient
frequency to assure that employees remain familiar with requirements applicable to them.
This training must be documented in a training record for each employee.

17. QUALIFICATION & VALIDATION PROGRAMS

This will be completed in accordance with appropriate Regulatory expectations and standard
BMS Anagni policies and guidelines.

18. COMPLIANCE WITH LOCAL REGULATIONS

BMS Anagni undertakes to obtain and maintain the appropriate authorisation to manufacture
the Products. BMS Anagni shall inform the Cadence Quality Assurance person responsible about
any change or withdrawal of such authorisation without undue delay.

19. SHIPPING PROTOCOL AND RESPONSIBILITIES FOR RECEIPT OF PRODUCT AND PLACEBO

Shipping and resolution of product defects shall be managed as specified in the Clinical
Supply Agreement between Lawrence Laboratories and Cadence Pharmaceuticals, dated 21
February 2006.

 

 

Cadence shall evaluate the shipping protocols and any available data supplied by BMS for
both the product and placebo to determine the suitability of this information to support the
shipping of product by Cadence. If the BMS shipping data does not support the Cadence
proposed shipping conditions and procedures, Cadence shall conduct a shipping study for the
drug product and/or placebo to demonstrate the acceptability of the shipping conditions.
The Cadence shipping protocol and study results shall be shared with BMS.

20. HISTORY SECTION

	 	 	 	 	 
	Version Number	 	Comment	 	Issue Date
	1

	 	First issue of the Quality Agreement
between Cadence and BMS Anagni for Products
listed in Appendix A
	 	June 2006

Issue date: This is defined as the date the document received final signature

 

 

Cadence Approval:

	 	 	 	 	 	 
	 
	 	 	 	 
	Signed:
	 	 
	 	
	
	 	 
	 	 
	 
	 

	 	Richard E. Lowenthal, MSc,	 	 
	 

	 	Vice President Regulatory Affairs and
Quality Assurance, Cadence
Pharmaceuticals	 	 

Lawrence Laboratories:

	 	 	 	 	 	 
	 
	 	 	 	 	
	Signed:
	 	 
	 		
	
	 	 
	 	 
	
	 

	 	Gillian O’GHara	 	 	
	 

	 	QA Director, Lawrence Labs	 	 	

BMS Anagni Approval:

	 	 	 	 	 	 
	 
	 	 	 	 
	Signed:
	 	 
	 	
	
	 	 
	 	 

	 

	 	Eugenio Cusimano	 	 
	 

	 	QC/QA Director & Qualified Person

Bristol-Myers Squibb BMS Anagni	 	 

 

 

APPENDIX A:

Products:

Acetaminophen (Perfalgan) Injection [Active Product] (FP)

Acetaminophen (Perfalgan) Injection Placebo (FP)

	 	 	 
	(BN)
	 	indicates this is a bulk nested Product

	 
	(B)
	 	indicates this is a bulk Product

	 
	(FP)
	 	indicates this is a Finished Product

APPENDIX B:

Cadence Quality Assurance

Quality Contacts — Richard E. Lowenthal, MSc

	 	 	 
	Phone:
	 	858-335-1300

	Fax:
	 	858-436-1401

	e-mail:
	 	rlowenthal@cadencepharm.com

Cadence Pharmaceutical Development

Product Development Contact — William Craig, PhD

	 	 	 
	Phone:
	 	858-354-0847

	Fax:
	 	858-436-1401

	e-mail:
	 	wcraig@cadencepharm.com

Bristol-Myers Squibb BMS Anagni

Quality Contact — Qualified Person

Eugenio Cusimano

QC/QA Director,

	 	 	 
	Phone:
	 	++39 0775 762210

	Fax:
	 	++39 0775 762285

	e-mail:
	 	eugenio.cusimano@bms.com

 

 

APPENDIX C:

Glossary of Terms

	 	 	 
	Pharmaceutical Product
	 	Any Product that may be defined as a Bulk Product or a Finished Product

	 	 	 

	Bulk Product
	 	Any Product which has completed all processing stages up to, but not
including, packaging in a primary container (e.g., blister, bottle).

	 	 	 

	Finished Product
	 	Any Product that has completed all processing stages and is in its final
pack for release to Cadence.

	 	 	 

	Authorized Person
	 	The person or persons charged with final release of the batch for
clinical studies outside of the European Union (EU).

	 	 	 

	Qualified Person
	 	The person or persons charged with certification and batch release of
medicinal Products within the European Union (EU) or European Economic Area (EEA).

	 	 	 

	cGMP
	 	Current Good Manufacturing Practices for Pharmaceuticals as described in regulations
promulgated by the FDA or equivalent regulatory agency in a foreign country or
jurisdiction.

	 	 	 

	Governmental Authority
	 	Any (i) national, state, provincial, local or any foreign or
supranational government; (ii) governmental, regulatory or administrative authority,
agency or commission; or (iii) any court, tribunal or judicial or arbitral body.

 

 

APPENDIX D:

Division of pharmaceutical responsibilities*

	 	 	 
	Contract Giver:
	 	Cadence Pharmaceuticals, Inc.

	 	 	 

	Contract Acceptor
	 	Bristol Myers Squibb, Anagni

	 	 	 	 	 
	 	 	Contract Giver	 	Contract Acceptor
	 
	 	 	 	 
	Agreement with the 

registration documents

	 	þ
	 	þ
	 
	 	 	 	 
	Active ingredient(s):
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	þ
	 	þ Note 1
	Supply/Procurement

	 	þ
	 	þ
	Testing

	 	o
	 	þ
	Release

	 	þ
	 	þ
	 
	 	 	 	 
	Excipients:
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	o
	 	þ Note 1
	Supply/Procurement

	 	o
	 	þ
	Testing

	 	o
	 	þ
	Release

	 	o
	 	þ
	 
	 	 	 	 
	Primary packaging: (Note 2)
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	þ
	 	þ Note 1
	Supply/Procurement

	 	o
	 	þ
	Testing

	 	o
	 	þ
	Release

	 	o
	 	þ
	 
	 	 	 	 
	Secondary packaging (Note 3):
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	þ
	 	þ Note 1
	Supply/Procurement

	 	o
	 	þ
	Testing

	 	o
	 	þ
	Release

	 	o
	 	þ
	 
	 	 	 	 
	Package leaflet: N/A
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	o
	 	o
	Clearance for printing/proof —reading

	 	o
	 	o
	Supply/Procurement

	 	o
	 	o
	Testing

	 	o
	 	o
	Release

	 	o
	 	o

 

 

 

			
	*	 	This list is not necessarily all inclusive and is intended only as a summary of the highlights
contained within the body of the Quality Agreement.

Cont’d

 

 

	 	 	 	 	 
	Bulk product/bulk nested Product:
	 	 	 	 
	 
	 	 	 	 
	Manufacturing directions

	 	o
	 	þ Note 1
	In-process control

	 	o
	 	þ
	Manufacture

	 	o
	 	þ
	Manufacturing record completion

	 	o
	 	þ
	Review of manufacturing documentation

	 	o
	 	þ
	Testing directions

	 	o
	 	þ Note 1
	Quality control/test record

	 	o
	 	þ
	Release

	 	þ
	 	þ
	Certificate of manufacture/conformance

	 	o
	 	þ
	Certificate of analysis

	 	o
	 	þ
	Release for dispatch

	 	o
	 	þ
	Assignment of batch number

	 	o
	 	þ
	Assignment of expiration date

	 	o
	 	þ Note 4
	Retain Samples

	 	þ
	 	þ see Section 6
	Stability Testing

	 	þ
	 	þ see Section 7
	Transportation to Contract Giver

	 	o
	 	þ
	Review of manufacturer certificates

	 	þ
	 	o
	 
	 	 	 	 
	Authorized or Qualified Person release of
Finished Product

	 	þ
	 	o
	 
	 	 	 	 
	Finished Product (Note 5)
	 	 	 	 
	 
	 	 	 	 
	Specification

	 	þ
	 	o Note 1
	Packaging directions

	 	þ
	 	o Note 1
	In-process control

	 	þ
	 	o
	Packaging

	 	þ
	 	o
	Packaging record completion

	 	þ
	 	o
	Review of packaging documentation

	 	þ
	 	o
	Testing directions

	 	þ
	 	o Note 1
	Quality control/test record

	 	þ
	 	þ
	Certificate of analysis

	 	þ
	 	þ
	Certificate of manufacture/conformance

	 	o
	 	þ
	Assignment of batch number

	 	þ
	 	o
	Assignment of expiration date

	 	þ
	 	o
	Retain Samples

	 	þ
	 	o
	Stability Testing

	 	o
	 	o
	Transportation to warehouse (compliance with GDP)

	 	o
	 	o
	Review of manufacturer certificates

	 	þ
	 	o
	Authorized or Qualified Person release of
Finished Product

	 	þ
	 	o

 

 

	 	 	 
	Note 1:
	 	This refers to documents prepared internally by BMS Anagni. Any such documentation must
be in accordance with the appropriate Product registration. BMS Anagni is responsible for the
bulk finished product and all requirements for release and documentation. Cadence is
responsible for labeling of the product and final packaging to produce the clinical finished
product.

	 	 	 

	Note 2:
	 	This applies to bulk nested Product and Finished Product only — see Appendix A

	 	 	 

	Note 3:
	 	This applies to Finished Product only — see Appendix A
(Secondary packaging will occur at both BMS Anagni for shipment to the United
States and also at a 3rd party clinical packaging site for shipment to clinical
sites)

	 	 	 

	Note 4:
	 	This applies to bulk nested Product only — see Appendix A

APPENDIX E:

     Testing Standards & Stability Protocols (attached)

[Note: Attached IND Stability Protocol as currently written]Exhibit 10.15

 

EXHIBIT 10.15

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.

Execution Copy

CLEAR VIEW PROJECTS

May 19, 2005

Mr. Ted Schroeder

President and CEO

By Mail:

Cadence Pharmaceuticals

12730 High Bluff Drive, Suite 410

San Diego, CA 93130

By Email:

tschroeder@CadencePharm.com

Dear Ted:

Thank you for offering Clearview Projects, Inc, (“Clearview”) the opportunity to provide
Cadence Pharmaceuticals (“Cadence” or “Company”) with consulting services
(“Services”). This engagement letter (“Engagement Letter”) sets forth the terms
and conditions under which Clearview will perform such Services. Subsequent sections of this
Engagement Letter are organized as follows:

	 	•	 	Background
	 
	 	•	 	Services
	 
	 	•	 	Fees and Expenses
	 
	 	•	 	Other Terms

Background

Cadence is a privately held, venture capital backed specialty pharmaceutical company focusing
on the hospital channel segment. Since its inception, the company has assembled an experienced
team of executives to fill out the senior management infrastructure. With this senior management
team in place, the company believes it is poised to scale up both its pipeline and commercial
launch activity.

Cadence’s first product, CPI-226, is a topical antimicrobial currently undergoing confirmatory
Phase III clinical trials. The primary endpoint for the CPI-226 Phase III trial is related to
so-called local catheter site infections. Management believes that confirmation of this endpoint
will lead to an FDA approval.

With CPI-226 as a starting base, the company seeks to acquire or in-license additional clinical
candidates or commercial products in order to fully develop the growth business model of the
company. Clearly, a key driver for scaling the initial growth curve of the company is this
product-level acquisition activity. To that end, you have identified three (3) late-stage

 

 

development program(s)/product(s) (“Three Targets”) for which you are in varying stages of
discussion with the current owner. Our understanding of the transaction situations associated with
each of the Three Targets is:

	•	 	Phase III Pain Management development-stage program. The rights
to this late-stage development program are currently owned by a
“Big Pharma” and you anticipate the need to structure an offer in
the very near future for exclusive US rights.
	 
	•	 	[***].
	 
	•	 	[***].

Services

Clearview will provide analytical and execution advice for all aspects of your efforts to
acquire rights associated with the Three Targets. These services will include:

	•	 	Assistance in accessing the appropriate decision making process
within the current corporate owners’ organization. This will
include interaction with management at all levels in the company’s
organization structure.
	 
	•	 	Advice and support in developing a strategic business case for the
implied investment required for the acquisition/in-licensing of
these products/programs. This would include any interaction you
may require with the Cadence Board of Directors.
	 
	•	 	Advice and support in structuring an offer and in executing all
aspects of the transaction process — including business due
diligence and negotiations (alongside counsel and other functional
experts).
	 
	•	 	Other related tasks that you may reasonably require in furthering
the acquisition initiatives.

As with the vast majority of our engagements, we will utilize a team structure to perform the
engagement services. This approach enables Clearview to emphasize particularly specialized
expertise depending on the underlying task at hand. [***], Vice President and leader of
Clearview’s partnering/alliance client activities, will oversee day-to-day aspects of the
engagement and will ensure that any mix of the professionals identified in Exhibit I are involved
as appropriate. In addition, other Clearview professional staff may be involved to effectively
carry out a variety of analytical and project management work activities.

During the term of this Engagement Letter, neither Cadence nor its Board will retain any other firm
to provide similar services to those being performed by Clearview and described herein
(“Competitive Firm”). A Competitive Firm, however, shall not include consultants providing

 

	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

2

 

specific expertise, support or advice — not in competition with the Services — relating to one or
more of the Three Targets.

The Services will be carried out for the specific use of Mr. Ted Schroeder, CEO of Cadence, and the
Board of Cadence. Commencement of the Services will be initiated upon the execution of this
Engagement Letter.

Fees and Expense

In consideration for our Services, Cadence will pay Clearview a cash monthly retainer
(“Monthly Retainer”) in the amount of $[***]. Should Cadence choose to stop its efforts
for pursuing a transaction for one or two of the Three Targets (“Lapsed Target”) and the
parties do not agree on a Substitute Target for each such Lapsed Target, then Clearview’s
Monthly Retainer would be reduced to $[***] payable in cash. “Substitute Target” shall be
a commercial or late-stage development program/product which, upon mutual agreement between Cadence
and Clearview, becomes a constituency of the Three Targets. In addition to this Monthly Retainer,
upon the closing of each individual transaction involving the acquisition/in-licensing of rights
associated with any one of the Three Targets (“Success Fee Transaction”), Cadence will pay
Clearview, or an affiliate, $[***] (“Success Fee”). The consideration for the Success Fee
shall be composed of $[***] paid in cash (“Cash Success Fee”) and $[***] paid in the form
of either issued Cadence common equity (“Equity Success Fee”) or cash, the choice of which
shall be at the discretion of Cadence (“Fee Choice”). Cadence shall make its Fee Choice
within [***] days of closing a Success Fee Transaction. The number of common shares related to the
Equity Success Fee shall be determined by dividing $[***] by the price-per-share associated with
the equity financing round completed by Cadence within [***] days of closing a Success Fee
Transaction. If no equity financing round is completed by Cadence within [***]days of closing a
Success Fee Transaction, then the number of common shares related to the Equity Success Fee shall
be determined by dividing $[***] by the price-per-share associated with the most recent equity
financing round completed by Cadence.

The Monthly Retainer and Success Fee payments shall not include direct out-of-pocket expenses
incurred by Clearview in carrying out the Services (“Expenses”). We will invoice you
separately for Expenses, which for this engagement, should be principally travel-related and any
purchased third party market research that both Cadence and Clearview mutually agree to be
appropriate. Expenses incurred by Clearview shall be reimbursed by the Company in cash upon
receipt of reasonable documentation.

All Monthly Retainer and Expense payments shall be remitted to Clearview within [***]
business days of the Company’s receipt of an invoice for such amounts. Success Fee payments shall
be remitted to Clearview at the closing of each such Success Fee Transaction. The Equity Success
Fee, however, shall be paid at the earlier of [***] days from closing a Success Fee
Transaction or within [***] business days of closing a Cadence equity financing round
subsequent to closing a Success Fee Transaction.

 

	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

3

 

All remittances to Clearview shall be wire-transferred in accordance with the following
instructions:

Bank: [***]

Account name: [***]

Account number: # [***]

SWIFT number: # [***]

SWIFT address: [***]

Other Terms

With no less than two weeks notice, (1) either party may terminate this Engagement Letter or
(2) Cadence may designate a Lapsed Target. In addition, (1) should Cadence terminate the
Engagement Letter and subsequently consummate a Success Fee Transaction within the [***] 
period after such termination, then Clearview shall be entitled to a Success Fee for each such
transaction occurrence and (2) should Cadence consummate a Lapsed Success Fee Transaction
within the [***] period after such Lapsed Target designation, then Clearview shall be
entitled to a Success Fee for each such transaction occurrence. “Lapsed Success Fee
Transaction” shall be the closing of an individual transaction involving the
acquisition/in-licensing of rights associated with a Lapsed Target.

Clearview agrees that for the [***] period following either the termination of this
Engagement Letter, or as applicable, designation of a Lapsed Target, it shall not attempt or assist
in the attempt to enter into a partnership (“Partnership”) related to any one of the Three
Targets or a Lapsed Target without the prior written consent of Cadence. Partnership shall
include a program/product-level licensing or acquisition transaction, BUT, shall specifically
exclude the acquisition of a division or company whose assets include any one of the Three Targets
or a Substitute Target as a minority subset.

Either the Company or Clearview may terminate this Engagement Letter upon written notice to the
other party in the event of the dissolution, liquidation, insolvency of the other party or in the
event of a voluntary or involuntary bankruptcy or reorganization petition involving such other
party.

IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL, INDIRECT, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING BUT NOT LIMITED TO LOST DATA,
LOST PROFITS OR SAVINGS, LOSS OF BUSINESS OR OTHER ECONOMIC LOSS) ARISING OUT OF, OR IN CONNECTION
WITH, THE SERVICES, WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OR KNEW OF THE POSSIBILITY OF SUCH
DAMAGES, AND REGARDLESS OF THE NATURE OF THE CAUSE OF ACTION OR THEORY ASSERTED. Clearview’s
liability for costs or damages allegedly incurred by Company arising out of, or in connection with,
Clearview’s performance of the Services pursuant to this Engagement Letter shall be limited to the
aggregate amount of Fees paid to Clearview pursuant to this Engagement Letter.

 

	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

4

 

Without limiting any other rights or remedies of Clearview under this Engagement Letter, and
regardless of any investigation made at any time by or on behalf of Clearview or any information
Clearview may have, the Company shall indemnify and save harmless Clearview, its directors,
officers, employees, agents and assigns from and against any liability, damages (including punitive
damages), injury (including property damage, personal injury or death), loss, claim, cost, debt,
expense, obligation, public charge, lawsuit, contract, agreement, undertaking or deficiency of any
kind or nature, whether known or unknown, fixed, actual, accrued, or contingent, liquidated or
unliquidated (including, but not limited to, reasonable attorneys’ fees and other costs and
expenses incident to proceedings or investigations or the defense of any claim whether or not
litigation is commenced), arising out of, resulting from, or relating to, any act or omission
(other than gross negligence or willful misconduct) of Clearview, its employees, agents, associates
or assigns that occurs during the term of this Engagement Letter. This indemnification shall
survive the termination of this Engagement Letter.

Cadence indemnifies and releases Clearview from all liability relating to any access to, or use of,
information prepared in any form whatsoever by Clearview in carrying out the Services
(“Clearview Information”) by any other party. The Company acknowledges and agrees that the
duties of Clearview under this Engagement Letter are owed solely to the Company. The advice (oral
or written) rendered by Clearview pursuant to this Engagement Letter is intended solely for the
benefit and use of the management of the Company and its Board in considering such matters to which
this Engagement Letter relates and the parties agree that such advice may not be relied upon by any
other person.

The Company also acknowledges that any projections or forward-looking statements contained in
Clearview Information involve risks, uncertainties and other factors that may cause actual results
to differ materially from those expressed or implied in such projections or forward-looking
statements and that it is likely that actual results will differ materially from those contemplated
by such projections or forward-looking statements, and that Clearview gives no representations or
warranties, express or implied, that any such projections or forward-looking statements will be
realized.

Neither party may transfer or assign any of its rights or obligations under this Engagement Letter
without the prior written consent of the other party.

All notices or communications hereunder shall be sent in by facsimile transmission (if available)
or email (if available), followed by a signed copy sent by commercial mail or courier, and shall be
deemed to have been given two days after being transmitted.

Notice to Clearview shall be addressed to:

Clearview Projects, Inc.

100 Overlook Center

Princeton, NJ 08540

609-580-3600

5

 

FAX: 609-580-0047

Attn: Chief Executive Officer

Notice to Company shall be addressed to:

Cadence Pharmaceuticals

12730 High Bluff Drive, Suite 410

San Diego, CA 93130

858-436-1400

FAX: 858-436-1401

Attn: Chief Executive Officer

Written notification of change in address, telephone, fax, email or contact person is required to
be provided by either party to the other party in the same manner as notices.

This Engagement Letter shall be governed by, construed and enforced in accordance with the laws of
the State of Delaware, excluding its choice of law provisions. Any suit, action or proceeding
seeking to enforce any provision of, or based on any matter arising out of or in connection with,
this Engagement Letter or the transactions contemplated hereby may be brought in the courts of the
State of New Jersey and the federal courts of the United States of America located in New Jersey.
Each of the parties (a) consents to the exclusive jurisdiction of such courts (and of the
appropriate appellate courts therefrom) in any such suit, action or proceeding, (b) irrevocably
waives, to the fullest extent permitted by law, any objection which it may now or hereafter have to
the laying of the venue of any such suit, action or proceeding in any such court or that any such
suit, action or proceeding which is brought in any such court has been brought in an inconvenient
forum, (c) will not attempt to deny or defeat such personal jurisdiction by motion or other request
for leave from any such court, and (d) will not bring any action relating to this Engagement Letter
or any of the transactions contemplated by this Engagement Letter in any other court. Process in
any such suit, action or proceeding may be served on any party anywhere in the world, whether
within or without the jurisdiction of any such court. Without limiting the foregoing, each party
agrees that service of process on such party as provided in this paragraph will be deemed effective
service of process on such party.

This Engagement Letter contains all of the understandings and agreements of the parties with
respect to the subject matter hereof and any and all prior understandings and agreements between
the parties are superseded by this Engagement Letter. This Engagement Letter may not be modified
unless the modification is in writing and executed by both parties.

6

 

We look forward to working with you on this exciting project. If this Engagement Letter is
satisfactory, please execute one copy below and return it to me by facsimile or in the envelope
provided.

	 	 	 	 	 
	 	Very truly yours,

Clearview Projects, Inc.:

 	 
	 	Name 	Jan S. Wolpert 	 
	 	Title  	CEO	 
	 	Signature  	/s/ Jan S. Wolpert
 	 
	 	Date 	5/20/05 	 
	 

Accepted and Agreed:

Cadence Pharmaceuticals:

	 	 	 	 	 
	Name  	Theodore R. Schroeder 	 	 	 
	Title  	President and CEO	 	 	 
	Signature  	/s/ Theodore R. Schroeder
 	 	 	 
	Date   	             5/20/05 	 	 	 
	 

7

 

Exhibit I. Clearview Bios

[***]

[***]

[***]

[***]

 

	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

8

 

[***]

[***]

[***]

 

	***	 	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

9

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