Exhibit 10.1
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.
Confidential
AMENDED & RESTATED
DEVELOPMENT AND SUPPLY AGREEMENT
By and Between
CADENCE PHARMACEUTICALS, INC.
and
BAXTER HEALTHCARE CORPORATION
CONFIDENTIAL
TABLE OF CONTENTS
1.0
BACKGROUND
3
2.0
DEFINITIONS
3
3.0
COOPERATIVE ORGANIZATION
4
4.0
DEVELOPMENT PLANS
5
5.0
PRODUCT REGISTRATIONS AND USER FEES
8
6.0
COMMERCIAL SUPPLY
9
7.0
MANUFACTURING FEE
13
8.0
API
15
9.0
EQUIPMENT AND FACILITIES
17
10.0
QUALITY MANAGEMENT
18
11.0
MARKETING
21
12.0
REPRESENTATIONS AND WARRANTIES
21
13.0
CONFIDENTIALITY
24
14.0
INTELLECTUAL PROPERTY
25
15.0
INDEMNIFICATION
29
16.0
ALTERNATE DISPUTE RESOLUTION
32
17.0
FORCE MAJEURE
32
18.0
RELATIONSHIP OF THE PARTIES
33
19.0
TERM AND TERMINATION
33
20.0
EFFECTS OF TERMINATION
34
21.0
NOTICES
36
CONFIDENTIAL
22.0
EXPORT
37
23.0
MISCELLANEOUS
37
EXHIBITS
EXHIBIT A
PRODUCT SPECIFICATIONS
EXHIBIT B
API SPECIFICATIONS
EXHIBIT C
MINIMUM BATCH SIZES AND MANUFACTURING FEE
EXHIBIT D
COST OF API AND METHODOLOGY FOR CALCULATING MANUFACTURING YIELD LOSSES
EXHIBIT E
BAXTER OWNED EQUIPMENT
EXHIBIT F
CADENCE OWNED EQUIPMENT
EXHIBIT G
CONFIDENTIAL DISCLOSURE AGREEMENT
EXHIBIT H
DEVEOPMENT PLAN TEMPLATE
EXHIBIT I
DEFINITIONS
2
CONFIDENTIAL
AMENDED AND RESTATED
DEVELOPMENT AND SUPPLY AGREEMENT
This AMENDED AND RESTATED DEVELOPMENT AND SUPPLY AGREEMENT, (this "Agreement")
is effective as of January 28, 2011 (the "Effective Date") by and between
CADENCE PHARMACEUTICALS, INC., a corporation organized and existing under the
laws of the State of Delaware and having its principal office at 12481 High
Bluff Drive, Suite 200, San Diego, CA 92130 ("Cadence") and BAXTER HEALTHCARE
CORPORATION, a corporation organized and existing under the laws of the State of
Delaware and having its principal office at One Baxter Parkway, Deerfield,
Illinois 60015 ("Baxter"). All references to "Cadence" and "Baxter" will include
their respective Affiliates.
1.0 BACKGROUND
Cadence has an exclusive license to rights in the United States and Canada to a
particular intravenous formulation of, and manufacturing process for, the
Compound.
Baxter manufactures and markets sterile products in glass containers for
parenteral administration of pharmaceutical preparations.
Cadence and Baxter entered into a Letter of Intent dated November 27, 2006, as
amended (collectively, the "LOI"), and executed a Development and Supply
Agreement dated July 18, 2007, as amended on October 11, 2007, March 1,
2009, October 15, 2009, and June 7, 2010 (collectively, the "Original
Agreement"), with respect to the provision of certain development and commercial
supply services by Baxter.
The Parties now wish to modify the terms of the Original Agreement to confirm
the terms and conditions under which Baxter will manufacture the Product for
commercial distribution, and establish the terms and conditions under which the
commercial manufacturing capacity for the Product at the Facility will be
expanded. Upon the Effective Date, the LOI and the Original Agreement shall be
superseded in their entirety by this Agreement.
THEREFORE, the Parties, intending to be legally bound, agree as follows:
2.0 DEFINITIONS
Certain capitalized terms