SECOND AMENDMENT TO OEM PURCHASE AND SUPPLY AGREEMENT
Exhibit 10.39
SECOND AMENDMENT TO OEM PURCHASE AND SUPPLY AGREEMENT
This Second Amendment (the “Amendment”) is made as of February 14, 2005, by and
between Cardiac Science, Inc., a Delaware corporation (“Supplier” or “Cardiac Science” or “CSI”),
a medical device developer and manufacturer of automated external defibrillators having its
principal place of business at 0000 Xxxx Xxxxxx, Xxxxxx, XX 00000 and GE Medical Systems
Information Technologies, Inc., a Wisconsin corporation (“GEMS-IT”), having its principal place
of business at 0000 X. Xxxxx Xxxxxx, Xxxxxxxxx, XX 00000. CSI and GEMS-IT may each be referred to
herein as a “Party” and collectively, the “Parties”.
W I T N E S S E T H:
WHEREAS, CSI and GEMS-IT are parties to an OEM Purchase and Supply Agreement dated July 29,
2003, an “Addendum 1” to the OEM Purchase and Supply Agreement dated as of March 24, 2004 and
Amendment One to OEM Purchase Agreement dated August 10, 2004 (collectively, the “OEM Purchase
and Supply Agreement”).
WHEREAS, CSI and GEMS-IT desire to supplement and amend the OEM Purchase and Supply
Agreement as set forth herein.
NOW THEREFORE, in consideration of the premises and other good and valuable consideration,
the receipt and adequacy of which is hereby acknowledged, it is agreed as follows:
1. Construction. Except as provided in this Amendment, the terms and conditions set
forth in the OEM Purchase and Supply Agreement shall remain unaffected by execution of this
Amendment. To the extent any provisions or terms set forth in this Amendment conflict with the
terms set forth in the OEM Purchase and Supply Agreement, the terms set forth in this Amendment
shall govern and control. Terms not otherwise defined herein, shall have the meanings set forth in
the OEM Purchase and Supply Agreement. This Amendment amends the OEM Purchase and
Supply Agreement and not the OEM Purchase Agreement entered into by the Parties on July 29,
2003.
2. CSI Roles and Responsibilities. To further define the role of CSI, and to more
explicitly set forth CSI’s responsibilities and obligations with respect to the OEM Purchase and
Supply Agreement and the OEM Products, the Parties agree that CSI shall be responsible for tracking
all OEM Products (as defined in Exhibit A to the OEM Purchase and Supply Agreement) sold by GEMS-IT
in the United States, in accordance with 21 C.F.R. 821. As the manufacturer of the OEM Products,
CSI is solely responsible for establishing records that accurately match end users with each of the
OEM Products. CSI is also responsible for establishing such records and maintaining them for
accessories that are trackable per 21 C.F.R. 821. CSI shall keep these records current and
up-to-date over the life of each OEM Product, according to FDA rules and regulations. Additionally,
CSI will implement audits of the tracking system per 21 C.F.R. 821 and make records of the audit
finds available to GEMS-IT upon request. CSI releases GEMS-IT, and agrees to indemnify, defend and
hold GEMS-IT harmless, from any obligation to maintain such records of its own, and from any
damages resulting from failure to comply with statutory or regulatory requirements with respect
thereto. In the event the FDA requests records in connection with an audit or if there is a recall
of an OEM Product and such records are requested, CSI will rely on its internal processes and
compliance procedures to respond appropriately and according to its obligations, as set forth
herein and in the OEM Purchase Agreement. GEMS-IT will share all customer contact information with
CSI for the purpose of: (a) direct order fulfillment by CSI from its manufacturing facility, and
(b) device tracking.
3. The last sentence of Paragraph 3 (“Powerheart® Cardiac Rhythm Module™ (CRM)”) on Exhibit A
to the OEM Purchase and Supply Agreement is deleted and replaced with
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the following: CRM may be private labeled with GEMS-IT specified labeling as agreed upon by the
Parties.
4. Governing Law. The validity, construction, performance and enforceability of this
Amendment shall be governed in all respects by the laws of the State of New York, without reference
to the choice-of-law provisions thereof.
5. Counterparts; Facsimile. This Amendment may be executed simultaneously in
multiple counterparts, each of which shall be deemed an original, but all of which taken together
shall constitute one and the same instrument. Execution and delivery of this Amendment by
exchange of facsimile copies bearing the facsimile signature of a party hereto shall constitute a
valid and binding execution and delivery of this Amendment by such party. Such facsimile copies
shall constitute enforceable original documents.
6. Severability. In the event any provision of this Amendment shall be determined to
be invalid or unenforceable under applicable law, all other provisions of this Amendment shall
continue in full force and effect unless such invalidity or unenforceability causes substantial
deviation from the underlying intent of the parties expressed in this Amendment or unless the
invalid or unenforceable provisions comprise an integral part of, or in inseparable from, the
remainder of this Amendment. If this Amendment continues in full force and effect as provided
above, the parties shall replace the invalid provision with a valid provision which corresponds as
far as possible to the spirit and purpose of the invalid provision.
7. Interpretation. This Amendment has been negotiated at arm’s length and between
persons sophisticated and knowledgeable in the matters dealt with in this Amendment. Each party has
been represented by experienced and knowledgeable legal counsel. Accordingly, any rule of law or
legal decision that would require interpretation of any ambiguities in this Amendment
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against the party that has drafted it is not applicable and is waived. The provisions of
this Amendment shall be interpreted in a reasonable manner to effect the purposes of the
parties and this Amendment.
8. Entire Agreement. The terms of this Amendment are intended by the parties to be
the final expression of their agreement with respect to the subject matter hereof and may not be
contradicted by evidence of any prior or contemporaneous agreement. The parties further intend
that this Amendment constitute the complete and exclusive statement of its terms and shall
supersede any prior agreement with respect to the subject matter hereof.
9. Headings. The article and section headings contained in this Amendment are for
reference purposes only and will not affect in any way the meaning or interpretation of this
Amendment.
IN WITNESS WHEREOF, the parties have caused this Agreement to be signed by their thereunto duly
authorized representatives as of the date first above written.
| Cardiac Science, Inc. | GE Medical System | |||||||||
| Information Technologies, Inc. | ||||||||||
By: Name: |
/s/ Xxxxxxx X. Xxxxx
|
By: Name: |
/s/ Xxxxxxxx Xxxxx
|
|||||||
Title:
|
Chairman and CEO | Title: | Vice President & General Manager | |||||||
| Cardiology Systems | ||||||||||
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