Document:

exv10w18

 

EXHIBIT
10.18

-1-

NOVARTIS PHARMA AG

BASEL, SWITZERLAND

(hereinafter “NOVARTIS”)

APPLICATION FOR SUPPLY OF MATERIALS

TERMS OF MATERIALS TRANSFER

	 	 	 	 	 
	
	 	 	 	(STAMP)

Please complete, sign and return this form by mail (do not telefax) to:

Novartis Pharma AG

PH Research Operations CH

Anna Maria Suter

K-136.P.15

Klybeckstrasse/P.O. Box

4002 Basel, Switzerland

Novartis Pharma Research Basel contact:

Company/Institution (name & address):

John Babitt

President and COO

CABG Medical Inc.

14505 21st Avenue North, Suite 212

Minneapolis, MN 55447

USA

Phone: +1 763 258 8005

Fax: +1 763 258 8008

e-mail: john.babitt@cabgmedical.com

(hereinafter jointly referred to as “Applicant”)

 

Material and amount required (“Materials”):

1) Everolimus (2 gms)

      

The Materials will be used for the following studies (“Studies”):

(study protocol to be provided to NOVARTIS upon request)

      

      

THIS IS AN APPLICATION REQUESTING NOVARTIS TO SUPPLY THE MATERIALS. NOVARTIS IS
UNDER NO OBLIGATION AT ANY TIME TO SUPPLY OR TO CONTINUE SUPPLYING THE MATERIALS.

 

 2 

Applicable terms and conditions:

The Applicant represents as follows and acknowledges that if NOVARTIS agrees to
supply the Materials to the Applicant, such representations shall become terms
of the agreement between NOVARTIS and the Applicant:

	1.	 	The Applicant is regularly engaged in conducting laboratory studies
or animal tests, and has all the required authorisations to perform
such experimental work in vitro or with laboratory animals in vivo at
the place of investigation. In particular, the Applicant is entitled
under all applicable laws and regulations to perform the Studies.
	 
	2.	 	The Materials will be used in full compliance with all laws and
regulations applicable in the country where the Studies are performed,
especially all guidelines for use of Materials and research conducted
with animals. The Applicant has adequate training and facilities to
study the Materials and will directly supervise the Studies.
	 
	3.	 	The Materials will be used solely for performance of the Studies in
the laboratories of the Applicant under suitable containment conditions
in accordance with all applicable laws and regulations. The Materials
will under no circumstances be administered to humans.
	 
	4.	 	The Materials will not be analyzed or modified other than necessary
for the purpose of the Studies without prior written consent of
NOVARTIS.
	 
	5.	 	The Materials will not be transferred or made available to any
individual other than those under the supervision and control of the
Applicant assigned to the performance of the Studies without the prior
written consent of NOVARTIS. At the end of the Studies, any unused
Materials will be either returned to NOVARTIS or disposed/destroyed
under the Applicant’s supervision in accordance with all applicable
laws and regulations and the instructions of NOVARTIS, if any.
	 
	6.	 	Any animals used in experiments with the Materials or derivatives
thereof will be disposed under the Applicant’s supervision in
accordance with all applicable laws and regulations and the
instructions of NOVARTIS, if any, and will under no circumstances be used
as food for humans or animals.

 

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	7.	 	Data regarding the dosage, safety and efficacy as well as data
regarding the analytical evaluation of the Material obtained in the
course of the Studies with the Materials will be submitted to NOVARTIS.
And will be considered Information as set forth in Section 10 below.
These data may be used by NOVARTIS and its Affiliates for its internal
business purposes, whereby Affiliate shall mean any corporation or
other business entity controlled by, controlling or under common
control of NOVARTIS. Control for the purposes of this definition shall
mean direct or indirect beneficial ownership of fifty percent (50%) or
more of the voting interest in an entity, or such other relationship
as, in fact, constitutes actual control.
	 
	8.	 	NOVARTIS will own and the Applicant herewith assigns all rights to
all patentable and non-patentable inventions and know-how relating to
the composition or manufacture of the Materials, or any use of the
Materials in treating or preventing restenosis, vulnerable plaque or
other cardiovascular diseases, or any other uses of the Materials,
which are made, discovered and/or improved during the course of the
Studies, but excluding inventions and know-how relating to Applicant’s
specific stent, polymer or drug delivery technologies. Applicant will
take all necessary steps for such assignment and will reasonably assist
NOVARTIS in the preparation of any patent applications on such
inventions.
	 
	9.	 	Where written or oral disclosure of the results by either Applicant
or NOVARTIS to any third party is foreseen, the full text of the
proposed disclosure will be sent by the party proposing the disclosure
to the non-disclosing party for review, comments and patent protection
evaluation at least 60 days prior to the intended submission for
publication or the intended oral presentation. The non-disclosing
party has the right to propose modifications to such proposed
disclosure. The non-disclosing party reserves the unrestricted right
to have deleted from the disclosure all of the non-disclosing party’s
confidential information which may be contained therein. In the case
of an objection arising in connection with the disclosure of
information in connection with a patentable invention, the
non-disclosing party may request, and the party proposing shall grant,
a delay for sixty (60) days for the purpose of filing patent
applications.
	 
	10.	 	All unpublished information provided by NOVARTIS or resulting from
the Studies (“Information”) will be held strictly confidential and will
not be disclosed to any third party. However, Information shall not
include any information of which can be shown by written evidence that
(i) at the time of first disclosure the information was already in the
possession of the receiving party, or (ii) the information is in the
public domain at the time of disclosure or (iii) the information has
been received by a third party which did not acquire it directly or
indirectly from NOVARTIS or any of its Affiliates.
	 
	11.	 	The Materials are being supplied to Applicant with no warranties,
express or implied, of merchantability or fitness for a particular
purpose or otherwise. In particular, NOVARTIS does not represent or
warrant that the use of the Materials will not infringe or violate any
patent or proprietary rights of third parties.
	 
	12.	 	The Materials are to be used with caution and prudence in any
experimental work, since not all of the characteristics are necessarily
known. Applicant shall bear all risk to it and/or any others
resulting, directly or indirectly, from its use, application, storage
or disposal/destroying.

 

 

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	13.	 	Applicant will indemnify, hold harmless and defend NOVARTIS, its
Affiliates and their respective officers, directors, employees and
agents against any and all claims, actions, demands, suits or causes of
action for damages arising out of or relating to Applicant’s use,
application, storage or disposal of the Materials. NOVARTIS shall not
be liable for any damages resulting from the use, application, storage
or disposal/destroying of the Materials by Applicant, except to the
extent such damages result directly from NOVARTIS’ gross negligence or
willful misconduct.
	 
	14.	 	This agreement is governed by, and construed in accordance with the
laws of Switzerland, except as they relate to the conflict of laws.
Any disputes between the parties are to be resolved by the ordinary
courts in Basel-City, Switzerland, without restricting any right of
appeal.

	 	 	 	 	 	 	 
	Agreement by Investigator:

	 
	 	 	 	 	 	 
	By:
	 	/s/ JOHN BABITT, COO	 	7/19/04
	 
	 	
 	 	
 
	

	 	(Signature)
	 	 	 	(Date)
	

	 	Name:
	 	John Babitt	 	 
	

	 	Function:
	 	President	 	 
	 
	 	 	 	 	 	 
	Agreement by Company/Institution:

	 
	 	 	 	 	 	 
	By:
	 	/s/ MANUEL A. VILLAFANA	 	7/19/04
	 
	 	
 	 	
 
	

	 	(Authorized signatory of employing
company or institution)
	 	(Date)
	

	 	Name:
	 	Manuel A. Villafana	 	 
	

	 	Function:
	 	Chairman/CEO	 	 

Acceptance of application and authorization to ship Materials:

Novartis Pharma AG

	 	 	 	 	 	 	 
	By:
	 	/s/ IVAN CSENDES	 	9 August 2004
	 
	 	
 	 	
 
	

	 	(Signature)
	 	 	 	(Date)
	

	 	Name:
	 	Ivan Csendes, PhD	 	 
	

	 	Function:
	 	Head Licensing Drug Delivery	 	 
	

	 	 	 	& Out-Licensing	 	 
	

	 	 	 	Business Development & Licensing	 	 

	 	 	 	 	 	 	 
	By:
	 	/s/ TOM CHAKRABORTI	 	10th August, 2004
	 
	 	
 	 	
 
	

	 	(Signature)
	 	 	 	(Date)
	

	 	Name:
	 	Tom Chakraborti	 	 
	

	 	Function:
	 	Senior Legal Counselexv10w19

 

EXHIBIT 10.19

AMENDMENT

This Amendment, effective October 11, 2004, is by and between SurModics, Inc.,
(“SURMODICS”), and CABG Medical, Inc. (“CABG”).

WHEREAS, the parties are party to that certain Clinical Coating Agreement,
effective April 15, 2003 (as amended June 30, 2004, the “Agreement”);

WHEREAS, the parties desire to clarify SURMODICS’ representations under the
Agreement.

NOW, THEREFORE, the parties agree as follows:

A. Amendment to the Agreement

     The following section 3.7 is added to the Agreement:

	 	3.7	 	Limitation of Remedies. WITH RESPECT TO ANY PRODUCT COATED BY SURMODICS
DURING THE TERM OF THE October 11, 2004 Letter Agreement BETWEEN THE
PARTIES, SURMODICS SHALL NOT BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL,
SPECIAL, EXTRAORDINARY, OR PUNITIVE DAMAGES OF ANY DESCRIPTION, WHETHER
FOR DAMAGE TO REPUTATION OR GOODWILL, LOST PROFITS, CLAIMS OF THIRD
PARTIES OR OTHERWISE, WHETHER SUCH ASSERTED DAMAGE PURPORTS TO BE BASED ON
WARRANTY OR GUARANTEE, INDEMNITY OR OTHER CONTRACT, CONTRIBUTION,
NEGLIGENCE OR OTHER TORT, OR OTHERWISE. THE PARTIES EXPRESSLY AGREE THAT
THE EXCLUSION OF SPECIAL, INCIDENTAL, CONSEQUENTIAL, AND PUNITIVE DAMAGES
SET FORTH HEREIN ARE AGREED ALLOCATIONS OF RISK AND SHALL SURVIVE THE
DETERMINATION OF ANY COURT OF COMPETENT JURISDICTION THAT ANY REMEDY
PROVIDED HEREIN FAILS OF ITS ESSENTIAL PURPOSE. UNDER NO CIRCUMSTANCES
SHALL SURMODICS’ LIABILITY HEREUNDER FOR ANY CAUSE EXCEED THE MONEY
RECEIVED BY SURMODICS FROM CABG FOR SURMODICS’ COATING SERVICES TO COAT
PRODUCT.

B. Full Force and Effect

     Except as amended hereby, the Agreement is unchanged and remains in full force
and effect.

IN WITNESS WHEREOF, the parties hereto execute this Amendment by their duly
authorized employees.

	 	 	 
	Accepted by:

	 	Accepted by:
	SurModics, Inc.

	 	CABG Medical, Inc.
	 
	 	 
	/s/ Bruce J. Barclay

	 	/s/ John Babitt, /s/ Manuel A. Villafana
	
 

	 	
 
	Signature

	 	Signature
	 
	 	 
	Bruce J. Barclay

	 	John Babitt, Manuel A. Villafana
	
 

	 	
 
	Printed Name

	 	Printed Name
	 
	 	 
	President & COO

	 	President, Chairman & CEO
	
 

	 	
 
	Title

	 	Title

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