Document:

exv10w11

 

EXHIBIT 10.11

Clinical Coating Agreement

	 	 	 
	SurModics, Inc.

	 	CABG Medical, Inc.
	9924
W 74th Street

	 	14505 21st Avenue North, Suite 212
	Eden Prairie, MN 55344

	 	Minneapolis, MN 55447
	 
	 	 
	(hereinafter referred to as “SURMODICS”)

	 	(hereinafter referred to as “CABG”)

WHEREAS, CABG and SURMODICS are parties to a Mutual Confidential Disclosure
Agreement, effective December 27, 2001 that prohibits CABG from using
SURMODICS’ coatings in human subjects;

WHEREAS, CABG desires to (i) evaluate SURMODICS’ proprietary coating
technology, and (ii) undertake limited human clinical trials of its devices
that are coated at SURMODICS’ facilities, and SURMODICS is willing to grant
its permission under the terms of this Agreement;

NOW, THEREFORE, for good and valuable consideration of which receipt is
acknowledged, the parties agree as follows:

	1.	 	PRIOR AGREEMENTS

The provisions of the Mutual Confidential Disclosure Agreement signed by
the parties and effective December 27, 2001 shall continue in full force
and effect to the extent not inconsistent with this Agreement.

	2.	 	CLINICAL COATING

	2.1	 	Product. “Product” means CABG’s stent couplings and throttles for
bypass grafts.
	 
	2.2	 	Grant. SURMODICS grants CABG the limited right to use Product coated
by SURMODICS under this Agreement in human clinical trials, such period of
utilization ending September 30, 2004.
	 
	2.3	 	Limited Right. Except as provided herein, this Agreement does not
grant CABG any license or rights under any patent rights or know-how of
SURMODICS.
	 
	2.4	 	Coating Period and Quantity. For the period ending June 30, 2004,
SURMODICS shall coat up to 1000 units of Product (each unit consisting of
one stent coupling and one throttle).
	 
	2.5	 	FDA Master Files. The reagents produced by SURMODICS and used to
coat Product for CABG’s human clinical trials shall meet the
specifications contained in master files submitted by SURMODICS to the
FDA and maintained by SURMODICS for purposes of premarket approval of
medical devices.
	 
	3.	 	REPRESENTATIONS AND WARRANTIES
	 
	3.1	 	Safety and Efficacy. CABG shall be solely responsible for
the safety and efficacy of all SURMODICS-coated Product to be
used in human clinical trials.
	 
	3.2	 	Sterilization and Testing. All SURMODICS-coated Product to be used
in human clinical trials shall be sterilized by CABG (or a third party
contracted by CABG for such purpose), before use and shall be subjected
by CABG to such quality control testing and performance testing before
use as is commonly required for medical products of this type and as is
required to ensure safety.

1

 

	3.3	 	Reports. CABG will make periodic reports to SURMODICS with respect to the
results of any
human clinical trials using SURMODICS-coated Product.
	 
	3.4	 	Compliance. CABG represents and warrants to SURMODICS that CABG will, at all times, use,
transport, and dispose of Product coated at SURMODICS’ facilities, in a manner that is in full
compliance with all applicable laws and regulations, specifically including regulatory and
export/import laws relating to human clinical trials of unapproved medical devices and specific to
the country or countries in which such human clinical trials are conducted.
	 
	3.5	 	Insurance. CABG represents and warrants to SURMODICS that CABG (a) has in place an
effective insurance program in a form reasonably sufficient to cover any foreseeable product
liability claim or claims arising out of the use, transport, or disposal of Product coated at
SURMODICS’ facilities, and (b) will provide SURMODICS with a certificate of insurance within
thirty (30) days after signing this Agreement.
	 
	3.6	 	No Warranties. SURMODICS MAKES NO WARRANTIES OF ANY KIND, EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT WITH RESPECT TO
ANY PRODUCT COATED AT SURMODICS’ FACILITIES,
	 
	4.	 	PRODUCT LIABILITY

CABG will defend and indemnify SURMODICS against all losses, liabilities,
lawsuits, claims, expenses (including attorney’s fees), costs, and judgments
incurred through personal injury, property damage, or other claims of third
parties, arising from the design, manufacture, use, or sale of Product coated
at SURMODICS’ facilities.

	5.	 	GOVERNING LAW

This Agreement shall for all purposes be governed and interpreted in accordance
with the laws of the State of Minnesota, except for its conflict of law
provisions.

IN WITNESS WHEREOF, the parties have executed this Agreement, effective on the
later of the dates on which this Agreement is signed by the parties below.

	 	 	 
	Accepted by:

	 	Accepted by:
	SurModics, Inc.

	 	CABG Medical, Inc.
	 
	 	 
	/s/ Robert W. Elliott, Jr

Signature

	 	/s/ Manuel A. Villafana
Signature
	 
	 	 
	ROBERT W. ELLIOTT, JR

	 	MANUEL A. VILLAFANA
	
 

	 	
 
	Printed Name

	 	Printed Name
	 
	 	 
	VP, LICENSING COUNSEL

	 	CHAIRMAN + CEO
	
 

	 	
 
	Title

	 	Title
	 
	 	 
	4/15/2003

Date

	 	4/10/03

Date

2exv10w12

 

\

EXHIBIT 10.12

MATERIALS TRANSFER AGREEMENT

MAYNE PHARMA (USA) INC

	 	 	 
	Recipient’s Name:

	 	CABG Medical, Inc.
	Name of Recipient’s Investigator:

	 	John L. Babitt, President
	Recipient’s Address:

	 	14505 21st Avenue North, Suite 212,

Minneapolis, Minnesota 55447

Mayne Pharma (USA) Inc (“Mayne”) agrees to transfer the materials to CABG
Medical, Inc. (“Recipient”) and Recipient agrees to use the Materials to carry
out the Research Plan described below on terms and conditions agreed to between
the Parties (Mayne and Recipient) and hereinafter appearing:

	•	 	The Recipient will coat pharmaceutical grade Paclitaxel on a cardiac
surgery device. Such device will serve as an artificial graft for
coronary artery bypass surgery. The Recipient will only coat the device
at the interface of such device and the target vessel. The Recipient will
conduct the following experiments on the coated device: (i) preclinical
evaluation of the Recipient’s Holly GraftTM System in a porcine model, and
will provide the data and results of such experiments as they related to
the utilized Paclitaxel (“Experimental Results”) to Mayne.

The materials and any accompanying know-how and data (hereinafter referred to
as “Materials”) to be provided to Recipient are described below:

Two Grams of Pharmaceutical Grade Paclitaxel

In consideration of Mayne agreeing to supply the Materials to the Recipient,
Mayne and the Recipient agree as follows:

	1.	 	Mayne shall provide the Materials solely for research and experimental
use only by Recipient’s Investigator, John L. Babitt, President, CABG
Medical, Inc. in his laboratory under suitable containment conditions.
The Materials will not be used for in vivo testing in human subjects.
Recipient’s use will be limited exclusively to the Research Plan and the
Materials will not be used for any other purpose. Use will be in
compliance with all applicable federal, state and local laws and
regulations, including, but not limited to, animal welfare laws and
regulations.
	 
	2.	 	Recipient shall not transfer, sell or otherwise distribute or disclose
the Materials to a third party for any purpose. This Agreement and the
resulting transfer of Materials constitute a non-exclusive,
non-transferable, limited licence to use the Materials, during the Term of
this Agreement ( or until this Agreement is terminated), solely as
described in the Research Plan for not-for-profit purposes. Recipient
shall not use the Materials for any products or processes for
profit-making or commercial purposes.
	 
	3.	 	The Materials and any intellectual property subsisting in or in relation
to them are the property of Mayne. Ownership and licensing of
Experimental Results and any inventions arising from Recipient’s use of
the Materials will be negotiated in good faith by the parties hereto
depending upon their relative contribution to the creation of the said
Experimental Results and inventions and any applicable laws and
regulations relating to inventorship. Recipient agrees to notify Mayne of
any invention report, improvement, patent application, patent, trade
secret or other intellectual property arising from the use of the Mayne
Materials by Recipient. Recipient agrees to provide the Experimental
Results, as they relate to the Materials, to Mayne at the earlier of the
conclusion of the Research Plan or one (1) year. Unless otherwise noted,
Mayne agrees to treat in confidence any of the results of the Research
Plan except for information that was previously known to Mayne or that is
or becomes publicly available through no fault of Mayne,.
	 
	4.	 	The Materials are supplied to Recipient WITHOUT WARRANTIES, EXPRESS OR
IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF MERCHANTABILITY OR
FITNESSS

 

 

	 	 	FOR A PARTICULAR PURPOSE. Recipient uses the Materials entirely at
Recipient’s own risk. Mayne makes no representations that the use of the
Materials will not infringe any patent or proprietary rights of third
parties. To the extent permitted by law, Mayne’s liability is limited to
the supply of the Materials.

	5.	 	Recipient will hold Mayne harmless and will indemnify and release and
keep indemnified and released Mayne and its trustees, officers, staff,
contractors, representatives and agents from and against any and all loss,
liability, damage (whether to persons or property), costs and expenses
(including without limitation legal expenses), claims, demands, suits or
other actions resulting directly or indirectly from the use, possession
and disposal of the Materials by Recipient. Recipient will notify Mayne
no later than 10 days after the Recipient becomes aware of any claim or
action relating to or involving the Materials in any way.
	 
	6.	 	Recipient agrees to treat in confidence the Material and all information,
written or oral, provided by Mayne about this Material except for
information that was previously known to Recipient or that is or becomes
publicly available through no fault of Recipient, or which is disclosed to
Recipient without a confidentiality obligation.
	 
	7.	 	This Material represents a significant investment on the part of Mayne
and is considered proprietary to Mayne. Recipient and Recipient’s
Investigator therefore agree to retain control over this Material and
further agree not to transfer the Material to anyone other than a person
under Recipient’s Investigator’s direct supervision (“Recipient Employee”)
without advance written approval of Mayne. Mayne reserves the right to
distribute the Material to others and to use it for its own purposes.
Recipient agrees to mark any Material forwarded to third parties for
processing/manufacturing as “proprietary.”
	 
	8.	 	Recipient or Recipient’s Investigator may not, without the prior written
consent of Mayne, use the Materials in any way not specified in the
Research Plan, including but not limited to:
	 
	 	 	a.     Remove the Materials from the U.S.A.;
	 
	 	 	b.     Change the nomenclature of the Materials;
	 
	 	 	c.     Make any commercial use of the Materials.

	 
	9.	 	In the event that Recipient desires to publish any information which
contain any Experimental Results obtained from the use of the Materials,
Recipient shall notify Mayne within 60 days prior to any disclosure to any
third party and shall obtain Mayne’s written approval prior to any such
disclosure or publication. However, reasonable approval will not be
withheld.
	 
	10.	 	This agreement will terminate automatically when the Research Project is
completed or three (3) years have elapsed, whichever occurs first
(“Term”). Notwithstanding the previous sentence, Mayne may terminate this
Agreement at any time or pursue any other remedy legally available to
Mayne for any activity which Mayne, in its sole discretion, deems to be a
misuse of the Materials or any breach of any provision of this Agreement.
Mayne may also terminate this Agreement without cause upon five (5) days
written notice to Recipient. Upon termination, the Material will be
returned to Mayne at Recipient’s cost or disposed of as directed by Mayne.
	 
	11.	 	This Agreement is governed by the laws of Minnesota.
	 
	12.	 	The undersigned representative of the Recipient certifies and affirms
that he/she is authorized to enter into this Agreement.
	 
	13.	 	This Agreement represents the entire understanding between the Parties,
and supersedes all other agreements, express or implied, between the
Parties concerning the Research Plan and/or Materials. This Agreement may
only be amended in a writing signed by the Parties.
	 
	14.	 	The waiver of a breach hereunder my be effected only by a writing signed
by the waiving party and shall not constitute a waiver of any other
breach.

 

 

ACCEPTED BY:

Signed by CABG Medical Inc

(by its authorised officer):

	 	 	 	 	 	 
	Title:

	 	President	 	Witness Signature: Bonnie L. Hutterer
	 
	 	 	
	 	 
	

	 	[TITLE]	 	 
	 
	 	 	 	 	 
	Signature:

	 	/s/ John L. Babitt	 	 
	

	 	[NAME]	 	 
	 
	 	 	 	 	 
	Date:

	 	3/16/04	 	 

Signed by Mayne Pharma (USA) Inc

(by its authorised officer):

	 	 	 	 	 	 	 
	Title:

	 	Vice President, Operations
	 	Witness
Signature:  
	 
	 	 
	 	 	

	 

	 	[TITLE]
	 	 
	

	 	 	 	 	 	 
	Signature:

	 	/s/ Brian McCudden	 	 	 	 
	

	 	[NAME]	 	 	 	 
	 
	 	 	 	 	 	 
	Date:	 	3/22/04

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00069-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00069-of-00352.parquet"}]]