EXHIBIT 10.11
LICENSE AGREEMENT
This Agreement ("Agreement") is effective as of September 24, 1990, by
and between CarboMedics, Inc., a Texas corporation with a place of business at
1300-B East Anderson Lane, Austin, Texas 78752 ("Licensor") and Helix BioCore,
Inc., 3905 Annapolis Lane, Minneapolis, Minnesota 55447 ("Licensee").
WHEREAS Licensor has been instrumental in the development of a cardiac
valve prosthesis and
WHEREAS Licensee desires to license the cardiac valve prosthesis and
Licensor is willing to grant a license upon the terms and conditions contained
in this Agreement and
WHEREAS Licensor and Licensee have entered into a supply contract (the
"Supply Contract"), development agreement (the "Development Agreement") and
option agreement all of even date herewith,
NOW, THEREFORE, in consideration of the premises and the faithful
performance of the mutual covenants and obligations contained in this Agreement,
the parties agree as follows:
Article I. Definitions
1.1 "Licensed Product" means a specific configuration of a bileaflet heart valve
prosthesis embodying at least one of the claims of U.S.P.N. 4,692,165
(hereinafter called the "Patent") and having substantially flat leaflets and
opposed pivot posts on an interior surface of an annular body of said heart
valve, said pivot posts comprising spherical surface portions, each pivot post
being receivable in a notch in a leaflet or constituent parts for such a
bileaflet heart valve prosthesis. The Licensed Product will comprise leaflets as
shown in Fig. 17 of the Patent and pivots as shown in Fig. 25 of the Patent.
1.2 CMI currently is the holder of U.S.P.N. 4,822,353 dated April 1, 1989 which
utilizes some corresponding figure attachments used in U.S.P.N. 4,692,165.
Licensee has no rights or claims to U.S.P.N. 4,822,353.
Article II. License Grant
2.1 In consideration of entering the Supply Contract and purchasing the
Components (as defined in the Supply Agreement) required by the Supply
Agreement, Licensor hereby grants to Licensee during the term of this Agreement
the exclusive worldwide right and license to use and sell the Licensed Product
and the right to assemble Components for the Licensed Product and sterilize and
package the Licensed Product. This License does not include the right to
sublicense or, except as provided in Section 2.3 below, the right to make or
have made the Components for the Licensed Product. Nor does it include any
inventions, patents, know-how, information, trade secrets, innovations and
enhancements which the Licensor may have or acquire relating to the Licensed
Product which is not disclosed in the Patent.
2.2 Licensee will use its best efforts to obtain all approvals necessary for
marketing of the Licensed Product.
2.3 If Licensor or its successors or assigns should be unable or unwilling to
manufacture Components for Licensee under the Supply Contract and Licensee and
its successors and assigns are not in breach of any provisions of the Supply
Contract, then Licensee will have the right and license to make or have made
Licensed Product. Notwithstanding the foregoing, if the failure of Licensor to
supply Components under the Supply Contract is the result of force majeure and
within 18 months after the force majeure event Licensor is again able to supply
all of Licensee's needs under the Supply Contract, then the license granted
under this Section 2.3 will automatically terminate.
Article III. Assistance by Licensor
3.1 Licensee will actively pursue and be responsible for submitting IDE, 510(K)
or PMA applications to the FDA and seeking such other regulatory approvals as
are necessary to bring the Licensed Product to domestic and foreign markets for
sale. Licensor agrees to use its best efforts to assist Licensee in responding
to any questions which the FDA or other applicable regulatory agency may have
regarding the manufacture of the Components for the Licensed Product.
3.2 Licensee covenants and agrees that during the term of this Agreement it will
use its best efforts to sell and market the Licensed Product. In furtherance of
its best efforts commitment set forth above, Licensee agrees to conduct all
material, performance, and histological tests and studies reasonably required to
support the development and sale of the Licensed Product, including an
application for pre-market approval from the U.S. F.D.A. Licensee agrees to meet
such standards in developing, manufacturing, and marketing the Licensed Product
as are reasonable and customary in the industry.
Article IV. Patents
4.1 In the event Licensor wishes to discontinue the maintenance of the Patent on
the Licensed Product, timely notice will be given to Licensee and Licensee will
have the right to continue such maintenance at its own expense.
Article V. Term and Termination
5.1 The term of this Agreement will commence on the date first hereinabove set
forth and continue until the expiration of the fifth Contract Year as defined in
the Supply Agreement unless Licensee fails to meet the minimum purchase
requirements for any year as set out in the Supply Agreement in which event
Licensor will have the option, immediately upon notice, to terminate this entire
Agreement or to terminate that portion of this Agreement which gives Licensee
exclusive rights in and to the Licensed Product. Upon expiration or rightful
termination of this Agreement by Licensee, Licensee will have a paid-up,
exclusive license in and to the Licensed Product.
5.2 In the event that either party breaches any of the terms of this Agreement,
(except failure to meet minimum purchases which will be governed by section 5.1
above) the non-breaching party will notify the other party in writing of the
nature of the breach. The breaching party will have 3 months from the date of
such notice to correct such breach. Upon failure to correct the breach within
said 3-month period, the non-breaching party will have the option to terminate
the Agreement by written notice of termination to the breaching party.
5.3 Should Licensee discontinue the development program or, after initial
commercialization, the sale of the Licensed Product, or fail to submit an IDE
application to the U.S. F.D.A. within three Contract Years as defined in the
Supply Agreement, Licensor may terminate this Agreement by giving Licensee 30
days written notice.
Article VI. Infringement Claims
Should any action be commenced against Licensor or Licensee which
alleges that the Licensed Product infringes the claims of any Letters Patent or
that the patent on the Licensed Product is invalid, the Licensee will have the
right but not obligation, to defend and settle such action. If Licensee fails or
refuses to defend or settle such action, then Licensor will have the right to
defend or settle it. The party not defending or settling such action will
cooperate with the other party in any manner reasonably requested for such
defense and/or settlement, at the expense of the party defending or settling
such action.
Article VII. Third Party Infringement
Should any Letters Patent licensed hereunder be infringed by a third
party by virtue of a product substantially similar to the Licensed Product, the
Licensee will have the right but not the obligation to prosecute any such action
at its own expense and retain any money collected through such action.
Notwithstanding the foregoing Licensor will have the right to prosecute an
action at its own expense if Licensee fails or refuses to do so or if some
product other than one substantially similar to the Licensed Product should
infringe the Patent and retain any money collected from such action.
Article VIII. Indemnification
Licensee agrees to be solely responsible for and to defend and
indemnify Licensor and to hold it harmless from any and all demands, claims,
causes of action, or damages including attorneys fees and expenses, arising out
of, resulting from or related to the design, manufacture, sale, distribution,
implantation or use of Licensed Product, regardless of whether the damages are
caused in whole or in part by the negligence of Licensor. It is the express
intention of the parties hereto, both Licensor and Licensee, that the indemnity
obligations and liabilities assumed by Licensee in this paragraph be without
monetary limit and without regard to causes thereof including but not limited to
any failure to warn, strict liability, or the negligence of Licensor its
officers, agents or employees, whether the negligence be sole, point, or
concurrent, active or passive. This indemnity will survive expiration or
termination of this Agreement and will be applicable to all claims regardless of
the legal theory on which they are based including, but not limited to, claims
of Licensor's negligence, breach of warranty, strict liability, and violation of
statute or government regulations, but excluding claims that the Licensed
Product infringes the patent of another.
Article IX. Notices
9.1 Any notice or communication to be given under this Agreement will be sent
certified mail, postage prepaid to the following addresses:
Licensor: CarboMedics, Inc.
1300-B East Anderson Lane
Austin, Texas 78752
Attention: President
With a copy to: Intermedics, Inc.
Post Office Box 4000
Angleton, Texas 77515-4000
Attention: General Counsel
Licensee: Helix BioCore, Inc.
3905 Annapolis Lane
Minneapolis, Minnesota 55447
Attention: President
9.2 Each party will have the right to change its address upon written notice of
its new address to the other party.
Article X. Miscellaneous
10.1 Neither Licensee nor Licensor will assign this Agreement without the prior
written consent of the other party. Notwithstanding the foregoing, either party
may freely assign this Agreement to any entity controlling, controlled by or
under common control with that party or succeeding to the entire business of
that party.
10.2 This Agreement, together with the Development, Supply and Option
Agreements, contains the entire agreement between the parties with respect to
the subject matter. No waiver, alteration or modification of any of the
provisions hereof will be binding unless in writing and signed by the parties
hereto. No waiver will be implied or continuing.
10.3 Nothing in this Agreement will be deemed or construed to constitute or
create between the parties a partnership, joint venture or agency.
10.4 This Agreement will be governed by the laws of the State of Texas.
10.5 Should any provision of this Agreement be rendered unlawful or invalid
because of any existing or subsequently enacted law or by a decree or order of a
court of last resort, the remaining provisions will continue in full force and
effect.
10.6 Licensee will cause all packages containing Licensed Product to be marked
with the legend, "Mfd. under Lic. U.S. Pat. 4,692,165."
IN WITNESS WHEREOF, the undersigned have caused this Agreement to be
executed and delivered as of the date first hereinabove set forth.
LICENSOR: LICENSEE:
CARBOMEDICS, INC. HELIX BIOCORE, INC.
By: /S/ Terry Marlatt By: /S/ M.A. Villafana
Terry Marlatt, President
Title: CEO
Printed Name: M.A. Villafana