FIRST AMENDMENT TO EXCLUSIVE LICENSE AND DEVELOPMENT
AGREEMENT
RUBICON MEDICAL, INC.
GUARDIAN RJL, INC.
and
XXXXXX LABORATORIES
Dated October 7, 2002
FIRST AMENDMENT TO EXCLUSIVE LICENSE AND DEVELOPMENT
AGREEMENT
THIS FIRST AMENDMENT TO EXCLUSIVE LICENSE AND DEVELOPMENT AGREEMENT (the
"Amendment") is entered into by and between Xxxxxx Laboratories, an Illinois
corporation having a principal place of business at 000 Xxxxxx Xxxx Xxxx,
Xxxxxx Xxxx, Xxxxxxxx 00000-0000 ("Abbott") and Rubicon Medical, Inc., a Utah
corporation having a principal place of business at 0000 Xxxx Xxxxxxxxx, Xxxx
Xxxx Xxxx, Xxxx 00000 ("Rubicon") and Guardian RJL, Inc., a Delaware
corporation, having a principal place of business at 000 Xxxx 00000 Xxxxx,
Xxxxxx, Xxxx 00000 ("Contractor").
BACKGROUND
WHEREAS, Rubicon, Abbott and Contractor entered into an Exclusive License
and Development Agreement as of June 29, 2000 (the "Agreement") regarding the
development, manufacture and sale of certain catheter products of which
Rubicon owns or has obtained rights to such products;
WHEREAS, Abbott has determined that actively pursuing the further
development of the catheter products contemplated to be developed and marketed
under the Agreement is no longer aligned with the business interests of
Xxxxxx'x cardiovascular business;
WHEREAS, Abbott and Rubicon have determined that it is in the best
interests of all parties that the Agreement be amended to reflect a transition
of the development work from Abbott to Rubicon and a one-time monetary payment
by Abbott to Rubicon as consideration for such transfer; and
WHEREAS, Rubicon, Abbott and Contractor wish to amend the Agreement to
provide for the transition of such development work.
NOW, THEREFORE, in consideration of the recitals and the mutual covenants
and obligations contained herein, the parties hereby agree as follows:
1. All words and expressions defined in the Agreement shall have the same
meanings when used in this Amendment as they have in the Agreement unless
such words or expressions are otherwise expressly defined or unless the
context otherwise requires.
2. Within forty-five (45) days after full execution of this Amendment,
Abbott shall have completed a technology transfer and assignment to
Rubicon of all of the items described in Exhibit A, which items comprise
all of the Rubicon Know-how and all of the Abbott Know-how. The
technology transfer shall also include a debriefing in sufficient detail
regarding the content of Abbott Know-how so as to enable Rubicon to
transition into the development work for the Guardian product. All
items included in the technology transfer shall be transferred to Rubicon
"as is" and "where is."
3. Sections 2.2 and 2.3 of the Agreement are deleted in their entirety.
4. Abbott shall have no further obligations under Articles 3 (except for the
obligations set forth in Section 5 of this Amendment), 4 and 5 of the
Agreement, and subject to Section 9 of this Amendment, Rubicon, in its
absolute discretion and at its sole cost, shall control, manage and
conduct any and all activities regarding the development, regulatory
approval, manufacture and sale of Product.
5. Abbott shall provide the following development and manufacturing
activities:
(a) At any time within the first ninety (90) days after full execution
of this Amendment, Rubicon, at its sole option, may request Abbott
to grind shafts for the Guardian product and supply such shafts to
Rubicon by providing Abbott with written notice of such request;
provided, however, that Abbott shall not be required to devote more
than sixty (60) hours of labor to the grinding of such shaft under
this Section 5(a). Upon receiving a written order or request for
shafts from Rubicon, Abbott shall provide Rubicon with a quotation
for the cost of the shafts, based on Xxxxxx'x direct costs (labor
and materials), along with a proposed delivery date. Rubicon shall
have fifteen (15) days to review and approve in writing such cost
quotation and delivery information. If Rubicon approves such
quotation with the fifteen (15)-day period, Abbott shall promptly
commence the requested work. Abbott shall invoice Rubicon for such
shafts at the quoted price and Rubicon shall pay such invoice within
thirty (30) days after the date of the invoice.
(b) For a period of thirty (30) days after full execution of this
Amendment, Rubicon may make a single request in writing that Abbott
manufacture not more than fifty (50) prototype Guardian products in
accordance with the specifications in effect and utilizing parts in
inventory, both as of the date hereof. If Rubicon provides Abbott
with a written notice within such thirty (30)-day period requesting
Abbott to manufacture such products, Abbott shall manufacture such
products at its own cost and shall deliver them to Rubicon within
thirty (30) days after receipt of such notice. Rubicon shall use
the products manufactured pursuant to this Section 5(b) for
demonstration and training purposes only, and shall not use them in
humans. Further, Rubicon shall indemnify, defend and hold harmless
Abbott and its Affiliates with respect to the use of such prototype
Guardian product, to the extent used in humans. If Rubicon fails
to request in writing the prototypes within the above-mentioned
thirty (30)-day period, Abbott shall have no further obligation to
Rubicon with respect to such additional prototype products, nor
shall it have any other obligation to provide alternative work or
any form of compensation to Rubicon.
6. The sublicense granted to Abbott under Section 6.1 of the Agreement and
the license granted to Abbott under Section 6.2 of the Agreement are both
hereby terminated as of the date of this Amendment. Abbott shall have no
further rights under the USC Patent Rights or the Other Patent Rights.
In addition, Abbott hereby grants to Rubicon and its Affiliates a
worldwide, royalty-free, exclusive license, including rights to
sub-license, under patent application U.S. Serial No. 10/150824 filed May
20, 2002, and any divisions or continuations thereof, to make, have made,
use, offer for sale, sell and import products in the field of distal
balloon occlusion devices for embolic protection, and a non-exclusive
license, without the right to sub-license, for other vascular
applications. Such license shall commence on the date of this Amendment
and continue until the expiration of such patent.
7. Except for the payment to be made pursuant to Section 8 of this Amendment
and the Development Fee already paid in full pursuant to Section 8.1 of
the Agreement, Abbott shall not be obligated to make any royalty,
development or milestone payment contemplated under the Agreement.
8. In consideration of Rubicon undertaking all clinical and development
activities under the Agreement at its sole cost and discretion, Abbott
shall pay Rubicon, within five (5) business days after the full execution
of this Amendment and in full satisfaction of any additional payments
contemplated under Articles 7 and 8 of the Agreement, a one-time lump sum
amount of Two Million Three Hundred Thousand Dollars ($2,300,000).
9. From the effective date of this Amendment until the earlier of thirty
(30) days after (a) CE Approval and/or (b) FDA approval for the Products
for either saphenous vein graft or carotid embolic protection
applications ("Right of First Negotiation Period"), Abbott shall have a
right of first negotiation for Abbott to obtain the exclusive right to
manufacture and market Product. In order for Abbott to exercise this
right of first negotiation, Abbott must provide Rubicon within such
thirty (30)-day period written notice of Xxxxxx'x intentions to
negotiate. The parties shall negotiate in good faith for a period of
sixty (60) days after Rubicon's receipt of Xxxxxx'x notice. If the
parties are unable to reach a definitive agreement regarding Product
within such sixty (60)-day period, the foregoing right of first
negotiation shall terminate without any further action on the part of
Rubicon or Contractor. Notwithstanding this right of first negotiation,
Rubicon shall be and shall remain free at any time to transfer, assign,
sell or otherwise dispose of any or all of its rights in and to Product
and the USC Patent Rights and Other Patent Rights without prior notice to
Abbott. In the event Rubicon consummates a transaction involving any or
all of Rubicon's rights in and to Product, USC Patent Rights and/or Other
Patent Rights, Xxxxxx'x right of first negotiation granted under this
Section 9, shall automatically terminate and be of no further force or
effect.
10. Articles 9 and 10 of the Agreement are deleted in their entirety.
11. Article 12 of the Agreement is deleted in its entirety.
12. Pursuant to Section 13.2 of the Agreement, Abbott and Rubicon shall
mutually agree to a press release regarding the subject matter of this
Amendment to be in a form as attached hereto as Exhibit B.
13. Under Section 14.1 of the Agreement, the Term shall be amended to so as
to remain in effect until the earlier of (a) the expiration of the Right
of First Negotiation Period, (b) execution of a definitive agreement
pursuant to Xxxxxx'x right of first negotiation, or (c) termination of
Xxxxxx'x right of first negotiation as a result of Rubicon's consummation
of an agreement with a Third Party, as described in Section 9 of this
Amendment.
14. Sections 14.3, 14.4, 14.5 and 14.7 of the Agreement are deleted in their
entirety.
15. Article 16 of the Agreement is deleted in its entirety.
16. Sections 17.13 and 17.14 of the Agreement are deleted in their entirety.
17. Abbott acknowledges that Contractor has fully performed all of its
obligations under the Agreement in accordance with the terms thereof and
has no further duties or obligations.
18. Except for indemnification as a result of claims from Third Parties
pursuant to Article 15 of the Agreement, any claims under this Amendment,
or any claims arising after the date of this Amendment under provisions
of the Agreement not terminated by this Amendment (collectively "Excluded
Matters"), Abbott, Rubicon and Contractor each hereby release and forever
waive and discharge any and all claims, actions, causes of action, suits,
damages, debts, or sums of money, of whatever kind or nature, whether in
law or equity, suspected or unsuspected, known or unknown, matured or
contingent, and costs and expenses thereof, including attorneys' fees,
which any of them now has or holds, or has at any time heretofore had or
held against the any of the other parties to this Amendment, arising out
of or in any way related to the Agreement or to any agreement executed by
and among the parties in accordance with the terms and conditions of the
Agreement.
It is the intention of the parties that the foregoing general
releases shall, except for the Excluded Matters, be effective as a full
and final accord and satisfaction, and as a bar to all actions, causes of
action, obligations, costs, expenses, attorneys' fees, damages, losses,
claims, liabilities and demands of any nature, character and kind, known
or unknown, suspected or unsuspected, in connection with the matters
released. In connection therewith, the parties hereby waive, to the
fullest extent allowed by law, any statutory or common law provision to
the effect that a general release does not extend to claims which
the creditor does not know or suspect to exist in his favor at the time
of executing the release, which if known by him must have materially
affected his settlement with the debtor. The parties expressly waive and
relinquish any and all rights and benefits which they may have under any
such provision of law. In connection with such waiver and relinquishment,
the parties hereby acknowledge that they are aware that they, or their
attorneys, may hereafter discover claims or facts in addition to or
different from those which they now know of or believe to exist with
respect to the subject matter of this Agreement, but that their intention
is to hereby fully, finally and forever settle and release all of the
disputes and differences, known or unknown, suspected or unsuspected,
which do now exist, which may exist in the future, or which heretofore
have existed between the parties. In furtherance of such intention, the
releases herein given shall be and remain in effect as a full and
complete general release, notwithstanding the discovery or existence
of any such additional or different claims or facts.
19. Except as otherwise amended pursuant to this Amendment, the Agreement is
unchanged and in full force and effect.
IN WITNESS WHEREOF, Abbott, Rubicon and Contractor have caused this
Amendment to be executed on its behalf by a duly authorized officer as of the
date hereof.
XXXXXX LABORATORIES RUBICON MEDICAL, INC.
By: /s/ By: /s/
---- ----
Title: President HPD Title: President/CEO
------------- -------------
Date: 10/7/02 Date: 10/8/02
------- -------
GUARDIAN RJL, INC.
By: /s/
----
Title: President
---------
Date: 10/8/02
-------
ACKNOWLEDGMENT AND CONSENT:
The undersigned University of Southern California acknowledges that it has
received and reviewed the First Amendment to Exclusive License and Development
Agreement dated October 3, 2002, among Rubicon Medical, Inc., Guardian RJL,
Inc. and Xxxxxx Laboratories (the "Amendment") to which this Acknowledgment
and Consent is attached and hereby consents to the same. The undersigned
further acknowledges that upon payment to the undersigned of $172,000 out of
the payment provided for in Section 8 of the Amendment, Rubicon shall be
current in the payment of all royalty and license obligations owing to the
undersigned. The undersigned further acknowledges that Xxxxxx Laboratories
has no outstanding obligations to it under (i) the Exclusive License and
Development Agreement dated June 29, 2000 among Rubicon Medical, Inc.,
Guardian RJL, Inc. and Xxxxxx Laboratories (the "Agreement"), (ii) the
Amendment or (iii) any other agreement among Rubicon Medical, Inc., Guardian
RJL, Inc., Xxxxxx Laboratories and/or the University of Southern California
regarding the subject matter of the Agreement and the Amendment.
UNIVERSITY OF SOUTHERN CALIFORNIA
By: /s/
----
Title: Senior Vice President Administration
------------------------------------
Date:
Exhibit A - Tech Transfer List
Manufacturing/Engineering
1) Engineering drawings
2) Tooling and Fixtures that can be exclusively used for the R&D,
manufacture, and/or test of Products.
3) Manufacturing Process Specifications
4) Coating test results
5) Assembly training programs/procedures
6) Device specific inventories, raw material, work-in-process,
finished goods
Purchasing
1) Vendor list, pricing, RFQ's and results
2) Vendor audit results
3) Purchasing specifications
Regulatory
1) Regulatory applications
2) FDA questions, comments, etc.
3) Regulatory responses to FDA
4) Informed Consents
5) Design History File
a. Design Inputs/Outputs
i. Minutes/Notes of Design Review Meetings/Other meetings
b. Verification/Validation Protocols
i. Design, Manufacturing, Packaging
ii. Reports/Data regarding testing
c. Failure Mode and Effect Analysis Procedures/Data
d. Vendor Contacts/Audits
e. Incoming Inspection Reports
f. Animal Study Protocol/Reports
g. Clinical Trial Protocol/Reports (trial results would
consist of a one page summary of the results along with a
copy of the case report forms. Note, this data is only on
pilot patients and it has not been monitored because we
were waiting to finish the training cases to start
monitoring the sites).
h. Equipment Resources
i. Calibrations
ii. PM
iii. Procedures
Quality
1) Incoming inspection processes, forms, etc.
2) Work-in-process inspection, forms, etc.
3) Final inspection processes, forms, etc.
4) Quality engineering/testing reports
Marketing (only data specific to the GuardianTM)
1) Latest version of revenue forecasts, U.S. & O.U.S.
2) Any physician feedback specific to the guardian
3) Factory cost
Research & Development
1) Review of improvements that were in process
2) Testing reports for past versions of the product and improvements
in process (where test data exists)
3) Vendors
Business & Legal
1) Competitive patent analysis (Medtronic PercuSurge and others
conference call to review)
2) USC to approve amendment
Note: All data listed above will be provided as it exists upon the
signing date for the amendment. Development of new data on behalf of Rubicon
will not be performed.
Exhibit B - Press Release
Rubicon Medical and Xxxxxx Laboratories Amend
License Agreement for Rubicon's Guardian System
October X, 2002: Salt Lake City, UT -- Rubicon Medical, Corp. (OTCBB:RMDC), a
Salt Lake City, Utah, based developer and manufacturer of medical devices and
products, today announced the amendment of the Exclusive License and
Development Agreement between Xxxxxx Laboratories and Rubicon Medical for the
Guardian balloon embolic protection system.
Under the terms of the amendment, Xxxxxx Laboratories has paid Rubicon Medical
a one-time payment of $2.3 million, and granted Rubicon a worldwide license
to all patents that have been developed by Abbott pertaining to the Guardian
System. In addition to receiving rights to the Abbott patents, Abbott will
transfer back to Rubicon all of the patent rights it received under the terms
of the Exclusive License and Development Agreement . Rubicon will xxxxx
Xxxxxx a right of first negotiation for manufacturing and distribution rights
if regulatory approval has been obtained in Europe or the United States by
Rubicon for either carotid or saphenous vein graft indications.
The technology transfer will take place over the next 45 days, wherein Abbott
will transfer all of the GuardianTM technology, inventory, manufacturing
processes, and clinical trial responsibility to Rubicon. Presently, a
European CE Xxxx clinical trial is pending, and Rubicon will have the option
to resume the study at its own expense. Several clinical sites in Europe have
been established and physicians have used and been trained in the use of the
Guardian System, and a human pilot study has been completed without adverse
events in Europe.
Rubicon will be performing an analysis of the market opportunities for the
Guardian System, and will determine whether to continue the clinical
development of the technology, or to license the technology to another partner
for the clinical development and distribution of the product.
Xx. Xxxxxxx X. Xxxxxx, President and CEO of Rubicon Medical commented, "The
amendment to our license agreement with Abbott provides Rubicon with the
financial capability to manage the development efforts of our complete line of
embolic protection devices. All of the rights to the Guardian System
technology, including Xxxxxx'x improvements to the technology, have been
returned to Rubicon on a worldwide exclusive basis. Moreover, a strong
clinical study framework has been established in Europe with excellent
clinical sites."
About Rubicon Medical
Rubicon Medical Corporation is a Salt Lake City-based developer and
manufacturer of interventional vascular medical devices and products. The
Company focuses on minimally invasive endovascular techniques and products
that are safer and more cost effective than surgery. Rubicon was proud to be
named one of the Top 100 Utah public companies by Utah Business magazine in
May 2002.
Forward Looking Statements: All forward-looking statements in this release
are based upon information available to the Company on the date of this
release. Any forward-looking statements involve risks and uncertainties,
including those risks and uncertainties described in the Company's filings
with the Securities and Exchange Commission, that could cause actual events or
results to differ materially from the events or results described in the
forward-looking statements, whether as a result of new information, future
events or otherwise. The Rubicon Filter and Guardian devices have not yet been
approved for sale in the U.S. or Europe, and no assurance exists that such
approvals will be obtained; Readers should not place undue reliance on these
forward-looking statements.
Medical Contacts: Xxxxxxx Xxxxx Investor Relations: Xxxx Xxxx or Xxxxx Xxxxxx
(000) 000-0000 786.924.1660
xxxxxxx@xxxxxxx.xxx xxxxxxxxxxxx@xxx.xxx
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