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EXHIBIT 10.1
TO
FORM 10-Q
"[*]" = confidential information omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential
treatment.
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AMENDMENT TO THE FIRST AMENDED AND RESTATED
LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF TENNESSEE RESEARCH
CORPORATION
AND
RGENE THERAPEUTICS, INC.
To All Those Concerned:
This is an Amendment to the First Amended And Restated License
Agreement between The University Of Tennessee Research Corporation and RGene
Therapeutics, Inc. having an effective date of October 12, 1995 (the
"Agreement"). UTRC and RGENE agree to amend the Agreement as of June 19, 1996,
effective as of October 12, 1995, as stated below.
Section 2.7 is hereby amended to recite:
2.7 It is specifically acknowledged that i) UTRC licensed
certain Technology to Argus Pharmaceuticals, Inc. ("Argus") through an agreement
effective as of November 1, 1993; ii) that effective October 12, 1995, Argus
Pharmaceuticals, Inc. changed its name to Aronex Pharmaceuticals, Inc.
("Aronex"); and iii) that Aronex and UTRC amended the November 1, 1993 Agreement
though a First Amended and Restated License Agreement executed on December 6 and
8, 1995. It is also specifically acknowledged that Aronex, then Argus, granted
RGENE a sublicense to its UTRC Technology through the Sublicense Agreement
effective April 6, 1994.
Section 4.1 is hereby amended to recite:
4.1 As consideration for the license hereby granted to
RGENE, including a license to the Technology licensed
to Aronex by UTRC and sublicensed to RGENE as set
forth above in Section 2.7, and which consideration
shall be accepted by UTRC as including payment in full
satisfaction of any consideration due UTRC by Aronex:
Section 4.1 C and 4.1 C (1) of the Agreement are hereby
amended to recite:
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C. RGENE shall pay to UTRC Running Royalties in an amount
equal to [*] of all Net Sales by RGENE and Affiliate
Sublicensees of Licensed Products that are covered by
a claim of an issued and unexpired patent included
within Licensed Patent Rights in the place of
manufacture, use, or sale, provided:
(1) If, in order to manufacture or sell any
Licensed Product covered by this Article
4.1C, RGENE or any Affiliate Sublicensees
are required to obtain from one or more
third parties who are not Affiliates other
royalty bearing license(s) for additional
drug delivery technology, the Running
Royalty rate payable hereunder on Net Sales
of that Licensed Product shall be reduced by
[*] for each such license actually entered
into by RGENE or an Affiliate Sublicensee,
provided that in no event shall the Running
Royalty rate be less than [*] of Net Sales
and further provided that the reduced
Running Royalty rate shall apply only to
sales of that Licensed Product on which
RGENE or an Affiliate Sublicensee actually
owes and pays a royalty to a non-Affiliate
third party.
Section 4.1 D and 4.1 D (1) of the Agreement are hereby
amended to recite:
D. RGENE shall pay UTRC Running Royalties in an amount
equal to [*] of all Net Sales of Licensed Products
that are not covered by the provisions of Article 4.1C
above by RGENE and Affiliate Sublicensees during each
calendar quarter during the term of this Agreement,
provided:
(1) If, in order to manufacture or sell any
Licensed Product covered by this Article
4.1D, RGENE or any Affiliate Sublicensees
are required to obtain from one or more
non-Affiliate third parties other royalty
bearing license(s) for additional drug
delivery technology, the Running Royalty
rate payable hereunder on Net Sales of that
Licensed Product shall be reduced by [*] for
each such license actually entered into by
RGENE or an Affiliate Sublicensee, provided
that in no event shall the Running Royalty
rate be less than [*] of Net Sales and
further provided that the reduced Running
Royalty rate shall apply only to sales of
that Licensed Product on which RGENE or an
Affiliate Sublicensee actually owes and pays
a royalty to a non-Affiliate third party.
Section 4.1 E of the Agreement is hereby amended to recite:
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[*] Confidential Treatment Requested
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E. RGENE shall pay to UTRC Sublicense Fees and Royalties
as follows:
(1) Sublicense Fees
For each sublicense and option to sublicense granted
hereunder, RGENE shall pay UTRC [*] of the net
compensation received by RGENE. The term "net
compensation" as used herein shall mean the gross
compensation received by RGENE under such sublicenses
less (a) running royalties and (b) any payment
received by RGENE from the sublicensee for (i)
purchase of Licensed Product from RGENE (the amount
excluded hereunder not to exceed RGENE's direct
out-of-pocket cost of manufacturing and shipping such
Licensed Product) and (ii) services provided by RGENE
to the sublicensee, directly or indirectly (the amount
deducted hereunder not to exceed RGENE's direct
out-of-pocket cost of providing such services).
(2) Sublicense Royalties
RGENE shall pay UTRC a Sublicense Royalty equal to
[*] of the running royalties received from RGENE's
sublicensees, RGENE shall be entitled to deduct from
such Sublicense Royalty an amount equal to running
royalties actually paid by RGENE to any non-Affiliate
licensor (other than UTRC) for the Licensed Product
that generated the Sublicense Royalty, provided that
in no event shall the Sublicense Royalty paid to UTRC
be so reduced by more than [*] and further provided
that UTRC shall receive as a Sublicense Royalty not
less than [*] nor more than [*] of the sublicensee's
Net Sales of Licensed Product.
(3) Notwithstanding the foregoing, UTRC will receive [*]
of any compensation received by RGENE as a result of
the License Agreement between RGENE and Pasteur
Merieux Serums & Vaccins S.A. dated December 15, 1995,
excluding sales of Licensed Product by RGENE to
Pasteur Merieux Serums & Vaccins S.A. or its
sublicensee (the amount excluded hereunder not to
exceed RGENE's direct out-of-pocket cost of
manufacturing and shipping such Licensed Product).
Section 8.1 shall be amended to recite:
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8.1 In the event that UTRC, The University of Tennessee, M
McMaster, any of their directors, officers, or employees, or any individual
named as an inventor of Licensed Patent Rights (hereinafter) "Indemnified Party"
is charged with infringement of a patent by a third party or is made a party in
any lawsuit (including but not limited to products liability actions) as a
result of the manufacture, use, or sale of any Licensed Product under this
Agreement or as a result of any obligation or activity of RGENE or its
sublicensees under the Agreement or any sublicense, RGENE shall:
A. defend or settle, at RGENE's expense, any such
claim of infringement or lawsuit;
B. assume all costs, expenses, damages and other
obligations for payments incurred as a consequence
of such charges of infringement or lawsuit; and
C. indemnify and hold such Indemnified Party harmless
for any and all damages, losses, liability, and
costs resulting from such charge of infringement
or lawsuit.
Section 8.6 shall be amended to recite:
8.6. RGENE agrees to carry such liability insurance as would
reasonably be expected of a company of RGENE's size and activities operating in
the pharmaceutical industry. At all times during this the term of this
Agreement, UTRC and McMaster shall be listed as an additional named insured on
such liability insurance policy(ies). RGENE agrees to provide written evidence
of such insurance upon request by UTRC or McMaster.
After 15.11, insert:
16. ARBITRATION
Except for the right of either party to apply to a court
of competent jurisdiction for a temporary restraining order, a preliminary
injunction, or other equitable relief to preserve the status quo or to prevent
irreparable harm, or to enforce the provisions of this Article 16, in the event
any dispute arises between any of the parties to this Agreement as to the
validity, construction, enforceability or performance of the Agreement or any of
its provisions, such dispute shall be settled by arbitration. The arbitration
shall be conducted in accordance with the rules of the American Arbitration
Association with a panel of three (3) arbitrators. The Federal rules of
discovery shall apply to the arbitration. The decision and judgment of the
arbitrators may be entered and enforced in any court having jurisdiction
thereof.
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IN WITNESS WHEREOF, the parties hereto have caused the Agreement to
have been amended and to be duly executed as of June 18, 1996 with an effective
date of October 12, 1995.
RGENE THERAPEUTICS, INC. THE UNIVERSITY OF TENNESSEE
RESEARCH CORPORATION
By: /s/ Martin Lindenberg By: /s/ Ann J. Roberson
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Name: Martin Lindenberg Name: Ann J. Roberson
Title: President and CEO Title: President
Date: June 19, 1996 Date: June 19, 1996
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Approved by MCMASTER UNIVERSITY
By: /s/ Ronald F. Childs
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Name: Ronald F. Childs
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Title: Vice President, Research
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Date: June 19, 1996
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