Exhibit 10.29
AMENDMENT AND CONFIRMATION OF
LICENSE AGREEMENT NO. 206-01.LIC
This Amendment and Confirmation of License Agreement No. 206-01.LIC,
("Amendment") is effective as of this 10th day of June, 2002 (the "Effective
Date") between the Arizona Board of Regents, a body corporate of the State of
Arizona, acting on behalf of and for Arizona State University, of Tempe, Arizona
("ASU"), and OXiGENE Europe AB, a corporation organized under the laws of Sweden
having its principal place of business located at Xxxxxxxxxxxxxxxx 0x, X-00000
Xxxxxxxxx, Xxxxxx, a subsidiary of OXiGENE, Inc., a Delaware corporation having
its principal place of business at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx
00000 ("OXiGENE").
License Agreement No. 206-01.LIC ("License Agreement") between the ASU and
OXiGENE, dated as of August 2, 1999, is hereby amended as follows:
1. Paragraph 1.5 is replaced in its entirety with the language set forth below:
"ASU's PATENT RIGHTS IV" or "ASU PATENT RIGHTS IV" shall mean (i) patent
rights to any and all Phosphate Pro-Drugs of each and all of those
compounds claimed in or covered by ASU PATENT RIGHTS III, including
combretastatins X-0, X-0 and A-3; combretastatins X-0, X-0, X-0, and B-4;
and combretastatins D-1 and D-2; and (ii) all additions, renewals,
divisions, substitutions, continuations, continuation-in-part applications
arising from ASU PATENT RIGHTS I, ASU PATENT RIGHTS II, ASU PATENT RIGHTS
III, or ASU PATENT RIGHTS IV (i), any patents issuing on said applications
or continuing applications including reissues, and any corresponding
extensions or foreign applications or patents, as well as any other patent
applications or patents describing the subject matter set forth above. For
the purposes of this agreement, this definition shall include only patent
rights deriving from research conducted using funding from either LICENSEE
or ASU internal funds, philanthropic funds or funds from the United States
Government. Inventions which are made exclusively under funding from third
party for-profit entities or Arizona State Agencies are excluded. Also
excluded are inventions that are made under funding from third party
for-profit entities or Arizona State Agencies in combination with funding
sources other than the United States Government.
2. The following paragraphs shall be added to the "Definitions" section of the
License Agreement:
1.20 "Phosphate Pro-Drug" or "Pro-Drug" shall mean a compound where one or more
phosphate groups are attached (by one or more bonds) to one or more phenol
groups of a COMBRETASTATIN compound, and such phosphate group(s) can be cleaved
by a phosphatase enzyme.
1.21 "Clinical Development" shall mean any point from submission of an IND to
the US FDA until such IND is withdrawn.
1.22 "Phase II Clinical Trial" shall mean a human clinical trial in any country
that is intended to initially evaluate the effectiveness of a drug for a
particular indication or indications in patients with the disease or indication
under study, or that would otherwise satisfy requirements of 21 CFR 312.21(b),
or its foreign equivalent. For the purposes of this Amendment, only Phase II
Clinical Trials of combretastatin pro-drugs may be used to trigger payments
pursuant to paragraph 4.3A.2 below.
1.23 "Phase III Clinical Trial" shall mean a pivotal human clinical trial in any
country the results of which could be used to establish safety and efficacy of a
drug as a basis for a marketing approval application submitted to the FDA, or
that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign
equivalent. For purposes hereof, Phase III Clinical Trial shall also include
Phase II/III and "fast track" Phase II trials designed to provide the safety and
efficacy data described above. For the purposes of this Amendment, only Phase
III Clinical Trials or Phase II/III and "fast track" Phase II trials of
combretastatin pro-drugs may be used to trigger payments pursuant to paragraph
4.3A.3 below.
1.24 "CA-1P" shall mean the Combretastatin A-1 Phosphate Pro-Drug described or
claimed in ASU PCT patent application No. WO 01/81355, attached hereto as
Exhibit A, the various structures of which are depicted on Exhibit "B" attached
hereto.
3. The title of Paragraph 4.3 is amended as follows:
"and ASU's PATENT RIGHTS IV" is deleted. The new title of Paragraph 4.3
shall be "For ASU's PATENT RIGHTS III:"
4. The following paragraph and subparagraphs thereof are added as Paragraph
4.3A:
4.3A FOR ASU's PATENT RIGHTS IV:
4.3A.1 $100,000 shall be payable within ten (10) days of the Effective Date
of this Amendment. In the event LICENSEE'S payment obligations for
ASU's PATENT RIGHTS IV are accelerated pursuant to Section 4.3A.5
below, such $100,000 payment shall be credited against the total
payments due for CA-1P under Section 4.3A.5(b) below.
4.3A.2 For each Phosphate Pro-Drug licensed under ASU PATENT RIGHTS IV(i)
that reaches a Phase II Clinical Trial, $100,000 shall be payable
within ten (10) days after the start of the first such Phase II
Clinical Trial.
4.3A.3 For each Phosphate Pro-Drug licensed under ASU PATENT RIGHTS IV(i)
that reaches a Phase III Clinical Trial, $400,000 shall be payable
within (10) days after the start of the first such Phase III Clinical
Trial.
4.3A.4 For each Phosphate Pro-Drug licensed under ASU PATENT RIGHTS IV(i)
for which a New Drug Application is filed in the United States (or for
which a foreign equivalent is filed elsewhere, if that occurs first),
$400,000 shall be payable within ten (10) days after the filing of the
first such New Drug Application or foreign equivalent, with the
exception of the filing of the first New Drug Application (or foreign
equivalent if that occurs first) relating to CA1-P, for which the
payment due within ten (10) days after the filing of the first such
application shall be $300,000.
4.3A.5 If LICENSEE has accumulated assets in the form of cash or cash
equivalents of $35,000,000 or more (as determined in accordance with
Paragraph 4.3A.5(g)), the payment schedule above (the "Standard
Schedule") shall be accelerated as follows for each Phosphate Pro-Drug
licensed under ASU PATENT RIGHTS IV(i) that is then in Clinical
Development:
4.3A.5(a) Upon such achievement, $200,000 shall be payable to ASU from
LICENSEE.
4.3A.5(b) After the payment set forth in Paragraph 4.3A.5(a) shall become
due, $100,000 shall be payable to ASU from LICENSEE at six month
intervals thereafter until such time as the total payments made
pursuant to Paragraph 4.3A with respect to each such Pro-Drug then in
Clinical Development shall equal $900,000. The parties agree that in
no event shall LICENSEE be obligated to pay more than a total of
$900,000 with respect to any Pro-Drug pursuant to paragraph 4.3A or
any sub-paragraph thereof.
4.3A.5(c) LICENSEE shall receive credits towards the $900,000 in payments
set forth in Paragraphs 4.3A.5(a) and 4.3A.5(b) for any amounts
previously paid for the relevant Phosphate Pro-Drug pursuant to
Paragraphs 4.3A.1 through 4.3A.4. Such credit shall first be given
against any payment due pursuant to Paragraph 4.3A.5(a) and, if the
credit exceeds $200,000, against any payment due pursuant to Paragraph
4.3A.5(b).
4.3A.5(d) If, upon LICENSEE achievement of an accumulation of $35,000,000
in cash or cash equivalent assets, LICENSEE has already paid $900,000
to ASU with respect to any Phosphate Pro-Drug then in Clinical
Development, no payment with respect to such Pro-Drug shall be due
pursuant to Paragraphs 4.3A.5(a) or 4.3A.5(b).
4.3A.5(e) Should LICENSEE'S obligation to make payments to ASU pursuant to
Paragraph 4.3A.5 be triggered by LICENSEE's accumulation of
$35,000,000 in cash or cash equivalent assets, that obligation shall
be suspended if and for so long as LICENSEE's accumulation of cash or
cash equivalent assets falls below $35,000,000, in each case as
determined in accordance with Paragraph 4.3A.5(g). If LICENSEE's
payment obligations pursuant to 4.3A.5 are suspended in accordance
with this paragraph 4.3A.5(e), LICENSEE's payment obligations shall
revert to the Standard Schedule and all payments made by LICENSEE
under paragraph 4.3A.5 shall be credited against the payments to be
made under the Standard Schedule.
4.3A.5(f) Nothing in Paragraph 4.3A.5 or any sub-paragraph thereof is
intended to give, and does not give, ASU any right to be informed
about, participate in or otherwise have any rights with regard to the
operation and/or control of LICENSEE, including its management and/or
financial decisions, except as may otherwise set forth in the License
Agreement.
4.3A.5(g) The determination as to whether LICENSEE has achieved an
accumulation of $35,000,000 or more in cash or cash equivalent assets
shall be based upon the data set forth in LICENSEE's quarterly SEC
filings and the audited financial statements contained therein.
4.3A.5(h) Nothing in this Paragraph 4.3 gives ASU the right to audit
LICENSEE's financial records or to demand that such an audit be
performed by LICENSEE in any manner other than as provided in
Paragraph 9.5.
5. Paragraph 7.2.2 shall be omitted in its entirety and noted in the License
Agreement as follows:
7.2.2 Deleted
6. All other provisions of the License Agreement shall remain in full force and
effect as previously written.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their duly authorized officers or representatives on the dates shown below.
OXIGENE, INC.
By: /s/ Xxxxxxxxx X. Xxxxxxxx
----------------------------
Name: Xxxxxxxxx X. Xxxxxxxx
Title:President and CEO
Date:_____________________________________
ARIZONA BOARD OF REGENTS
By: /s/ Xxxx Xxxxxxxxx
-------------------
Name: Xxxx Xxxxxxxxx
Title:
Date: ______________________________________
