EXHIBIT 10.10
PATENT AND TECHNOLOGY LICENSE AGREEMENT
THIS PATENT AND TECHNOLOGY LICENSE AGREEMENT ("LICENSE AGREEMENT") is
made by and between the BOARD OF REGENTS ("BOARD") OF THE UNIVERSITY OF TEXAS
SYSTEM ("SYSTEM"), an agency of the State of Texas, whose address is 000 Xxxx
0xx Xxxxxx, Xxxxxx, Xxxxx 00000, on behalf of THE UNIVERSITY OF TEXAS AT
AUSTIN ("UNIVERSITY"), which is a component institution of SYSTEM, and PEGAS
PHARMACEUTICALS, INC., a corporation duly organized and existing under the
laws of Delaware, whose address is 0000 Xxxx Xxxx Xxxx, Xxxxx Xxxx,
Xxxxxxxxxx 00000 ("LICENSEE").
W I T N E S S E T H:
Whereas BOARD owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to
LICENSED SUBJECT MATTER which were developed at UNIVERSITY prior to the
effective date of this LICENSE AGREEMENT and, in addition, may be developed
at UNIVERSITY pursuant to the RESEARCH AGREEMENT;
Whereas BOARD desires to have the LICENSED SUBJECT MATTER developed and
used for the benefit of LICENSEE, the inventor(s), BOARD, and the public as
outlined in the Intellectual Property Policy promulgated by the BOARD; and
Whereas LICENSEE wishes to obtain a license from BOARD to practice
LICENSED SUBJECT MATTER.
NOW, THEREFORE, in consideration of the mutual covenants and premises
herein contained, the parties hereto agree as follows:
I. EFFECTIVE DATE
This LICENSE AGREEMENT shall be effective as of June 11, 1992 ("EFFECTIVE
DATE"), subject to approval by BOARD.
II. DEFINITIONS
As used in this LICENSE AGREEMENT, the following terms shall have the
meanings indicated:
2.1 "LICENSED FIELD" shall mean treatment of any medical condition of
humans including without limitation [*]
* Confidential treatment has been requested for marked portion
[*]. The "LICENSED FIELD", however, shall not include treatment of medical
conditions of humans by means of (a) coated medical devices [*], except any
type of angioplasty catheter, endoscope, laparoscope, intravascular stent, or
controlled release device for drug delivery, (b) cell encapsulation, (c) the
systemic release of therapeutic substances, or (d) the use of polymeric
systems to prolong the systemic half-life of therapeutic substances. BOARD
shall be free to license PATENT RIGHTS and TECHNOLOGY RIGHTS to other parties
in all fields of use outside the LICENSED FIELD.
2.2 "LICENSED PRODUCT" shall mean any product, component or material the
manufacture, use or sale of which would infringe a VALID CLAIM.
2.3 "LICENSED SUBJECT MATTER" shall mean inventions, discoveries and
information covered by PATENT RIGHTS or TECHNOLOGY RIGHTS within the LICENSED
FIELD.
2.4 "LICENSED TERRITORY" shall mean the entire world.
2.5 "NET SALES" shall mean the gross revenues actually received by
LICENSEE or SUBSIDIARIES from the SALE of LICENSED PRODUCTS, less (a) normal
and customary rebates, and cash and trade discounts, (b) sales, use and/or
other excise taxes or duties actually paid, (c) the cost of any packages and
packing, (d) insurance costs and outbound transportation charges prepaid or
allowed, (e) import and/or export duties actually paid, and (f) amounts
allowed or credited due to returns (not to exceed the original billing or
invoice amount).
2.6 "PATENT RIGHTS" shall mean any and all rights in and to inventions,
discoveries or information relating to the manufacture, use or sale of
biomedical hydrogels or surface coatings covered by patents and/or patent
applications whether domestic or foreign, and all divisions, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof, and
any letters patents that issue thereon, conceived or reduced to practice
either prior to the EFFECTIVE DATE and which name Xx. Xxxxxxx X. Xxxxxxx as
either sole or joint inventor, or after the EFFECTIVE DATE and arising out of
or in connection with the RESEARCH PROGRAM, and which BOARD has or may have
the right to license or sublicense to LICENSEE under this LICENSE AGREEMENT.
The PATENT RIGHTS in existence in the LICENSED TERRITORY as of the EFFECTIVE
DATE are set forth on Schedule A attached hereto and incorporated herein.
2.7 "RESEARCH AGREEMENT" shall mean a certain Sponsored Research
Agreement by and between the UNIVERSITY and LICENSEE effective as of June 1,
1992.
* Confidential treatment has been requested for marked portion
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2.8 "RESEARCH PROGRAM" shall mean the Research Program conducted by
UNIVERSITY under the direction of Xxxxxxxxx Xxxxxxx X. Xxxxxxx pursuant to
the RESEARCH AGREEMENT in accordance with the description set forth in
Attachment A attached thereto.
2.9 "SALE" or "SELL" or "SOLD" shall mean the transfer or disposition of
a LICENSED PRODUCT for value to a party other than LICENSEE or a SUBSIDIARY,
which transfer or disposition would, but for the rights and license granted
hereunder, infringe a VALID CLAIM in the country in which such LICENSED
PRODUCT is transferred or disposed.
2.10 "SUBSIDIARY" shall mean any corporation or other entity that is
directly or indirectly controlling, controlled by or under common control
with LICENSEE. For the purpose of this definition, "control" shall mean the
direct or indirect ownership of more than fifty percent (50%) of the shares
of the subject entity entitled to vote in the election of directors (or, in
the case of an entity that is not a corporation, for the election of the
corresponding managing authority).
2.11 "TECHNOLOGY RIGHTS" shall mean any and all rights in any technical
information, know-how, process, procedure, composition, device, method,
formula, protocol, technique, software, design, drawing or data relating to
biomedical hydrogels or surface coatings which is not covered by the PATENT
RIGHTS but which is necessary for practicing an invention, discovery or
information covered by the PATENT RIGHTS, conceived or reduced to practice
either prior to the EFFECTIVE DATE, or after the EFFECTIVE DATE and arising
out of or in connection with the RESEARCH PROGRAM, and which BOARD has or may
have the right to license or sublicense to LICENSEE under this LICENSE
AGREEMENT.
2.12 "VALID CLAIM" shall mean either (a) a claim of an issued and
unexpired patent included within the PATENT RIGHTS, which has not been held
unenforceable, unpatentable or invalid by a court or other governmental
agency of competent jurisdiction, and which has not been admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a
claim in a hypothetical issued patent corresponding to a pending claim in a
patent application within the PATENT RIGHTS, provided that if such pending
claim has not issued as a claim of an issued patent within the PATENT RIGHTS
within six (6) years after the filing date from which such patent application
takes priority, such pending claim shall not be a VALID CLAIM for purposes of
this LICENSE AGREEMENT. In the event that a claim of an issued patent within
the PATENT RIGHTS is held by a court or other governmental agency of
competent jurisdiction to be unenforceable, unpatentable or invalid, and such
holding is reversed on appeal by a higher court or agency of competition
jurisdiction, such claim shall be reinstated as a VALID CLAIM hereunder.
III. REPRESENTATIONS AND WARRANTIES
3.1 Except for the rights, if any, of the Government of the United
States of America, as set forth in Paragraph 3.2, BOARD represents and
warrants that (a) BOARD is the owner of the entire right, title, and interest
in and to LICENSED SUBJECT MATTER, (b) BOARD has the sole
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right and authority to enter into this LICENSE AGREEMENT and grant the rights
and licenses hereunder, (c) BOARD has not previously granted and will not
grant any rights in the LICENSED SUBJECT MATTER or LICENSED PRODUCTS that are
inconsistent with the rights and licenses granted to LICENSEE herein, (d) to
the best of BOARD's knowledge, as of the EFFECTIVE DATE, but without research
into the matter, the LICENSED PRODUCTS do not infringe any patent rights,
trade secrets or other proprietary rights of any third party, and (e)
SCHEDULE A includes all patents and patent applications within the PATENT
RIGHTS existing as of the EFFECTIVE DATE, and BOARD owns no rights in any
other patent or patent application, the claims of which would dominate the
claims of a patent or patent application within the PATENTS RIGHTS as applied
to the LICENSED FIELD.
3.2 LICENSEE understands that the LICENSED SUBJECT MATTER may have been
developed under a funding agreement with the Government of the United States
of America and, if so, that the Government may have certain rights relative
thereto. This LICENSE AGREEMENT is explicitly made subject to the
Government's rights under any such Government funding agreement and any
applicable law or regulation. To the extent that there is a conflict between
any such Government funding agreement, applicable law or regulation, and this
LICENSE AGREEMENT, the terms of such Government funding agreement, applicable
law or regulation shall prevail.
3.3 NEITHER PARTY MAKES ANY REPRESENTATIONS OTHER THAN THOSE EXPRESSLY
STATED IN THIS LICENSE AGREEMENT, AND SPECIFICALLY, BOARD MAKES NO EXPRESS OR
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
IV. LICENSE
4.1 Subject to the terms and conditions of this LICENSE AGREEMENT, BOARD
hereby grants to LICENSEE a royalty-bearing, exclusive right and license
under LICENSED SUBJECT MATTER to manufacture, have manufactured, use and sell
LICENSED PRODUCTS, to practice any method, process or procedure within the
PATENT RIGHTS or the TECHNOLOGY RIGHTS, and to otherwise exploit the LICENSED
SUBJECT MATTER, within the LICENSED TERRITORY for use within the LICENSED
FIELD. This grant shall be subject to the payment by LICENSEE to BOARD of
all consideration as provided in this LICENSE AGREEMENT, and shall be further
subject to rights retained by BOARD to:
(a) Subject to Article XII below, and Articles VI and VII of the
RESEARCH AGREEMENT, publish the general scientific findings from research
related to LICENSED SUBJECT MATTER; and
(b) Use any information contained in LICENSED SUBJECT MATTER for
research, teaching and other educationally-related purposes.
* Confidential treatment has been requested for marked portion
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4.2 LICENSEE may extend the right and license granted to LICENSEE under
Paragraph 4.1 to any SUBSIDIARY provided that such SUBSIDIARY consents to be
bound by this LICENSE AGREEMENT to the same extent as LICENSEE.
4.3 LICENSEE and any SUBSIDIARY may grant and authorize sublicenses
within the scope of the right and license granted to LICENSEE pursuant to
this LICENSE AGREEMENT; provided, however, that any such right and license
granted to a sublicensee shall not include the right to grant sublicenses.
LICENSEE and any SUBSIDIARY, if applicable, shall monitor the operations of
their respective sublicensees in connection with the obligations of LICENSEE
and any SUBSIDIARY pursuant to this LICENSE AGREEMENT, and shall take all
reasonable steps to ensure that such sublicensees comply fully with such
obligations. LICENSEE shall promptly inform BOARD of the name and address of
each such sublicensee. Upon termination of this LICENSE AGREEMENT, any and
all existing sublicenses granted by LICENSEE or any SUBSIDIARY, if
applicable, shall survive; provided that such sublicensees promptly agree in
writing to be bound by the terms of this LICENSE AGREEMENT.
4.4 The right and license under the LICENSED SUBJECT MATTER granted to
LICENSEE pursuant to Paragraph 4.1 shall inure to the benefit of and may be
extended to any customer, direct or indirect, of LICENSED PRODUCTS
manufactured by or for LICENSEE, SUBSIDIARIES and/or sublicensees of either
LICENSEE or a SUBSIDIARY hereunder insofar as the inventions, discoveries and
information covered by the LICENSED SUBJECT MATTER may be practiced by such
customer in connection with application or use of such LICENSED PRODUCTS.
4.5 BOARD agrees to promptly provide to LICENSEE copies of all
documented information in BOARD's possession pertaining to LICENSED PRODUCTS
and the manufacture or use of LICENSED PRODUCTS that in each case BOARD has
the right to provide to LICENSEE, including without limitation all
preclinical and clinical trial data, if any, and related reports,
manufacturing information and the like. Subject to Article XII, LICENSEE
shall have the right to use and disclose such information to the extent
reasonably necessary to exploit the rights and license granted to LICENSEE
under this LICENSE AGREEMENT.
4.6 If at any time during the term of this LICENSE AGREEMENT BOARD
establishes a bona fide detailed plan to develop a product covered by the
LICENSED SUBJECT MATTER (a "PRODUCT"), or receives such a plan from a
reputable third party with resources reasonably necessary to develop and
commercialize such PRODUCT, BOARD may give written notice to LICENSEE of such
event. If LICENSEE is not then developing, producing or using a LICENSED
PRODUCT that is substantially similar to or intended for a similar purpose as
the PRODUCT that BOARD or such third party proposes to develop, and the
development or sublicensing of such a PRODUCT is not within LICENSEE's
business plans or activities for development and commercialization on a
schedule that either reasonably approximates that of such third party or is
more favorable than that of such third party, LICENSEE shall elect one of the
following options following BOARD's notice:
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(a) Undertake reasonable efforts to sponsor research toward the
development of such PRODUCT (directly or indirectly through third parties),
and thereafter develop, produce, sell, use or sublicense such PRODUCT; or
(b) Release its rights under this LICENSE AGREEMENT to such PRODUCT.
Following BOARD's notice to LICENSEE under this Paragraph 4.6, BOARD shall
provide to LICENSEE a written research plan for the development of the
PRODUCT in sufficient detail to enable LICENSEE to determine its capability
to develop such PRODUCT, together with such other information as LICENSEE may
reasonably request for purposes of such determination. LICENSEE shall have
one hundred twenty days (120) after receipt of such plan and information to
notify BOARD of LICENSEE's election under this Paragraph 4.6.
V. PAYMENTS AND REPORTS
5.1 In consideration of the rights and license granted by BOARD to
LICENSEE under this LICENSE AGREEMENT, LICENSEE agrees to pay BOARD a
non-refundable, non-creditable license fee equal to [*]. LICENSEE shall pay
such fee in accordance with the following schedule:
(a) Within ten (10) days after the EFFECTIVE DATE, [*];
(b) Upon the first anniversary of the EFFECTIVE DATE, [*];
(c) Upon the second anniversary of the EFFECTIVE DATE, [*];
(d) Upon the third anniversary of the EFFECTIVE DATE, [*]; and
(e) Upon the fourth anniversary of the EFFECTIVE DATE, [*].
5.2 In further consideration of the rights and license granted by BOARD
to LICENSEE under this LICENSE AGREEMENT, LICENSEE agrees to pay BOARD in
connection with the development of the first LICENSED PRODUCT [*] in
accordance with the following schedule:
(a) Upon submission of an Investigation New Drug application ("IND"),
or the equivalent thereof, to the United States of America Food and Drug
Administration ("FDA")
* Confidential treatment has been requested for marked portion
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for the first LICENSED PRODUCT by LICENSEE or a SUBSIDIARY or a sublicensee
of either LICENSEE or a SUBSIDIARY, [*];
(b) Upon completion of Phase I human clinical trials of the first
LICENSED PRODUCT by LICENSEE or a SUBSIDIARY or a sublicensee of either
LICENSEE or a SUBSIDIARY, [*];
(c) Upon completion of Phase III human clinical trials of the first
LICENSED PRODUCT by LICENSEE or a SUBSIDIARY or a sublicensee of either
LICENSEE or a SUBSIDIARY, [*];
(d) Upon submission of a New Drug Application ("NDA"), or the
equivalent thereof, to the FDA for the first LICENSED PRODUCT by LICENSEE
or a SUBSIDIARY or a sublicensee of either LICENSEE or a SUBSIDIARY, [*];
and
(e) Upon the first commercial SALE of the first LICENSED PRODUCT by
LICENSEE or a SUBSIDIARY or a sublicensee of either LICENSEE or a
SUBSIDIARY, [*].
All payments made to BOARD by LICENSEE pursuant to this Paragraph 5.2 shall
be non-refundable and non-creditable payments and shall apply to the
development of the first LICENSED PRODUCT only.
5.3 In further consideration of the rights and license granted by BOARD to
LICENSEE under this LICENSE AGREEMENT, LICENSEE agrees to pay BOARD:
(a) [*] of any SUBLICENSE FEES received by LICENSEE or SUBSIDIARIES
in connection with the grant of a sublicense to a third party relating to
the manufacture, use or sale of a LICENSED PRODUCT in any medical treatment
within the LICENSED FIELD, except treatment of post-surgical adhesions; and
(b) [*] of any SUBLICENSE FEES received by LICENSEE or SUBSIDIARIES
in connection with the grant of a sublicense to a third party relating to
the manufacture, use or sale of a LICENSED PRODUCT in the treatment of
post-surgical adhesions.
"SUBLICENSEE FEES" shall mean all cash license fees paid or payable to
LICENSEE upon execution of a sublicense between LICENSEE or a SUBSIDIARY and
a third party relating to LICENSED PRODUCTS, but such fees shall not include
advances against future royalties that are to be credited against future
running royalties to be paid by sublicensee on sale of LICENSED PRODUCTS,
LICENSED PRODUCT development funds, equity investments, or scientific
* Confidential treatment has been requested for marked portion
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benchmark payments or payments for past research expenditures relating to
development of LICENSED PRODUCTS.
5.4 In further consideration of the rights and license granted by BOARD to
LICENSEE under this LICENSE AGREEMENT, except as otherwise provided in
Paragraph 5.5, LICENSEE agrees to pay to BOARD a running royalty equal to:
(a) [*] of NET SALES attributed to SALES of LICENSED PRODUCTS by
LICENSEE and/or SUBSIDIARIES; and
(b) [*] of NET SALES attributed to SALES of LICENSED PRODUCTS by
sublicensees of either LICENSEE or a SUBSIDIARY.
5.5 In the event that a LICENSED PRODUCT is approved for marketing by
the FDA, or other similar government agencies in the LICENSED TERRITORY, with
a label claim for use in the treatment of post-surgical adhesions, LICENSEE
agrees to pay to BOARD a running royalty equal to:
(a) [*] of NET SALES attributed to SALES of LICENSED PRODUCTS by
LICENSEE and/or SUBSIDIARIES for use of such LICENSED PRODUCTS in treatment
of post-surgical adhesions; and
(b) [*] of NET SALES attributed to SALES of LICENSED PRODUCTS by
sublicensees of either LICENSEE or a SUBSIDIARY for use of such LICENSED
PRODUCTS in treatment of post-surgical adhesions.
5.6 The running royalties under Paragraph 5.4 and Paragraph 5.5 shall be
payable only for SALES of LICENSED PRODUCTS by LICENSEE, SUBSIDIARIES or
sublicensees of either LICENSEE or a SUBSIDIARY beginning upon the date of
the first SALE of such LICENSED PRODUCT in any country in the LICENSED
TERRITORY by LICENSEE, SUBSIDIARIES or sublicensees of either LICENSEE or a
SUBSIDIARY after obtaining approval for marketing of such LICENSED PRODUCTS
by the FDA, or other similar government agencies, in such country, and
continuing until the date that SALES of such LICENSED PRODUCTS would not
infringe a VALID CLAIM in the country in which such SALES occur.
5.7 Notwithstanding the foregoing, if LICENSEE is required to pay
royalties to third parties in connection with the SALE of LICENSED PRODUCTS
either under license agreements for other technologies which LICENSEE, in
LICENSEE's reasonable judgment, determines are desirable to be incorporated
in such LICENSED PRODUCTS, or under license agreements with third parties
that are joint owners of patent applications or patents within the PATENT
RIGHTS, and the total royalties to be paid by LICENSEE to BOARD and third
parties would exceed [*] on SALES of LICENSED PRODUCTS by LICENSEE and/or
SUBSIDIARIES, or [*] on SALES of LICENSED PRODUCTS by sublicensees of either
LICENSEE or a
* Confidential treatment has been requested for marked portion
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SUBSIDIARY, the amounts to be paid under Paragraph 5.4 and/or Paragraph 5.5
shall be reduced in accordance with the following formulas:
(a) Royalties payable on SALES by LICENSEE and/or SUBSIDIARIES of
LICENSED PRODUCTS shall equal [*] of NET SALES payable as royalties
to BOARD and third parties on SALES by LICENSEE and/or SUBSIDIARIES of
LICENSED PRODUCTS (prior to the adjustment hereunder and any similar
adjustment in the amount to be paid to such third parties). However,
after adjustment in accordance with this Paragraph 5.7(a) (which adjustment
shall be made after deduction in royalties pursuant to Paragraph 7.3, if
any), royalties payable to BOARD on SALES of LICENSED PRODUCTS by LICENSEE
and/or SUBSIDIARIES shall not be less than [*] of NET SALES attributed to
such SALES, unless LICENSEE, pursuant to Paragraph 5.8, converts the
license granted to LICENSEE under Paragraph 4.1 to a non-exclusive license.
(b) Royalties payable on SALES by sublicensees of either LICENSEE
or a SUBSIDIARY of LICENSED PRODUCTS shall equal [*] of NET SALES payable
as royalties to BOARD and third parties on SALES by sublicensees of either
LICENSEE or a SUBSIDIARY of LICENSED PRODUCTS (prior to the adjustment
hereunder and any similar adjustment in the amount to be paid to such
third parties). However, after adjustment in accordance with this
Paragraph 5.7(b) (which adjustment shall be made after deduction in
royalties pursuant to Paragraph 7.3, if any), royalties payable to BOARD
on SALES of LICENSED PRODUCTS by sublicensees of either LICENSEE or a
SUBSIDIARY shall not be less than [*] of NET SALES attributed to such
SALES.
Notwithstanding the foregoing, the adjustment in this Paragraph 5.7 shall not
apply if such adjustment would increase the amounts payable under Paragraph
5.4 or Paragraph 5.5 above.
5.8 Effective upon written notice to BOARD, LICENSEE may convert the
license granted to LICENSEE under Paragraph 4.1 to a non-exclusive license.
In such event, the amounts to be paid to BOARD under Paragraph 5.4 and
Paragraph 5.5 following such notice, after any adjustment under Paragraph
5.7, if applicable, shall be reduced by [*]; provided, however, that in no
event shall the amounts payable to BOARD under Paragraph 5.4 and Paragraph
5.5 be less than [*] of NET SALES.
5.9 In the event that more than one patent within the PATENT RIGHTS is
applicable to any LICENSED PRODUCT subject to royalties under this Article V,
then only one royalty shall be paid to BOARD in respect of such quantity of
the LICENSED PRODUCTS and in any event duplication of the running royalty
shall be avoided. It is understood that royalties shall only be payable
under this Article V with respect to LICENSED PRODUCTS whose sale would
infringe a
* Confidential treatment has been requested for marked portion
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VALID CLAIM in the country in which such LICENSED PRODUCT is SOLD. No
royalty shall be payable under Paragraph 5.4 or Paragraph 5.5 above with
respect to the SALE of LICENSED PRODUCTS between or among LICENSEE and
SUBSIDIARIES, provided that such LICENSED PRODUCTS are to be resold to
unrelated third parties, or with respect to any fees or other payments paid
between or among LICENSEE and SUBSIDIARIES; nor shall a royalty be payable
under Paragraph 5.4 or Paragraph 5.5 with respect to SALES of LICENSED
PRODUCTS for use in clinical trials or as samples, or for LICENSED PRODUCTS
that are otherwise SOLD at a price less than [*]. "MANUFACTURING COST" shall
mean the fully burdened cost of manufacturing a LICENSED PRODUCT including
without limitation the direct cost of labor, materials and allocable
pharmaceutical manufacturing overheads in accordance with generally accepted
accounting principles consistently applied.
5.10 LICENSEE shall keep complete and accurate records of SALES by
LICENSEE, SUBSIDIARIES and sublicensees of either LICENSEE or a SUBSIDIARY
and NET SALES, and any SUBLICENSEE FEES received by LICENSEE or SUBSIDIARIES,
in sufficient detail to enable the amounts payable hereunder to be
determined. Upon BOARD's written request, but not more frequently than once
per calendar year, LICENSEE shall permit representatives or agents of BOARD,
at BOARD's expense, to examine such records during LICENSEE's regular
business hours for the purpose of and to the extent necessary to verify any
report required under this LICENSE AGREEMENT with respect to SALES and
SUBLICENSEE FEES made not more than three (3) years prior to the date of
BOARD's request. In the event that the amounts due to BOARD are determined
to have been underpaid, LICENSEE shall pay to BOARD any amount due and
unpaid, together with interest on such amount at the prime rate in effect at
Bank of America NT&SA, San Francisco, California, or at the maximum rate
permitted by law, whichever is lower.
5.11 In each calendar year during the term of this LICENSE AGREEMENT
first beginning after commercialization of a LICENSED PRODUCT or receipt by
LICENSEE or SUBSIDIARIES of any SUBLICENSEE FEES, within ninety (90) days
after March 31, June 30, September 30 and December 31, LICENSEE shall deliver
to BOARD at the address listed in Paragraph 5.13, a true and accurate report,
giving such particulars of the business conducted by LICENSEE, SUBSIDIARIES
and sublicensees of either LICENSEE or a SUBSIDIARY, if any, during the
preceding three (3) calendar months under this LICENSE AGREEMENT as are
pertinent to an account for payments hereunder. Such report shall include at
least (a) the total number of SALES; (b) the total of NET SALES; (c) the
total amount of SUBLICENSEE FEES received by LICENSEE and SUBSIDIARIES; (d)
the calculation of amounts due BOARD pursuant to this Article V; and (e) the
total amount so calculated and due BOARD. Simultaneously with the delivery
of each such report, LICENSEE shall pay to BOARD the total royalties amount,
if any, due to BOARD for the period of such report. If no royalties are due,
LICENSEE shall so report.
5.12 Upon the request of BOARD but not more frequently than once per
calendar year, LICENSEE shall deliver to BOARD a written report as to
LICENSEE's efforts and accomplishments during the preceding year in
commercializing LICENSED SUBJECT MATTER in the LICENSED TERRITORY and its
commercialization plans for the upcoming year.
* Confidential treatment has been requested for marked portion
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5.13 All amounts payable hereunder by LICENSEE shall be payable in United
States of America Dollars. If any currency conversion shall be required in
connection with the payment of royalties hereunder, such conversion shall be
made by using the exchange rates used by LICENSEE in calculating LICENSEE's
own revenues for financial reporting purposes. Any income or other tax that
LICENSEE, SUBSIDIARIES, or sublicensees of either LICENSEE or a SUBSIDIARY
are required by statute to withhold with respect to the amounts payable under
this LICENSE AGREEMENT shall be deducted from such amounts, and LICENSEE
shall furnish BOARD with proper evidence of the taxes paid. Checks shall be
made payable to The University of Texas at Austin and mailed to: Executive
Vice President and Xxxxxxx, The University of Texas at Austin, Xxxx Xxxxxxxx
000, Xxxxxx, Xxxxx, 00000-0000, Attention: Xxxxxxxx X. Xxxxxxxxx.
VI. TERM AND TERMINATION
6.1 The term of this LICENSE AGREEMENT shall commence on the EFFECTIVE
DATE and continue in full force and effect until expiration, revocation or
invalidation of the last patent within the PATENT RIGHTS licensed to
LICENSEE, unless terminated earlier pursuant to this Article VI.
Notwithstanding the above, upon the expiration, but not an earlier
termination of this LICENSE AGREEMENT, LICENSEE shall have a non-exclusive,
fully paid-up right and license under the LICENSED SUBJECT MATTER to use and
exploit the TECHNOLOGY RIGHTS.
6.2 This LICENSE AGREEMENT will terminate:
(a) Upon BOARD's written notice to LICENSEE after ninety (90) days
written notice to LICENSEE if LICENSEE breaches or defaults on any
material obligation under this LICENSE AGREEMENT; provided that such
ninety (90) day notice specifies the nature of the breach; and provided
further that LICENSEE may avoid such termination if before the end of
such ninety (90) day period LICENSEE notifies BOARD in writing that such
breach or default has been cured and states the manner of such cure.
However, if LICENSEE disputes such breach in writing within such ninety
(90) day period, BOARD shall not have the right to terminate this
LICENSE AGREEMENT unless and until a court of competent jurisdiction has
determined that this LICENSEE AGREEMENT was materially breached and such
determination is final, and LICENSEE fails to cure such breach within
ninety (90) days after such determination. For purposes of this
Paragraph 6.2(a), a determination by a court of competent jurisdiction
shall be deemed final if such determination either is not appealed, or
is appealed to and upheld or otherwise confirmed by a court of appeals
to which an appeal for review of such determination may be made
directly; or
(b) In its entirety or as to any particular patent application or
patent within the PATENT RIGHTS, upon LICENSEE's sixty (60) days prior
written notice to BOARD. From and after the effective date of a
termination under this Paragraph 6.2(b) with respect to a particular
patent application or patent, such patent application and patent shall
cease to be within the PATENT RIGHTS for all purposes of this LICENSE
AGREEMENT. Upon a
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termination of this LICENSE AGREEMENT in its entirety under this
Paragraph 6.2(b), all rights and obligations of LICENSEE and BOARD shall
terminate, except as provided in Paragraphs 6.3, 6.4 and 6.5 below.
6.3 Upon termination of this LICENSE AGREEMENT for any reason, nothing
herein shall be construed to release either party of any obligation matured
prior to the effective date of such termination.
6.4 In the event that this LICENSE AGREEMENT is terminated for any
reason, LICENSEE, SUBSIDIARIES and customers of either LICENSEE or a
SUBSIDIARY may, after the effective date of such termination, sell or
otherwise dispose of all LICENSED PRODUCTS and parts therefor that LICENSEE,
SUBSIDIARIES and customers of either LICENSEE or a SUBSIDIARY may have on
hand on the effective date of such termination, subject to LICENSEE's payment
to BOARD of royalties pursuant to Article V of this LICENSE AGREEMENT. Upon
termination of this LICENSE AGREEMENT for any reason, any sublicense granted
by LICENSEE or SUBSIDIARY, if any, under this LICENSE AGREEMENT shall
survive, provided that the sublicensee promptly agrees in writing to be bound
by the terms of this LICENSE AGREEMENT.
6.5 Articles II, VI, IX, X, XI, XII and XV shall survive the expiration
and any termination of this Agreement. Except as otherwise provided in this
Article VI, all rights and obligations of the parties under this Agreement
shall terminate upon the expiration or termination of this Agreement.
VII. INFRINGEMENT
7.1 In the event that any of the PATENT RIGHTS are infringed by a third
party, LICENSEE and/or a sublicensee of either LICENSEE or a SUBSIDIARY shall
have, subject to Paragraph 7.2, the first right and obligation to institute
and prosecute any action or proceeding to enforce the PATENT RIGHTS with
respect to such infringement including without limitation settlement
discussions relating to, and any declaratory judgment action arising from,
such infringement by competent counsel of LICENSEE's choice or, if
applicable, such sublicensee's choice. If LICENSEE or, if applicable, a
sublicensee of either LICENSEE or a SUBSIDIARY institutes and prosecutes any
such action or proceeding, LICENSEE or such sublicensee, if applicable, shall
have an exclusive right to control such action or proceeding. In the event
that LICENSEE or a sublicensee of either LICENSEE or a SUBSIDIARY commences
an action to enforce the PATENT RIGHTS, LICENSEE shall have the right during
the pendency of the action to withhold [*] of the royalties payable to BOARD
hereunder based on the SALE of the LICENSED PRODUCTS covered by the patent or
patent within the PATENT RIGHTS in dispute to offset LICENSEE's and such
sublicensee's out-of-pocket legal expenses incurred in connection with such
action or proceeding. Any portion of such withheld royalties that is not so
applied, shall be promptly paid to BOARD after such action or proceeding is
resolved or abandoned. Any amounts recovered from third parties by LICENSEE
or a sublicensee of
* Confidential treatment has been requested for marked portion
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either LICENSEE or a SUBSIDIARY with respect to the PATENT RIGHTS in such
action or proceeding shall be applied first to reimburse any outstanding
legal expenses of the action or proceeding incurred by LICENSEE or such
sublicensee, and then to reimburse BOARD for any royalties or fees withheld
under this Paragraph 7.1 with respect to such action or proceeding. Any
amounts remaining shall be included in NET SALES for purposes of calculating
royalties owed pursuant to Paragraph 5.4 and/or Paragraph 5.5, as applicable.
7.2 In the event that any of the PATENT RIGHTS are infringed by a third
party, and LICENSEE and/or a sublicensee of either LICENSEE or a SUBSIDIARY,
if appropriate, has not instituted action or proceedings against such third
party to enforce the PATENT RIGHTS, or has not concluded settlement
discussions with such third party, or LICENSEE or a SUBSIDIARY has not
granted to such third party sublicense rights under the PATENT RIGHTS, within
one (1) year of LICENSEE's or such sublicensee's receipt of information of
such third party's infringement of the PATENT RIGHTS, BOARD and LICENSEE and
such sublicensee, if appropriate, will consult with one another in an effort
to determine whether the infringement is a substantial infringement of the
PATENT RIGHTS and whether a reasonably prudent licensee would have instituted
such action or proceedings, concluded such settlement negotiations, and/or
granted such sublicense rights within such one (1) year period in light of
all relevant business and economic factors (including without limitation the
projected cost of such action or proceedings, the likelihood of success on
the merits, the probable amount of any damage award, the prospects for
satisfaction of any judgment against the alleged infringer, the possibility
of counterclaims against BOARD, LICENSEE and/or such sublicensee, the
diversion of LICENSEE's and/or such sublicensee human and economic resources,
the impact of any possible adverse outcome on LICENSEE and/or such
sublicensee, and the effect any publicity might have on the respective
reputations and goodwill of BOARD and LICENSEE and/or such sublicensee). If
after such consultation BOARD and LICENSEE and such sublicensee, if
appropriate, have not reached agreement and LICENSEE and/or such sublicensee,
if appropriate, does not institute action or proceedings against, or enter
into settlement negotiations with, or grant sublicense rights to a
substantial infringer, BOARD shall have the right to enforce the PATENT
RIGHTS relating to infringement by such a substantial infringer on behalf of
BOARD and LICENSEE and/or such sublicensee. Any amounts recovered from third
parties by BOARD with respect to the PATENT RIGHTS in such action or
proceeding shall be retained by BOARD.
7.3 LICENSEE shall notify BOARD promptly in writing of any claim
asserted against LICENSEE, SUBSIDIARIES and/or a sublicensee of either
LICENSEE or a SUBSIDIARY by any third party alleging infringement of any
patent owned by such third party in connection with manufacture, use or sale
of LICENSED PRODUCTS or practice, of any method, process or procedure within
the PATENT RIGHTS. Notwithstanding anything herein to the contrary, if in
LICENSEE's reasonable judgment, the manufacture, use or sale of LICENSED
PRODUCTS or the practice of any method, process or procedure within the
PATENT RIGHTS by LICENSEE, SUBSIDIARIES or sublicensees of either LICENSEE or
a SUBSIDIARY would infringe a BLOCKING PATENT owned or controlled by a third
party, LICENSEE shall have the right to deduct from the royalties payable to
BOARD under Article V the amount which LICENSEE, SUBSIDIARIES or a
sublicensee of either LICENSEE or a SUBSIDIARY, as the case may be, shall
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pay or shall continue to pay to such third party for rights and license under
such BLOCKING PATENT to manufacture, use or sell such LICENSED PRODUCTS or
practice of any method, process or procedure within the PATENT RIGHTS.
"BLOCKING PATENT" shall mean any issued and unexpired patent not within the
PATENT RIGHTS the claims of which cover a LICENSED PRODUCT or any method,
process or procedure within the PATENT RIGHTS and, but for rights and license
granted by the party that owns or controls such patent, would be infringed by
the manufacture, use or sale of such LICENSED PRODUCT or the practice of any
method, process or procedure within the PATENT RIGHTS. However, by reason of
this Paragraph 7.3, the royalty payable to BOARD under Paragraph 5.4(a)
and/or Paragraph 5.5(a) shall not be reduced to less than [*] of NET SALES
attributed to SALES of LICENSED PRODUCTS by LICENSEE and/or SUBSIDIARIES, and
the royalty payable to BOARD under Paragraph 5.4(b) and/or Paragraph 5.5(b)
shall not be reduced to less than [*] of NET SALES attributed to SALES of
LICENSED PRODUCTS by sublicensees of either LICENSEE or a SUBSIDIARY. The
reduction in royalty pursuant to this Paragraph 7.3 shall be made prior to
calculating any adjustment under Paragraph 5.7. In the event that LICENSEE,
SUBSIDIARIES or a sublicensee of either LICENSEE or a SUBSIDIARY receives a
claim from a third party alleging an infringement for which LICENSEE would be
entitled to deduct royalties under this Paragraph 7.3, LICENSEE shall have
the right to withhold [*] of the royalties payable to BOARD hereunder and
apply such amounts against LICENSEE's and such sublicensee's out-of-pocket
expenses incurred in defending such claim. Any withheld amounts that are not
so used shall promptly be reimbursed to BOARD after the resolution of such
claim.
7.4 In any suit, action or other proceeding in connection with
enforcement and/or defense of the PATENT RIGHTS, the parties shall cooperate
fully, including without limitation, subject to the statutory authority of
the Attorney General of the State of Texas as applicable to BOARD, by joining
as a party plaintiff and executing such documents as the party prosecuting
such suit, action or other proceeding may reasonably request. Upon the
request and at the expense of the party prosecuting such suit, action or
other proceeding, the other party shall make available at reasonable times
and under appropriate conditions all relevant personnel, records, papers,
information, samples, specimens and other similar materials in such other
party's possession.
VIII. ASSIGNMENT
This LICENSE AGREEMENT may not be assigned by LICENSEE without the prior
written consent of BOARD, except to a party that succeeds to all or
substantially all of LICENSEE's business or assets relating to this LICENSE
AGREEMENT whether by sale, merger, operation of law or otherwise; provided
that such assignee or transferee promptly agrees in writing to be bound by
the terms and conditions of this LICENSE AGREEMENT. BOARD may assign its
right to receive payments hereunder.
IX. PATENT MARKING
* Confidential treatment has been requested for marked portion
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LICENSEE agrees to xxxx permanently and legibly all products and
documentation manufactured, used or sold by LICENSEE under this LICENSE
AGREEMENT with such patent notice as may be permitted or required under Xxxxx
00, Xxxxxx Xxxxxx Code.
X. INDEMNIFICATION AND INSURANCE
10.1 LICENSEE shall hold harmless and indemnify BOARD, SYSTEM,
UNIVERSITY, the Regents of the SYSTEM, officers, employees and agents from
and against amounts paid to third parties as a result of claims, demands, or
causes of action whatsoever, including without limitation those arising on
account of any injury or death of persons or damage to property caused by, or
arising out of, or resulting from, the exercise or practice of the rights and
license granted under this LICENSE AGREEMENT by LICENSEE or its officers,
employees, agents or representatives; provided that (a) LICENSEE receives
prompt notice of any such claim, demand or cause of action, (b) LICENSEE
shall not be obligated to indemnify any party in connection with any
settlement for any claim, demand or cause of action unless LICENSEE consents
in writing to such settlement, and (c) subject to the statutory duty of the
Texas Attorney General, LICENSEE shall have the first right to defend any
such claim, demand or cause of action and, if LICENSEE elects to exercise
such first right, the exclusive right to control the defense thereof.
10.2 During the term of human clinical trials intended for purposes of
obtaining approval for marketing of LICENSED PRODUCTS by the FDA, or other
similar government agencies in the LICENSED TERRITORY, LICENSEE shall
maintain, at LICENSEE's expense, at least [*] of product liability insurance
per occurrence from an insurance company or companies reasonably satisfactory
to BOARD. The insurance policy relating to such coverage shall name BOARD as
an additional party insured by way of endorsement or otherwise. After
initiation of such human clinical trials, and on an annual basis thereafter,
LICENSEE shall deliver or cause to be delivered to BOARD an insurance
certificate evidencing the insurance coverage required pursuant to this
Paragraph 10.2. Prior to commercialization of any LICENSED PRODUCTS,
LICENSEE and BOARD shall negotiate in good faith an appropriate minimum level
of insurance coverage based upon usual and customary standards in the medical
products industry relevant to such LICENSED PRODUCTS.
XI. USE OF BOARD AND COMPONENTS'S NAME
LICENSEE shall not use the name of The University of Texas at Austin,
SYSTEM, BOARD, or Regents on LICENSED PRODUCTS or in advertising products
that incorporate or are covered by the PATENT RIGHTS or the TECHNOLOGY RIGHTS
without BOARD's express written consent.
XII. CONFIDENTIAL INFORMATION
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The parties may, from time to time, in connection with this LICENSE
AGREEMENT and the work contemplated under the RESEARCH AGREEMENT, disclose to
each other CONFIDENTIAL INFORMATION. "CONFIDENTIAL INFORMATION" shall mean
any information disclosed in writing by a party to either this LICENSE
AGREEMENT or the RESEARCH AGREEMENT to any of the other parties to either
this LICENSE AGREEMENT or the RESEARCH AGREEMENT, and marked by the
disclosing party with the legend "CONFIDENTIAL" or other similar legend
sufficient to identify such information as confidential proprietary
information of the disclosing party. Each party will use best efforts to
prevent the disclosure of the other party's CONFIDENTIAL INFORMATION to third
parties; provided that LICENSEE may disclose BOARD's CONFIDENTIAL INFORMATION
to the extent reasonably necessary to exploit the rights and license granted
to LICENSEE hereunder or pursuant to the RESEARCH AGREEMENT; and provided
further that the recipient party's obligations under this Article XII shall
not apply to CONFIDENTIAL INFORMATION that:
(a) is disclosed orally; provided, however, that the recipient
party's obligations under this Article XII shall apply to information
disclosed orally if such information is reduced to writing and marked
with the legend "CONFIDENTIAL" by the disclosing party within thirty
(30) days after disclosure thereof;
(b) is in the recipient party's possession at the time of disclosure
thereof as demonstrated by documentary evidence;
(c) is or later becomes part of the public domain through no fault of
the recipient party;
(d) is received from a third party having no obligations of
confidentiality to the disclosing party;
(e) is developed independently by the recipient party without access
to the disclosing party's CONFIDENTIAL INFORMATION; or
(f) is required by law or regulation to be disclosed; provided,
however, that the party subject to such disclosure requirement has
provided written notice to the other party promptly to enable such other
party to seek a protective order or otherwise prevent disclosure of such
CONFIDENTIAL INFORMATION.
In the event that LICENSEE reasonably determines that disclosure of
CONFIDENTIAL INFORMATION is necessary to exploit the rights and license
granted to LICENSEE hereunder or pursuant to the RESEARCH AGREEMENT, LICENSEE
agrees that LICENSEE shall not disclose to a third party CONFIDENTIAL
INFORMATION of any of the other parties to either this LICENSE AGREEMENT or
the RESEARCH AGREEMENT, unless either such third party has executed a
confidentiality agreement with LICENSEE containing terms and conditions
substantially similar to this Article XII, or, with respect to governmental
agencies or other regulatory bodies, other
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usual and customary procedures in the medical products industry are utilized
to protect such CONFIDENTIAL INFORMATION. The obligations of the parties
pursuant to this Article XII with respect to CONFIDENTIAL INFORMATION of the
other party shall continue in full force and effect for a period of five (5)
years after expiration or termination of the later of either this LICENSE
AGREEMENT or the RESEARCH AGREEMENT.
XIII. PATENTS AND INVENTIONS
13.1 BOARD shall have the right to file and prosecute any patent
application and maintain any patent that may issue therefrom within the
PATENT RIGHTS, and LICENSEE shall pay BOARD's expenses relating to filing and
prosecuting of such patent applications and maintaining such patents, unless
LICENSEE elects not to pay such expenses pursuant to LICENSEE's rights under
Paragraph 13.5. In addition, in the event that LICENSEE desires that BOARD
file a patent application on any invention arising out of or in connection
with the RESEARCH PROGRAM and BOARD elects to do so, BOARD shall have the
right to file and prosecute such patent application and maintain any patent
that may issue therefrom, and LICENSEE shall pay BOARD's expenses relating to
filing and prosecuting of such patent applications and maintaining such
patents, unless LICENSEE elects not to pay such expenses pursuant to
LICENSEE's rights under Paragraph 13.5. LICENSEE shall pay BOARD's expenses
relating to filing and prosecuting of such patent applications and
maintaining such patents within thirty (30) days after receipt of BOARD's
written invoice. Subject to the rights and license granted to LICENSEE
pursuant to Article IV of this LICENSE AGREEMENT, BOARD shall own all right,
title and interest in and to any patent applications, and any patents that
may issue therefrom, within the PATENT RIGHTS or that disclose inventions
arising out of or in connection with the RESEARCH PROGRAM made solely by
employees of BOARD and jointly by employees of BOARD and LICENSEE. Such
patent applications and patents issuing therefrom shall be deemed to be
patent applications and patents within the PATENT RIGHTS.
13.2 BOARD agrees to consult with LICENSEE in a timely manner concerning
the selection of patent counsel for the purpose of filing and prosecuting
patent applications within the PATENT RIGHTS. BOARD further agrees to
consult with LICENSEE in a timely manner concerning (i) scope and content of
patent applications within the PATENT RIGHTS prior to filing such patent
applications and (ii) content of and proposed responses to official actions
of the United States Patent and Trademark office and foreign patent offices
during prosecution of such patent applications. For purposes of this
Paragraph 13.2, "timely" shall mean sufficiently in advance of any decision
by BOARD or any deadline imposed upon written response by BOARD so as to
allow LICENSEE to meaningfully review such decision or written response and
also provide comments to BOARD in advance of such decision or deadline to
allow LICENSEE's comments to be considered and incorporated into BOARD's
decision or written response.
13.3 BOARD agrees to keep LICENSEE informed in a timely manner of the
contents, status and progress of all patent applications within the PATENT
RIGHTS filed and prosecuted by
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BOARD. BOARD further agrees that BOARD will not allow any such patent
application or any patent that may issue therefrom to become abandoned until
LICENSEE has determined, and informed BOARD in writing, that LICENSEE does
not desire to continue prosecution or appeal(s) or maintenance of such patent
application or patent. For purposes of this Paragraph 13.3, "timely" shall
mean sufficiently in advance of any decision by BOARD or any deadline imposed
upon written response by BOARD so as to allow LICENSEE to meaningfully review
such decision or written response and also provide comments to BOARD in
advance of such decision or deadline to allow LICENSEE's' comments to be
considered and incorporated into BOARD's decision or written response.
13.4 In the event that BOARD elects not to file any patent application
within the PATENT RIGHTS, or thereafter elects not to continue prosecution of
any such patent application, or elects not to maintain any patent that may
issue therefrom, LICENSEE shall have the right, at LICENSEE's option and
expense, to file for and prosecute such patent application and maintain such
patent using patent counsel selected by LICENSEE and approved by BOARD, such
approval not to be unreasonably withheld. BOARD shall reasonably cooperate
with and assist LICENSEE in connection with any filing, prosecution and
maintenance activities undertaken by LICENSEE in accordance with this
Paragraph 13.4. LICENSEE agrees to consult with BOARD with respect to such
filing, prosecution and maintenance activities and to take into account all
comments provided by BOARD, including without limitation, comments concerning
(i) scope and content of patent applications within the PATENT RIGHTS prior
to filing such patent applications and (ii) content of and proposed responses
to official actions of the United States Patent and Trademark office and
foreign patent offices during prosecution of such patent applications.
13.5 With respect to the filing of any patent application within the
PATENT RIGHTS by either BOARD or LICENSEE, or the prosecution of any such
patent application within the PATENT RIGHTS, or the maintenance of any patent
within the PATENT RIGHTS that may issue therefrom, if LICENSEE elects not to
pay the expenses actually incurred by BOARD in filing and prosecuting such
patent application and maintaining such patent, or if LICENSEE elects not to
file for or continue prosecution of a patent application (whether such patent
application was filed by BOARD or LICENSEE) or maintain any patent that may
issue therefrom within the PATENT RIGHTS pursuant to LICENSEE's rights under
Paragraph 13.4, in any country, LICENSEE shall promptly notify BOARD in
writing sufficiently in advance of any deadline to enable BOARD, at BOARD's
expense, to file for or continue prosecution of such patent application,
and/or maintain such patent. Thereafter, LICENSEE shall have no further
rights or obligations with respect to such patent application and/or such
patent in such country.
XIV. DUE DILIGENCE
14.1 LICENSEE shall use commercially reasonable efforts to bring one or
more LICENSED PRODUCTS to market and to meet the market demand therefor.
BOARD shall have a right after two (2) years from the EFFECTIVE DATE to
terminate the exclusivity of the license
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granted by BOARD to LICENSEE pursuant to Paragraph 4.1 in any national
political jurisdiction within the LICENSED TERRITORY at any time upon written
notice to LICENSEE if LICENSEE fails to provide written evidence that
LICENSEE has commercialized or is using commercially reasonable efforts to
commercialize a LICENSED PRODUCT within one hundred eighty (180) days after
receiving written notice from BOARD of BOARD's intention to terminate such
exclusivity; provided that termination of such exclusivity shall not occur
unless and until a court of competent jurisdiction has determined that
LICENSEE has not satisfied LICENSEE's obligations hereunder and such
determination is final. For purposes of this Paragraph 14.1, a determination
by a court of competent jurisdiction shall be deemed final if such
determination either is not appealed, or is appealed to and upheld or
otherwise confirmed by a court of appeals to which an appeal for review of
such determination may be made directly. Evidence provided by LICENSEE in
writing that LICENSEE has an ongoing and active research, development,
manufacturing, marketing or sublicensing program (as appropriate), directed
toward production and sale of LICENSED PRODUCTS within either the United
States or Europe shall be deemed satisfactory evidence that LICENSEE has
commercialized or is using commercially reasonable efforts to commercialize a
LICENSED PRODUCT and to meet the market demand therefor. In the event that
termination of the exclusivity of the license granted herein occurs in any
national political jurisdiction pursuant to this Paragraph 14.1, BOARD agrees
to negotiate in good faith with LICENSEE lower royalty rates with respect to
SALES of LICENSED PRODUCTS in such jurisdiction and other terms and
conditions relating to a non-exclusive right and license under LICENSED
SUBJECT MATTER to manufacture, have manufactured, use and sell LICENSED
PRODUCTS, to practice any method, process or procedure within the PATENT
RIGHTS or the TECHNOLOGY RIGHTS, and to otherwise exploit the LICENSED
SUBJECT MATTER, within such national political jurisdiction for use within
the LICENSED FIELD. This Paragraph 14.1 sets forth BOARD's sole remedy for a
failure by LICENSEE to meet LICENSEE's obligations under this Paragraph 14.1.
14.2 If LICENSEE's rights under this LICENSE AGREEMENT become
non-exclusive pursuant to Paragraph 14.1 above, and BOARD grants a license
under the PATENT RIGHTS to a third party for lower fees and/or at a lower
royalty rate than those set forth in Article V above or negotiated in good
faith pursuant to the parties obligations under Paragraph 14.1, BOARD shall
so notify LICENSEE and the amounts payable by LICENSEE hereunder shall be
reduced to such lower amounts.
XV. GENERAL
15.1 This LICENSE AGREEMENT, together with the RESEARCH AGREEMENT,
constitutes the entire understanding and only agreement between the parties
with respect to the subject matter hereof and supersedes any and all prior
negotiations, representations, agreements, and understandings, written or
oral, that the parties may have reached with respect to the subject matter
hereof. No agreements altering or supplementing the terms hereof may be made
except by means of a written document signed by the duly authorized
representatives of each of the parties hereto.
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15.2 LICENSEE's sole obligation to bring LICENSED PRODUCTS to market and
meet the market demand therefor is as set forth in Article XIV. Nothing in
this LICENSE AGREEMENT shall be deemed to require LICENSEE to otherwise
exploit the LICENSED SUBJECT MATTER for commercial purposes, or prevent
LICENSEE from commercializing products similar to or competitive with a
LICENSED PRODUCT.
15.3 In the event either party hereto is prevented from or delayed in the
performance of any of its obligations hereunder by reason of acts of God,
war, strikes, riots, storms, fires, or any other cause whatsoever beyond the
reasonable control of the party, the party so prevented or delayed shall be
excused from the performance of any such obligation to the extent and during
the period of such prevention or delay.
15.4 Any notice or other communication required by this LICENSE AGREEMENT
shall be made in writing and given by prepaid, first class, certified mail,
return receipt requested, and shall be deemed to have been served on the date
received by the addressee at the following address or such other address as
may from time to time be designated to the other party in writing:
If to BOARD: BOARD OF REGENTS
The University of Texas System
000 Xxxx 0xx Xxxxxx
Xxxxxx, Xxxxx 00000
ATTENTION: System Intellectual Property
Office
with a copy to:
Executive Vice President and Xxxxxxx
The University of Texas at Xxxxxx
Xxxx Xxxxxxxx 000
Xxxxxx, Xxxxx 00000-0000
ATTENTION: Xxxxxxxx X. Xxxxxxxxx
If to LICENSEE: PEGAS PHARMACEUTICALS, INC.
0000 Xxxx Xxxx Xxxx
Xxxxx Xxxx, Xxxxxxxxxx 00000
ATTENTION: Vice President,
Corporate Development
15.5 LICENSEE shall comply with all applicable federal, state and local
laws and regulations in connection with its activities pursuant to this
LICENSE AGREEMENT.
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15.6 This LICENSE AGREEMENT shall be governed by, and construed and
interpreted in accordance with, the laws of the State of Texas; provided,
however, that all questions with respect to validity of any patents or patent
applications within the PATENT RIGHTS shall be determined in accordance with
the laws of the respective country in the territory in which such patents or
patent applications shall have been granted or filed, as applicable.
15.7 A waiver, express or implied, by either BOARD or LICENSEE of any
right under this LICENSE AGREEMENT or of any failure to perform or breach
hereof by the other party hereto shall not constitute or be deemed to be a
waiver of any other right hereunder or of any other failure to perform or
breach hereof by such other party, whether of a similar or dissimilar nature
thereto.
15.8 Headings included herein are for convenience only, do not form a
part of this LICENSE AGREEMENT and shall not be used in any way to construe
or interpret this LICENSE AGREEMENT.
15.9 If any provision of this LICENSE AGREEMENT shall be found by a court
of competent jurisdiction to be void, invalid or unenforceable, the same
shall be reformed to comply with applicable law or stricken if not so
reformable, so as not to affect the validity or enforceability of the
remainder of this LICENSE AGREEMENT.
15.10 This LICENSE AGREEMENT may be executed in counterparts, each of
which shall be deemed an original, but which together shall constitute one
and the same instrument.
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IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
representatives to execute this LICENSE AGREEMENT.
BOARD OF REGENTS OF THE PEGAS PHARMACEUTICALS, INC.
UNIVERSITY OF TEXAS SYSTEM ("LICENSEE")
("BOARD")
By: /s/ Xxxxxx X. Xxxxx By: /s/ Xxxx Xxxxx
---------------------------- -----------------------------
Xxxxxx X. Xxxxx Name: Xxxx Xxxxx
Acting Vice Chancellor ------------------------
for Asset Management Title: CEO
-----------------------
APPROVED AS TO CONTENT:
By: /s/ Xxxxxxx X. Xxxxxxxxxx
----------------------------
Xxxxxxx X. Xxxxxxxxxx
President
The University of Texas at Austin
APPROVED AS TO FORM:
By:/s/ Xxxxxx X. Xxxxx, Xx.
-----------------------------
Xxxxxx X. Xxxxx, Xx.,
Office of General Counsel
CERTIFICATE OF APPROVAL
I hereby certify that the foregoing Agreement was approved by the Board
of Regents of The University of Texas System on the 11th day of June, 1992
and that the person whose signature appears above is authorized to execute
such Agreement on behalf of the Board.
/s/ Xxxxxx X. Xxxxx
-------------------------------------
Executive Secretary, Board of Regents
The University of Texas System
XXXXXX X. XXXXX
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SCHEDULE A
PATENT RIGHTS
COUNTRY FILING DATE
UTSB# SERIAL NO. (PRIORITY) TITLE/INVENTORS
-------------------------------------------------------------------------------
496 U.S. 843,485 [*] Photopolymerizable
Biodegradable Hydrogels as
Tissue Contracting Materials
and Controlled-Release
Carriers
Xxxxxxx, Xxxxxxx X.
Xxxxxx, Xxxxxxxxxxxxxx X.
Xxxxxxx, Amapreet S.
* Confidential treatment has been requested for marked portion
