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REDACTED VERSION
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EXHIBIT 10.21
To
Targeted Genetics Corporation's
Form 10-K
For the Year Ended
December 31, 1996
"[ * ]" = omitted, confidential material, which material has been
separately filed with the Securities and Exchange Commission pursuant to a
request for confidential treatment.
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EXHIBIT 10.21
REVISED LICENSE AGREEMENT
This Agreement is made and entered into this 1st day of October, 1996,
(Effective Date) by and between the UNIVERSITY OF PITTSBURGH - OF THE
COMMONWEALTH SYSTEM OF HIGHER EDUCATION, a non-profit corporation, organized and
existing under the laws of the Commonwealth of Pennsylvania, having its
principal office at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (UNIVERSITY) and
TARGETED GENETICS CORPORATION, ▇▇▇▇ ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇ (LICENSEE).
WHEREAS, UNIVERSITY and RGene Therapeutics, Inc. entered into a License
Agreement dated October 12, 1994 (1994 LICENSE AGREEMENT) for certain
intellectual property rights;
WHEREAS, RGene Therapeutics, Inc. is now merged into a wholly owned
subsidiary of LICENSEE;
WHEREAS, UNIVERSITY and LICENSEE are desirous of revising the 1994 LICENSE
AGREEMENT;
WHEREAS, UNIVERSITY is the owner of certain intellectual property relating
to therapeutic drug delivery technology developed by Leaf ▇▇▇▇▇, Ph.D. (▇▇.
▇▇▇▇▇) a member of the faculty at UNIVERSITY, and has the right as specified
herein to grant licenses to such intellectual property;
WHEREAS, UNIVERSITY desires to have the LICENSED TECHNOLOGY utilized in the
public interest;
WHEREAS, LICENSEE has represented to UNIVERSITY, to induce UNIVERSITY to
enter into this Agreement, that LICENSEE is experienced in the development,
production, manufacture, marketing and sale of products and/or the use of
similar products to the LICENSED TECHNOLOGY (as defined below) and that LICENSEE
shall commit itself to a thorough, vigorous and diligent program of exploiting
the LICENSED TECHNOLOGY so that public utilization results therefrom;
WHEREAS, the LICENSED TECHNOLOGY is the subject matter of a Sponsored
Research Agreement between UNIVERSITY and LICENSEE; and
WHEREAS, LICENSEE desires to obtain a license under the PATENT RIGHTS
and/or LICENSED TECHNOLOGY upon the terms and conditions hereinafter set forth.
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NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, the parties hereto agree as follows:
ARTICLE 1 - DEFINITIONS
For purposes of this Agreement, the following words and phrases shall have
the following meanings:
1.1 AFFILIATE shall mean, with respect to UNIVERSITY, any clinical or
research entity in Pittsburgh which is operated or managed as a facility under
the University of Pittsburgh Medical Center, whether or not owned by UNIVERSITY.
1.2 LICENSEE shall mean Targeted Genetics Corporation and all entities at
least fifty percent (50%) owned or controlled by Targeted Genetics Corporation,
an entity which directly or indirectly owns or controls more than fifty percent
(50%) of the voting stock of Targeted Genetics Corporation and any entity, the
majority ownership of which is directly or indirectly common to the ownership of
Targeted Genetics Corporation.
1.3 LICENSED TECHNOLOGY shall mean any product or part thereof or process
which is within the FIELD OF USE and is:
(a) covered in whole or in part by an issued, unexpired or pending claim
contained in the PATENT RIGHTS in the country in which any such
product or part thereof is made, used or sold or in which any such
process is used or sold;
(b) manufactured by using a process or is employed to practice a process
which is covered in whole or in part by an issued, unexpired claim or
a pending claim contained in the PATENT RIGHTS in the country in which
any process that is included in LICENSED TECHNOLOGY is used or in
which such product or part thereof is used or sold;
(c) developed, manufactured or employing any part of the TECHNOLOGY or the
NEW TECHNOLOGY.
Notwithstanding the foregoing, LICENSED TECHNOLOGY shall not include any
discovery or invention in the field of HIV transfection to the extent (and only
to the extent) such discovery or invention (i) resulted from the use of
materials provided under, and (ii) is subject to the right of first refusal in
favor of [ * ] pursuant to that certain
Statement of Investigator and Material Transfer Agreement for In Vitro or
Laboratory Animal Tests, dated October 19, 1993, between [ * ] and
UNIVERSITY.
* Confidential Treatment Requested
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1.4 NET SALES shall mean LICENSEE's and its sublicensees' gross sales
revenue for products or processes included in LICENSED TECHNOLOGY and produced
hereunder less the sum of the following:
(a) actual cost of freight charges or freight absorption, separately stated in
such invoice;
(b) actual trade, quantity or cash discounts allowed, if any;
(c) sales, tariff duties and/or use taxes separately stated on each
invoice.
1.5 PATENT RIGHTS shall mean all UNIVERSITY United States and foreign
patents, patent applications and any patents filed or issued with respect to the
LICENSED TECHNOLOGY from time to time during the term of this Agreement, and any
and all divisions, reissues, re-examinations, renewals, continuations,
continuations-in-part, extensions and patents issued thereon.
1.6 TECHNOLOGY shall mean any and all know-how, information, processes,
formulae, patterns, compilations, programs, devices, method, techniques,
compounds, products, data, preparations and usage information or materials and
sources thereof, whether patentable or unpatentable, in each case that relates
to the PATENT RIGHTS and which have been developed in a laboratory at UNIVERSITY
under the direct supervision of ▇▇. ▇▇▇▇▇ as of the date hereof or during the
term of the Sponsored Research Agreement referenced below, including that
described in the patent applications listed on Exhibit A hereto.
1.7 NEW TECHNOLOGY shall mean any technology within the Field of Use, that
is developed after the Effective Date and prior to the expiration of the
Sponsored Research Agreement in a laboratory at UNIVERSITY under supervision of
▇▇. ▇▇▇▇▇ or any such technology developed under the Sponsored Research
Agreement between UNIVERSITY and RGene Therapeutics, Inc. dated October 12,
1994.
1.8 SPONSORED RESEARCH AGREEMENT shall mean that certain Sponsored Research
Agreement dated the date hereof and attached hereto as Exhibit B by and between
LICENSEE and UNIVERSITY and the Sponsored Research Agreement between UNIVERSITY
and RGene Therapeutics, Inc. dated October 12, 1994 relating to certain research
to be conducted under the supervision of ▇▇. ▇▇▇▇▇.
1.9 FIELD OF USE shall mean all therapeutic applications related to the
delivery of proteins/pepides or oligonucleotides/nucleic acids, including but
not limited to genes.
ARTICLE 2 - GRANT
2.1 UNIVERSITY hereby grants, to the extent it may lawfully do so, the
right to practice under the PATENT RIGHTS, within the FIELD OF USE only, the
right and exclusive license throughout the entire world to make, have made, use
and sell the
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LICENSED TECHNOLOGY to the end of the term for which the PATENT RIGHTS are
issued, or, if no PATENT RIGHTS are issued, for ten (10) years from the date
hereof, unless this Agreement is terminated sooner as provided herein. The
license granted hereby is subject to the rights of the United States government,
if any, as set forth in 35 U.S.C. Article 200, et seq.
2.2 UNIVERSITY reserves the royalty-free, nonexclusive right to practice
under the PATENT RIGHTS to use the LICENSED TECHNOLOGY for its own noncommercial
education and research purposes.
2.3 At the end of the exclusive period hereof, the license granted
hereunder shall become nonexclusive.
2.4 LICENSEE shall have the right to enter into sublicensing arrangements
for the rights, privileges and licenses granted hereunder only during the
exclusive period of this Agreement upon prior written notice to UNIVERSITY. Such
sublicenses may extend past the expiration date of the exclusive period of this
Agreement, but any exclusivity of such sublicenses shall expire upon the
expiration of LICENSEE's exclusivity.
2.5 LICENSEE agrees that any sublicense granted by it shall provide that
the obligations to UNIVERSITY of Articles 2, 7, 8, 9, 10, 11 and 15 of this
Agreement shall be binding upon the sublicensee as if it were party to this
Agreement.
2.6 LICENSEE agrees to forward to UNIVERSITY a copy of any and all
sublicense agreements promptly upon execution thereof. LICENSEE further agrees
to attach copies of the Articles set forth in 2.5, above, to each sublicense
agreement.
2.7 The license granted hereunder shall not be construed to confer any
rights upon LICENSEE by implication, estoppel or otherwise as to any technology
not specifically set forth herein.
ARTICLE 3 - DUE DILIGENCE
3.1 LICENSEE shall use its best efforts to bring the LICENSED TECHNOLOGY to
market through a thorough, diligent program for the exploitation of LICENSED
TECHNOLOGY and PATENT RIGHTS and to continue active, diligent marketing efforts
for the LICENSED TECHNOLOGY throughout the life of this Agreement.
3.2 LICENSEE shall be deemed to have met the requirements contained in
Article 3.1 so long as LICENSEE is conducting sales of the LICENSED TECHNOLOGY
or is conducting an active clinical development program of the LICENSED
TECHNOLOGY and at all times during the duration of the Sponsored Research
Agreement of even date herewith by and between UNIVERSITY and LICENSEE,
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provided, however, that prior to the expiration of the Sponsored Research
Agreement, * LICENSEE and UNIVERSITY shall agree upon specific performance
milestones relating to the clinical development of the LICENSED TECHNOLOGY in
accordance with a proposed development schedule submitted by LICENSEE.
3.3 LICENSEE's failure to perform in accordance with 3.1 and 3.2 hereof
shall be grounds for UNIVERSITY to terminate this Agreement pursuant to the
terms of Article 11.1 (a) hereof, and, upon termination, all rights to and
interest in the LICENSED TECHNOLOGY and PATENT RIGHTS shall revert to
UNIVERSITY. Notwithstanding the foregoing, if UNIVERSITY asserts such failure of
performance by LICENSEE, the parties shall enter into negotiations to resolve
the matter and, if unable to do so within sixty (60) days, the parties agree to
proceed to arbitration in accordance with Article 10 hereof.
ARTICLE 4 - ROYALTIES AND OTHER LICENSE CONSIDERATION
4.1 In consideration of the rights, privileges and license granted by
UNIVERSITY hereunder, LICENSEE shall pay royalties and other monetary
consideration as follows:
(a) Initial license fee, nonrefundable and not credited against royalties,
of $[ * ] payable as follows:
(i) $[ * ] immediately upon execution of this Agreement;
and
(ii) $[ * ] immediately upon filing of the first patent
application with respect to the LICENSED TECHNOLOGY; and
(iii) $[ * ] immediately upon filing of the second patent
application with respect to the LICENSED TECHNOLOGY.
(b) Royalties in an amount equal to [ * ]% of NET SALES of the
LICENSED TECHNOLOGY in any country for which PATENT RIGHTS have
issued, per calendar quarter; or royalties in an amount equal to
[ * ]% of NET SALES in any country where no patent issues;
(c) Minimum royalty in the amount of $[ * ] per calendar year, payable
beginning in 1997, at the end of each calendar year, if such minimum
royalty is greater than the aggregate annual royalty computed in
accordance with Article 4.1(b) above, provided that all royalty
payments made under Article 4.1(b) shall be credited against such
minimum royalty * Confidential Treatment Requested
* Confidential Treatment Requested
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* Confidential Treatment Requested
amount. However, to the extent that the LICENSEE is commercially
pursuing multiple products or processes incorporating the LICENSED
TECHNOLOGY, then the minimum royalty specified above shall be $[ * ]
per product or process incorporating the LICENSED TECHNOLOGY which are
being commercially pursued by LICENSEE, on the same terms as above.
(d) [ * ]% of any upfront fees received by LICENSEE pursuant to any
sublicense under Article 2.4 hereof.
(e) [ * ] shares of LICENSEE unregistered common stock, fully paid and
non-assessable, issued under the name of the UNIVERSITY as
shareholder. Of these shares, [ * ] shall be held in escrow by
LICENSEE until June 19, 1997 pursuant to the Agreement and Plan of
Merger among LICENSEE, TGC Acquisition Corporation and RGene
Therapeutics, Inc. dated April 16, 1996, and [ * ] shares of which
shall be registered by LICENSEE on or before June 19, 1997.
4.2 Royalty payments, pursuant to Article 4.1(b) above, shall be paid to
UNIVERSITY in United States dollars and directed to the address set forth in
Article 12 hereof within sixty (60) days after the end of each March 31, June
30, September 30 and December 31. The minimum royalty, pursuant to Article 4.1
(c) above, shall be paid to UNIVERSITY in like manner by December 15 of the
calendar year in which the minimum royalty is due.
4.3 Royalty payments which are overdue shall bear interest at the rate of
8% per annum.
4.4 To the extent permissible under then applicable laws and regulations,
LICENSEE shall sell products and/or processes resulting from LICENSED TECHNOLOGY
to UNIVERSITY and its AFFILIATES upon request at such price(s) and on such terms
and conditions as such products and/or processes are made available to
LICENSEE's most favored customer. LICENSEE agrees that it will provide
UNIVERSITY and its AFFILIATES the opportunity to purchase such products or
processes at the same time as any other United States clinical institution.
Notwithstanding the above, the parties agree that a failure by LICENSEE to
comply with the terms of this Section 4.4 shall not be deemed to be a default
for purposes of Section 11.1 hereof.
4.5 Sublicense upfront payments under Article 4.1(d) shall be reduced by
any amount of the sublicense upfront payments that LICENSEE is required to make
to the *
Confidential Treatment Requested
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University of Tennessee pursuant to the Amendment to the First Amended and
Restated License Agreement between the University of Tennessee Research
Corporation and RGene Therapeutics, Inc., effective October 12, 1995.
Furthermore, if such sublicense also sublicenses rights under the License
Agreement between UNIVERSITY and LICENSEE of even date, sublicense upfront
payments under Article 4.1(d) after reduction for payments to the University of
Tennessee shall be further reduced by 50% to reflect payments to UNIVERSITY
under such License Agreement.
4.6 The License Fee in Article 4.1(a) and shares of LICENSEE stock in
Article 4.1(e) are new considerations solely for this Restated License Agreement
and are not applicable to the 1994 LICENSE AGREEMENT.
ARTICLE 5 - REPORTS
5.1 Within thirty (30) days after each March 31, June 30, September 30 and
December 31 of each year during the term of this Agreement, beginning after the
first commercial sale of LICENSED TECHNOLOGY, LICENSEE shall deliver to
UNIVERSITY true and accurate reports of the following information in a form
acceptable to UNIVERSITY:
(a) number of LICENSED TECHNOLOGY products manufactured and sold by
LICENSEE and all sublicensees;
(b) total ▇▇▇▇▇▇▇▇ for such products;
(c) accounting for all LICENSED TECHNOLOGY processes used or sold by
LICENSEE and all sublicensees;
(d) deductions set forth in Article 1.4;
(e) total royalties due; and
(f) name and addresses of sublicensees.
5.2 If no royalties shall be due hereunder, LICENSEE shall so advise
UNIVERSITY in writing within thirty (30) days after the end of any calendar
quarter for which no royalties are due.
5.3 LICENSEE shall keep full, true and accurate books of account, in
accordance with generally accepted accounting principles, containing all
information that may be necessary for the purpose of showing the amounts payable
to UNIVERSITY hereunder. Said books of account shall be kept at LICENSEE's
principal place of business. Said books and the supporting data shall be open at
all reasonable times for three (3) years following the end of the calendar year
to which they pertain, to the inspection of UNIVERSITY or its agents for the
purpose of verifying LICENSEE's royalty statement or compliance in other
respects with this Agreement.
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ARTICLE 6 - PATENT PROSECUTION
6.1 UNIVERSITY has or shall apply for, seek prompt issuance of and maintain
during the term of this Agreement the PATENT RIGHTS in the United States and in
such foreign countries as may be designated by LICENSEE within a reasonable time
in advance of the required foreign filing dates. LICENSEE shall have the
opportunity to advise and cooperate with UNIVERSITY in the prosecution, filing
and maintenance of such patents.
6.2 All fees and costs, including attorneys' fees, relating to the filing,
prosecution and maintenance of the PATENT RIGHTS shall be the responsibility of
LICENSEE, whether incurred prior to or after the date of this Agreement and
payments by LICENSEE therefore shall not be creditable against royalties. Such
fees and costs incurred by UNIVERSITY prior to the date hereof will be payable
by LICENSEE to UNIVERSITY within fifteen (15) business days of the invoicing by
UNIVERSITY to LICENSEE.
ARTICLE 7 - INFRINGEMENT ACTIONS
7.1 Each party shall inform the other promptly in writing of any alleged
infringement of the PATENT RIGHTS by a third party and of any available evidence
thereof.
7.2 During the term of this Agreement, LICENSEE shall have the right, but
shall not be obligated, to prosecute at its own expense all infringements of the
PATENT RIGHTS and, in furtherance of such right, UNIVERSITY hereby agrees that
LICENSEE may include UNIVERSITY as a party plaintiff in any such suit, without
expense to UNIVERSITY. The total cost of any such infringement action commenced
or defended solely by LICENSEE shall be borne by LICENSEE and LICENSEE shall
keep any recovery or damages for past infringement derived therefrom subject to
payment of royalties thereon at the rate established in Article 4.1(b), after
application of the costs incurred by LICENSEE in prosecuting such infringement
actions, including legal fees. LICENSEE may, for such purposes, use the name of
UNIVERSITY as party plaintiff. Notwithstanding the above, LICENSEE's right to
bring such an infringement action shall remain in effect only for so long as the
license granted herein remains exclusive.
7.3 If within six (6) months after having been notified of any alleged
infringement, LICENSEE shall have been unsuccessful in persuading the alleged
infringer to desist and shall not have brought and shall not be diligently
prosecuting an infringement action, or if LICENSEE shall notify UNIVERSITY at
any time prior thereto of its intention not to bring suit against any alleged
infringer, then, and in those events only, UNIVERSITY shall have the right, but
shall not be obligated, to prosecute at its own expense any infringement of the
PATENT RIGHTS, and UNIVERSITY may, for such purposes, use the name of LICENSEE
as party plaintiff. No settlement, consent judgment or other voluntary final
disposition of the suit may be entered into by either party without the
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consent of the other, which consent shall not unreasonably be withheld. In any
settlement or other conclusion, by litigation or otherwise, UNIVERSITY shall be
entitled to share in the monetary award therefrom in at least an amount
proportional to the royalty rate established in Article 4.1(b) above, and
LICENSEE shall be entitled to offset against royalties due hereunder all costs
incurred by LICENSEE in prosecution of any such infringement, including legal
fees. LICENSEE shall indemnify UNIVERSITY against any order for costs that may
be made against UNIVERSITY in such proceedings.
7.4 In the event that a declaratory judgment action alleging invalidity or
noninfringement of any of the PATENT RIGHTS shall be brought against UNIVERSITY,
LICENSEE, at its option, shall have the right, within thirty (30) days after
commencement of such action, to intervene and take over the sole defense of the
action at its own expense.
7.5 In any infringement suit either party may institute to enforce the
PATENT RIGHTS pursuant to this Agreement, the other party hereto shall, at the
request and expense of the party initiating such suit, cooperate in all respects
and, to the extent possible, have its employees testify when requested and make
available relevant records, papers, information, samples, specimens, and the
like.
ARTICLE 8 - INDEMNIFICATION/INSURANCE/LIMITATION OF LIABILITY
8.1 LICENSEE shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold UNIVERSITY, its trustees, officers,
employees and affiliates, harmless against all claims and expenses, including
legal expenses and reasonable attorneys' fees, arising out of the death of or
injury to any person or persons or out of any damage to property or the
environment, and against any other claim, proceeding, demand, expense and
liability of any kind whatsoever resulting from the production, manufacture,
sale, use, lease, consumption or advertisement of the LICENSED TECHNOLOGY by
LICENSEE, its affiliates or sublicensees or arising from any obligation of
LICENSEE hereunder, except to the extent caused by the negligence, recklessness
or willful misconduct of UNIVERSITY or its personnel and agents, for which
UNIVERSITY shall similarly hold harmless and indemnify LICENSEE, its officers,
employees, agents or representatives.
8.2 Prior to such time as LICENSEE or its sublicensees commence human
clinical trials for LICENSED TECHNOLOGY or otherwise commence marketing such
LICENSED TECHNOLOGY, LICENSEE shall maintain in force such liability insurance
policies and coverages as are required under applicable laws and regulations. At
such time as LICENSEE commences marketing the LICENSED TECHNOLOGY, LICENSEE
shall maintain in force such liability insurance in such amounts and for such
coverages as is customarily taken by similar companies in its industry, to the
extent such coverages are reasonably available. LICENSEE shall use its best
efforts to have such policies provide that the insurer will give UNIVERSITY not
less than 30 days' advance notice of any material changes in or cancellation of
coverage, and to provide UNIVERSITY with
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commensurate coverage as would be provided if UNIVERSITY were named as an
additional insured thereunder.
ARTICLE 9 - ASSIGNMENT
9.1 Except as provided in Article 2.4, this Agreement is not assignable and
any attempt to do so shall be null and void, except in the event of sale of all
or substantially all of the assets of LICENSEE. LICENSEE shall provide
UNIVERSITY with prior written notice of such sale.
ARTICLE 10 - ARBITRATION
10.1 Except as to issues relating to the validity, enforceability or
final determination of infringement of any patent contained in the PATENT RIGHTS
licensed hereunder, any and all claims, disputes or controversies arising under,
out of, or in connection with this License Agreement which has not been resolved
in good faith negotiations between the parties, shall be resolved by a board of
three (3) arbitrators in accordance with the rules, then in effect, of the
American Arbitration Association. Such independent board shall be composed of
three panelists, of sufficient education, scientific experience and national
reputation to address such issues. The board shall be composed of an individual
selected by UNIVERSITY, an individual selected by LICENSEE and an individual
selected by LICENSEE and UNIVERSITY. The decision of such panel shall be final
and binding upon the parties and enforceable in any court of competent
jurisdiction.
ARTICLE 11 - TERMINATION
11.1 UNIVERSITY shall have the right to terminate this Agreement if:
(a) LICENSEE shall default in the performance of any of the
obligations herein contained and such default has not been cured
within thirty (30) days after receiving written notice thereof
from UNIVERSITY; or
(b) LICENSEE shall cease to carry out its business, become bankrupt
or insolvent, apply for or consent to the appointment of a
trustee, receiver or liquidator of its assets or seek relief
under any law for the aid of debtors.
(c) LICENSEE shall terminate the Sponsored Research Agreement with
UNIVERSITY for further work on the LICENSED TECHNOLOGY for any
reason, except breach thereof by UNIVERSITY, termination by
mutual consent, termination for ▇▇. ▇▇▇▇▇'▇ departure from
UNIVERSITY as described in Section 2.03 of the Sponsored Research
Agreement, or expiration of the term of Sponsored Research
Agreement.
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11.2 LICENSEE may terminate this Agreement upon six (6) months' prior
written notice to UNIVERSITY and upon payment of all amounts due UNIVERSITY
through the effective date of the termination.
11.3 Upon termination of this Agreement neither party shall be released
from any obligation that matured prior to the effective date of such
termination. LICENSEE and any sublicensee may, however, after the effective date
of such termination, sell all products under the LICENSED TECHNOLOGY, provided
that LICENSEE shall pay to UNIVERSITY the royalties thereon as required by
Article 4 hereof and submit the reports required by Article 5 hereof.
ARTICLE 12 - NOTICES
12.1 Any notice or communication pursuant to this Agreement shall be
sufficiently made or given if sent by certified, first-class mail, postage
prepaid, addressed to the address below or as either party shall designate by
written notice to the other party.
In the case of UNIVERSITY:
Office of Technology Transfer
and Intellectual Property
911 ▇▇▇▇▇▇▇ ▇▇▇▇ Union
University of Pittsburgh
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
In the case of LICENSEE:
Targeted Genetics Corporation
▇▇▇▇▇ ▇▇▇
▇▇▇▇ ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
ARTICLE 13 - AMENDMENT, MODIFICATION
13.1 This Agreement may not be amended or modified except by the execution
of a written instrument signed by the parties hereto.
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ARTICLE 14 - REPRESENTATIONS, WARRANTIES AND LIMITATIONS OF
LIABILITY
14.1 University
(a) UNIVERSITY is a non-profit corporation, validly existing and in
good standing under the laws of the Commonwealth of Pennsylvania.
(b) The execution, delivery and authority to execute and deliver this
Agreement have been duly authorized by all necessary action on
the part of the UNIVERSITY.
(c) UNIVERSITY has the power and authority to execute and deliver
this Agreement and to perform its obligations under this
Agreement.
(d) UNIVERSITY hereby represents and warrants that, other than the
grant set forth herein, including, without limitations, any
non-exclusive license that UNIVERSITY may be required by law to
grant to the United States of America or to a foreign state
pursuant to an existing or future treaty with the United States
of America, it has not encumbered, restricted, transferred or
otherwise burdened the TECHNOLOGY.
(e) UNIVERSITY hereby represents and warrants that on the date
hereof, it is not aware of any infringement of or by the PATENT
RIGHTS or any claims by any other party in and to the TECHNOLOGY.
(f) EXCEPT AS OTHERWISE EXPRESSLY SET FORTH 1N THIS AGREEMENT,
UNIVERSITY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
AND VALIDITY OF TECHNOLOGY CLAIMS, ISSUED OR PENDING. NOTHING 1N
THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR
WARRANTY GIVEN BY UNIVERSITY THAT THE PRACTICE BY LICENSEE OF THE
LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE TECHNOLOGY OF
ANY THIRD PARTY.
14.2 Licensee. LICENSEE represents and warrants that:
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(a) It is a corporation duly organized, validly existing and in good
standing under the laws of the State of Washington.
(b) The execution, delivery and performance of this Agreement have been
duly authorized by all necessary corporate action on the part of
LICENSEE.
(c) It has the corporate power and authority to execute and deliver this
Agreement and to perform its obligations under this Agreement.
ARTICLE 15-MISCELLANEOUS
15.1 This Agreement shall be construed and interpreted in accordance with
the laws of the Commonwealth of Pennsylvania.
15.2 The parties acknowledge that this Agreement together with the
Sponsored Research Agreement, sets forth the entire understanding and agreement
of the parties hereto as to the subject matter hereof and supersedes all
previous understandings between the parties, written or oral, regarding such
subject matter.
15.3 Nothing contained in this Agreement shall be construed as conferring
any right to use in advertising, publicity or other promotional activities any
name, trade name, trademark, or other designation (including any contraction,
abbreviation, or simulation of any of the foregoing). Without the express
written approval of the other party, neither party shall use any designation of
the other party in any promotional activity associated with this Agreement or
the LICENSED TECHNOLOGY. Neither party shall issue any press release or make any
similar written public statement in regard to this Agreement without the prior
written approval of the other party which approval shall not be unreasonably
withheld.
15.4 If one or more of the provisions of this Agreement shall be held
invalid, illegal or unenforceable, the remaining provisions shall not in any way
be affected or impaired thereby. In the event any provision is held, illegal or
unenforceable, the parties shall use reasonable efforts to substitute a valid,
legal and enforceable provision which, insofar as is practical, implements
purposes of the section held invalid, illegal and unenforceable.
15.5 Failure at any time to require performance of any of the provisions
herein shall not waive or diminish a party's right thereafter to demand
compliance therewith or with any other provision. Waiver of any default shall
not waive any other default. A party shall not be deemed to have waived any
rights hereunder unless such waiver is in writing and signed by a duly
authorized officer of the party making such waiver.
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ARTICLE 16 - CLINICAL TRIALS
16.1 LICENSEE recognizes the desire of UNIVERSITY and its AFFILIATES to
perform Phase I clinical trials for products which incorporate the LICENSED
TECHNOLOGY. LICENSEE further recognizes UNIVERSITY and its AFFILIATES wish to be
granted preferential consideration in conducting Phase II and III clinical
trials for such products. UNIVERSITY recognizes that products which incorporate
LICENSED TECHNOLOGY will generally also incorporate technology licensed from
other institutions and that LICENSEE may be obligated or deem it advisable to
conduct clinical trials at such other institutions or their AFFILIATES.
UNIVERSITY also recognizes that additional medical centers may be involved in
Phase II and III clinical trial, as may be necessary. LICENSEE agrees to give
due consideration to conducting clinical trials at UNIVERSITY and its
AFFILIATES, to the extent permitted by its obligations to others.
IN WITNESS WHEREOF, the parties have set their hands and seals.
UNIVERSITY OF PITTSBURGH - OF THE
COMMONWEALTH SYSTEM OF HIGHER
WITNESS: EDUCATION
/s/ ▇▇▇▇ ▇▇▇▇▇▇ By /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------- -------------------------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Interim Vice Chancellor for Business
WITNESS: TARGETED GENETICS CORPORATION
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By H. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
------------------------------- -------------------------------
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16
* Confidential Treatment Requested
Exhibit A
to Revised License Agreement
between University of Pittsburgh and Targeted Genetics Corporation
"Stable Lipid-Comprising Drug Delivery Complexes and Methods for Their
Production"
U.S. Patent Application Serial No. 08/376,701
Filed January 23, 1995
PCT Application 2710-4000
Filed January 23, 1996 designating all countries
"Novel Cationic Cholesteryl Derivatives Containing Derivatives Containing
Cyclic Polar Groups"
U.S. Patent Application Serial No. [ * ]
Filed [ * ]
"A Cytoplasmic Gene Expression System Which Utilizes a Prokaryotic RNA
Polymerase Autogene"
U.S. Patent Application Serial No. [ * ]
Filed [ * ]
"Emulsion Formulations and Their Use as Vehicles for the Delivery of
Hydrophilic Biologically Active Molecules to Cells"
U.S. Patent Application Serial No. [ * ]
Filed [ * ]
* Confidential Treatment Requested
131