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REDACTED VERSION
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EXHIBIT 10.20
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 10.20
EXCLUSIVE SUBLICENSE AGREEMENT
THIS AGREEMENT is made and entered into this 23rd day of July 1996
("Effective Date") by and between: Alkermes, Inc., 00 Xxxxxx Xxxxxx, Xxxxxxxxx,
XX 00000, (hereinafter referred to together with its subsidiaries and affiliated
companies as "LICENSOR" ) and Targeted Genetics Corporation, 0000 Xxxxx Xxx,
Xxxxx 000, Xxxxxxx, Xxxxxxxxxx 00000, (hereinafter referred to together with its
subsidiaries and affiliated companies as "LICENSEE").
WHEREAS, LICENSOR is the exclusive licensee from the Children's Hospital
Research Foundation/Children's Hospital, Inc. of certain "Licensed Patent
Rights" and "Licensed Materials" relating to Adeno-Associated Virus (AAV)
packaging cell lines invented by Xx. Xxxxxx X. Xxxxxxx and has the right to
grant sublicenses under Licensed Patent Rights and to Licensed Materials.
WHEREAS, LICENSEE desires to obtain certain sublicensing rights under the
Licensed Patent Rights and to the Licensed Materials upon the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein the parties hereto agree as follows:
ARTICLE I
DEFINITIONS
1.1 "LICENSEE" shall include the following:
(a) a related company of LICENSEE, the voting stock of which is directly
or indirectly at least fifty percent (50%) owned or controlled by
LICENSEE;
(b) an organization which directly or indirectly owns or controls more
than fifty percent (50%) of the voting stock of LICENSEE;
(c) an organization, the majority ownership of which is directly or
indirectly common to the majority ownership of LICENSEE.
1.2 "Licensed Patent Rights", as used herein, shall mean all of the following:
(a) U.S. Patent Application Serial No. 08/254,358, filed June 6, 1994, and
Serial No. 08/475,391, filed June 7, 1995, "Adeno-Associated Virus
Materials", invented by Xxxxxx X. Xxxxxxx.
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(b) to the extent that the following contain one or more claims to the
invention or inventions claimed in (a) above: divisions, continuations
and continuations-in-part of (a) above, all divisions and
continuations of these continuations-in-part, divisions and
continuations, and any reissues, extensions or reexaminations of the
foregoing patents;
(c) to the extent that the following contain one or more claims to the
invention or inventions claimed in (a) above: all counterpart foreign
applications and patents to (a) and (b) above;
(d) any other patent applications, including divisions, continuations,
continuations-in-part, reissues, extensions, reexaminations and
counterpart foreign applications thereof, that contain one or more
claims to the invention or inventions claimed in (a) above or any
improvements to such invention or inventions; and
(e) any patents issuing in respect of any of the applications, divisions,
continuations, continuations-in-part, reissues, extensions,
reexaminations and counterpart foreign applications referenced in
clauses (a), (b), (c) and (d) above.
1.3 "Licensed Materials", as used herein, shall mean the C12 adeno-associated
virus packaging cell line developed by the Children's Hospital Research
Foundation/Children's Hospital, Inc. and any improvements thereto.
1.4 "Licensed Product(s)", as used herein, shall mean any product which cannot
be manufactured, used or sold without utilizing Licensed Materials or
which, in the course of manufacture, use or sale would, in the absence of
this Agreement, infringe one or more issued claims of the Licensed Patent
Rights that have not been held invalid or unenforceable by an unappealed or
unappealable judgement of a court of competent jurisdiction or expired.
1.5 "Net Sales" shall mean revenue received by LICENSEE from sales of Licensed
Products by LICENSEE, its sublicensee(s) or agent(s) less the sum of the
following:
(a) discounts allowed in amounts customary in the trade,
(b) sales taxes, tariff duties, and/or use taxes which are directly
imposed and are with reference to particular sales;
(c) outbound transportation prepaid or allowed;
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(d) amounts allowed or credited on returns; and
(e) charges deemed uncollectible under generally accepted accounting
principles.
1.6 "Field of Use" shall mean the following:
Treatment and prevention of pulmonary diseases.
1.7 "Optioned Field(s) of Use" shall mean the following:
Optioned Field 1. Treatment and prevention of infectious diseases.
Optioned Field 2. Treatment of benign or malignant tumors.
Optioned Field 3. Treatment and prevention of cardiovascular disorders.
Optioned Field 4. Treatment and prevention of metabolic/endocrinology
disorders (e.g., Gaucher disease).
Optioned Field 5. Treatment and prevention of hematopoietic/immune
disorders.
Optioned Field 6. Systemic and mucosal delivery of secreted proteins.
Optioned Field 7. Treatment and prevention of gastrointestinal diseases.
ARTICLE II
GRANT
2.1 LICENSOR hereby grants to LICENSEE a worldwide exclusive sublicense under
Licensed Patent Rights and to Licensed Materials to make, have made, use, lease,
have sold and sell Licensed Products in the Field of Use.
2.2 LICENSOR hereby grants to LICENSEE under Licensed Patent Rights and to
Licensed Materials the exclusive right to grant one or more sublicenses to its
rights to make, have made, use, lease, have sold and sell Licensed Products in
the Field of Use.
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* Confidential Treatment Requested
2.3 LICENSOR reserves unto itself the personal, non-transferable right to make,
have made, and use Licensed Product(s) and Licensed Material in the Field of Use
for internal research purposes only, and for no other purpose in the Field of
Use.
2.4 LICENSEE hereby agrees grants to LICENSOR an exclusive, worldwide
royalty-free license to make, have made, use and sell products under any patent
rights owned by LICENSEE for improvements on the C12 cell line in the field of
nervous system diseases including, without limitation, brain cancers.
ARTICLE III
COMPENSATION-ROYALTIES
3.1 For the rights, privileges and license granted hereunder, LICENSEE shall
pay royalties to LICENSOR in the manner hereinafter provided to the end of the
term of the Licensed Patent Rights on a country-by-country basis or until this
Agreement shall be terminated as hereinafter provided, whichever occurs first.
LICENSEE agrees to pay to LICENSOR a royalty of [ * ] on the amount of annual
Net Sales of Licensed Products that are less than or equal to [ * ] and a
royalty of [ * ] on the amount of annual Net Sales of Licensed Products that
exceed [ * ]. For sales in any country in which no Licensed Patent Rights exist,
such royalty shall be reduced [ * ] on the amount of annual Net Sales of
Licensed Products incorporating, based upon or made by employing the Licensed
Material or the technology described in the Licensed Patent Rights.
3.2 Notwithstanding the foregoing, if LICENSEE is required to pay royalties to
an unaffiliated third party(ies) for sales of Licensed Products for which
payments are also due to LICENSOR ("Third Party Royalties"), then the royalties
to be paid by LICENSEE to LICENSOR shall be reduced by the amount that the sum
of the LICENSOR's royalty percentage and Third Party royalty percentage are in
excess of [ * ] of Net Sales of Licensed Products, but in no event shall the
LICENSOR'S royalty percentage be reduced to less than [ * ].
3.3 No multiple royalties shall be payable because any Licensed Product, its
manufacture, use, lease or sale are or shall be covered by multiple claims or
more than one Licensed Patent Right licensed under this Agreement.
* Confidential Treatment Requested
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* Confidential Treatment Requested
3.4 In addition to royalties, LICENSEE agrees to pay LICENSOR the following
sums within thirty (30) days of the time that each of the milestones listed
below:
(a) The sum of [ * ] upon execution of this Agreement and [ * ] payable
one (1) year from the Effective Date;
(b) The sum of [ * ] for the first Phase I clinical trial, or equivalent
in a foreign country, initiated by LICENSEE or one of its sublicensees
for a Licensed Product;
(c) The sum of [ * ] for the first Phase II clinical trial, or equivalent
in a foreign country, initiated by LICENSEE or one of its sublicensees
for a Licensed Product (Phase I/II or equivalent in a foreign country
will be considered a Phase I trial);
(d) The sum of [ * ] for the first Phase III clinical trial, or equivalent
in a foreign country, initiated by LICENSEE or one of its sublicensees
for a Licensed Product for which a Phase II clinical trial was
initiated and, consequently, a milestone payment was made to LICENSOR
pursuant to paragraph 3.4(c);
(e) The sum of [ * ] for the first Phase III clinical trial, or equivalent
in a foreign country, initiated by LICENSEE or one of its sublicensees
for a Licensed Product for which no Phase II clinical trial was
initiated and, consequently, no milestone payment was made to LICENSOR
pursuant to paragraph 3.4(c); and
(f) The sum of [ * ] for the first Product Licensing Application, or
equivalent in a foreign country, approved for LICENSEE's or one of its
sublicensee's Licensed Product.
3.5 Royalty payments made pursuant to Paragraph 3.1, supra, shall be made
quarterly for the three (3) month periods ending March 31, June 30, September 30
and December 31 of each calendar year and shall be due and payable within 45
days of the termination of each calendar half year--i.e., such payments shall be
due or payable on or before May 15, August 14, November 15 and February 14 in
each calendar year.
* Confidential Treatment Requested
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*Confidential Treatment Requested
3.6 All monies due to LICENSOR hereunder shall be paid in United States
dollars. LICENSEE shall be responsible for making the payment to the LICENSOR.
The rate of exchange to be used in computing the amount of currency equivalent
to United States dollars due to LICENSOR shall be made at the rate of exchange
at Chase Manhattan Bank for the three (3) month trailing average for the
calendar quarter for which payment is due.
3.7 If LICENSEE grants a sublicense to the Licensed Patent Rights or the
Licensed Materials to a third party, for value other than royalties based on
sales of Licensed Products, LICENSEE shall pay LICENSOR [ * ] of all proceeds
paid to LICENSEE in consideration for such grant of a sublicense, including any
premium paid over the market value of the LICENSEE's common stock by a
sublicensee in connection with an equity purchase, but excluding such royalties
paid to LICENSEE in connection therewith, up to a maximum of [ * ] per year in
the year that such proceeds are paid to LICENSEE ("Non-Royalty Fees"). Any such
payment shall be made within thirty (30) days after receipt of such Non-Royalty
Fees by LICENSEE. Notwithstanding the foregoing, in no event shall LICENSEE: a)
be obligated to pay LICENSOR a share of any proceeds that LICENSEE receives from
a third party as research and development funding, milestone payments, or equity
purchase, other than any premium paid on an equity purchase; or b) enter into a
paid-up sublicense to Licensed Patent Rights or Licensed Materials with a third
party without the written consent of LICENSOR.
3.8 In the event that LICENSEE transfers or otherwise sublicenses Licensed
Patent Rights or Licensed Materials to a third party in combination with
patent(s) and/or other right(s) of a third party(ies) and LICENSEE is due and
receives Non-Royalty Fees, then LICENSEE shall pay LICENSOR an equitable portion
of such Non-Royalty Fees as determined by the good faith negotiations of
LICENSEE and LICENSOR.
ARTICLE IV
LICENSE OPTION
4.1 LICENSOR hereby grants to LICENSEE an exclusive right of first negotiation
to sublicense on an exclusive basis the Licensed Patent Rights and the Licensed
Materials for one or more of the Optioned Fields of Use ("License Option"). Upon
written notification by LICENSEE to LICENSOR of an intent to acquire exclusive
rights to an Optioned Field(s)
* Confidential Treatment Requested
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* Confidential Treatment Requested
of Use, LICENSOR shall negotiate with LICENSEE in good faith to reach agreement
on commercially reasonable terms for a sublicense to such Optioned Field(s) of
Use. Upon notification to LICENSOR by a third party of an intent to acquire
license rights to an optioned Field of Use, LICENSOR shall provide LICENSEE
written notification of such notice, and LICENSEE, at its own discretion, shall
have the option to negotiate with LICENSOR in good faith for a period of at
least sixty (60) days from the date of such notification ("Option Period") to
reach agreement on commercially reasonable terms for a sublicense to LICENSEE to
such Optioned Field(s) of Use. If LICENSEE elects not to negotiate, or if the
parties do not reach agreement during the Option Period, then LICENSOR may grant
a sublicense in respect of such Optioned Field(s) of Use to the Third Party on
terms that are no more favorable than those that were last offered by LICENSOR
to LICENSEE during the Option Period. The License Option shall expire one (1)
year from the Effective Date and may be renewed at LICENSEE's sole discretion
for subsequent one (1) year periods at the rate of [ * ] per year, reduced pro
rata in proportion to the number of Optioned Fields of Use which have previously
been sublicensed either to LICENSEE or to third parties.
ARTICLE V
RECORD KEEPING AND REPORTS
5.1 LICENSEE agrees to keep accurate records in sufficient detail to enable the
royalties payable by LICENSEE to LICENSOR hereunder to be determined, and agrees
to permit said records to be examined from time to time during the life of this
Agreement, and for one (1) year after the expiration and termination of this
Agreement, at reasonable intervals (but not more than once per calendar year) by
an independent auditor mutually agreeable to the parties, during normal business
hours, and to the extent necessary to verify the reports and payments required
hereunder. Such auditor shall only disclose to LICENSOR whether or not royalties
payable hereunder have been accurately computed and paid, and no other
information. In the event any such audit reveals an underpayment, LICENSEE shall
promptly remit the deficiency to LICENSOR. In the event any such audit reveals
an overpayment, the excess shall be credited against any future payments due to
LICENSOR hereunder.
5.2 LICENSEE agrees to furnish LICENSOR with written Reports within two (2)
months of the termination of each calendar quarter (i.e., such written Reports
shall be due as in Paragraph 3.3 supra) setting forth separately by model number
or other identifying
* Confidential Treatment Requested
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designation, the total number of Licensed Products theretofore made and sold
hereunder during the preceding calendar quarter and the royalties due thereon.
Each such Report shall be accompanied by a copy of any sub-sublicensee's Report
received subsequent to LlCENSEE's prior Report and prior to LlCENSEE's current
Report.
5.3 LICENSOR shall maintain in confidence, and shall not disclose to any third
party or use for any purpose not expressly authorized by this Agreement, all
information provided to LICENSOR and/or its auditor pursuant to this Article V
and to Article VII. LICENSOR shall obtain written agreement from LICENSOR's
auditor who shall inspect LICENSEE's records pursuant to Article 5.1, for
LICENSEE's benefit, to be bound by the foregoing confidentiality obligation.
Such confidentiality obligation shall survive any termination or expiration of
this Agreement. Notwithstanding the foregoing, the confidentiality obligation
shall not extend to the disclosure of data, documents or information to
judicial, governmental or other official agencies, or in accordance with common
practice, to the extent that such disclosure is required by any applicable
securities laws or self regulatory agencies.
ARTICLE VI
PATENT RIGHTS
6.1 LICENSOR shall, in the first instance, have the sole and exclusive right to
file any and all patent applications, both foreign and domestic, falling within
the scope of this Agreement; and LICENSOR shall be responsible for all costs,
fees and expenses incurred in connection with the filing, prosecution and
maintenance of any such patent application and the maintenance of any patent
issuing thereon. Any such patent shall be included within this Agreement as part
of the Licensed Patent Rights.
6.2 LICENSOR shall notify LICENSEE of the issuance of any Licensed Patent
Rights, and any expiration, lapse, revocation, surrender, invalidation or
abandonment of any Licensed Patent Rights.
6.3 If, at any time during the term of this Agreement, LICENSOR elects not to
file a patent application or to abandon any pending patent application or any
patent issued thereon, either foreign or domestic, it shall notify LICENSEE of
that decision at least two (2) months prior to any deadline for filing any
response or taking any other action necessary to file or maintain any such
application and/or patent in existence; and, thereafter, LICENSEE shall have the
right and option to participate, together with other licensees to such patent
application or issued patent, in the filing or prosecution of any such patent
application and/or the maintenance of any such patent, at LICENSEE's expense;
and, any patent issuing therefrom shall be exclusively licensed to LICENSEE in
the Field of Use and any Optioned Fields of Use as to which LICENSEE has
exercised its option pursuant to Article IV on a royalty-free basis.
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ARTICLE VII
DUE DILIGENCE
7.1 LICENSEE, during the entire term of this Agreement, shall utilize
commercially reasonable efforts in proceeding with the development, manufacture,
sale and commercial exploitation of Licensed Product(s), and in creating a
supply and demand for same; provided, however, that LICENSEE shall be entitled
to exercise prudent business judgment in meeting its reasonable diligence
obligations hereunder.
7.2 LICENSEE agrees to keep LICENSOR informed of its progress on the commercial
exploitation of Licensed Product(s) hereunder by annual reports due within sixty
(60) days following the end of each calendar year.
ARTICLE VIII
PATENT MARKING
8.1 LICENSEE shall xxxx, and shall require its sub-licensee(s) to xxxx, each
Licensed Product made and sold by it or by them with an appropriate patent
marking identifying the pendency of any U.S. application and/or any issued U.S.
or foreign patent forming any part of Licensed Patent Rights.
ARTICLE IX
TERM AND TERMINATION
9.1 This Agreement, and the rights, privileges and license granted herein,
shall be in force from the Effective Date hereof and shall remain in full force
and effect thereafter until the last to expire of Licensed Patent Rights unless
sooner terminated in accordance with the provision set forth herein below. It
is, however, understood by the parties hereto that LlCENSEE's obligation to pay
royalties to LICENSOR under this Agreement shall terminate in the event of a
judicial determination that no portion of such Licensed Patent Rights are valid,
infringed and/or enforceable by a decision of a tribunal of competent authority
where such decision is final or by lapse of time becomes final and unappealable.
9.2 LICENSEE may terminate this Agreement and concomitant future obligations
upon thirty (30) days written notice to LICENSOR.
9.3 If LICENSEE shall cease to carry on its business, this Agreement shall
terminate upon notice by LICENSOR.
9.4 Should LICENSEE fail to make any payment whatsoever due and payable to
LICENSOR hereunder, LICENSOR shall have the right to terminate this Agreement
effective on thirty (30) days notice, unless LICENSEE shall make all such
payments to LICENSOR within said thirty (30) day period. Upon the expiration of
the thirty (30) day
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period, if LICENSEE shall not have made all such payments to LICENSOR, the
rights, privileges and license granted hereunder shall automatically terminate.
9.5 Upon any material breach or default of this Agreement by LICENSEE other
than those occurrences set out in Articles 9.3 and 9.4 hereinabove, LICENSOR
shall have the right to terminate this Agreement and the rights, privileges and
license granted hereunder effective on sixty (60) days notice to LICENSEE. Such
termination shall become automatically effective unless LICENSEE shall have
cured any such material breach or default prior to the expiration of the sixty
(60) day period. In the event that LICENSOR asserts a breach of this Agreement
under Article 7.1, this Agreement shall remain in full force and effect until
the matter is resolved by the parties themselves or under arbitration as
provided for under Article 18.
ARTICLE X
DISPOSITION OF LICENSED PRODUCTS
ON HAND UPON TERMINATION
10.1 In the event of any termination of this Agreement, LICENSEE and its
sub-licensees shall have the right to use or sell all the Licensed Products on
hand at the time of such termination, provided that LICENSEE shall be obligated
to pay to the LICENSOR a royalty on such sales as set forth in this Agreement
if, at that time, there remains in existence any of Licensed Patent Rights
covering the manufacture, use or sale of such Licensed Product(s).
ARTICLE XI
PATENT ENFORCEMENT
11.1 If LICENSEE shall have supplied LICENSOR with written evidence
demonstrating infringement of the Licensed Patent Rights by a third party,
LICENSEE may, by written notice, request LICENSOR to take steps to assert such
Licensed Patent Rights against such infringing product. LICENSOR shall within
six (6) months of the receipt of such notice either (a) cause such infringement
to terminate or (b) initiate and continue legal proceedings against the
infringer, or pursue other equivalent legal or patent remedies. If LICENSOR
fails to take either of the actions specified in clause (a) or (b) above,
LICENSEE may, upon notice to LICENSOR, discontinue making royalty payments to
LICENSOR that are due hereunder, and have further royalty payments waived by
LICENSOR until LICENSOR in good faith takes and continues such action, at which
time only future royalties shall be due. Notwithstanding the foregoing, if the
infringement ceases at any time, TGC's obligations shall continue at full force
from the time that infringement ceases.
11.2 In the event LICENSOR fails to terminate the infringement within the six
(6) months of written notification from LICENSEE informing LICENSOR of an
alleged infringement, and does not institute litigation against the infringer
for that purpose within such period, then LICENSEE shall have the right to bring
an action against the infringer for
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that purpose. LICENSOR shall cooperate fully with LICENSEE, at LICENSEE's
expense, in connection with any such action. Such cooperation shall include
(without limitation) LICENSOR's permitting LICENSEE to bring the action in
LICENSOR's name and LICENSOR's executing any consents or assignments necessary
or useful to permit LICENSEE to enforce the Licensed Patent Rights against the
infringer. LICENSEE shall be entitled to deduct all expenses incurred by it in
connection with any such action from the royalties and other amounts that would
otherwise be payable to LICENSOR hereunder; provided that to the extent any
amounts are finally awarded to LICENSEE in such action or are paid to LICENSEE
in settlement thereof, such amounts shall be paid over to LICENSOR until all
amounts so withheld have been repaid. Any amounts so awarded or paid in
settlement in excess of the amounts so withheld shall be retained by LICENSEE.
ARTICLE XII
PUBLICITY
12.1 The parties agree that neither party will use the name of the other party,
or any abbreviation thereof, expressly or by implication, or disclose the
existence or nature of this Agreement, in any news, publicity release,
advertisement or other public disclosure, without the express prior written
approval of the other party. Notwithstanding the foregoing, each party hereby
consent to references to it (1) in such reports or documents sent to
stockholders or filed with or submitted to any governmental regulatory agencies
or bodies or stock exchanges or as may be required to obtain investment capital,
or (2) pursuant to any requirements of applicable law or governmental
regulations, provided that, in the event of any such disclosure, the party
making such disclosure shall afford the other party the prior opportunity to
review the text of such disclosure, the other party shall promptly respond to
the disclosing party, and the disclosing party shall use its best efforts to
comply with any reasonable requests by the other party regarding changes.
ARTICLE XIII
WAIVER
13.1 No omission or delay of either party hereto in requiring due and punctual
fulfillment of the obligations of the other party hereto shall be deemed to
constitute a waiver by such party of its rights to require such due and punctual
fulfillment, or of any other of its remedies hereunder.
ARTICLE XIV
WARRANTIES
14.1 LICENSOR warrants that it has the lawful right to grant the sublicense set
forth herein. LICENSOR furthers represents and warrants to LICENSEE that, to the
best of its knowledge, it is the exclusive licensee of the Children's Hospital
Research Foundation/Children's Hospital, Inc. in respect of the Licensed Patent
Rights and the Licensed Materials in all fields and that neither LICENSOR nor to
the best of LICENSOR's knowledge, the Children's Hospital Research
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Foundation/Children's Hospital, Inc. has granted any licenses, sublicenses, or
other rights in respect of the Licensed Patent Rights or the Licensed Materials
in the Field of Use or any Optioned Field of Use.
14.2 LICENSOR makes no express or implied warranties of merchantability or
fitness of the Licensed Products for any particular purpose.
14.3 Nothing in this Agreement shall be construed as:
i) a warranty or representation by the LICENSOR as to the patentability,
validity or scope of any of the Licensed Patent Rights;
ii) except as provided in Section 14.1, a warranty or representation that
anything made, used, sold or otherwise disposed of under any license granted in
this Agreement is or will be free from infringement of patents or proprietary
rights of third parties; or,
iii) an obligation to bring or prosecute actions or suits against third
parties for infringement.
ARTICLE XV
SUCCESSION AND ASSIGNABILITY
15.1 This Agreement and the rights and benefits conferred upon LICENSEE
hereunder may not be assigned nor transferred by LICENSEE without the prior
written consent of LICENSOR, except in the event of sale of all or a portion of
the business of LICENSEE, in which event LICENSEE, upon written notification to
LICENSOR, may assign this Agreement to a wholly owned subsidiary or to a
purchaser of substantially all of its assets relating to the subject matter of
the Agreement.
15.2 This Agreement shall be binding upon and inure to the benefit of the
successors, representatives and assigns of the parties hereto.
ARTICLE XVI
INDEMNITY
16.1 LICENSEE agrees to indemnify, hold harmless and defend LICENSOR, its
officers, employees and agents, against any and all claims, suits, losses,
damages, costs, fees and expenses, including reasonable attorney's fees,
resulting from or arising out of LICENSEE's
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exercise of its rights granted under this Agreement including, but not limited
to, product liability, any damages, losses or liabilities whatsoever with
respect to death or injury to any person and damage to any property arising from
the production, manufacture, sale, lease, consumption, advertisement,
possession, use or operation of Licensed Products by LICENSEE or its
sub-licensees or their customers in any manner whatsoever.
16.2 LICENSOR agrees to indemnify, hold harmless and defend LICENSEE and its
officers, employees and agents against any and all claims, suits, losses,
damages, costs, fees and expenses (including attorneys' fees) resulting from or
arising out of LICENSOR's grant of the sublicense granted under this Agreement
including, but not limited to, any amounts payable by LICENSOR to its
licensor(s) of the Licensed Patent Rights or the Licensed Materials or other
persons or entities having rights in respect of the Licensed Patent Rights or
the Licensed Materials.
16.3 In the event of any claim for which indemnification will be sought pursuant
to Section 16.1 or 16.2, the indemnified party will give the indemnifying party
prompt written notice of such claim. The indemnifying party shall have the sole
right to control the defense and settlement of any such claim and shall not be
liable for any settlement that the indemnifying party does not approve in
writing in advance. The indemnified party will cooperate fully with the
indemnifying party, at the indemnifying party's expense, in connection with the
defense and settlement of any such claim.
16.4 Prior to entering clinical trials, LICENSEE further agrees to obtain and
maintain in force a comprehensive or commercial form general liability insurance
policy supporting its obligations under Article 16.1. This insurance shall
provide LICENSOR with insurance coverage that is commensurate with the insurance
coverage that LICENSOR would have otherwise been provided had the LICENSOR been
named as additional insured on the LICENSEE's comprehensive general liability
insurance, and provide for prior notice to LICENSOR before cancellation. The
limits of such insurance shall be commercially reasonable amounts for personal
injury or death, and for property damage. Upon request, LICENSEE shall provide
LICENSOR with Certificates of Insurance evidencing the same.
ARTICLE XVII
NOTICES
17.1 Any payment, notice or other communication required or permitted to be
given by either party hereto shall be deemed to have been properly given and be
effective on the date of delivery if delivered, in writing, in person, by
facsimile, by overnight mail or by first class certified mail with postage
prepaid and return receipt requested to the respective addresses set forth
below, or to such other address as either party shall designate by written
notice given to the other party:
In the case of LICENSOR:
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Alkermes, Inc.
Chief Financial Officer
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
In the case of LICENSEE:
President, Targeted Genetics Corporation
0000 Xxxxx Xxx, Xxxxx 000
Xxxxxxx, XX 00000
ARTICLE XVIII
ARBITRATION; APPLICABLE LAW
18.1 All disputes that may arise, including, but not limited to, disputes
arising under Article 7.1, in connection with this agreement and that are not
resolved by the parties themselves shall be submitted to binding arbitration
under the commercial rules and regulations then obtaining of the American
Arbitration Association relating to voluntary arbitrations. All costs of
arbitration shall be divided equally between the parties. The award shall be
binding and conclusive on each of the parties, and it may be enforced by the
party in whose favor it runs in any court of competent jurisdiction at the
option of the successful party.
18.2 In the event of any arbitration as provided in Section 18.1, (i) venue for
the arbitration shall lie exclusively in the state and county of the principal
executive offices of the party against whom the arbitration is initiated, and
(ii) the law governing this Agreement for purposes of the arbitration shall be
the law of the state of the principal executive offices of the party against
whom the arbitration is initiated.
ARTICLE XIX
MISCELLANEOUS
19.1 The headings of the several sections of this Agreement are inserted for
convenience and reference only; and, are not intended to be a part of or to
affect the meaning or interpretation of this Agreement.
19.2 This Agreement will not be binding upon the parties until it has been
signed by, or on behalf of, each party, in which event it shall be effective as
of the Effective Date.
19.3 No amendment or modification hereof shall be valid or binding upon the
parties unless made in writing and signed as aforesaid.
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19.4 This Agreement embodies the entire understanding of the parties and
supersedes all previous communications, representations or understandings,
either oral or written, between the parties relating to the subject matter
hereof.
19.5 If any provision, or provisions, of this Agreement shall be held to be
invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions shall not be in any way affected or impaired thereby.
19.6 In witness whereof, both the LICENSOR and LICENSEE have executed this
Agreement, in duplicate originals but collectively evidencing only a single
contract, by their respective officers hereunto duly authorized, on the day and
year hereinafter written.
IN WITNESS WHEREOF, the parties have executed this Agreement through duly
authorized representatives as of the date first above written.
ALKERMES, INC.
By: /s/ Xxxxxxx Xxxxxxx
---------------------------------------------------
Title: Sr. Vice President and Chief Financial Officer
TARGETED GENETICS CORPORATION
By: /s/ H. Xxxxxxx Xxxxxx
---------------------------------------------------
Title: President and CEO
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