LICENSE AGREEMENT
*Certain
confidential information contained in this document, marked by brackets,
has been omitted and filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
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THIS
AGREEMENT (the “Agreement”) is made and is effective December 5, 2006, (the
“Effective Date”) by and between Targeted Genetics Corporation, a corporation
having a principal place of business at 0000 Xxxxx Xxx, Xxxxx 000, Xxxxxxx,
Xxxxxxxxxx 00000 (“TGC”), and Amsterdam Molecular Therapeutics B.V. (“AMT”), a
corporation having a principal place of business at Xxxxxxxxxxxx 00, 0000 XX
Xxxxxxxxx, Xxx Xxxxxxxxxxx.
RECITALS
WHEREAS,
TGC has exclusively licensed the Licensed Patent Rights (relating to an AAV1
Vector gene delivery system) from the University of Pennsylvania as part of
a
license agreement entered into between TGC and the University of Pennsylvania
(“UPenn”) with the effective date of June 1, 2002 (“UPenn Agreement”).
WHEREAS,
AMT is developing an AAV1 product to treat LPL type 1 and LPL type 5 deficiency
that requires a license to the Licensed Patent Rights and therefore seeks a
license to the Licensed Patent Rights in the Field, as such terms are defined
herein; and
WHEREAS,
TGC is willing to grant such a license on the terms set forth herein and the
University of Pennsylvania is willing to acknowledge such grant of a sublicense.
NOW
THEREFORE, the parties agree as follows:
1.
DEFINITIONS
1.1 “AAV1
Vector” means the adeno-associated virus serotype 1 vector technology which
includes without limitation the AAV serotype 1 rep, cap, and ITR sequences
and
proteins whether utilized in whole or in part to deliver therapeutic genes
into
cells, and which is the subject of the Licensed Patent Rights
1.2 “Affiliate”
means any company or other legal entity other than AMT in whatever country
organized, controlling, controlled by or under common control with AMT. The
term
“control” means possession, direct or indirect, of the powers to direct, cause
or significantly influence the direction of the management and policies of
the
company or entity in question, whether through the ownership of voting
securities, by contract or otherwise.
1.3 “Federal
Government Interest” means the rights of the United States Government under
Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C. 200-212, and any
regulations issued thereunder, as such statute or regulations may be amended
from time to time hereafter.
1.4 “Field”
means treatment of LPL deficiency type 1 and LPL deficiency type 5 by in vivo
gene therapy utilizing an AAV1 Vector encoding the LPL gene.
1.5 “Included
CIPs” has the meaning given in Paragraph 1.9.
1.6 “License”
has the meaning given in Paragraph 2.1.
1.7 “LPL”
means Lipoprotein Lipase.
1.8 “Licensed
Patent Rights” means rights to any subject matter described or claimed in U.S.
Patent Nos. 6,759,237 and 7,105,345;and all foreign counterparts including
all
continuations, divisionals, and any continuation-in-part applications, to the
extent that such continuation-in- part (or any continuation or divisional
thereof) has claims directed to subject matter enabled and described in U.S.
Patent Nos. 6.759,237 and 7,105,345 and such claims are necessary or relevant
for the Field ( collectively, “Included CIPs”); any patents issuing on said
applications, continuing applications, divisional applications, including
reissues and reexaminations thereof, and any foreign applications or patents
corresponding directly thereto.
1.9 “Licensed
Product” means a product in the Field that, absent the License, would in the
country of sale infringe any Valid Claim within the Licensed Patent Rights
in
such country.
1.10 “Net
Sales” means [*].
1.11 “Person”
means an individual, sole proprietorship, partnership, limited partnership,
limited liability partnership, corporation, limited liability company, business
trust, joint stock company, trust, unincorporated association, joint venture,
or
other similar entity or organization, including without limitation, a government
or political subdivision, department or agency of a government.
1.12 “Royalties”
has the meaning given in Paragraph 4.1.
1.13 “Third
Party” means any Person other than AMT, TGC or any of their respective
Affiliates.
1.14 “Valid
Claim” means
i)
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a
claim of an issued and unexpired patent included within Licensed
Patent
Rights, which has not been held permanently revoked, unenforceable
or
invalid by a decision of a court or other governmental agency of
competent
jurisdiction, unappealable or un-appealed within the time allowed
for
appeal, and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise;
or
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*Confidential
Treatment Requested
ii)
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a
claim of a pending patent application included within Licensed Patent
Rights which claim was filed and is being prosecuted in good faith
and has
not been abandoned or finally disallowed without the possibility
of appeal
or refiling of the application, provided that no more than [eight
(8)]
years have passed since the earliest priority date for such
application.
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2.
GRANT
2.1 TGC
grants to AMT a non-exclusive, non-sublicensable license under the Licensed
Patent Rights in each country of the world where there are Valid Claims of
Licensed Patent Rights, to make, have made, develop, use, sell, offer to sell
and import Licensed Products (the “License”).
2.2 AMT
acknowledges that in accordance with the Federal Government Interest, the United
States government retains certain rights in intellectual property funded in
whole or part under any contract, grant or similar agreement with a Federal
agency, including but not limited to the requirement that Licensed Products
subject to sale in the United States must be substantially manufactured in
the
United States. The license grant of this Article 2 is expressly subject to
all
of such rights.
2.3 UPenn
retains the reserved right to use, and to permit other for-profit or nonprofit
organizations to use, the Licensed Patent Rights strictly for educational and
for research purposes. Any such rights of U Penn or a third party to practice
the Licensed Patent Rights for educational or research purposes shall be
royalty-free.
3.
CONSIDERATION
AND MAINTENANCE FEES
3.1 Upon
signing this Agreement, AMT shall pay to TGC a $1,750,000 fee in consideration
of the License.
3.2 Upon
the
first anniversary of the Effective Date and upon each anniversary during the
Term thereafter, AMT shall pay to TGC a $[*]
maintenance fee for maintenance of the License.
4.
ROYALTIES
AND PAYMENTS
4.1 AMT
shall
pay to TGC earned royalties based on Net Sales (“Royalties”) in the amount of:
(i) [*]
percent
([*]%)
of the
Net Sales of Licensed Products if cumulative Net Sales are less than
$[*],
or (ii)
[*]
percent
([*]%)
of the
Net Sales of Licensed Products if cumulative Net Sales are equal to or greater
than $[*]
but less
than $[*],
or
(iii) [*]
percent
([*]%)
of Net
Sales of Licensed Products if cumulative Net Sales are $[*]
or more.
[*] The
Net
Sales thresholds in such section (i)-(iii) will be applied separately to each
distinct Licensed Product, but where the same Licensed Product is packaged
or
labeled differently in different nations, or otherwise to accommodate the same
to different markets or indications, the Net Sales thereof in all such nations,
markets and indications shall be aggregated.
*Confidential
Treatment Requested
4.2 In
addition to the Royalties and other payments set forth herein, AMT shall pay
TGC
the following “Milestone Payments.” For the purposes of this Agreement, the
human clinical trial designations of phase I, phase II, phase III, and Biologic
License Application, or BLA, while referring to United States Food and Drug
Administration shall also be construed to mean any such jurisdiction the
equivalent designation applied to clinical trial and drug development of similar
status by the appropriate foreign governmental health regulatory agency.
[*]:
Section
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Milestone
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Milestone
Payments
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4.2.1
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[*]
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$[*]
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4.2.2
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[*]
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$[*]
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4.2.3
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[*]
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$[*]
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4.2.4
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[*]
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$[*]
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4.2.5
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[*]
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$[*]
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4.3 Royalties
accruing to TGC shall be paid to TGC on a quarterly basis. Each such payment
will be for royalties which accrued within the most recently completed calendar
quarter and payment shall be made by AMT within thirty (30) days of the end
of
such calendar quarter.
4.4 Milestone
Payments shall be paid to TGC within thirty (30) days of
achievement.
4.5 Royalty
or Milestone Amounts that are not paid when due shall accrue interest from
the
due date until paid, at a rate equal to one and one quarter percent (1.25%)
per
month (or the maximum allowed by law, if less).
4.6 AMT
must
maintain complete and accurate books and records which enable the Royalties,
fees, and payments payable under this Agreement to be verified. The records
for
each calendar quarter must be maintained for three (3) years after the
submission of each report under Article 4. Upon reasonable prior written notice
to AMT from TGC, AMT shall permit a certified public accountant or a person
possessing similar professional status and associated with an independent
accounting firm reasonably acceptable to AMT to inspect all books and records
relating to the sales of Licensed Products by AMT as necessary to verify the
same. Access to these books and records pertaining to Net Sales must be made
available no more than once each calendar year for each Licensed Product, during
normal business hours, and once each year for each Licensed Product during
each
of the three (3) years after expiration or termination of this Agreement. The
accounting firm shall enter into appropriate obligations with AMT to treat
all
information it receives during its inspection in confidence. The accounting
firm
shall disclose to the parties only whether such books and records are correct
and details concerning any discrepancies, but no other information shall be
disclosed to TGC. The charges of the accounting firm shall be paid by TCG,
except if a review or audit of such books and records of AMT determines that
AMT
has underpaid royalties on Licensed Products by five percent (5%) or more then
AMT must pay the charges of the accounting firm in connection with such review
or audit. Notwithstanding the foregoing, AMT agrees to conduct, at its expense,
an independent audit of sales and Royalties with respect to a Licensed Product
at least every two (2) years once annual sales of such Licensed Product are
greater than five million dollars ($5,000,000) per annum. The audit shall
address, at a minimum, the amount of gross sales by or on behalf of AMT during
the audit period, the amount of funds owed to TGC under this Agreement, and
whether the amount owed has been paid to TGC and is reflected in the records
of
the AMT. A report by the auditors shall be submitted promptly to TGC upon
completion.
*Confidential
Treatment Requested
4.7 In
the
event that any patent or any claim thereof included within the Licensed Patent
Rights shall be held invalid or unenforceable in a final decision by a court
of
competent jurisdiction from which no appeal has or can be taken, any and all
obligation to pay Royalties based solely on such patent or claim shall cease
as
of the date of such final decision.
4.8 Any
component of Net Sales denominated in currencies other than U.S. Dollars shall
be converted into U.S. Dollars in accordance with the provisions of this
paragraph, and reported in U.S. Dollars. All payments required under this
Agreement from time to time shall be made in U.S. Dollars. Any currency
conversions shall be made using the average quarterly exchange rates published
regularly by Citibank, New York, or its successor. The average will be
calculated by summing the exchange rates for the final business day of each
of
the three (3) months in the applicable calendar quarter and dividing by three
(3). All currency conversions will be calculated to an accuracy of three (3)
digits after the decimal point.
5.
PATENT
FILING, PROSECUTION AND MAINTENANCE
5.1 As
between the parties, TGC shall have the responsibility for the preparation,
filing, prosecution and maintenance of the Licensed Patent Rights in the United
States and foreign countries for which patent protection has been sought. TGC
shall maintain the Licensed Patent Rights in all territories for the maximum
time period permitted by applicable law, including by timely paying all
applicable maintenance fees and diligently prosecuting any patent applications
and diligently defending any Third Party challenges to validity or
enforceability.
*Confidential
Treatment Requested
6.
PATENT
INFRINGEMENT
6.1 In
the
event that AMT
learns of the infringement of any Licensed Patent Rights by the manufacture,
use
or sale of a product in the Field, AMT shall so inform TGC in writing and shall
provide TGC with reasonable evidence of such infringement.
6.2 As
between the parties, TGC shall have the first right but not the obligation
to
prosecute such infringement of the Licensed Patent Rights. In the event such
infringement relates specifically to the manufacture, use or sale of a product
in the Field, AMT shall have the right but not the obligation to participate
in
such infringement litigation and be represented by counsel of its choice at
its
own expense. In the event TGC notifies AMT that it will not bring such action
as
it relates specifically to the manufacture, use or sale of a product in the
Field, AMT at it is own expense shall have the right to bring such action and
shall cause TGC to be joined in such action in jurisdictions where it is
necessary for TGC to be named in order for AMT to have standing in such
infringement litigations; provided, however, that AMT shall allow TGC to
participate and be represented by counsel of its own choice at AMT’s sole
expense. AMT shall not nor shall AMT cause TGC to settle or compromise any
such
suit in a manner that imposes any obligations or restrictions on TGC or grants
any License Patent Rights without TGC’s written permission.
6.3 Each
party shall, at the request and expense of the party initiating such suit,
cooperate in all respects, including being joined as a named party, and, to
the
extent possible, have its employees testify when requested and make available
relevant records, papers, information, samples, specimens, and the like. No
such
suit shall be settled by a party in any manner which diminishes the rights
of
the other party hereto under this Agreement without the written agreement of
both parties.
6.4 Any
legal
action against a third party under this Section 6 shall be at the expense of
the
party on account of whom suit is brought and recoveries recovered thereby shall
first be allocated to reimburse the expenses of the parties on a pro rata basis,
after which, when the infringement relates to the manufacture, use or sale
of a
product in the Field,, any remaining recoveries shall belong to AMT and AMT
shall pay TGC royalty amounts set forth in Section 4 on such remaining
recoveries as if such recoveries were Net Sales.
7.
REPORTING
7.1 AMT
will
make quarterly royalty reports to TGC on or before each January 30, April 30,
July 30 and October 30 of each year (i.e., within thirty (30) days from the
end
of each calendar quarter) and certified by the chief financial officer of AMT.
Each such royalty report will cover AMT’s most recently completed calendar
quarter and will show: (a) the gross sales and Net Sales of Licensed Products
sold by AMT during the most recently completed calendar quarter, including
(i)
all amounts invoiced, billed, or received; and (ii) the number of units and
the
country of sale; and (b) the Royalties payable hereunder with respect to such.
If no sales of Licensed Products have been made during any reporting period,
a
statement to this effect shall be provided by AMT to TGC.
7.2 Progress
Reports.
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Treatment Requested
7.2.1 AMT
will
provide TGC with a written plan relating to AMT’s development in the Field (the
“Development Plan”) within thirty (30) days after the signing of this Agreement
by both parties. The Development Plan will outline the disease indications,
patient populations to be addressed, publicly available information on
competition and estimates of development timelines for AMT’s products in the
Field. The Development Plan will separately address activities applicable to
each Licensed Product.
7.2.2 At
or
within thirty (30) days following each anniversary of the Effective Date, AMT
will provide TGC with a written progress report that describes any progress
made
against the Development Plan (as supplemented by progress reports, where
applicable) submitted a year earlier and plans for development in the coming
year. AMT shall also notify TGC within thirty (30) days of the first commercial
sale of any Licensed Product.
7.2.3 AMT
will
provide TGC with audited financial statements, produced by a certified public
accounting firm, ninety (90) days following the end of each of AMT’s fiscal
years, as well as a copy of any management letter recommendations submitted
by
the auditors.
7.2.4 Where
applicable AMT will provide TGC with copies of reports such as Form 10-K and
Form 10-Q filings made to the United States Securities and Exchange Commission
or other similar regulatory agency outside of the United States.
7.2.5 TGC
shall
keep the Development Plan, all such progress reports, financial statements
and
any other information AMT provided to TCG under this Section 7 confidential,
other than the provision of such reports to the University of Pennsylvania
as
required under the UPenn Agreement, for five (5) years or until the time, if
any, of the first commercial sale of any Licensed Product(s).
8.
TERM
OF THE AGREEMENT
8.1 Unless
otherwise terminated in accordance with the terms of this Agreement, this
Agreement shall be in force from the Effective Date until the last to
expire
Valid Claim of Licensed Patent Rights (the “Term”).
8.2 Any
termination of this Agreement shall not affect the rights and obligations set
forth in the following Articles:
Article
6.4 Allocation of Patent Infringement Recovery
Article
11.2 Disposition of Licensed Products on Hand upon Termination
Article
13 Use of Names and Trademarks
Article
15 Indemnification
Article
20 Failure to Perform
Article
21 Governing Law
9.
TERMINATION
BY TGC
9.1 If
AMT
violates or fails to pay Royalties, Milestone Payments or fees under Articles
3
or 4, or (ii) breaches or fails to perform, or has any other default, under
any
contractual obligation of AMT to TGC and fails to repair any default in Sections
9.1(i) or 9.1(ii) within thirty (30) days after receipt of such notice of
breach, TGC shall have the right to terminate this Agreement by a second written
notice (“Notice of Termination”) to AMT. If a Notice of Termination is sent to
AMT, this Agreement shall terminate fifteen (15) days after receipt of such
notice unless other terms are mutually agreed upon.
*Confidential
Treatment Requested
9.2 If
AMT
shall cease its operations other than in connection with a reorganization of
its
business in connection with a redomociliation or other corporate event unrelated
to the solvency of AMT, 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 then TGC shall have the right to
terminate the License.
10.
TERMINATION
BY AMT
10.1 AMT
shall
have the right to terminate this Agreement at any time, effective sixty (60)
days after receipt by TGC of a written notice of termination delivered pursuant
to this section.
10.2 AMT
may
terminate this Agreement with immediate effect by giving written notice to
TGC,
if TGC ceases its operations, becomes insolvent, applies for or consents to
the
appointment of a trustee, receiver or liquidator of its assets, or seeks relief
under any law for the aid of debtors. If TGC violates or fails to perform any
material term or covenant of this Agreement, then AMT may give written notice
of
such default (“Notice of Default”) to TGC. If TGC fails to repair such default
within thirty (30) days after receipt of such Notice of Default, AMT shall
have
the right to terminate this Agreement by a Notice of Termination to TGC,
effective immediately.
11.
EFFECT
OF TERMINATION, DISPOSITION OF LICENSED PRODUCTS UPON
TERMINATION
11.1 Effect
of Termination.
Upon
the termination of this Agreement, except pursuant to Paragraph 10.2, the
License granted by TGC to AMT hereunder shall revert to TGC.
11.2 Upon
termination of this Agreement for any reason, except pursuant to Paragraph
10.2,
AMT shall have the right to dispose of all previously made or partially made
Licensed Products, within a period of three (3) months; provided, however,
that
the sale of such Licensed Products shall be subject to the terms of this
Agreement including, but not limited to, the payment of Royalties at the rate
and at the time provided herein and the rendering of reports.
11.3 Upon
termination of this Agreement for any reason, except pursuant to Paragraph
10.2,
AMT shall pay, within thirty (30) days to TGC, pursuant to Section 3 and 4,
any
and all amounts due within sixty (60) days of receipt by TGC of a notice of
termination from AMT.
11.4 Upon
the
termination of this Agreement pursuant to Paragraph 10.2 or the termination
of
the UPenn Agreement, TGC’s rights hereunder shall be assigned directly to the
UPenn and shall remain in full force and effect under the terms hereof; and,
provided that AMT is not in material breach of this Agreement, the rights and
obligations of AMT herein (including but not limited to the License) shall
continue in full force and effect without expansion, restriction, inhibition
or
diminution; provided that [*].
*Confidential
Treatment Requested
11.5
Nothing
herein shall constitute a waiver of either party's right to seek damages in
the
event of a material breach of this Agreement by the other party.
12.
PATENT
MARKING
12.1 AMT
agrees to xxxx all Licensed Products made, used or sold under the terms of
this
Agreement, or their containers, in accordance with the applicable patent marking
laws.
13.
USE
OF NAMES AND TRADEMARKS
13.1 Unless
required by law, 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 of either
party
hereto or the UPenn (including any contraction or abbreviation of the
foregoing).
13.2 Unless
required by law, neither party shall disclose, at any time, the financial terms
or events upon which financial obligations are triggered in the License, save
that TGC and AMT shall have the right to do so (i) to the extent such disclosure
is required in publicly filed financial statements or other public statements
under rules governing a stock exchange (e.g., the rules of the United States
Securities and Exchange Commission, NASDAQ, NYSE, Amsterdam, UKLA or any other
stock exchange on which securities issued by either Party may be listed); and
(ii) to its actual or potential investment bankers; (iii) to existing and
potential investors in connection with an offering or placement of securities
for purposes of obtaining financing for its business and to actual and
prospective lenders for the purpose of obtaining financing for its business;
and
(iv) to a bona fide potential acquiror or merger partner for the purposes of
evaluating entering into a merger or acquisition, provided, however, any such
persons must be obligated to hold in confidence and not make use of such
confidential information for any purpose. A press release acknowledging the
grant of the License by TGC to AMT shall be publicly disclosed by either or
both
parties, only upon mutual agreement of the text of such release by both parties.
14.
REPRESENTATIONS,
WARRANTIES AND COVENANTS
14.1 Each
party hereby represents, warrants, and covenants to the other party as of the
Effective Date as follows:
i) such
party (i) has the power and authority and the legal right to enter into this
Agreement and perform its obligations hereunder, and (ii) has taken all
necessary action on its part required to authorize the execution and delivery
of
this Agreement and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of such party and constitutes
a
legal, valid, binding obligation of such party and is enforceable against it
in
accordance with its terms;
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ii) such
party is not aware of any pending or threatened litigation (and has not received
any communication) that alleges that such party’s activities related to this
Agreement have violated, or that by conducting the activities as contemplated
herein such party would violate, any of the intellectual property rights of
any
other Person;
iii) all
necessary consents, approvals and authorizations of all governmental authorities
and other Persons or entities required to be obtained by such party in
connection with this Agreement have been obtained; and
14.2 TGC
hereby represents, warrants, and covenants to AMT
as of
the Effective Date that TGC is the exclusive licensee of the Licensed Patent
Rights. During the term of this Agreement, TGC shall use its best efforts not
to
encumber or diminish the rights granted to AMT hereunder, including, without
limitation, by not committing any acts or permitting the occurrence of any
omissions that would cause the breach or termination of the UPenn Agreement.
TGC
shall promptly provide AMT with notice of any alleged breach or termination
of
the UPenn Agreement. As of the date hereof, TGC is not in breach of the UPenn
Agreement, and it is in full force and effect.
15.
DISCLAIMER
OF WARRANTY; INDEMNIFICATION
15.1 THE
LICENSED PATENT RIGHTS AND LICENSED PRODUCTS ARE PROVIDED ON AN “AS IS” BASIS
AND TGC MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT
THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, TGC MAKES NO REPRESENTATION
OR
WARRANTY: (i) OF COMMERCIAL UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR
A
PARTICULAR PURPOSE; OR (iii) THAT THE USE OF THE LICENSED PATENT RIGHTS AND
LICENSED PRODUCTS UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT
OR TRADEMARK OR OTHER PROPRIETARY OR PROPERTY RIGHTS OF OTHERS. TGC SHALL NOT
BE
LIABLE TO AMT OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM ARISING FROM THE
USE
OF THE LICENSED PATENT RIGHTS AND LICENSED PRODUCTS LICENSED UNDER THIS
AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF LICENSED PRODUCTS; OR ANY
CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT,
SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.
15.2 AMT
will
defend, indemnify and hold harmless TGC and its trustees, officers, agents
and
employees and UPenn and its trustees, officers, agents and employees both
collectively and severally (individually, an “Indemnified
Party”,
and
collectively, the “Indemnified
Parties”),
from
and against any and all liability, loss, damage, action, claim or expense
suffered or incurred by the Indemnified Parties (including attorney’s fees)
(individually, a “Liability”,
and
collectively, the “Liabilities”)
that
results from or arises out of (a) the development, use, manufacture, promotion,
sale or other disposition of any Licensed Product by AMT or its collaborators
or
distributors; and (b) any breach by AMT of any covenant or agreement contained
in this Agreement; and (c) the enforcement by an Indemnified Party of its rights
under this Section. . Without limiting the foregoing, AMT will defend, indemnify
and hold harmless the Indemnified Parties from and against any Liabilities
resulting from:
*Confidential
Treatment Requested
15.2.1 any
product liability or other claim of any kind related to the use by a third
party
of a Licensed Product that was manufactured, sold or otherwise disposed
of
by
AMT, or its collaborators or distributors, pursuant to and within the scope
of
such relationships;
15.2.2 a
claim
by a third party that the use by AMT or its collaborators or distributors,
pursuant to and within the scope of such relationships, of Licensed Patent
Rights or the design, composition, manufacture, use, sale or other disposition
of any Licensed Product by AMT infringes or violates any patent, copyright,
trademark or other intellectual property rights of such third party;
and
15.2.3
clinical
trials or studies conducted by or on behalf of AMT, or its collaborators or
distributors, pursuant to and within the scope of such relationships, relating
to the Licensed Products and Licensed Patent Rights, including, without
limitation, any claim by or on behalf of a human subject of any such clinical
trial or study, any claim arising from the procedures specified in any protocol
used in any such clinical trial or study, any claim of deviation, authorized
or
unauthorized, from the protocols of any such clinical trial or study, and any
claim resulting from or arising out of the manufacture or quality control by
a
third party of any substance administered in any clinical trial or
study.
Notwithstanding
the foregoing, however, the Liabilities shall not include, and in no instance
shall AMT be required to indemnify any Indemnified Party with respect to, any
liability, claims, lawsuits, losses, damages, costs or expenses to the extent
the same are determined to be the result of any Indemnified Party’s gross
negligence or willful misconduct.
15.3 The
Indemnified Party shall promptly notify AMT of any claim or action giving rise
to Liabilities subject to the provisions of the foregoing Section. AMT shall
have the right to defend or to cause to be defended any such claim or action,
at
its cost and expense. AMT shall not settle or compromise any such claim or
action in a manner that imposes any restrictions or obligations on TGC or grants
any rights to Licensed Patent Rights or Licensed Products (other than to the
extent AMT has the right to grant such rights under this Agreement) without
TGC’s prior written consent. If AMT fails or declines to assume the defense of
any such claim or action within thirty (30) days after notice thereof, TGC
may
assume the defense of such claim or action for the account and at the risk
of
AMT, and any Liabilities related thereto shall be conclusively deemed a
liability of AMT; provided however, that TGC shall not settle such claim or
action if such settlement affects Licensed Patent Rights other than those
specifically at issue in such claim or action without AMT’s written permission,
which shall not be unreasonably withheld. AMT shall pay promptly to the
Indemnified Party any Liabilities to which the foregoing indemnity relates,
as
incurred. The indemnification rights of TGC or other Indemnified Party contained
herein are in addition to all other rights which such Indemnified Party may
have
at law or in equity or otherwise.
16.
INSURANCE
16.1 AMT
shall
procure and maintain a policy or policies of commercial general liability
insurance, including broad form and contractual liability, in a minimum amount
of $[*]
combined
single limit per occurrence and in the aggregate as respects personal injury,
bodily injury and property damage arising out of AMT’s performance of this
Agreement.
*Confidential
Treatment Requested
16.2 AMT
shall, upon commencement of clinical trials involving Licensed Products, procure
and maintain a policy or policies of product liability insurance in a minimum
amount of $[*]
combined
single limit per occurrence and in the aggregate as respects bodily injury
and
property damage arising out of AMT’s performance of this Agreement.
16.3 AMT
shall
provide TGC with certificates evidencing the insurance coverage required herein
and all subsequent renewals thereof. Such certificates shall provide that AMT’s
insurance carrier(s) notify TGC in writing at least 30 days prior to
cancellation or material change in coverage. TGC will retain such certificates
and notices from AMT’s insurance carrier.
16.4 TGC
shall
periodically review the adequacy of the minimum limits of liability specified
herein. Further, TGC reserves the right to require AMT to adjust such coverage
limits in accordance with prevailing industry norms, to the extent TGC is
required to do the same by UPenn pursuant to the UPenn Agreement. The specified
minimum insurance amounts shall not constitute a limitation on AMT’s obligation
to indemnify TGC under this Agreement.
17.
NOTICES
17.1 Any
notice or payment required to be given to either party shall be deemed to have
been properly given and to be effective (a) on the date of delivery if delivered
in person or (b) five (5) days after mailing if mailed by a nationally
recognized courier or by first-class certified mail, postage paid, to the
respective addresses given below, or to such other address designated by written
notice, or sent via facsimile transmission to the number specified
below.
For AMT: |
Xxxxxxxxxxxx
00
X.X.
Xxx 00000
0000
XX Xxxxxxxxx
Xxx
Xxxxxxxxxxx
Fax:
00 (0) 00 000 00 00
Attention:
CFO
|
For TGC: |
0000
Xxxxx Xxx, Xxxxx 000
Xxxxxxx,
Xxxxxxxxxx 00000
Fax:
x0 000 000-0000
Attention:
Chief Executive Officer
|
18.
ASSIGNABILITY
18.1 This
Agreement is binding upon and shall inure to the benefit of the
parties and their successors and assigns.
18.2 This
Agreement may not be assigned by AMT without first obtaining the express written
consent of TGC. TGC shall not unreasonably withhold consent for AMT to assign
this Agreement to a Third Party in the event that AMT transfers all or
substantially all of the business of AMT to which the License relates to a
Third
Party. Such Third Party shall assume all royalty obligations to TGC hereunder.
TGC further acknowledges that it shall not be entitled to any Royalty or other
compensation from the transaction pursuant to which the transfer to a Third
Party of all or substantially all of the business of AMT to which the License
relates took place.
*Confidential
Treatment
Requested
19.
WAIVER
19.1 It
is
agreed that no waiver by either party hereto of any breach or default of any
of
the covenants or agreements herein set forth shall be deemed a waiver as to
any
subsequent and/or similar breach or default.
19.2 UPenn,
by
its signature on this Agreement, expressly acknowledges and agrees (1) to the
terms of this sublicense; (2) to the extent that any term of this sublicense
is
in conflict with the UPenn Agreement, the terms of this Agreement shall govern
as to the rights and obligations of AMT to TGC and AMT to UPenn pursuant to
this
Agreement; and (3) to the extent any term of this sublicense is in conflict
with
the UPenn Agreement, other than the UPenn Agreement terms of Section 4.1.2
and
4.1.5, 4.3.2 and 4.3.3, the terms of this Agreement shall govern as to the
obligation of TGC to UPenn as they relate to this specific Agreement. TGC shall
be obligated to comply with Sections 4.1.2, 4.1.5, 4.3.2 and 4.3.3 of the UPenn
Agreement as they relate to the financial obligations of TGC to UPenn arising
from the grant of this sublicense to AMT, unless mutually agreed otherwise
between TGC and UPenn.
20.
FAILURE
TO PERFORM
20.1 In
the
event of a failure of performance due under the terms of this Agreement and
if
it becomes necessary for either party to undertake legal action against the
other on account thereof, then the prevailing party shall be entitled to
reasonable attorney’s fees in addition to costs and necessary
disbursements.
21.
GOVERNING
LAW
21.1 This
Agreement shall be interpreted and construed in accordance with the laws of
the
Commonwealth
of Pennsylvania without regard to the principles of conflicts of laws, but
the
scope and validity of any patent or patent application shall be governed by
the
applicable laws of the country of such patent or patent application. Each party
hereby submits itself to the non-exclusive jurisdiction of the federal or state
courts located in the Commonwealth of Pennsylvania, and any courts of appeal
therefrom, and waives any objection (on grounds of lack of jurisdiction, or
forum non conveniens or otherwise) to the exercise of such jurisdiction over
it
by any such courts, in connection with any action that may be brought in such
courts.
22.
FORCE
MAJEURE
22.1 For
a
period of ninety (90) days, the parties to this Agreement shall be excused
from
any performance required hereunder if such performance is rendered impossible
or
unfeasible due to any catastrophe or other major event beyond their reasonable
control, including, without limitation, war, riot, and insurrection; laws,
proclamations, edicts, ordinances or regulations; strikes, lockouts or other
serious labor disputes; and floods, fires, explosions, or other natural
disasters. When such events have abated, the parties’ respective obligations
hereunder shall resume.
23.
RIGHTS
IN BANKRUPTCY
23.1 All
rights and licenses (including
but not limited to the License) granted under or pursuant to this Agreement
by
TGC to AMT are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property”
as defined under Section 101 of the U.S. Banckruptcy Code. The parties agree
that AMT, as licensee of such rights under this Agreement, shall retain and
may
fully exercise all of its rights and elections under the U.S. Bankruptcy Code
and to the fullest extent permitted by law.
24.
MISCELLANEOUS
24.1 The
headings of the several sections are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
The
English language is the official language of this Agreement and that text of
the
Agreement shall prevail over any translation thereof.
24.2 This
Agreement will not be binding upon the parties until it has been signed below
on
behalf of each party, in which event, it shall be effective as of the dated
recited on page one.
24.3 No
amendment or modification hereof shall be valid or binding upon the parties
unless made in writing and signed on behalf of each party.
24.4 This
Agreement embodies the entire understanding of the parties and shall supersede
all previous communications, representations or understandings, either oral
or
written, between the parties relating to the subject matter hereof.
24.5 If
any
provisions contained in this Agreement are or become invalid, are ruled illegal
by any court of competent jurisdiction or are deemed unenforceable under then
current applicable law from time to time in effect during the term hereof,
it is
the intention of the parties that the remainder of this Agreement shall not
be
affected thereby, provided that a party’s rights under this Agreement are not
materially affected. It is further the intention of the parties that in lieu
of
each such provision which is invalid, illegal, or unenforceable, there be
substituted or added as part of this Agreement a provision which shall be as
similar as possible in economic and business objectives as intended by the
parties to such invalid, illegal or unenforceable, provision, but shall be
valid, legal and enforceable.
IN
WITNESS WHEREOF, both TGC and AMT have executed this Agreement, in duplicate
originals, by their respective officers hereunto duly authorized, on the day
and
year hereinafter written.
Amsterdam
Molecular Therapeutics, B.V.
|
Targeted
Genetics Corporation
|
|
By
/s/ Xxxxxx X.X. Xxxxx
|
By
/s/ H. Xxxxxxx Xxxxxx
|
|
|
|
|
Name
Xxxxxx X.X. Xxxxx
|
Name
H. Xxxxxxx Xxxxxx
|
|
Title
CEO
|
Title
Pres & CEO
|
Acknowledged
and accepted by:
The
Trustees of the University of Pennsylvania
By
/s/ Xxxx X. Xxxxx
Name
Xxxx
X. Xxxxx, Ph.D.
Title
Managing Director
ATTACHMENT
1
Articles
from the UPenn Agreement which would be added to this Agreement, pursuant to
Section 11.4 of this Agreement .
9.5-
Penn
hereby represents that (i) to its knowledge it has the lawful right to grant
the
licenses granted herein, and (ii) all actions necessary with respect to due
authorization, execution and performance of this Agreement to make it legal,
valid, binding and enforceable with regard to Penn have been taken.
12.1 Targeted
shall comply with all prevailing laws, rules and regulations pertaining to
the
development, testing, manufacture, marketing, sale, use, import or export of
products. Without limiting the foregoing, it is understood that this Agreement
may be subject to United States laws and regulations controlling the export
of
technical data, computer software, laboratory prototypes and other commodities,
articles and information, including the Arms Export Control Act as amended
in
the Export Administration Act of 1979, and that the parties’ obligations
hereunder are contingent upon compliance with applicable United States export
laws and regulations. The transfer of certain technical data and commodities
may
require a license from the cognizant agency of the United States Government
and/or written assurances by Targeted that Targeted shall not export data or
commodities to certain foreign countries without prior approval of such agency.
Penn neither represents that a license is not required nor that, if required,
it
will issue.
12.9 Nothing
in this Agreement, express or implied, is intended to confer on any person,
other than the parties hereto, the Covered Affiliates, or their permitted
assigns, any benefits, rights or remedies.
12.10 Penn
and
Targeted shall not discriminate against any employee or applicant for employment
because of race, color, sex, sexual or affectional preference, age, religion,
national or ethnic origin, or handicap.