REDACTED VERSION
EXHIBIT 10.13
To
Targeted Genetics Corporation's
Form 10-K
For the Year Ended
December 31, 1997
"[ * ]" = omitted, confidential material, which material has been
separately filed with the Securities and Exchange Commission pursuant to a
request for confidential treatment.
EXHIBIT 10.13
LICENSE AGREEMENT
MICHIGAN FILE 492c2 TECHNOLOGY
THERAPEUTIC LICENSE
This is an Agreement, effective as of the 28th day of March, 1994 (the
"Effective Date"), entered into by Targeted Genetics Corporation, a corporation
incorporated in the State of Washington, with offices located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇ #▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("LICENSEE"), the Regents of the
University of Michigan, a constitutional corporation of the State of Michigan
("MICHIGAN"), and HSC Research and Development Limited Partnership, a
partnership organized and subsisting under the laws of the Province of Ontario,
Canada ("RDLP"). LICENSEE, MICHIGAN and RDLP agree as follows:
1. BACKGROUND.
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1.1 Michigan and the Research Institute of the Hospital for Sick Children
of Toronto, Ontario, Canada ("HSC") have conducted research relating to cystic
fibrosis. As a result of that research, MICHIGAN and RDLP have developed rights
in the "Licensed Patents" defined below.
1.2 LICENSEE desires to obtain, and MICHIGAN and RDLP, consistent with
their missions of education and research, desire to grant a license of the
Licensed Patents on the terms and conditions listed below.
2. DEFINITIONS.
-----------
2.1 "TECHNOLOGY", as used in this Agreement, shall mean the information,
manufacturing techniques, data, designs or concepts developed by MICHIGAN and
HSC, covering the gene for cystic fibrosis and uses thereof as encompassed by
U.S. Patent Application No. 401,609 entitled "Cystic Fibrosis Gene."
2.2 "Parties", in singular or plural usage as required by the context,
shall mean LICENSEE, MICHIGAN and/or RDLP.
2.3 "Affiliate(s)" shall mean any individual, corporation, partnership,
proprietorship or other entity controlled by, controlling, or under common
control with LICENSEE through equity ownership, ability to elect directors, or
by virtue of a majority of overlapping directors, and shall include any
individual, corporation, partnership, proprietorship or other entity directly or
indirectly owning, owned by or under common ownership with LICENSEE to the
extent of
thirty percent (30%) or more of the voting shares, including shares owned
beneficially by such party.
2.4 "Licensed Patent(s)" shall mean U.S. Patent Application No. 401,609
entitled "Cystic Fibrosis Gene." and all foreign equivalent patent applications
and Patent Cooperation Treaty filings, and all patents issuing therefrom in
which MICHIGAN and/or RDLP has or acquires a property interest (currently
including the applications listed in the Appendix attached to this Agreement).
"Licensed Patent(s)" shall also include any divisional, continuation (excluding
continuations-in-part), reissue, reexamination or extension of the above-
described patent applications and resulting patents, along with any extended or
restored term, and any confirmation patent, registration patent, or patent of
addition.
2.5 "Valid Claim(s)" means any claim(s) in an unexpired patent or pending
in a patent application included within the Licensed Patents which has not been
held unenforceable, unpatentable, or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer. If in any country there should be
two or more such decisions conflicting with respect to the validity of the same
claim, the decision of the higher or highest tribunal shall thereafter control;
however, should the tribunals be of equal rank, then the decision or decisions
upholding the claim shall prevail when the conflicting decisions are equal in
number, and the majority of decisions shall prevail when the conflicting
decisions are unequal in number.
2.6 "Product(s)" shall mean any product(s) whose manufacture, use or sale
in any country would, but for this Agreement, comprise an infringement,
including contributory infringement, of one or more Valid Claims.
2.7 "Field of Use" shall refer to the field for which Products may be
designed, manufactured, used and/or marketed under this Agreement, and shall
mean solely Products to be used for the therapeutic treatment or prophylaxis of
the disease cystic fibrosis.
2.8 "Net Sales" shall mean the sum, over the term of this Agreement, of
all amounts received and all other consideration received (or, when in a form
other than cash or its equivalent, the fair market value thereof when received)
by LICENSEE and its Affiliates from persons or entities due to or by reason of
the sale or other distribution of Products, or the use of Products, including
any use by LICENSEE and Affiliates in the performance of services for their
customers;
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less the following deductions and offsets, but only to the extent such sums are
otherwise included in the computation of Net Sales, or are paid by LICENSEE and
not otherwise reimbursed: refunds, rebates, replacements or credits actually
allowed and taken by purchasers for return of Products; customary trade,
quantity and cash discounts actually allowed and taken; excise, value-added, and
sales taxes actually paid by LICENSEE for Products; and shipping and handling
charges actually paid by LICENSEE for Products.
2.9 "Royalty Quarter(s)" shall mean the three-month periods ending on the
last day of March, June, September and December of each year.
2.10 "Territory" means all countries of the world.
2.11 "First Therapeutic Sale" shall mean the first sale of any Product
(including any sale of a service using a Product in the Field of Use) by
LICENSEE or an Affiliate, other than for use in clinical trials being conducted
to obtain FDA or other governmental approvals to market Products.
3. GRANT OF LICENSE.
----------------
3.1 MICHIGAN and RDLP hereby grant to LICENSEE a non-exclusive license
under the Licensed Patents to make, have made, use (including use in the
performance of services for its customers), market and sell, in the Territory,
Products designed and marketed solely for use in the Field of Use.
3.2 MICHIGAN and RDLP reserve the right to license and use all aspects of
the TECHNOLOGY and the Licensed Patents for any use or purpose, including the
right to develop and produce Products.
3.3 The license granted to LICENSEE herein shall be without the right to
sublicense, except that LICENSEE may sublicense Affiliate(s) who agree to be and
are bound in writing to the terms and conditions of this Agreement to the same
extent as LICENSEE. LICENSEE agrees to strictly monitor and enforce compliance
with the terms and conditions of this Agreement by all Affiliate sublicensees.
3.4 If through exercise of its license under Paragraph 3.1 LICENSEE learns
of therapeutic or prophylactic fields of use for Products outside of the Field
of Use, then MICHIGAN and RDLP shall, upon LICENSEE's request, discuss in good
faith whether a separate agreement may be negotiated to provide LICENSEE the
rights necessary to develop and distribute Products designed and marketed for
such fields of use.
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4. CONSIDERATION.
-------------
4.1 LICENSEE shall pay to MICHIGAN a one-time license issue fee of U.S.
$40,000.00, forthwith following the Effective Date. Notwithstanding any other
terms of this Agreement, this Agreement and the license granted hereunder shall
not become effective until such issue fee is received by MICHIGAN.
4.2 LICENSEE shall also pay MICHIGAN, with respect to each Royalty
Quarter, a royalty [ * ] of the Net Sales of LICENSEE and Affiliates.
4.3 The obligation to pay MICHIGAN a royalty under this Article 4 is
imposed only once with respect to the same unit of Product regardless of the
number of Valid Claims or Licensed Patents covering the same; however, for
purposes of determination of payments due hereunder, whenever the term "Product"
may apply to a property during various stages of manufacture, use or sale, Net
Sales, as otherwise defined, shall be derived from the sale, distribution or use
of such Product by LICENSEE or Affiliates at the stage of its highest invoiced
value to unrelated third parties.
4.4 LICENSEE shall pay to MICHIGAN an annual license maintenance fee.
This annual fee shall accrue in the Royalty Quarter ending in March of the years
specified below, and shall be due and payable and included with the report for
that quarter.
If LICENSEE defaults in the payment of any annual license maintenance fee,
and fails to remedy that default within thirty (30) days after written notice of
it by MICHIGAN, then this Agreement and the license rights conveyed herein shall
terminate.
The annual license maintenance fees shall be as follows:
(1) In 1994 and 1995: [ * ];
(2) In 1996, 1997 and 1998: [ * ];
(3) in 1999, and in each year thereafter during the term of this Agreement
up to and including the year in which LICENSEE first obtains FDA approval or
other governmental approval to distribute or use Products in the Field of Use:
[ * ];
[*] Confidential Treatment Requested
4
Also, notwithstanding (1-3) above (and in place of the amounts therein listed,
when applicable):
(4) In the first calendar year following the year in which LICENSEE
obtains the approval described in (3) above, and in each year thereafter during
the term of this Agreement up to and including the year in which the First
Therapeutic Sale occurs: [ * ];
Also, notwithstanding (1-4) above (and in place of the amounts therein
listed, when applicable);
(5) In the first calendar year following the First Therapeutic Sale:
[ * ];
(6) In the second year following the First Therapeutic Sale: [ * ];
(7) In the third year following the First Therapeutic Sale: [ * ];
and
(8) In the fourth year following the First Therapeutic Sale, and in each
year thereafter during the term of this Agreement; [ * ].
Each annual fee paid under (5-8) above may be credited by LICENSEE in full
against all earned royalties otherwise to be paid to MICHIGAN under Paragraph
4.2 for the calendar year in which the specific annual fee is paid. The year
for which such credits against royalties may be taken includes the Royalty
Quarter in which the annual fee accrues and the next three Royalty Quarters.
Each annual fee paid under (1-4) above may be credited by LICENSEE in full
against all earned royalties otherwise to be paid to MICHIGAN under Paragraph
4.2 after such annual fee is paid.
4.5 If it is necessary for LICENSEE to take any license(s), in a given
country, under valid third party patents which would be infringed by the
practice of Licensed Patents in that country, then LICENSEE can deduct up to
[ * ] of the royalties otherwise due and payable in each Royalty Quarter
under Paragraph 4.2 above for Net Sales in that country, until such time as
LICENSEE has recovered an amount equal to [ * ] of the royalty paid to
such third parties; provided that in no event shall such deducted amounts be
applied to reduce or require
[*] Confidential Treatment Requested
5
reimbursement of the annual fees required under Paragraph 4.4. This Paragraph
is not intended to imply an obligation upon MICHIGAN or RDLP to reimburse
LICENSEE's above-described third-party royalties; the rights granted to LICENSEE
in this Paragraph shall not exceed the ability of the above-described mechanism
(i.e., a [ * ] of royalties due upon Net Sales in the country in question)
to reimburse such expenses. LICENSEE shall make an accounting to MICHIGAN of all
such third-party royalties, and all resulting deductions from royalties
otherwise due and payable to MICHIGAN, as part of its reporting obligations
under Article 5 below.
5. REPORTS.
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5.1 Within sixty (60) days after the close of (i) any Royalty Quarter in
which a fee under Paragraph 4.4 accrues, and (ii) each Royalty Quarter following
the First Therapeutic Sale during the term of this Agreement (including the
close of any Royalty Quarter immediately following any termination of this
Agreement), LICENSEE shall report to MICHIGAN all royalties accruing to MICHIGAN
during such Royalty Quarter. Such quarterly reports shall indicate for each
Royalty Quarter the gross sales and Net Sales of Products by LICENSEE and
Affiliates, and any other revenues with respect to which payments are due, and
the amount of such payments, as well as the various calculations used to arrive
at said amounts, including the quantity, description (nomenclature and type
designation), country of manufacture and country of sale of Products. In case
no payment is due for any such period, LICENSEE shall so report.
5.2 LICENSEE covenants that it will promptly establish and consistently
employ a system of specific nomenclature and type designations for Products so
that various types can be identified and segregated, where necessary; LICENSEE
and Affiliates shall consistently employ such system when rendering invoices
thereon and henceforth agree to inform MICHIGAN, or its auditors, when requested
as to the details concerning such nomenclature system as well as to all
additions thereto and changes therein.
5.3 LICENSEE shall keep, and shall require its Affiliates to keep, true
and accurate records and books of account containing data reasonably required
[*] Confidential Treatment Requested
6
for the computation and verification of payments to be made as provided by this
Agreement, which records and books shall be open for inspection upon reasonable
notice during business hours by an independent certified accountant selected by
MICHIGAN. Said right of inspection will exist for six (6) years from the date
of origination of any such record, and this requirement and right of inspection
shall survive any termination of this Agreement. The independent certified
accountant shall provide to MICHIGAN only such information from LICENSEE's books
and records as is necessary to verify the accuracy or degree of inaccuracy of
the payments made under this Agreement. MICHIGAN shall be responsible for all
expenses of such inspection, except that if such inspection reveals an
underpayment of royalties to MICHIGAN in excess of ten percent (10%) for any
year, then said inspection shall be at LICENSEE's expense and such underpayment
shall become immediately due and payable to MICHIGAN.
5.4 The reports provided for hereunder shall be certified by an authorized
representative of LICENSEE to be correct to the best of LICENSEE's knowledge and
information.
6. TIMES AND CURRENCIES OF PAYMENTS.
--------------------------------
6.1 Payments accrued during each Royalty Quarter shall be due and payable
in Ann Arbor, Michigan on the date each quarterly report is due (as provided in
Paragraph 5.1), shall be included with such report and shall be paid in United
States dollars. ▇▇▇▇▇▇▇▇ agrees to make all payments due hereunder to MICHIGAN
by check made payable to "The Regents of The University of Michigan," and sent
by prepaid, certified or registered mail, return receipt requested, to the
address for notices set forth in Article 19 herein.
6.2 On all amounts outstanding and payable to MICHIGAN, interest shall
accrue from the date such amounts are due and payable at two percentage points
above the prime lending rate as established by the Chase Manhattan Bank N.A., in
New York City, New York, or at such lower rate as may be required by law.
6.3 Where Net Sales are generated in foreign currency during any Royalty
Quarter, such foreign currency shall be converted into its equivalent in United
States dollars at the exchange rate of such currency as reported (or if
erroneously reported, as subsequently corrected) in the Wall Street Journal on
the last business day of that Royalty Quarter (or if not reported on that date,
as quoted by the Chase Manhattan Bank, N.A., in New York City, New York).
7
6.4 Except as provided in the definition of Net Sales, all royalty
payments to MICHIGAN under this Agreement shall be without deduction for sales,
use, excise, personal property or other similar taxes or other duties imposed on
such payments by the government of any country or any political subdivision
thereof; and any and all such taxes or duties shall be assumed by and paid by
LICENSEE.
7. COMMERCIALIZATION.
-----------------
7.1 It is understood that LICENSEE has the responsibility to do all that
is necessary for any governmental approvals to manufacture and/or sell Products.
7.2 LICENSEE agrees to use reasonable efforts to develop Products, obtain
any government approvals necessary, and manufacture and sell Products at the
earliest possible date; and to effectively exploit, market and manufacture in
sufficient quantities to meet anticipated customer demand and to make the
benefits of the Products reasonably available to the public.
7.3 Within fifteen (15) days of the First Therapeutic Sale, LICENSEE shall
report by written letter to MICHIGAN the date and general terms of that sale.
8. PATENT APPLICATIONS AND MAINTENANCE.
-----------------------------------
8.1 MICHIGAN and RDLP shall control all aspects of filing, prosecuting,
and maintaining Licensed Patents, including foreign filings and Patent
Cooperation Treaty filings. MICHIGAN and RDLP may in their sole discretion
decide to refrain from or to cease prosecuting or maintaining any of the
Licensed Patents, including any foreign filing or any Patent Cooperation Treaty
filing.
8.2 MICHIGAN shall notify LICENSEE of the issuance of any Licensed Patent
and the Valid Claims included therein, and any lapse, revocation, surrender,
invalidation or abandonment of any Licensed Patent or Valid Claim.
9. INFRINGEMENT.
------------
9.1 If LICENSEE becomes aware of or reasonably suspects infringement of
Licensed Patents by third parties, LICENSEE agrees to promptly notify Michigan
of such alleged infringement.
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9.2 MICHIGAN and RDLP shall take such measures as are in their reasonable
discretion appropriate to stop or discourage substantial infringements of the
Licensed Patents. On request by the LICENSEE, MICHIGAN and RDLP shall inform
LICENSEE of any measures being taken in response to any particular event or
allegation of infringement.
If MICHIGAN and RDLP fail to commence reasonable efforts to stop or
discourage a continuing substantial infringement of the Licensed Patents in any
country within six (6) months of MICHIGAN's receipt of written notice by
LICENSEE of that infringement, then LICENSEE may, upon written notice to
MICHIGAN, withhold royalty payments accruing under this Agreement upon Net Sales
which are thereafter generated in the country in which the infringement is
occurring, instead placing such royalty payments in escrow with an escrow agent
satisfactory to MICHIGAN and LICENSEE. If, within six (6) months of such notice
by LICENSEE, MICHIGAN or RDLP commences reasonable efforts to stop or discourage
the infringement, then LICENSEE's withheld royalties shall be released from
escrow and paid to MICHIGAN. If MICHIGAN and RDLP fail to commence such
reasonable efforts, then the withheld payments shall be released and returned to
LICENSEE and further royalty payments by LICENSEE with respect to Net Sales
generated in the country in which the infringement is occurring shall be waived
by MICHIGAN until MICHIGAN or RDLP in good faith commences such reasonable
efforts, upon which date the waiver of royalties by MICHIGAN shall terminate and
royalties accruing upon LICENSEE's Net Sales generated in that country after
that date shall be due and payable as provided in this Agreement.
An infringement shall not be deemed substantial under this paragraph unless
it can be demonstrated that it generates more than the equivalent of five
million U.S. Dollars (U.S. $5,000,000.00) in sales of infringing products for
use in the Field of Use, and that such sales comprise five percent or more (in
dollar volume) of the total sales market in the Field of Use in that country.
Reasonable efforts to be made by MICHIGAN and RDLP to stop or discourage
infringements may include notices, attempts to properly license the infringer,
or legal proceedings to enjoin or claim damages from the infringement. The
reasonable efforts to be made by MICHIGAN or RDLP shall not be deemed to include
the commencement or maintenance of any legal proceeding where the projected cost
of the proceeding exceeds either the royalties received by MICHIGAN and RDLP for
the practice of the Licensed Patents in the Field of Use in that country, or the
damages likely to be actually awarded and collected as a result of the
proceeding.
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10. NO WARRANTIES; LIMITATION ON MICHIGAN'S AND RDLP'S LIABILITY.
------------------------------------------------------------
10.1 MICHIGAN and RDLP, including their fellows, officers, employees and
agents, make no representations or warranties that any Licensed Patent is or
will be held valid, or that the manufacture, use, sale or other distribution of
any Products will not infringe upon any patent or other rights not vested in
MICHIGAN or RDLP.
10.2 MICHIGAN HSC AND RDLP, INCLUDING THEIR FELLOWS, OFFICERS, EMPLOYEES
AND AGENTS, MAKE NO REPRESENTATIONS, EXTEND NO WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ASSUME NO
RESPONSIBILITIES WHATEVER WITH RESPECT TO DESIGN, DEVELOPMENT, MANUFACTURE, USE,
SALE OR OTHER DISPOSITION BY LICENSEE OR AFFILIATES OF PRODUCTS.
10.3 THE ENTIRE RISK AS TO THE DESIGN, DEVELOPMENT, MANUFACTURE, OFFERING
FOR SALE, SALE OR OTHER DISPOSITION, AND PERFORMANCE OF PRODUCTS IS ASSUMED BY
LICENSEE AND AFFILIATES. In no event shall MICHIGAN, RDLP or HSC, including
their fellows, officers, employees and agents, be responsible or liable for any
direct, indirect, special, incidental, or consequential damages or lost profits
to LICENSEE, Affiliates or any other individual or entity regardless of legal
theory. The above limitations on liability apply even though MICHIGAN, RDLP, or
HSC, including their fellows, officers, employees or agents, may have been
advised of the possibility of such damage.
10.4 LICENSEE shall not, and shall require that its Affiliates do not,
make any statements, representations or warranties or accept any liabilities or
responsibilities whatsoever to or with regard to any person or entity which are
inconsistent with any disclaimer or limitation included in this Article 10.
10.5 REGARDLESS OF ANY RESEARCH OR TESTING THAT MAY HAVE BEEN DONE AT HSC
OR MICHIGAN, HSC, MICHIGAN AND RDLP MAKE NO REPRESENTATIONS REGARDING HOW
PRODUCTS CAN OR SHOULD BE USED IN THE THERAPEUTIC TREATMENT OR PROPHYLAXIS OF
THE DISEASE CYSTIC FIBROSIS.
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11. INDEMNITY; INSURANCE.
--------------------
11.1 LICENSEE shall defend, indemnify and hold harmless and shall require
its Affiliates licensed hereunder to defend, indemnify and hold harmless
MICHIGAN, RDLP and HSC, as well as their fellows, officers, trustees, directors,
employees and agents, for and against any and all claims, demands, damages,
losses, and expenses of any nature (including attorneys' fees and other
litigation expenses), resulting from, but not limited to, death, personal
injury, illness, property damage, economic loss or products liability arising
from or in connection with, any of the following:
(1) Any manufacture, use, sale or other disposition by LICENSEE, Affiliates
or their transferees, of Products;
(2) The direct or indirect use by any person of Products made, used, sold
or otherwise distributed by LICENSEE or Affiliates;
(3) The use by LICENSEE or Affiliates of any invention related to the
TECHNOLOGY or the Licensed Patents.
11.2 MICHIGAN and RDLP shall be entitled to participate at their option
and expense through counsel of its own selection, and may join in any legal
actions related to any such claims, demands, damages, losses and expenses under
Paragraph 11.1 above.
11.3 LICENSEE shall purchase and maintain in effect a policy of product
liability insurance covering all claims with respect to any Products
manufactured, sold, licensed or otherwise distributed by LICENSEE and
Affiliates, and shall specify MICHIGAN, RDLP and HSC, including their fellows,
officers, trustees, directors and employees, as additional insureds (or
otherwise extend such coverage to include those Parties). LICENSEE shall
furnish certificate(s) of such insurance to MICHIGAN, upon request.
12. TERM AND TERMINATION.
--------------------
12.1 Upon any termination of this Agreement, and except as provided herein
to the contrary, all rights and obligations of the Parties hereunder shall
cease, except as follows:
(1) Obligations to pay royalties and other sums accruing hereunder up to
the day of such termination;
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(2) MICHIGAN's rights to inspect books and records as described in Article
5, and LICENSEE's obligations to keep such records for the required time;
(3) Obligations of defense and indemnity under Article 11;
(4) Any cause of action or claim of LICENSEE RDLP or MICHIGAN accrued or to
accrue because of any breach or default by the other Party hereunder;
(5) The general rights, obligations, and understandings of Articles 2, 10,
15, 17, 26 and 27; and
(6) All other terms, provisions, representations, rights and obligations
contained in this Agreement that by their sense and context are intended to
survive until performance thereof.
12.2 This Agreement will become effective on its Effective Date and,
unless terminated under another, specific provision of this Agreement, will
remain in effect until and terminate upon the last to expire of Licensed
Patents.
12.3 If LICENSEE shall at any time default in the payment of any royalty
or the making of any report hereunder, or shall make any false report, or shall
commit any material breach of any covenant or promise herein contained, and
shall fail to remedy any such default, breach or report within thirty (30) days
after written notice thereof by MICHIGAN specifying such default, then MICHIGAN
and RDLP may, at their option, terminate this Agreement and the license rights
granted herein by notice in writing to such effect. Any such termination shall
be without prejudice to any Party's other legal rights for breach of this
Agreement.
12.4 LICENSEE may terminate this Agreement by giving MICHIGAN a notice of
termination, which shall include a statement of the reasons, whatever they may
be, for such termination and the termination date established by LICENSEE, which
date shall not be sooner than ninety (90) days after the date of the notice.
Such notice shall be deemed by the Parties to be final.
12.5 In the event LICENSEE shall at any time during the term of this
Agreement deal with Products in any manner which violates the laws, regulations
or similar legal authority of any jurisdiction including, but not limited to,
the public health requirements relating to Products or the design, development,
manufacture, offering for sale, sale or other disposition of Products, the
license
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granted herein shall terminate immediately with respect to such Products within
the territory encompassed by such jurisdiction.
13. ASSIGNMENT.
----------
Due to the unique relationship between the Parties, this Agreement shall
not be assignable by LICENSEE without the prior written consent of MICHIGAN and
RDLP. Any attempt to assign this Agreement without such consent shall be void
from the beginning. MICHIGAN and RDLP shall not unreasonably withhold consent
for LICENSEE to assign this Agreement to a purchaser of all or substantially all
of LICENSEE's business. No assignment shall be effective unless and until the
intended assignee agrees in writing with RDLP and MICHIGAN to accept all of the
terms and conditions of this Agreement. Further, LICENSEE shall refrain from
pledging any of the license rights granted in this Agreement as security for any
creditor.
14. REGISTRATION AND RECORDATION.
----------------------------
14.1 If the terms of this Agreement, or any assignment or license under
this Agreement are or become such as to require that the Agreement or license or
any part thereof be registered with or reported to a national or supranational
agency of any area in which LICENSEE or Affiliates would do business, LICENSEE
will, at its expense, undertake such registration or report. Prompt notice and
appropriate verification of the act of registration or report or any agency
ruling resulting from it will be supplied by LICENSEE to MICHIGAN.
14.2 Any formal recordation of this Agreement or any license herein
granted which is required by the law of any country, as a prerequisite to
enforceability of the Agreement or license in the courts of any such country or
for other reasons, shall also be carried out by LICENSEE at its expense, and
appropriately verified proof of recordation shall be promptly furnished to
MICHIGAN.
15. LAWS AND REGULATIONS OF THE UNITED STATES AND CANADA; EXPORT.
------------------------------------------------------------
15.1 Activities under this Agreement shall be subject to all appropriate
United States and Canadian laws and regulations now or hereafter applicable.
15.2 LICENSEE shall comply, and shall require its Affiliates licensed
hereunder to comply, with all provisions of any applicable laws, regulations,
rules and orders relating to the license herein granted and to the testing,
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production, transportation, export, packaging, labeling, sale or use of
Products, or otherwise applicable to LICENSEE's or its Affiliates' activities
hereunder.
15.3 LICENSEE shall obtain, and shall require its Affiliates to obtain,
such written assurances regarding export and reexport of technical data
(including Products made by use of Technical data) as may be required by the
United States Office of Export Administration Regulations, and LICENSEE hereby
gives such written assurances as may be required under those Regulations to
MICHIGAN.
15.4 LICENSEE shall obtain, and shall require its Affiliates to obtain,
such authorization regarding export and re-export of technical data (including
Products made by use of technical data) as may be required by the Department of
External Affairs, Export Controls Division, or any authorization necessary for
export from or import into Canada, and LICENSEE hereby gives written assurances
as may be required under those regulations to RDLP.
16. BANKRUPTCY.
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If during the term of this Agreement, LICENSEE shall make an assignment for
the benefit of creditors, or if proceedings in voluntary or involuntary
bankruptcy shall be instituted on behalf of or against Licensee, or if a
receiver or trustee shall be appointed for the property of LICENSEE, MICHIGAN
and RDLP may, at their option, terminate this Agreement and revoke the license
herein granted by written notice to LICENSEE.
17. PUBLICITY.
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▇▇▇▇▇▇▇▇ agrees to refrain from using and to require Affiliates to refrain
from using the name of MICHIGAN, RDLP and HSC in publicity or advertising
without the prior written approval of that entity. Notwithstanding the
foregoing, MICHIGAN, RDLP, and HSC hereby consent to references to them (1) in
informational 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 by law when obtaining investment capital, or (2) pursuant
to any requirements of applicable law or governmental regulations, provided
that, in the event of such disclosure, LICENSEE shall afford MICHIGAN, RDLP, and
HSC the prior opportunity to review the text of such disclosure. LICENSEE shall
use its best efforts to comply with any reasonable request by Michigan, RDLP,
and HSC regarding changes.
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18. PRODUCT MARKING.
---------------
LICENSEE agrees to mark, and to require Affiliates to mark, Products with
the appropriate patent notice as approved by RDLP or MICHIGAN (when
appropriate), such approval not to be unreasonably withheld.
19. NOTICES.
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Any notice, request, report or payment required or permitted to be given or
made under this Agreement by a Party shall be given by sending such notice by
certified or registered mail, return receipt requested, to the address set forth
below or such other address as such Party shall have specified by written notice
given in conformity herewith. Any notice not so given shall not be valid unless
and until actually received, and any notice given in accordance with the
provisions of this Paragraph shall be effective when mailed.
To LICENSEE: Targeted Genetics Corporation
▇▇▇▇ ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇ #▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: President
To MICHIGAN: The University of Michigan
Technology Management Office
Wolverine Tower, Room ▇▇▇▇
▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
U.S.A.
Attn: File No. 492c2
with a copy to: HSC Research and Development
Limited Partnership
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇
Attn: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
20. INVALIDITY.
----------
In the event that any term, provision, or covenant of this Agreement shall
be determined by a court of competent jurisdiction to be invalid, illegal or
15
unenforceable, that term will be curtailed, limited or deleted but only to the
extent necessary to remove such invalidity, illegality or unenforceability, and
the remaining terms, provisions and covenants shall not in any way be affected
or impaired thereby.
21. ENTIRE AGREEMENT AND AMENDMENTS.
-------------------------------
This Agreement contains the entire understanding of the Parties with
respect to the matter contained herein. The Parties may, from time to time
during the continuance of this Agreement, modify, vary or alter any of the
provisions of this Agreement, but only by an instrument duly executed by
authorized officials of all Parties hereto.
22. WAIVER.
------
No waiver by a Party of any breach of this Agreement, no matter how long
continuing or how often repeated, shall be deemed a waiver of any subsequent
breach thereof, nor shall any delay or omission on the part of a Party to
exercise any right, power, or privilege hereunder be deemed a waiver of such
right, power or privilege.
23. ARTICLE HEADINGS.
----------------
The Article headings herein are for purposes of convenient reference only
and shall not be used to construe or modify the terms written in the text of
this Agreement.
24. NO AGENCY RELATIONSHIP.
----------------------
The relationship between the Parties is that of independent contractor and
contractees. LICENSEE shall not be deemed to be an agent of MICHIGAN or RDLP in
connection with the exercise of any rights hereunder, and shall not have any
right or authority to assume or create any obligation or responsibility on
behalf of MICHIGAN or RDLP.
25. FORCE MAJEURE.
-------------
No Party hereto shall be deemed to be in default of any provision of this
Agreement, or for any failure in performance, resulting from acts or events
beyond the reasonable control of such Party, such as Acts of God, acts of civil
or military authority, civil disturbance, war, strikes, fires, power failures,
natural catastrophes or other "force majeure" events.
16
26. GOVERNING LAW.
-------------
This Agreement and the relationships of the Parties shall be governed in
all respects by the law of the State of Michigan* (notwithstanding any
provisions governing conflict of laws under such Michigan law to the
contrary),** except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent has
been granted.
27. JURISDICTION AND FORUM.
----------------------
LICENSEE hereby consents to the jurisdiction of the courts of the State of
Michigan over any dispute concerning this Agreement or the relationship of the
Parties. Should LICENSEE bring any claim, demand or other action against
MICHIGAN or RDLP, including their fellows, officers, employees or agents,
arising out of this Agreement or the relationship between the Parties, LICENSEE
agrees to bring said action only in an appropriate court of the State or
Province of that Party.
28. 'MOST FAVORED NATION' STATUS.
----------------------------
If MICHIGAN and RDLP grants a license under the Licensed Patents and in the
Field of Use to any third party which is substantially the same as the license
granted to LICENSEE under Article 3 above, for all or any part of the Territory,
but which requires a royalty rate or license maintenance fees lower than those
required of LICENSEE under this Agreement, then MICHIGAN and RDLP shall offer
those terms to LICENSEE for that part of the Territory, to be effective as of
the effective date of the license to that third party.
*or the Province of Ontario
**depending upon the jurisdiction in which any action relating to the Agreement
is brought
17
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement in
triplicate originals by their duly authorized officers or representatives.
FOR TARGETED GENETICS CORPORATION
By ▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
------------------------------
(authorized representative)
Typed Name ▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
----------------------
Title Pres. & CEO
---------------------------
Date March 21, 1994
----------------------------
FOR HSC RESEARCH AND DEVELOPMENT FOR THE REGENTS OF THE UNIVERSITY OF
LIMITED PARTNERSHIP MICHIGAN
By ▇. ▇▇▇▇▇▇▇▇ By ▇▇▇▇▇▇ ▇. ▇▇▇▇
------------------------------ ------------------------------------
(authorized representative) (authorized representative)
Typed Name ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Typed Name ▇▇▇▇▇▇ ▇. ▇▇▇▇
---------------------- ----------------------------
Title President Title Director, Intellectual Properties
--------------------------- ----------------------------------
Date March 28, 1994 Date August 26, 1993
---------------------------- ----------------------------------
18
APPENDIX TO LICENSE AGREEMENT
MICHIGAN FILE #492C2 TECHNOLOGY - THERAPEUTIC LICENSE
BETWEEN
THE REGENTS OF THE UNIVERSITY OF MICHIGAN,
HSC RESEARCH AND DEVELOPMENT LIMITED
PARTNERSHIP, AND
TARGETED GENETICS CORPORATION
"Cystic Fibrosis Gene" - Patents Pending
Country Serial Number Filing Date
------- ------------- -----------
United States 401,609 August 31, 1989
Ireland 3024/90 August 21, 1990
PCT CA90/00267 August 20, 1990
WO 91/02796 March 7, 1991
EPO* 90912428.1 August 20, 1990
Japan 511424/90 August 20, 1990
Canada 2066204-2 August 20, 1990
Australia 61616/90 August 20, 1990
*Note: EPO designated states include the following countries: Austria,
Belgium, Switzerland and Liechtenstein, Germany, Denmark, Spain, France, United
Kingdom, Italy, Luxembourg, Netherlands, Sweden