Exhibit 10.1
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MATERIAL IN THIS DOCUMENT
HAS BEEN OMITTED PURSUANT
TO A CONFIDENTIAL TREATMENT REQUEST
SUBLICENSE AGREEMENT
THIS AGREEMENT is made this 27th day of July 2006, by and between Diamyd
Therapeutics AB, a subsidiary to Diamyd Medical AB, both corporations having a
principal place of business at Xxxxxxxxxx 00X, 0xx Xxxxx, XX-000 00 Xxxxxxxxx,
Xxxxxx (hereinafter referred to as "DIAM") and Neurologix Inc., a corporation
having a principal place of business at Xxx Xxxxxx Xxxxx, Xxxx Xxx, XX 00000
(together with any subsidiary that hereinafter may be formed by Neurologix Inc.
to exploit the Licensed Patent Rights hereinafter referred to as "NLX").
RECITALS
WHEREAS, NLX is developing a product to treat Xxxxxxxxx'x disease using GAD 65
and GAD67 in combination with an adeno-associated virus (AAV) delivery system;
and
WHEREAS, NLX seeks a license from DIAM, to develop and commercialize the use of
GAD 65 in combination with AAV to treat Xxxxxxxxx'x disease, under the rights of
US Patent Number 6,682,906 and related US and international patents and
applications as referenced at Appendix A ; and
WHEREAS, DIAM is the exclusive licensee and owner of several patents and patent
applications involving GAD, including but not limited to therapeutic
applications to US Patent Number 6,682,906 and thereto belonging US and
international patents and applications, entitled "Cloned Glutamic Acid
Decarboxylase" (GAD)," that relate to, among other things, the gene sequence for
GAD 65, said patent owned by the Regents of the University of California, Los
Angeles; and
WHEREAS, GAD 65 is believed to have numerous therapeutic applications, including
but not limited to treatments for diabetes and Xxxxxxxxx'x disease;
WHEREAS, DIAM is willing to grant such a license to NLX on the terms set forth
herein,
NOW THEREFORE, the parties agree as follows:
THIS AGREEMENT WILL NOT ENTER INTO FORCE UNTIL SUCH TIME (THE "EFFECTIVE DATE")
THAT DIAM HAS PROVIDED A ONE-PAGE LETTER, SIGNED BY THE REGENTS AND DIAM, TO
NLX STATING THAT THE REGENTS HAS REVIEWED THIS AGREEMENT AND DIAM IS ENTITLED
TO OFFER THE RIGHTS THAT ARE THE SUBJECT OF THIS NLX SUBLICENSE (THE "REGENTS
LETTER"). THE REGENTS LETTER SHALL BE PROVIDED WITHIN 45 DAYS FROM THE DATE THE
NLX SUBLICENSE IS SIGNED BY BOTH PARTIES. IN THE EVENT THE REGENTS LETTER IS
NOT PROVIDED BY DIAM, THEN THIS AGREEMENT WILL BE NULL AND VOID AND NEITHER
PARTY WILL HAVE A CLAIM ON THE OTHER PARTY.
1. DEFINITIONS
1.1 "Adeno-Associated Virus" or "AAV" shall mean a i) single
stranded DNA virus encoding two proteins (rep and cap) that ii)
cannot replicate on its own but rather requires a cell to be
co-infected with Adenovirus in order to replicate, that iii) in
the absence of co-infection with adenovirus, AAV goes into a
latent phase, and that iv) upon infection of a cell,
incorporates its DNA into genome of host cell into a specific
site on 19th chromosome.
1.2 "Affiliate" means any company or other legal entity other than
NLX in whatever country organized, controlling, controlled by or
under common control with NLX. 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 NLX, whether through the ownership of voting
securities, by contract or otherwise.
1.3 "Field" shall mean treatment of Xxxxxxxxx'x Disease by AAV Gene
Therapy. For clarity, sales resulting from "off-label" use in
any therapeutic indications other than Xxxxxxxxx'x Disease is
not permitted under this license.
1.4 "First Commercial Sale" means the first sale of any Licensed
Product by NLX or its Affiliates, following approval of its
marketing by the appropriate governmental agency for the country
in which the sale was made, and when governmental approval is
not required, the first sale in that country.
1.5 "GAD 65" shall mean the GAD 65 as is covered by the Licensed
Patent Rights.
1.6 "Gene Therapy" shall mean the treatment of certain disorders,
not limited to those caused by genetic anomalies or
deficiencies, by introducing specific engineered genes into a
patient's brain.
1.7 "Licensed Method" shall mean any process or method in the Field
that, absent this License, would infringe a claim within the
Licensed Patent Rights.
1.8 "Licensed Patent Rights" shall mean rights to any subject matter
claimed in U.S. Patent No. 6,682,906; any continuing
applications thereof, including divisions but excluding any
additional continuation-in-part applications, except to the
extent that any such continuation-in-part has claims directed to
subject matter enabled and described in U.S. Patent No.
6,682,906; any patents issuing on said applications, continuing
applications and divisional applications including reissues and
reexaminations thereof, and any foreign counterparts thereto. A
list of patents issued and pending is included at Appendix A.
1.9 "Licensed Product" shall mean a product that shall include GAD
65, the manufacture, use or sale of which would employ a
Licensed Method or, absent a license, infringe a claim within
the Licensed Patent Rights.
1.10 "Net Sales" means the total amount received by NLX or its
Affiliates or Sublicensees from the sale or distribution of
Licensed Products less the sum of the following deductions where
applicable: sales, use, tariff, import/export duties or other
excise taxes imposed upon particular sales; transportation
charges and allowances or credits to customers because of
rejections or returns. Sales between or among NLX and its
Affiliates or Sublicensees shall be excluded from the
computation of Net Sales, except where such Affiliates or
Sublicensees are end users (i.e., the entity that makes the last
sale to the consumer), but Net Sales shall include the
subsequent final sales to third parties by such Affiliates or
Sublicensees.
1.11 "Xxxxxxxxx'x Disease" shall mean a neurodegenerative disease of
the substantia nigra, an area in the basal ganglia of the brain
that is associated with the destruction of brain cells that
produce dopamine resulting in low production of dopamine and is
physically characterized by muscular tremor.
1.12 "Person" shall mean 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
1.13 "Regents" shall mean the THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA, a California corporation having its corporate
offices located at 000 Xxxxxxxx Xxxxx, 00xx Xxxxx, Xxxxxxx,
Xxxxxxxxxx 00000-0000.
1.14 Regents License means the exclusive license entered into between
DIAM and Regents dated February 15, 1994, including all
amendments and modifications thereto, that grants DIAM the
exclusive rights, under the rights of US Patent Number 6,682,906
and related US and international patents and applications to
develop and commercialize the Licensed Patent Rights in the
Field.
1.15 "Sublicensee" means any third party sublicensed by NLX to make,
have made, use or sell Licensed Products or to practice Licensed
Methods.
1.16 "Third Party" means any at arms-length Person other than NLX,
DIAM or any of their respective Affiliates.
2. GRANT
2.1 DIAM hereby grants to NLX a non-exclusive sublicense, under the
Licensed Patent Rights to make, have made, use and sell and import Licensed
Products and to practice Licensed Methods in the Field (the "License').
2.2 The Licensed Patent Rights were developed with United States
Government funds, and a royalty-free nonexclusive license has been granted to
the United States Government, as required under 35 U.S.C. ss.201-212.
Accordingly, the License shall be subject to any overriding obligations to the
United States federal government under 35 U.S.C. ss.201-212.
2.3 Pursuant to the Regents Letter, in the event the Regents License
is terminated by its terms or by Regents or DIAM, except for what is written in
Section 18.1 a) b) and c) of this Agreement. NLX's rights hereunder shall be
assigned directly to Regents and shall remain in full force and effect under the
terms hereof except that the duties of Regents under such assigned License shall
not be greater than the duties of Regents under the Regents License. As of the
date of this Agreement, the duties of Regents under the Regents License are not
less than the duties of DIAM under this Agreement.
3. SUBLICENSEES
3.1 DIAM grants to NLX the right to issue non-exclusive sublicenses
(Sublicenses) of its License to Third Parties.
3.2 [CONFIDENTIAL]
3.3 All such Sublicenses shall include the reserved rights of Regents
under this License. To the extent applicable, Sublicenses shall also be subject
to the rights of the United States federal government under 35 U.S.C.
ss.201-212.
3.4 NLX shall provide an unredacted copy of any Sublicense within 15
days of execution thereof.
3.5 NLX shall provide to DIAM a copy of all information submitted to
NLX by Sublicensees relevant to the computation of the payments due from NLX to
DIAM under this Article 3.
4. CONSIDERATION and MAINTENANCE FEES
4.1 NLX agrees transfer to DIAM a license issue fee of USD 500,000
(five hundred thousand). The license issue fee is non-refundable and is not an
advance against royalties and shall be in DIAM's account within 30 (thirty)
calendar days from the Effective Date of this Agreement.
4.2 In further consideration for the License and beginning on January
1, 2008, and on each subsequent January 1 during the Term, NLX shall pay an
annual License Maintenance Fee of seventy five thousand dollars (USD 75,000) to
DIAM. The License Maintenance Fee may be offset against royalty or sublicense
income paid to DIAM for that year.
5. ROYALTIES
5.1 NLX shall pay to DIAM earned royalties ("Royalties") on the Net
Sales of Licensed Products in the Field sold by NLX, its Affiliates or
Sublicensees in the following amounts:
5.1.1 [CONFIDENTIAL]
5.1.2 [CONFIDENTIAL]
5.2 In addition to the Royalties set out at 5.1, NLX shall pay DIAM
the following Milestone Payments:
5.2.1 [CONFIDENTIAL]
5.2.2 [CONFIDENTIAL]
The obligation to make Milestone Payments shall be triggered upon the first time
that the specified annual Net Sales are reached, regardless of whether such
sales are made by NLX, its Affiliates or Sublicensees.
5.3 In the event a Licensed Product is sold in a combination package
with one or more other products or services not covered by Licensed Patent
Rights or is sold as part of a single product containing such other products,
not limited to pumps or tubing sets, for purposes of calculating earned
royalties on such package, Net Sales will be calculated as the gross selling
price of such combination package or service.
5.4 Royalties shall be payable on Licensed Products covered by the
Licensed Patent Rights. Earned Royalties shall accrue for the duration of the
License.
5.5 Royalties accruing to DIAM shall be paid to DIAM 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 NLX within
thirty (30) days of the end of such calendar quarter.
5.6 All monies due DIAM under this Agreement shall be payable in
United States funds by wire transfer to an account to be established by DIAM.
When Licensed Products are sold for monies other than United States dollars, the
earned Royalties will first be determined in the foreign currency of the country
in which such Licensed Products were sold and then converted into equivalent
United States funds. The exchange rate will be that established by the Bank of
America in San Francisco, California on the last day of the reporting period.
5.7 Any tax for the account of DIAM required to be withheld by NLX
under the laws of any foreign country shall be promptly paid by NLX for and on
behalf of DIAM to the appropriate governmental authority, and NLX shall use its
best efforts to furnish DIAM with proof of payment of such tax. NLX shall be
responsible for all bank transfer charges. All payments made by NLX in
fulfillment of DIAM ' tax liability in any particular country shall be credited
against earned royalties or fees due DIAM for that country. Nothing herein shall
require NLX to be responsible for or pay any taxes on the income of DIAM
5.8 If at any time legal restrictions prevent the prompt remittance
of part or all Royalties by NLX with respect to any country where a Licensed
Product is sold, NLX shall have the right and option to make such payments by
depositing the amount thereof in local currency to DIAM 's account in a bank
or other depository in such country. If after one year of good-faith efforts
by DIAM to recover the monies, the Royalties still cannot be returned to the
United States, Licensee will be responsible for payment in the United States.
5.9 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, all obligation to pay Royalties based on such patent or claim or any
claim patentably indistinct therefrom shall cease as of the date of such final
decision. NLX shall not, however, be relieved from paying any Royalties that
accrued before such decision or that are based on another patent or claim not
involved in such decision.
6. DUE DILIGENCE
6.1 Upon the execution of this Agreement, NLX shall diligently
proceed with the development, manufacture and sale (collectively referred to
as "commercialization") of the Licensed Products in order to comply with the
diligence milestones listed below. If Licensee is unable to perform any of the
following with respect to the commercialization of Licensed Products, DIAM in
its sole discretion, shall have the right and option to terminate this
License.
[CONFIDENTIAL]
7. PATENT FILING, PROSECUTION AND MAINTENANCE
7.1 Under the Regents License, The Regents shall have the
responsibility for the preparation, filing, prosecution and maintenance of the
Licensed Patent Rights in the United States and in the foreign countries with
counsel of The Regents' choice. Under the Regents License, DIAM has he right to
review and comment on certain prosecution matters.
7.2 In the event that DIAM or the Regents abandons any patent
application or issued patent licensed under this Agreement, DIAM shall give NLX
at least thirty (30) days' prior notice.
8. PATENT INFRINGEMENT
8.1 In the event that NLX learns of the substantial infringement in
the Field of any patent in Licensed Patent Rights, NLX shall so inform DIAM in
writing and shall provide DIAM with reasonable evidence of such infringement.
Both parties to this Agreement agree that during the Term, neither party will
notify a third party of the infringement of any of Licensed Patent Rights in the
Field without first obtaining consent of the other party, which consent shall
not be unreasonably denied. Both parties shall fully cooperate to terminate such
infringement without litigation.
8.2 Under the Regents License, the Regents have certain rights to act
as the lead party in any infringement litigation to enforce the Licensed Patent
Rights. In the event the Regents decide not to lead such litigation, DIAM shall
determine which party shall act as the lead party in any litigation action
against the infringement of the Licensed Patent Rights in the Field. In the
event DIAM determines it will act as the lead party in the infringement suit,
NLX shall have the right to participate in any such infringement litigation and
be represented by counsel of its choice when such litigation relates
specifically to a Licensed Product. The Regents has the right at all times to
join such suit at its own expense.
8.3 In any infringement suit either party may institute to enforce
the Licensed Patent Rights pursuant to this Agreement, the other party shall,
at the request and expense of the party initiating such suit, cooperate in all
respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information, samples,
specimens, and the like. 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.
8.4 Such legal action shall be at the expense of the party on account
of whom suit is brought and all recoveries recovered thereby shall belong to
such party.
9. PROGRESS AND ROYALTY REPORTS
9.1 Commencing on June 30, 2006, NLX shall submit to DIAM and the
Regents, semi-annual written progress reports covering NLX's activities related
to the development and testing of all Licensed Products and the obtaining of the
governmental approvals necessary for marketing. These progress reports shall be
made for each Licensed Product for the Term of this Agreement.
9.2 NLX agrees to report to DIAM and the Regents the date of the
First Commercial Sale of Licensed Products in the Field.
9.3 After the First Commercial Sale of a Licensed Product, NLX will
make quarterly royalty reports to DIAM 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). Each such royalty report will cover NLX's most
recently completed calendar quarter and will show: (a) the gross sales and Net
Sales of Licensed Products sold by NLX during the most recently completed
calendar quarter; (b) the number of each type of Licensed Product sold; and (c)
the Royalties payable hereunder with respect to such.
9.4 If no sales of Licensed Products have been made during any
reporting period, a statement to this effect shall be required.
10. BOOKS AND RECORDS
10:1 NLX shall keep books and records accurately showing all Licensed
Products manufactured, used, and/or sold under the terms of this Agreement. Such
books and records shall be preserved for at least five (5) years from the date
of the payment to which they pertain and shall be open to inspection by
representatives or agents of DIAM or the Regents at reasonable times.
10.2 The fees and expenses of DIAM's or the Regents' representatives
performing such an examination shall be borne by the requesting party. However,
if an error in Royalties of more than five percent (5%) of the total Royalties
due for any quarterly period is discovered, then the fees and expenses of the
representatives shall be borne by NLX.
11. TERM OF THE AGREEMENT
11.1 Unless otherwise terminated by operation of law or by acts of
the parties in accordance with the terms of this Agreement, this Agreement
shall be in force from the Effective Date until the last to occur of: (a)
expiration of the last to expire patent; or (b) until such time as any claims
under a properly filed patent application have been fully prosecuted, or (c)
17 years (the "Term").
11.2 Any termination of this Agreement shall not affect the rights
and obligations set forth in the following Articles:
Article 3.6 Sublicensee Assignment
Article 10 Books and Records
Article 14 Disposition of Licensed Products on Hand upon
Termination
Article 16 Use of Names and Trademarks
Article 18 Indemnification
Article 23 Failure to Perform.
12. TERMINATION BY DIAM
12.1 If NLX violates or fails to perform any material term or
covenant of this Agreement, including but not limited to i) sales of Licensed
Products outside the Field ("off-label sales"), ii) obligations to pay Fees
and Royalties under Articles 4 and 5 and , and iii) obligations with respect
to Diligence Milestones at Article 6, then DIAM may give written notice of
such default ("Notice of Default") to Licensee. If Licensee fails to repair
such default within forty five (45) days after the effective date of the
Notice of Default, or, if the breach cannot be cured within forty five (45)
days, DIAM shall have the right to terminate this Agreement and the License by
a second written notice ("Notice of Termination") to NLX. If a Notice of
Termination is sent to NLX, this Agreement shall automatically terminate on
the effective date of such notice. Such termination shall not relieve NLX of
its obligation to pay any royalty or license fees owing at the time of such
termination and shall not impair any accrued right of DIAM. These notices
shall be subject to Article 19 (Notices).
12.2 If NLX shall cease to carry out its business, become bankrupt or
insolvent, apply for or consent to the appointment of a trustee, receiver or
liquidator of its assets or seek relief under any law for the aid of debtors
then DIAM shall have the right to terminate this License.
13. TERMINATION BY NLX
13.1 NLX shall have the right at any time to terminate this Agreement
by giving notice in writing to DIAM. Such notice of termination shall be subject
to Article 19 (Notices) and shall be effective ninety (90) days after effective
date of such notice.
13.2 Any termination pursuant to Paragraph 13.1 shall not relieve NLX
of any obligation or liability accrued hereunder prior to such termination or
rescind anything done by NLX or any payments made to DIAM hereunder prior to the
time such termination becomes effective, and such termination shall not affect
in any manner any rights of DIAM arising under this Agreement prior to such
termination.
14. EFFECT OF TERRMINATION, DISPOSITION OF LICENSED PRODUCTS
UPON TERMINATION
14.1 Effect of Termination. Upon the termination of this Agreement,
all licenses granted by DIAM to NLX hereunder shall revert to DIAM. Furthermore,
upon the termination of this Agreement to the extent permissible by law: (a) NLX
shall promptly return to DIAM all relevant records, materials and confidential
information provided by DIAM concerning the Licensed Patent Rights in the
possession or control of NLX; and (b) DIAM shall promptly return to NLX any
confidential information of NLX in DAIM's possession or control.
14.2 Upon termination of this Agreement, NLX shall have the right to
dispose of all previously made or partially made Licensed Products, but no more,
within a period of six (6) 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.
15. PATENT MARKING
15.1 NLX 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.
16. USE OF NAMES AND TRADEMARKS
16.1 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 either party's employees (including contraction, abbreviation or
simulation of any of the foregoing). Unless required by law, the use of the name
DIAM(R) or "The Regents of the University of California" or the name of any
campus of the University of California is expressly prohibited.
17. LIMITED WARRANTY
17.1 THIS LICENSE AND THE ASSOCIATED PATENT RIGHTS ARE PROVIDED
WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER WARRANTY, EXPRESS OR IMPLIED. DIAM AND THE REGENTS MAKE NO REPRESENTATION
OR WARRANTY THAT THE MANUFACTURE, USE OR SALE OF THE LICENSED PRODUCTS WILL NOT
INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
17.2 IN NO EVENT WILL DIAM, THE REGENTS OR NLX BE LIABLE FOR ANY
INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS
LICENSE OR THE USE OF THE INVENTION OR LICENSED PRODUCTS OR THE USE OR THE
PRACTICE OF LICENSED METHODS.
17.3 Nothing in this Agreement shall be construed as:
17.3.1 a warranty or representation as to the validity or
scope of the Licensed Patent Rights; or,
17.3.2 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 of third parties; or,
17.3.3 an obligation for DIAM or Regents to furnish any
know-how; or,
17.3.4 an obligation to bring or prosecute actions or suits
against third parties for patent infringement except
as provided in Article 8 (Patent Infringement); or,
17.3.5 conferring by implication, estoppel or otherwise any
license or rights other than defined under "Licensed
Patent Rights" in this Agreement regardless of whether
such rights are dominant or subordinate to "Licensed
Patent Rights", including explicitly the the U.S.
patent application Serial No. 07/579,007 entitled
"Improved Methods for the Diagnosis and Treatment of
Diabetes" by Baekkeskov and any continuing
applications, continuation-in-part applications,
and/or divisional applications thereto; and any
patents issuing on said applications, including
reissue and reexaminations thereof; and any foreign
applications or patent corresponding directly thereto.
18. REPRESENTATIONS AND INDEMNIFICATION
18.1 DIAM represents and warrants:
(a) the execution and delivery of this Agreement and the
performance of its obligations hereunder do not violate or breach any other
agreement to which DIAM is bound;
(b) To the best of DIAM's knowledge, the Licensed Patent Rights
existing as of the Effective Date are subsisting, valid and enforceable, and no
claim has been made alleging that the Licensed Patent Rights infringes or
otherwise violates any intellectual property or proprietary right of any Third
Party.
(c) To the best of DIAM's knowledge, as of the Effective Date, no
party is infringing the Licensed Patent Rights.
18.2 NLX agrees to indemnify, hold harmless and defend DIAM and the
Regents, its officers, employees, and agents; the inventors of the patents and
patent applications in the Licensed Patent Rights and their respective employers
from and against any and all liability, claims, suits, losses, damages, costs,
fees, and expenses resulting from or arising out of exercise of this License.
18.3 NLX, at its sole cost and expense, shall insure its activities in
connection with the work under this Agreement and obtain, keep in force and
maintain Comprehensive or Commercial Form General Liability Insurance
(contractual liability included) with limits as follows:
18.3(a) Each occurrence $1,000,000
18.3(b) products/completed operations aggregate $5,000,000
18.2(c) personal and advertising injury $1,000,000
18.3(d) general aggregate (commercial form only) $5,000,000
18.4 It should be expressly understood, however, that the coverages and
limits referred to under Paragraph 18.4 shall not in any way limit the liability
of NLX. NLX shall furnish DIAM and the Regents with certificates of insurance
evidencing compliance with all requirements. NLX shall not be required to insure
its activities relative to the products' liability risks until commencing use of
Licensed Products in human subjects. Such insurance shall:
18.4(a) provide for thirty (30) day advance written notice to
the Regents of any modification;
18.4(b) indicate that DIAM and the Regents of the University
of California has been endorsed as an Insured under
the coverages referred to under Paragraph 18.2; and
18.4(c) include a provision that the coverages will be
primary and will not participate with nor will be
excess over any valid and collective insurance or
program of self-insurance carried or maintained by
DIAM or the Regents.
18.5 NLX shall maintain such commercial general liability insurance
beyond the expiration or termination of this Agreement during: (i) the period
that any product, process, or service, relating to, or developed pursuant to,
this Agreement is being commercially distributed or sold by NLX or by a
Sublicensee or Affiliate of NLX, and (ii) a reasonable period after the period
referred to in Subsection (3)(i) above which in no event shall be less than five
(5) years.
19. NOTICES
19.1 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
first-class certified mail, postage paid, to the respective addresses given
below, or to such other address designated by written notice.
For NLX: Xxx Xxxxxx Xxxxx,
Xxxx Xxx, XX 00000
Attention: Xx. Xxxxxx Xxxxxxx
For DIAM: Xxxxxxxxxx 00X,
0xx Xxxxx,
XX-000 00 Xxxxxxxxx, Xxxxxx
Attention: Xx. Xxxxxx Xxxxx-Xxxxxx
19.2 DIAM will be responsible for providing all notices to the
Regents that may be required under the Regents License.
20. ASSIGNABILITY
20.1 This Agreement is binding upon and shall inure to the benefit of
DIAM, its successors and assigns, but shall be personal to DIAM and assignable
by NLX only with the written consent of DIAM, which consent shall not be
unreasonably withheld. The consent of DIAM shall not be required where the
assignment is in conjunction with the transfer of all or substantially all of
the business of NLX to which this License relates.
21. LATE PAYMENTS
21.1 In the event royalty payments or fees are not received by DIAM
when due, NLX shall pay to DIAM interest charges at a rate per annum of ten
percent (10%) simple interest calculated from the date payment was due until
actually received by DIAM.
22. WAIVER
22.1 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.
23. FAILURE TO PERFORM
23.1 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.
24. GOVERNING LAWS
24.1 THIS AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE
WITH THE LAWS OF THE STATE OF CALIFORNIA, 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.
25. FOREIGN GOVERNMENT APPROVAL OR REGISTRATION
25.1 If this Agreement or any associated transaction is required by
the law of any nation to be either approved or registered with any
governmental agency, NLX shall assume all legal obligations to do so.
26. EXPORT CONTROL LAWS
26.1 NLX shall observe all applicable United States and foreign laws
with respect to the transfer of Licensed Products and related technical data to
foreign countries, including, without limitation, the International Traffic in
Arms Regulations (ITAR) and the Export Administration Regulations.
27. PREFERENCE FOR UNITED STATES INDUSTRY
27.1 Because this Agreement grants a right to a particular use of an
The Regents' invention, NLX agrees that any Licensed Products embodying this
Licensed Patent Rights or produced through the use thereof to be sold in the
United States will be manufactured in the United States to the extent required
by 35 U.S.C. ss.201-212.
28. FORCE MAJEURE
28.1 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.
29. MISCELLANEOUS
29.1 All rights and licenses granted under or pursuant to this
Agreement by DIAM to NLX 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. Bankruptcy
Code. In the event of a declaration of bankruptcy by DIAM, the parties agree
that NLX, 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.
29.2 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.
29.3 No amendment or modification hereof shall be valid or binding
upon the parties unless made in writing and signed on behalf of each party.
29.4 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.
29.5 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 DIAM and NLX have executed this Agreement, in duplicate
originals, by their respective officers hereunto duly authorized, on the day and
year hereinafter written.
NEUROLOGIX INC. DIAMYD THERAPEUTICS AB
By
/s/ Xxxx X. Xxxxxx By /s/ Xxxxxx Xxxxx-Xxxxxx
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Name Xxxx X. Xxxxxx Name Xxxxxx Xxxxx-Xxxxxx
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Title Chief Financial Officer Title President
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Date: August 4, 2006 Date: July 27, 2006
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