LICENSE AGREEMENT
Exhibit 10.1
THIS
LICENSE AGREEMENT (the “Agreement”) dated as of
December 31, 2014 (the “Effective Date”), is entered
into between ID4 Pharma, LLC (“ID4”), a having a place
of business at 0000 Xxxxxxxx Xxxxx, Xxxxxxxxx, XX 00000, and Oxis
Biotech, Inc., a Delaware corporation (“Company”),
having a place of business at 0000
Xxxxx Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, XX 00000 .
WHEREAS, ID4 owns
or has rights in the Technology (as defined below).
WHEREAS, Company
desires to obtain an exclusive license under ID4’s rights in
the Technology on the terms and conditions set forth
below.
WHEREAS, Xxxxxxxx
Xxx, Ph.D. and Company have entered into a Consulting Agreement
dated December 31, 2014 (attached hereto as Schedule
C).
WHEREAS, Xxxxxxxx
Xxx, Ph.D. and Company have entered into a Confidentiality
Agreement dated December 31, 2014 (attached hereto as Schedule
D).
NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:
For
purposes of this Agreement, the terms defined in this
Section 1 shall have the respective meanings set forth
below:
1.1 “Affiliate” shall mean,
with respect to any Person, any other Person which directly or
indirectly controls, is controlled by, or is under common control
with, such Person. A Person shall be regarded as in control of
another Person if it owns, or directly or indirectly controls, at
least fifty percent (50%) of the voting stock or other ownership
interest of the other Person, or if it directly or indirectly
possesses the power to direct or cause the direction of the
management and policies of the other Person by any means
whatsoever.
1.2 “Competent Authority(ies)”
or “Competent
Regulatory Authority(ies)” shall mean, collectively,
(a) the governmental entities in each country or supranational
organization that is responsible for the regulation of any Product
intended for use in the Field or the establishment, maintenance
and/or protection of rights related to the Licensed IP Rights
(including the FDA, the EMEA and the MHLW), or (b) any other
applicable regulatory or administrative agency in any country or
supranational organization that is comparable to, or a counterpart
of, the foregoing.
1.3 “EMEA” shall mean the
European Agency for the Evaluation of Medicinal Products of the
European Union, or the successor thereto.
1.4 “FDA” shall mean the Food
and Drug Administration of the United States, or the successor
thereto.
1.5 “Field” shall mean
compounds and methods for detection, diagnosis, prognosis,
monitoring or predisposition testing of any disease, state or
condition in humans or other animals..
1.6 “First
Commercial Sale” shall mean, with respect to any
Product, the first sale of such Product after all applicable
marketing and pricing approvals (if any) have been granted by the
applicable governing health authority of such country.
1.7 “Licensed IP Rights” shall
mean, collectively, the Licensed Patent Rights and the Licensed
Know-How Rights.
1.8 “Licensed Know-How Rights”
shall mean all trade secret and other know-how rights in and to all
data, information, compositions and other technology (including,
but not limited to, formulae, procedures, protocols, techniques and
results of experimentation and testing) which are necessary or
useful for Company to make, use, develop, sell or seek regulatory
approval to market a composition, or to practice any method or
process, at any time claimed or disclosed in any issued patent or
pending patent application within the Licensed Patent Rights or
which otherwise relates to the Technology.
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1.9 “Licensed Patent Rights”
shall mean (a) the patents and patent applications listed on
Schedule A hereto, (b) all patents and patent applications in
any country of the world that claim or cover the Technology in
which ID4 heretofore or hereafter has an ownership or
(sub)licensable interest, (c) all divisions, continuations,
continuations-in-part, that claim priority to, or common priority
with, the patent applications listed in clauses (a) - (b) above or
the patent applications that resulted in the patents described in
clauses (a) - (b) above, and (d) all patents that have issued
or in the future issue from any of the foregoing patent
applications, including utility, model and design patents and
certificates of invention, together with any reissues, renewals,
extensions or additions thereto.
1.10 “NDA”
shall mean a New Drug Application, or similar application for
marketing approval of a Product for use in the Field submitted to
the FDA, or its foreign equivalent.
1.11 “Net
Sales” shall mean, with respect to any Product, the
gross sales price of such Product invoiced by Company or its
Affiliate to customers who are not Affiliates (or are Affiliates
but are the end users of such Product) less, to the extent actually
paid or accrued by Company or its Affiliate (as applicable),
(a) credits, allowances, discounts and rebates to, and
chargebacks from the account of, such customers for nonconforming,
damaged, out-dated and returned Product; (b) freight and
insurance costs incurred by Company or its Affiliate (as
applicable) in transporting such Product to such customers;
(c) cash, quantity and trade discounts, rebates and other
price reductions for such Product given to such customers under
price reduction programs; (d) sales, use, value-added and
other direct taxes incurred on the sale of such Product to such
customers; (e) customs duties, tariffs, surcharges and other
governmental charges incurred in exporting or importing such
Product to such customers; (f) sales commissions incurred on
the sale of such Product to such customers; and (g) an
allowance for uncollectible or bad debts determined in accordance
with generally accepted accounting principles.
1.12 “Net
Sublicensing Revenues” shall mean, with respect to any
Product, the aggregate cash consideration received by Company or
its Affiliates in consideration for the sublicense under the
Licensed Patent Rights or Licensed Know-How Rights by Company or
its Affiliates to a Third Party sublicensee with respect to such
Product (including royalties received by Company or its Affiliates
based on sales of such Product by such sublicensee, but excluding
amounts received to reimburse Company’ or its
Affiliates’ cost to perform research, development or similar
services conducted for such Product after signing the agreement
with the Third Party, in reimbursement of patent or other
out-of-pocket expenses relating to such Product, or in
consideration for the purchase of any debt or securities of Company
or its Affiliates).
1.13 “Person”
shall mean an individual, corporation, partnership, limited
liability company, trust, business trust, association, joint stock
company, joint venture, pool, syndicate, sole proprietorship,
unincorporated organization, governmental authority or any other
form of entity not specifically listed herein.
1.14 “Phase I
Clinical Trial” shall mean a human clinical trial that
is intended to initially evaluate the safety and/or pharmacological
effect of a Product in subjects or that would otherwise satisfy
requirements of 21 C.F.R. 312.21(a), or its foreign
equivalent.
1.15 “Phase II
Clinical Trial” shall mean a human clinical trial in
any country that is intended to initially evaluate the
effectiveness of a Product for a particular indication or
indications in patients with the disease or indication under study
or would otherwise satisfy requirements of
21 CFR 312.21(b), or its foreign equivalent.
1.16 “Phase IIa
Clinical Trial” shall mean a Phase II Clinical
Trial that is solely intended to make a preliminary determination
of the effectiveness of a Product for a particular indication or
indications in patients with the disease or indication under
study.
1.17 “Phase IIb
Clinical Trial” shall mean a Phase II Clinical
Trial, other than one that is solely intended to make a preliminary
determination of the effectiveness of a Product for a particular
indication or indications in patients with the disease or
indication under study.
1.18 “Phase III
Clinical Trial” shall mean a human clinical trial in
any country, the results of which could be used to establish safety
and efficacy of a Product as a basis for an NDA or would otherwise
satisfy requirements of 21 CFR 312.21(c), or its foreign
equivalent.
1.19 “Product(s)”
shall mean any product for use in the Field that if made, used,
sold, offered for sale or imported absent the license granted
hereunder would infringe a Valid Claim, or that otherwise uses or
incorporates the Licensed Know-How Rights.
1.20 “Registration(s)”
shall mean any and all permits, licenses, authorizations,
registrations or regulatory approvals (including NDAs) required
and/or granted by any Competent Authority as a prerequisite to the
development, manufacturing, packaging, marketing and selling of any
product.
1.21 “Royalty
Term” shall mean, with respect to each Product in each
country, the term for which a Valid Claim remains in effect and
would be infringed but for the license granted by this Agreement,
by the use, offer for sale, sale or import of such Product in such
country.
1.22 “Technology”
shall mean compounds and uses for treating p62 mediated diseases as
described in the Licensed IP Rights.
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1.23 “Territory”
shall mean worldwide.
1.24 “Third
Party” shall mean any Person other than ID4, Company
and their respective Affiliates.
1.25 “Valid
Claim” shall mean a claim of an issued and unexpired
patent included within the 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 unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or
unenforceable through reissue or disclaimer or
otherwise.
2. REPRESENTATIONS
AND WARRANTIES
2.1 Mutual Representations and
Warranties. Each party hereby represents and warrants to the
other party as follows:
2.1.1 Such
party is an individual or corporation duly organized, validly
existing and in good standing under the laws of the state in which
it is incorporated.
2.1.2 Such
party (a) has the power and authority and the legal right to
enter into this Agreement and to perform its obligations hereunder,
and (b) has taken all necessary action on its part 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, enforceable against
such party in accordance with its terms.
2.1.3 All
necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained
by such party in connection with this Agreement have been
obtained.
2.1.4 The
execution and delivery of this Agreement and the performance of
such party’s obligations hereunder (a) do not conflict with
or violate any requirement of applicable laws or regulations, and
(b) do not conflict with, or constitute a default under, any
contractual obligation of it.
2.2 ID4 Representations and
Warranties. ID4 hereby represents and warrants to Company as
follows:
2.2.1 ID4
(a) is the owner or exclusive licensee of the Licensed IP
Rights and has the sole right to execute this Agreement on behalf
of the other co-owner/inventors as evidenced by Schedule B, and has
not granted to any Third Party any license or other interest in the
Licensed IP Rights, (b) is not aware of any Third Party
patent, patent application or other intellectual property rights
that would be infringed (i) by practicing any process or
method or by making, using or selling any composition which is
claimed or disclosed in the Licensed Patent Rights or which
constitutes Licensed Know-How Rights, or (ii) by making, using
or selling Products, and (c) is not aware of any infringement
or misappropriation by a Third Party of the Licensed IP
Rights.
3. LICENSE
GRANT
3.1 Licensed IP Rights. ID4 hereby
grants to Company an exclusive license (with the right to grant
sublicenses) under the Licensed IP Rights to conduct research and
to develop, make, have made, use, offer for sale, sell and import
Products in the Territory for use in the Field.
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3.2 Sublicenses. ID4 grants to
Company the right to grant sublicenses to third parties, provided
that (i) the Sublicensee agrees to abide by all the terms and
provisions of this Agreement; (ii) Company remains fully liable for
the performance of its and its Sublicensee’s obligations
hereunder; and (iii) Company notifies ID4 of any grant of a
sublicense and provide to ID4 upon ID4 request a copy of any
sublicense agreement.
3.3 Availability of the Licensed IP
Rights. ID4 shall provide Company with a copy of all
information available to ID4 relating to the Licensed IP Rights,
Products or Technology, including without limitation:
(a) regulatory submissions, (b) communications with the
Competent Authorities (including the minutes of any meetings),
(c) trial master files, including case report forms,
(d) listings and tables of results from the clinical trials,
(e) treatment-related serious adverse event reports from the
clinical trials, (f) storage of and access permission to any
retained samples of materials used in clinical trials, and
(g) access to CROs involved in the clinical
trials.
3.4 Registrations. ID4 acknowledges
and agrees that Company shall own all Registrations for Products
for use in the Field in each country in the Territory.
Additionally, ID4 acknowledges and agrees that Company shall have
the right to conduct pre-clinical and clinical development
activities outside of the Xxxxxxxxx. XX0 hereby grants to Company a
free-of-charge right to reference and use and have full access to
all other Registrations and all other regulatory documents that
relate to the Licensed IP Rights, Products or Technology, including
INDs, BLAs, NDAs and DMFs (whether as an independent document or as
part of any NDA, and all chemistry, manufacturing and controls
information), and any supplements, amendments or updates to the
foregoing (for the purposes of this Section, the “Right of
Reference”). Company shall have the right to (sub)license the
Right of Reference to its sublicensees and Affiliates.
3.5 Access to Manufacturers. ID4
shall use his commercially reasonable efforts to provide access to
Company to any suppliers of the API form of any Product for use in
the Field on terms and conditions no less favorable than those
terms and conditions between ID4 and such supplier.
4.1.1 Royalty Rate. During the
applicable Royalty Term for a Product, subject to the terms and
conditions of this Agreement, Company shall pay to ID4 royalties,
with respect to each Product, equal to (a) THREE percent (3%)
of Net Sales of such Product by Company and its Affiliates, and
(b) TWENTY-FIVE percent (25%) of Net Sublicensing
Revenues for such Product. Only one royalty shall be owing for a
Product regardless of how many Valid Claims cover such Product for
the life of the last to expire Patent in a country having Valid
Claim.
4.1.2 Third Party Royalties. If
Company, its Affiliates or sublicensees is required to pay
royalties to any Third Party in order to exercise its rights
hereunder to make, have made, use, sell, offer to sale or import
any Product, then Company shall have the right to credit one
percent (1%) of such Third Party royalty payments against the
royalties owing to ID4 under Section 4.1.1 above with respect
to sales of such Product in such country; provided, however, that
Company shall not reduce the amount of the royalties paid to ID4
under Section 4.1.1 above by reason of this
Section 4.1.2, with respect to sales of such Product in such
country, to less than one percent (1%) of Net Sales of such Product
in such country. In consideration of the right to sublicense third
parties granted under Section 3.2, Company shall pay to ID4 ten
percent (10%) of all royalties received by Company from its
Sublicensees if the sublicense is executed on or before the first
anniversary of the Effective Date of the License Agreement signed
between the parties, and ten percent (10%) of all royalties
received by Company from its Sublicensees if the Sublicense is
executed thereafter. In no event, however, shall Company pay ID4
less than the amount which would have been due under Section 4.1.2
of this Agreement in the absence of a sublicense.
4.2 Diligence Fee. A good faith
diligence fee of TWENTY FIVE THOUSAND dollars ($25,000.00) paid
upon the execution of the Letter of Intent (Schedule C). Said good
faith diligence fee shall be credited against any monies owed by
Company to ID4 as a result of the parties executing this License
Agreement.
4.3 License Fee. Company shall pay
ID4 a non-refundable license fee of SEVENTY FIVE THOUSAND dollars
($75,000.00) which shall be payable upon execution of this
Agreement.
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4.4 Milestones. Company shall pay
to ID4 the following milestone payment within thirty (30) days
following the first achievement of the applicable
milestone:
(i)
FIFTY THOUSAND
dollars ($50,000.00) due upon filing of an investigational new drug
application with a competent regulatory authority anywhere in the
world.
(ii)
FIFTY THUOSAND
dollars ($50,000.00) due upon initiation of the first Phase 1 human
clinical trial anywhere in the world.
(iii)
ONE HUNDRED
THOUSAND dollars ($100,000.00) due upon initiation of the first
Phase 2 human clinical trial anywhere in the world.
(iv)
TWO HUNDRED FIFTY
THOUSAND dollars ($250,000.00) due upon initiation of the first
Phase 3 human clinical trial anywhere in the world.
(v)
TWO HUNDRED FIFTY
THOUSAND dollars ($250,000.00) due upon receipt of the first
marketing approval from a competent regulatory authority anywhere
in the world.
5.1 Royalty Reports. Within sixty
(60) days after the end of each calendar quarter during the term of
this Agreement following first to occur of the First Commercial
Sale of a Product and the receipt by Company or its Affiliates of
Net Sublicensing Revenues, Company shall furnish to ID4 a quarterly
written report showing in reasonably specific detail (a) the
calculation of Net Sales during such calendar quarter; (b) the
calculation of Net Sublicensing Revenues for such quarter;
(c) the calculation of the royalties, if any, that shall have
accrued based upon such Net Sales and Net Sublicensing Revenues;
(d) the withholding taxes, if any, required by law to be
deducted with respect to such sales; and (e) the exchange
rates, if any, used in determining the amount of United States
dollars. With respect to sales of Products invoiced in United
States dollars, the gross sales, Net Sales and royalties payable
shall be expressed in United States dollars. With respect to
(i) Net Sales invoiced in a currency other than United States
dollars and (ii) cash consideration paid in a currency other
than United States dollars by Company’s sublicensees
hereunder, all such amounts shall be expressed both in the currency
in which the distribution is invoiced and in the United States
dollar equivalent. The United States dollar equivalent shall be
calculated using the average of the exchange rate (local currency
per US$1) published in The
Wall Street Journal, Western Edition, under the heading
“Currency Trading” on the last business day of each
month during the applicable calendar quarter.
5.2.1 Upon
the written request of ID4 and not more than once in each calendar
year, Company shall permit an independent certified public
accounting firm of nationally recognized standing selected by ID4
and reasonably acceptable to Company, at ID4’s expense, to
have access during normal business hours to such of the financial
records of Company as may be reasonably necessary to verify the
accuracy of the payment reports hereunder for the eight (8)
calendar quarters immediately prior to the date of such request
(other than records for which ID4 has already conducted an audit
under this Section.
5.2.2 If
such accounting firm concludes that additional amounts were owed
during the audited period, Company shall pay such additional
amounts within thirty (30) days after the date ID4 delivers to
Company such accounting firm’s written report so concluding.
The fees charged by such accounting firm shall be paid by ID4;
provided, however, if the audit discloses that the royalties
payable by Company for such period are more than one hundred ten
percent (110%) of the royalties actually paid for such period, then
Company shall pay the reasonable fees and expenses charged by such
accounting firm.
5.2.3 ID4
shall cause its accounting firm to retain all financial information
subject to review under this Section 5.2 in strict confidence;
provided, however, that Company shall have the right to require
that such accounting firm, prior to conducting such audit, enter
into an appropriate non-disclosure agreement with Company regarding
such financial information. The accounting firm shall disclose to
ID4 only whether the reports are correct or not and the amount of
any discrepancy. No other information shall be shared. ID4 shall
treat all such financial information as Company’ Confidential
Information.
6. PAYMENTS
6.1 Payment Terms. Royalties shown
to have accrued by each royalty report provided for under
Section 5 above shall be due on the date such royalty report
is due. Payment of royalties in whole or in part may be made in
advance of such due date.
6.2 Exchange Control. If at any
time legal restrictions prevent the prompt remittance of part or
all royalties with respect to any country in the Territory where
the Product is sold, Company shall have the right, in its sole
discretion, to make such payments by depositing the amount thereof
in local currency to ID4’s account in a bank or other
depository institution in such country. If the royalty rate
specified in this Agreement should exceed the permissible rate
established in any country, the royalty rate for sales in such
country shall be adjusted to the highest legally permissible or
government-approved rate.
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6.3 Withholding Taxes. Company
shall be entitled to deduct the amount of any withholding taxes,
value-added taxes or other taxes, levies or charges with respect to
such amounts, other than United States taxes, payable by Company,
its Affiliates or sublicensees, or any taxes required to be
withheld by Company, its Affiliates or sublicensees, to the extent
Company, its Affiliates or sublicensees pay to the appropriate
governmental authority on behalf of ID4 such taxes, levies or
charges. Company shall use reasonable efforts to minimize any such
taxes, levies or charges required to be withheld on behalf of ID4
by Company, its Affiliates or sublicensees. Company promptly shall
deliver to ID4 proof of payment of all such taxes, levies and other
charges, together with copies of all communications from or with
such governmental authority with respect thereto.
7. RESEARCH
AND DEVELOPMENT OBLIGATIONS
7.1 Research and Development
Efforts. Company shall use its commercially reasonable
efforts to conduct such research, development and preclinical and
human clinical trials as Company determines are necessary or
desirable to obtain regulatory approval to manufacture and market
such Products as Company determines are commercially feasible in
the Territory, and shall use its commercially reasonable efforts to
obtain regulatory approval to market, and following approval to
commence marketing and market each such Product in such countries
in the Territory as Company determines are commercially
feasible.
7.2 Consulting Agreement. ID4 shall
use his reasonable efforts in performing the services identified in
the Consulting Agreement executed between ID4 and Company on
December __, 2014 and attached hereto as Schedule C.
7.3 Records. ID4 and Company shall
maintain records, in sufficient detail and in good scientific
manner, which shall reflect all work done and results achieved in
the performance of its research and development regarding the
Products.
7.4 Reports. Within ninety (90)
days following the end of each calendar year during the term of
this Agreement, ID4 shall prepare and deliver to Company a written
summary report which shall describe (a) the research performed
to date employing the Licensed IP Rights, (b) the progress of
the development, and testing of Products in clinical trials, and
(c) the status of obtaining regulatory approvals to market
Products.
8.1 Confidential Information.
Nothing contained in this Agreement shall supersede the
confidentiality requirements set forth in the Consulting Agreement
and Confidentiality Agreement signed by the parties; each agreement
dated December __, 2014 attached hereto as Schedule C and Schedule
D, respectively. Said Consulting Agreement and Confidentiality
Agreement shall both remain in full force and effect.
9.1 Patent Prosecution and
Maintenance. Company shall have the right to control, at its
sole cost, the preparation, filing, prosecution and maintenance of
all patents and patent applications within the Licensed Patent
Rights. Company shall give ID4 an opportunity to review and comment
on the text of each patent application subject to this
Section 9.1 before filing, and shall supply ID4 with a copy of
such patent application as filed, together with notice of its
filing date and serial number. ID4 shall cooperate with Company,
execute all lawful papers and instruments and make all rightful
oaths and declarations as may be necessary in the preparation,
prosecution and maintenance of all patents and other filings
referred to in this Section 9.1. If Company, in its sole
discretion, decides to abandon the preparation, filing, prosecution
or maintenance of any patent or patent application in the Licensed
Patent Rights, then Company shall notify ID4 in writing thereof and
following the date of such notice (a) ID4 shall be responsible
for and shall control, at its sole cost, the preparation, filing,
prosecution and maintenance of such patents and patent
applications, and (b) Company shall thereafter have no license
under this Agreement to such patent or patent
application.
9.2 Notification of Infringement.
Each party shall notify the other party of any substantial
infringement in the Territory known to such party of any Licensed
Patent Rights and shall provide the other party with the available
evidence, if any, of such infringement.
9.3 Enforcement of Patent Rights.
Company, at its sole expense, shall have the right to determine the
appropriate course of action to enforce Licensed Patent Rights or
otherwise xxxxx the infringement thereof, to take (or refrain from
taking) appropriate action to enforce Licensed Patent Rights, to
defend any declaratory judgments seeking to invalidate or hold the
Licensed Patent Rights unenforceable, to control any litigation or
other enforcement action and to enter into, or permit, the
settlement of any such litigation, declaratory judgments or other
enforcement action with respect to Licensed Patent Rights, in each
case in Company’s own name and, if necessary for standing
purposes, in the name of ID4 and shall consider, in good faith, the
interests of ID4 in so doing. If Company does not, within one
hundred twenty (120) days of receipt of notice from ID4, xxxxx the
infringement or file suit to enforce the Licensed Patent Rights
against at least one infringing party in the Xxxxxxxxx, XX0 shall
have the right to take whatever action it deems appropriate to
enforce the Licensed Patent Rights; provided, however, that, within
thirty (30) days after receipt of notice of ID4’s intent to
file such suit, Company shall have the right to jointly prosecute
such suit and to fund up to one-half (½) the costs of such
suit. The party controlling any such enforcement action shall not
settle the action or otherwise consent to an adverse judgment in
such action that diminishes the rights or interests of the
non-controlling party without the prior written consent of the
other party. All monies recovered upon the final judgment or
settlement of any such suit to enforce the Licensed Patent Rights
shall be shared, after reimbursement of expenses, in relation to
the damages suffered by each party. If Company does not receive
sufficient monies from a final judgment or settlement to cover its
expenses for such suit, Company shall have the right to credit up
to fifty percent (50%) of such expenses against any royalties or
other fees owing by Company pursuant to Section 4
above.
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9.4 Cooperation. In any suit to
enforce and/or defend the License Patent Rights pursuant to this
Section 9, the party not in control of such suit shall, at the
request and expense of the controlling party, reasonably cooperate
and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information,
samples, specimens, and the like.
10.1 Expiration.
Subject to Sections 10.2 and 10.3 below, this Agreement shall
expire on the expiration of Company’ obligation to pay
royalties to ID4 under Section 4.1 above. The license grant
under Section 3.1 shall be effective at all times prior to
such expiration and following such expiration of this Agreement
(a) Company shall have a fully paid-up, non-exclusive license
under the Licensed Know-How Rights to conduct research and to
develop, make, have made, use, sell, offer for sale and import
Products in the Territory for use in the Field, and
(b) Sections 3.5 and 3.6 shall survive.
10.2 Termination by Company. Company
may terminate this Agreement, in its sole discretion, upon thirty
(30) days prior written notice to ID4. This includes and is not
limited to the failure to revive U.S. Patent Application Serial No.
14/237,494 from abandoned status.
10.3 Termination for Cause. Except
as otherwise provided in Section 12, ID4 may terminate this
Agreement upon or after the breach of any material provision of
this Agreement by Company if Company has not cured such breach
within ninety (90) days after receipt of express written notice
thereof by ID4; provided, however, if any default is not capable of
being cured within such ninety (90) day period and Company is
diligently undertaking to cure such default as soon as commercially
feasible thereafter under the circumstances, ID4 shall have no
right to terminate this Agreement.
10.4 Effect
of Expiration or Termination. Expiration or termination of
this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination, and the
provisions of Sections 8, 9, 10, 11 and 13 shall survive the
expiration or termination of this Agreement. Upon any termination
of this Agreement, ID4 shall grant a direct license to any
sublicense of Company hereunder having the same scope as such
sublicense and on terms and conditions no less favorable to such
sublicensee than the terms and conditions of this Agreement,
provided that such sublicensee is not in default of any applicable
obligations under this Agreement and agrees in writing to be bound
by the terms and conditions of such direct license.
11.1 Indemnification.
Company shall defend, indemnify and hold ID4 harmless from all
losses, liabilities, damages and expenses (including
attorneys’ fees and costs) incurred as a result of any claim,
demand, action or proceeding arising out of any breach of this
Agreement by Company, or the gross negligence or willful misconduct
of Company in the performance of its obligations under this
Agreement, except in each case to the extent arising from the gross
negligence or willful misconduct of ID4 or the breach of this
Agreement by ID4.
11.2 Procedure.
ID4 promptly shall notify Company of any liability or action in
respect of which ID4 intends to claim such indemnification, and
Company shall have the right to assume the defense thereof with
counsel selected by Company. The indemnity agreement in this
Section 11 shall not apply to amounts paid in settlement of
any loss, claim, damage, liability or action if such settlement is
effected without the consent of Company, which consent shall not be
withheld unreasonably. The failure to deliver notice to Company
within a reasonable time after the commencement of any such action,
if prejudicial to its ability to defend such action, shall relieve
Company of any liability to ID4 under this Section 11, but the
omission so to deliver notice to Company will not relieve it of any
liability that it may have to ID4 otherwise than under this
Section 11. ID4 under this Section 11, its employees and
agents, shall cooperate fully with Company and its legal
representatives in the investigation and defense of any action,
claim or liability covered by this indemnification.
11.3 Insurance.
Company shall maintain product liability insurance with respect to
the research, development, manufacture and sales of Products by
Company in such amount as Company customarily maintains with
respect to the research, development, manufacture and sales of its
similar products. Company shall maintain such insurance for so long
as it continues to research, develop, manufacture or sell any
Products, and thereafter for so long as Company customarily
maintains insurance covering the research, development, manufacture
or sale of its similar products.
Neither
party shall be held liable or responsible to the other party nor be
deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this
Agreement to the extent, and for so long as, such failure or delay
is caused by or results from causes beyond the reasonable control
of the affected party including but not limited to fire, floods,
embargoes, war, acts of war (whether war be declared or not), acts
of terrorism, insurrections, riots, civil commotions, strikes,
lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority or the
other party.
7
13.1 Notices.
Any consent, notice or report required or permitted to be given or
made under this Agreement by one of the parties hereto to the other
party shall be in writing, delivered by any lawful means to such
other party at its address indicated below, or to such other
address as the addressee shall have last furnished in writing to
the addressor and (except as otherwise provided in this Agreement)
shall be effective upon receipt by the addressee.
ID4:
Xx. Xxxxxxxx Xxx, Ph.D.
0000
Xxxxxxxx Xxxxx
Xxxxxxxxx, XX
00000
Company:
Xxxxxxx Xxxxxxx
Chairman &
CEO
Oxis
Biotech, Inc.
0000
Xxxxx Xxxxxxx Xxxxx
Xxxxxxx
Xxxxx, XX 00000
with a
copy
to:
DLA Piper US
0000
Xxxxxxxxx Xxxxx, Xxxxx 0000
Xxx
Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxx X.
Xxxxx
13.2 Governing
Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard
to the conflicts of law principles thereof.
13.3 Arbitration.
Any dispute, controversy or claim initiated by either party arising
out of, resulting from or relating to this Agreement, or the
performance by either party of its obligations under this Agreement
(other than (a) any dispute, controversy or claim regarding
the validity, enforceability, claim construction or infringement of
any patent rights, or defenses to any of the foregoing, or
(b) any bona fide third party action or proceeding filed or
instituted in an action or proceeding by a Third Party against a
party to this Agreement), whether before or after termination of
this Agreement, shall be finally resolved by binding arbitration.
Whenever a party shall decide to institute arbitration proceedings,
it shall give written notice to that effect to the other party. Any
such arbitration shall be conducted under the Commercial
Arbitration Rules of the American Arbitration Association by a
panel of three arbitrators appointed in accordance with such rules.
Any such arbitration shall be held in Los Angeles, California. The
method and manner of discovery in any such arbitration proceeding
shall be governed by California Code of Civil Procedure § 1282
et seq. (including without limitation California Code of Civil
Procedure § 1283.05). The arbitrators shall have the authority
to grant specific performance and to allocate between the parties
the costs of arbitration in such equitable manner as they
determine. Judgment upon the award so rendered may be entered in
any court having jurisdiction or application may be made to such
court for judicial acceptance of any award and an order of
enforcement, as the case may be. In no event shall a demand for
arbitration be made after the date when institution of a legal or
equitable proceeding based upon such claim, dispute or other matter
in question would be barred by the applicable statute of
limitations. Notwithstanding the foregoing, either party shall have
the right, without waiving any right or remedy available to such
party under this Agreement or otherwise, to seek and obtain from
any court of competent jurisdiction any interim or provisional
relief that is necessary or desirable to protect the rights or
property of such party, pending the selection of the arbitrators
hereunder or pending the arbitrators’ determination of any
dispute, controversy or claim hereunder.
8
13.4 Assignment.
Company shall not assign its rights or obligations under this
Agreement without the prior written consent of ID4; provided,
however, that Company may, without such consent, assign this
Agreement and its rights and obligations hereunder (a) to any
Affiliate, or (b) in connection with the transfer or sale of
all or substantially all of its business to which this Agreement
relates, or in the event of its merger, consolidation, change in
control or similar transaction. Any permitted assignee shall assume
all obligations of its assignor under this Agreement.
13.5 Waivers
and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions
herein contained, shall be valid unless made in writing and signed
by duly authorized representatives of the parties
hereto.
13.6 Entire
Agreement. This Agreement embodies the entire agreement
between the parties and supersedes any prior representations,
understandings and agreements between the parties regarding the
subject matter hereof. There are no representations, understandings
or agreements, oral or written, between the parties regarding the
subject matter hereof that are not fully expressed
herein.
13.7 Severability.
Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective
to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the
remaining provisions hereof and without affecting the validity or
enforceability of any of the terms of this Agreement in any other
jurisdiction.
13.8 Waiver.
The waiver by either party hereto of any right hereunder or the
failure to perform or of a breach by the other party shall not be
deemed a waiver of any other right hereunder or of any other breach
or failure by said other party whether of a similar nature or
otherwise.
13.9 Counterparts.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
IN
WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date.
LICENSOR:
ID4
By:
/s/ Xiang-Xxx
Xxx
Name:
Xiang-Xxx Xxx,
Ph.D.
Title
Managing
Member
LICENSEE: Oxis
Biotech, Inc.
By:
/s/ Xxxxxxx
Xxxxxxx
Name:
Xxxxxxx
Xxxxxxx
Title:
Chairman &
CEO
9
SCHEDULE
A
LICENSED PATENT RIGHTS
1.
PCT/US2012/049911
(WO2013022919A1)
2.
USSN
61/521,287
3.
USSN
14/237,494
4.
Chinese Patent
Application No. 201280048718; Pre-grant Publ. No.
103930166
10
SCHEDULE
B
ASSIGNMENT
DOCUMENTS
1.
Assignment document
from University of Pittsburgh to inventors (Patent family of USSN
14/237,494).
2.
Assignment document
from Inventors to Dr. Xiang-Xxx Xxx (Patent family of USSN
14/237,494) .
3.
Assignment document
from Dr. Xiang-Xxx Xxx to ID4Pharma, LLC (Patent family of USSN
14/237,494).
11
SCHEDULE
C
CONSULTING
AGREEMENT
12
SCHEDULE
D
CONFIDENTIALITY
AGREEMENT
13
