Exhibit 10.4
LICENSE AGREEMENT
THIS
LICENSE AGREEMENT (this “Agreement”) dated as of
September 3, 2015 (the “Effective Date”), is entered
into between Daniel A. Vallera, an individual having a place of
residence at ____________________________________ , Jeffrey Lion,
an individual having a place of residence at
____________________________________ (collectively hereinafter
“Licensor”), and Oxis Biotech, Inc., a Delaware
corporation (“Company” or “Oxis”), having a
place of business at 1402 North
Beverly Drive, Beverly Hills, CA 90210 .
WHEREAS, Licensor
owns or has rights in the Technology (as defined
below).
WHEREAS, Oxis
desires to obtain an exclusive license under Licensor’s
rights in the Technology on the terms and conditions set forth
below.
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 the treatment of any disease, state or
condition in humans.
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, all CD19 scFv and CD22 scFv clones used
to manufacture DT2219ARL, the aggregation reducing linker (ARL)
technology used to manufacture DT2219ARL, and the mutated and
deimmunized form of truncated diphtheria toxin used to manufacture
DT2219ARL) which are necessary or useful for Oxis to make, use,
develop, sell or seek regulatory approval to market a composition
such as DT2219ARL, 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.
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 Licensor 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 Oxis 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 Oxis 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 Oxis 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 Oxis or its
Affiliates in consideration for the sublicense under the Licensed
Patent Rights or Licensed Know-How Rights by Oxis or its Affiliates
to a Third Party sublicensee with respect to such Product
(including royalties received by Oxis or its Affiliates based on
sales of such Product by such sublicensee, but excluding amounts
received to reimburse Oxis’ 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 Oxis 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 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.
1.17 “Product(s)”
shall mean DT2219ARL, a CD19/CD22 bispecific scFv antibody-drug
conjugate containing aggregation reducing linkers and a mutated and
deimmunized form of a truncated diphtheria toxin 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.
1.18 “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.
1.19 “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.
1.20 “Technology”
shall mean all compositions, CD19 scFv producing clones, CD22 scFv
producing clones, aggregation reducing linkers (ARL), mutated and
deimmunized form of a truncated diphtheria toxin, formulae,
procedures, formulations, methods of manufacture, in vitro data, and animal and human
in vivo data related to
Products, and all uses thereof for treating diseases in
humans.
1.21 “Territory”
shall mean worldwide.
1.22 “Third
Party” shall mean any Person other than Licensor, Oxis
and their respective Affiliates.
1.23 “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 is a 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 Licensor Representations and
Warranties. Licensor hereby represents and warrants to Oxis
as follows:
2.2.1 Licensor
(a) is the owner of the Licensed IP Rights and has the sole
right to execute this Agreement, 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. Licensor
hereby grants to Oxis 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, have sold,
and import Products in the Territory for use in the
Field.
3.2 Sublicenses. Licensor
grants to Oxis 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) Oxis remains fully liable
for the performance of its and its Sublicensee’s obligations
hereunder; and (iii) Oxis notifies Licensor of any grant of a
sublicense and provide to Licensor upon Licensor request a copy of
any sublicense agreement.
3.3 Availability of the Licensed IP
Rights. Licensor shall provide Oxis with a copy of all
information available to Licensor 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, (g)
manufacturing and quality control procedures and formulation
procedures, and (h) access to CMOs and CROs involved in the
clinical trials.
3.4 Registrations. Licensor
acknowledges and agrees that Oxis shall own all Registrations for
Products for use in the Field in each country in the Territory.
Additionally, Licensor acknowledges and agrees that Oxis shall have
the right to conduct pre-clinical and clinical development
activities outside of the Territory. Licensor hereby grants to Oxis
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”). Oxis shall have the right to (sub)license the
Right of Reference to its sublicensees and Affiliates.
3.5 Access to Manufacturers.
Licensor shall use his commercially reasonable efforts to provide
access to Oxis to any suppliers of Products and any form of any
Product for use in the Field on terms and conditions no less
favorable than those terms and conditions between Licensor and such
supplier.
4. FINANCIAL
CONSIDERATIONS
4.1.1 Royalty Rate. During the
applicable Royalty Term for a Product, subject to the terms and
conditions of this Agreement, Oxis shall pay to Licensor royalties,
with respect to each Product, equal to (a) THREE percent (3%)
of Net Sales of such Product by Oxis 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 Oxis,
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 Oxis
shall have the right to credit one percent (1%) of such Third Party
royalty payments against the royalties owing to Licensor under
Section 4.2.1 above with respect to sales of such Product in
such country; provided, however, that Oxis shall not reduce the
amount of the royalties paid to Licensor under Section 4.2.1
above by reason of this Section 4.2.2, 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, Oxis
shall pay to Licensor ten percent (10%) of all royalties received
by Oxis 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 Oxis from its Sublicensees if the Sublicense
is executed thereafter. In no event, however, shall Oxis pay
Licensor less than the amount which would have been due under
Section 4.2.2 of this Agreement in the absence of a
sublicense.
4.2 License Fee. Oxis shall pay
Licensor a non-refundable license fee of ONE HUNDRED AND FIFTY
THOUSAND dollars ($150,000.00) which shall be payable upon
execution of this Agreement.
4.3 Milestone Payments. Oxis shall
pay to Licensor the following clinical development milestone
payments within thirty (30) days following the first achievement of
the applicable milestone:
4.3.1 TWO
HUNDRED FIFTY THOUSAND dollars ($250,000.00) due upon initiation of
a Phase Ib/II clinical trial;
4.3.2 TWO
HUNDRED FIFTY THOUSAND dollars ($250,000.00) due upon initiation of
a Phase III clinical trial;
4.3.3 ONE
MILLION dollars ($1,000,000.00) due upon receipt by Oxis of
marketing approval by any Competent Regulatory Authority within the
Territory.
Each of
the foregoing Milestone Payments shall be paid only one
time.
5. ROYALTY REPORTS AND
ACCOUNTING
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 Oxis or its Affiliates of Net
Sublicensing Revenues, Oxis shall furnish to Licensor 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 Oxis’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 Licensor and not more than once in each
calendar year, Oxis shall permit an independent certified public
accounting firm of nationally recognized standing selected by
Licensor and reasonably acceptable to Oxis, at Licensor’s
expense, to have access during normal business hours to such of the
financial records of Oxis 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 Licensor 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, Oxis shall pay such additional amounts
within thirty (30) days after the date Licensor delivers to Oxis
such accounting firm’s written report so concluding. The fees
charged by such accounting firm shall be paid by Licensor;
provided, however, if the audit discloses that the royalties
payable by Oxis for such period are more than one hundred ten
percent (110%) of the royalties actually paid for such period, then
Oxis shall pay the reasonable fees and expenses charged by such
accounting firm.
5.2.3 Licensor
shall cause its accounting firm to retain all financial information
subject to review under this Section 5.2 in strict confidence;
provided, however, that Oxis shall have the right to require that
such accounting firm, prior to conducting such audit, enter into an
appropriate non-disclosure agreement with Oxis regarding such
financial information. The accounting firm shall disclose to
Licensor only whether the reports are correct or not and the amount
of any discrepancy. No other information shall be shared. Licensor
shall treat all such financial information as Oxis’
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, Oxis shall have the right, in its sole
discretion, to make such payments by depositing the amount thereof
in local currency to Licensor’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.
6.3 Withholding Taxes. Oxis 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 Oxis, its
Affiliates or sublicensees, or any taxes required to be withheld by
Oxis, its Affiliates or sublicensees, to the extent Oxis, its
Affiliates or sublicensees pay to the appropriate governmental
authority on behalf of Licensor such taxes, levies or charges. Oxis
shall use reasonable efforts to minimize any such taxes, levies or
charges required to be withheld on behalf of Licensor by Oxis, its
Affiliates or sublicensees. Oxis promptly shall deliver to Licensor
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. Oxis shall use its commercially reasonable efforts
to conduct such research, development and preclinical and human
clinical trials as Oxis determines are necessary or desirable to
obtain regulatory approval to manufacture and market such Products
as Oxis 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
Oxis determines are commercially feasible.
7.2 Records. Licensor and Oxis
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.
7.3 Reports. Within ninety (90)
days following the end of each calendar year during the term of
this Agreement, Licensor shall prepare and deliver to Oxis 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. CONFIDENTIALITY
8.1 For purposes of
this Agreement “Confidential Information" means any and all
information and material disclosed by the disclosing party to the
recipient or obtained by recipient through inspection or
observation of discloser’s property or facilities (before or
after the signing of this Agreement, and whether in writing, or in
oral, graphic, electronic or any other form), including, but not
necessarily limited to, trade secret, know-how, idea, invention,
process, technique, algorithm, program (whether in source code or
object code form), hardware, device, design, schematic, drawing,
formula, data, plan, strategy and forecast of, technical,
engineering, manufacturing, product, marketing, all notes, books,
papers, diagrams, documents, reports, memoranda, servicing,
financial, personnel and other information and materials of,
discloser and its employees, consultants, investors, affiliates,
licensors, suppliers, vendors, customers, clients and other persons
and entities, disclosed by one Party to the other.
8.2 Licensor and Oxis
agree that the recipient of Confidential Information shall not
disclose, cause, or permit to be disclosed said information to any
third party or parties, subject to the exceptions contained herein,
without the prior written consent of the disclosing
Party.
8.3 Confidential
Information may be disclosed to consultants, agents, and advisors
of either Licensor or Oxis; provided, those to whom information or
data is disclosed, regarding or concerning the matters contemplated
herein, shall become parties to this Agreement or otherwise be
bound to maintain such information in confidence under terms at
least as protective as those provided herein. Either Party may also
disclose such information as it deems appropriate to its employees
provided such employees have a need to know. Licensor and Oxis
agree to enforce the terms and provisions of this Agreement as to
any such employee, consultant, agent or advisor who receives
Confidential Information hereunder, and to assume liability for
breach of this Agreement by any or all such persons.
8.4 Notwithstanding
anything to the contrary contained herein, the recipient of
Confidential Information disclosed hereunder shall be under no duty
to maintain the confidentiality of any such information which it
can reasonably establish:
8.4.1 At
the time of disclosure is within the public domain;
8.4.2 After
disclosure becomes a part of the public domain through no fault,
act or failure to act, error, effort or breach of this Agreement by
the recipient;
8.4.3 Is
known to the recipient at the time of disclosure as evidenced by
recipient’s contemporaneous written
documentation;
8.4.4 Is
required by order, statute or regulation, of any government
authority to be disclosed to any federal or state agency, court or
other body, provided, however that any Party directed to disclose
information pursuant to a subpoena or other legal compulsion shall
use its best efforts under the circumstances to promptly notify the
disclosing Party of same so as to provide or afford the disclosing
Party the opportunity to obtain such protective orders or other
relief as the compelling court or other entity may
grant.
8.4.5 Confidential
Information will not be deemed to have been published merely
because individual portions of the information have been separately
published, but only if all material features comprising such
information have been published in combination.
8.5 Neither Licensor
nor Oxis will use for its own purpose(s), nor cause or permit to be
used by others, either directly or indirectly, any Confidential
Information disclosed hereunder without the prior written consent
of the Party making such disclosure.
9.1 Patent Prosecution and
Maintenance. Oxis 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. Oxis shall give Licensor an opportunity to review and
comment on the text of each patent application subject to this
Section 9.1 before filing, and shall supply Licensor with a
copy of such patent application as filed, together with notice of
its filing date and serial number. Licensor shall cooperate with
Oxis, 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 Oxis, 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 Oxis shall notify Licensor in writing thereof
and following the date of such notice (a) Licensor 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) Oxis 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.
Oxis, at its sole expense, shall have the right to determine the
appropriate course of action to enforce Licensed Patent Rights or
otherwise abate 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 Oxis’ own name and, if necessary for standing
purposes, in the name of Licensor and shall consider, in good
faith, the interests of Licensor in so doing. If Oxis does not,
within one hundred twenty (120) days of receipt of notice from
Licensor, abate the infringement or file suit to enforce the
Licensed Patent Rights against at least one infringing party in the
Territory, Licensor 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
Licensor’s intent to file such suit, Oxis 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 Oxis does not
receive sufficient monies from a final judgment or settlement to
cover its expenses for such suit, Oxis shall have the right to
credit up to fifty percent (50%) of such expenses against any
royalties or other fees owing by Oxis pursuant to Section 4
above.
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. TERMINATION
10.1 Expiration.
Subject to Sections 10.2 and 10.3 below, this Agreement shall
expire on the expiration of Oxis’ obligation to pay royalties
to Licensor 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) Oxis 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 Oxis. Oxis may
terminate this Agreement, in its sole discretion, upon thirty (30)
days prior written notice to Licensor. This includes and is not
limited to the failure of U.S. Patent Application Serial No.
13/256,812 to issue as a U.S. patent, or for Product to fail during
clinical development.
10.3 Termination for Cause. Except
as otherwise provided in Section 12, Licensor may terminate
this Agreement upon or after the breach of any material provision
of this Agreement by Oxis if Oxis has not cured such breach within
ninety (90) days after receipt of express written notice thereof by
Licensor; provided, however, if any default is not capable of being
cured within such ninety (90) day period and Oxis is diligently
undertaking to cure such default as soon as commercially feasible
thereafter under the circumstances, Licensor shall have no right to
terminate this Agreement.
10.3.1
Termination by
Licensor: Estimated costs associated with DT2219 ARL are estimated
to be $639,351.23 as per the University of Minnesota Clinical Trial
Office’s 3 year budget, hereby included as Exhibit A.
Licensor may terminate this agreement if Oxis does not fund over
the next three years all costs associated with the 30 subjects
(patients) needed to finish the Phase 1-2 trial estimated to be
$639,351.23. Oxis’s obligations to Licensor shall be
considered to be in compliance once the 30 subjects have been
treated or if Oxis has paid $639,351.23 towards the budget for the
Clinical trial, or the Clinical Trial is cancelled.
10.4 :
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, 11, 13 shall survive
the expiration or termination of this Agreement brought about by a
default or non-compliance by Licensor of any portion or provision
of this agreement. Upon termination of this agreement, Licensor
shall grant a direct license to any sublicense of Oxis 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. However, upon any termination of this agreement
brought about by a default or non-compliance of any portion or
provision of this agreement by Licensee shall result in the
revocation of Oxis’s license and any sublicenses for DT2219
ARL (Product).
11.1 Indemnification.
Oxis shall defend, indemnify and hold Licensor 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 Oxis, or the gross negligence or willful misconduct of
Oxis 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 Licensor or the breach of this Agreement
by Licensor.
11.2 Procedure.
Licensor promptly shall notify Oxis of any liability or action in
respect of which Licensor intends to claim such indemnification,
and Oxis shall have the right to assume the defense thereof with
counsel selected by Oxis. 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 Oxis, which consent shall not be
withheld unreasonably. The failure to deliver notice to Oxis within
a reasonable time after the commencement of any such action, if
prejudicial to its ability to defend such action, shall relieve
Oxis of any liability to Licensor under this Section 11, but
the omission so to deliver notice to Oxis will not relieve it of
any liability that it may have to Licensor otherwise than under
this Section 11. Licensor under this Section 11, its
employees and agents, shall cooperate fully with Oxis and its legal
representatives in the investigation and defense of any action,
claim or liability covered by this indemnification.
11.3 Insurance.
Oxis shall maintain product liability insurance with respect to the
research, development, manufacture and sales of Products by Oxis in
such amount as Oxis customarily maintains with respect to the
research, development, manufacture and sales of its similar
products. Oxis shall maintain such insurance for so long as it
continues to research, develop, manufacture or sell any Products,
and thereafter for so long as Oxis 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.
13. MISCELLANEOUS
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.
Licensor:
Daniel A. Vallera, Ph.D.
________________________
________________________
Jeffrey
Lion
________________________
________________________
Oxis:
Anthony Cataldo
Chairman &
CEO
Oxis
Biotech, Inc.
1402
North Beverly Drive
Beverly
Hills, CA 90210
with a
copy
to:
DLA Piper US
4365
Executive Drive, Suite 1100
San
Diego, California 92130
Attention: Lisa A.
Haile, Ph.D, Esq.
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. All legal fees
attributed to completion of any lawsuits brought on be either party
will be the responsibility of the loosing party.
13.3 Assignment.
Oxis shall not assign its rights or obligations under this
Agreement without the prior written consent of Licensor; provided,
however, that Oxis 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.
13.4 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.
13.5 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.
13.6 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.
13.7 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.
13.8 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.
13.10 Bankruptcy.
In the event Company enters into voluntary bankruptcy, involuntary
bankruptcy, or such similar proceeding or order that would
adversely affect its ability to perform its obligations hereunder,
this Agreement shall terminate.
IN
WITNESS WHEREOF, the parties have executed this Agreement effective
as of the Effective Date.
For LICENSOR:
|
By: /s/
Daniel A. Vallera
|
|
By: /s/
Jeffrey Lion
|
|
Name:
Daniel A.Vallera, Ph.D.
|
|
Name:
Jeffrey Lion
|
|
|
|
|
|
For Oxis Biotech Inc.:
|
|
|
|
By: /s/ Anthony J. Cataldo
|
|
|
|
Name:
Anthony J. Cataldo
|
|
|
|
Title:
Chairman & Chief Executive Officer
|
|
|
SCHEDULE A
LICENSED PATENT RIGHTS
SCHEDULE B
ASSIGNMENT DOCUMENTS
1.
Assignment document
from University of Minnesota to Licensor granting exclusive
ownership to patent family of USSN 13/256,812 to
Licensor.
Schedule
C
Clinical
Services Agreement (To Be Added Upon Execution of the CSA as per
7.1.1)
