Blueprint





 







Exhibit 10.2



LICENSE AGREEMENT


 


THIS
LICENSE AGREEMENT (the “Agreement”), effective as
of March 10, 2015 (the “Effective Date”), is made
by and between Oxis Biotech, Inc., a Delaware corporation, having a
place of business at 1407 North Beverly Drive, Beverly Hills, CA
90210 (“OXIS”) and MultiCell
Immunotherapeutics, Inc., a Delaware corporation, having a place of business at 68
Cumberland Street, Suite 301, Woonsocket, RI 02895 (hereinafter
“MCIT”).


 


WHEREAS, MCIT owns
technology and patent rights in the field of antibody-drug
conjugates;


 


WHEREAS, OXIS
desires to obtain a license under MCIT’s rights in the field
of antibody-drug conjugates on the terms and conditions set forth
below; and,


 


WHEREAS, MCIT and
OXIS have entered into a Research Agreement (“RA”),
effective March 10, 2015, to which this License Agreement is an
Exhibit.


 


NOW,
THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as
follows:


 


1.           DEFINITIONS


 


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)” shall mean, collectively, (a) the
governmental entities in each country or supranational organization
that is responsible for the regulation of any Licensed Human
Therapeutic Product intended for use in the Exclusive 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           “Deliverables”
shall means the Anti-FZD7mAb/O-1663, anti-FZD7mAb/O-1663/Taxol, and
anti-FZD7mAb/XIE3-P62 antibody-drug conjugates delivered by MCIT
pursuant to the RA.


 


1.4           “EMEA”
shall mean the European Medicines Agency which is responsible for
evaluation of human medicinal products for the European Union, or
the successor thereto.


 


1.5           “Exclusive
Field” shall mean the use of Licensed Human Therapeutic
Products for in vivo
treatment of triple negative breast cancer or multiple
myeloma/secondary osteoporosis in humans.


 


1.6           “FDA”
shall mean the Food and Drug Administration of the United States,
or the successor thereto.


 


1.7           “MCIT
IP Rights” shall mean, collectively, the MCIT Patent Rights
and the MCIT Technology Know-How Rights.


 


1.8           “MCIT
Technology Know-How Rights” shall mean all MCIT 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 arising from the Developed Results
under the RA, as defined therein) which are necessary or useful for
OXIS to make, have made, use, have used, develop, sell, have sold,
or seek regulatory approval to market Licensed Human Therapeutic
Products, 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           “MCIT
Patent Rights” shall mean MCIT’s patent application
listed in Appendix A hereto including all issues, reissues,
renewals, extensions, continuations, continuations-in-part,
divisions and foreign counterparts.


 


1.10           “Licensed
Human Therapeutic Product” shall mean a Licensed Product that
is synthesized for and intended for in vivo therapeutic use in
humans.


 


1.11           “Licensed
Product” shall mean an antibody-drug conjugate therapeutic
product containing FZD7 monoclonal antibody and either (a)
2-(4-phenylcyclohexyl)-5-(1’,1’-dimethylheptyl)-resorcinol
(“O-1663”) or (b)
2-((3,4-bis(benzyloxy)benzyl)amino)ethan-1-ol (“XRK3”
or “XIE3-P62”) or (c) O-1663 and Taxol, that if made,
used, sold, offered for sale or imported by OXIS or its Affiliate
absent the license granted hereunder would infringe a Valid Claim
of the Licensed Patent Rights, or otherwise use or incorporate the
Licensed Technology Know-How Rights. For convenience, the chemical
structures and alternative names for O-1663, XIE3-P62 and Taxol as
shown in Appendix 2 attached hereto.


 


1.12           “Licensed
Research Product” shall mean a Licensed Product that is
synthesized for and intended for research use only in preclinical
studies and IND enabling studies in vitro and in vivo in mammals, other than
humans.


1.13           “NDA”
shall mean a New Drug Application, or a Biological License
Application (“BLA”), or similar application for
marketing approval of a Licensed Human Therapeutic Product
submitted to the FDA, or its foreign equivalent.


 


1.14           “Net
Sales” shall mean, with respect to any Licensed Human
Therapeutic Product, the gross sales price of such Licensed Human
Therapeutic Product invoiced by OXIS or its Affiliate to customers
who are not Affiliates (or are Affiliates but are the end users of
such Licensed Human Therapeutic 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 Licensed Human Therapeutic Product; (b) freight
and insurance costs incurred by OXIS or its Affiliate (as
applicable) in transporting such Licensed Human Therapeutic Product
to such customers; (c) cash, quantity and trade discounts, rebates
and other price reductions for such Licensed Human Therapeutic
Product given to such customers under price reduction programs,
provided that all such discounts shall not exceed 3% of gross sales
price on an annual basis; (d) sales, use, value-added and other
direct taxes incurred on the sale of such Licensed Human
Therapeutic Product to such customers; and (e) customs duties,
tariffs, surcharges and other governmental charges incurred in
exporting or importing such Licensed Human Therapeutic Product to
such customers.


 


1.15           “Net
Sublicensing Revenues” shall mean, with respect to any
Licensed Human Therapeutic 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
sub-licensee with respect to such Licensed Human Therapeutic
Product including royalties received by OXIS or its Affiliates
based on sales of such Licensed Human Therapeutic Product by such
sub-licensee, but excluding amounts received to reimburse
OXIS’ or its Affiliates’ cost to perform research,
development or similar services conducted for such Licensed Human
Therapeutic Product after signing the agreement with the Third
Party, in reimbursement of patent or other out-of-pocket expenses
relating to such Licensed Human Therapeutic Product, or in
consideration for the purchase of any debt or securities of OXIS or
its Affiliates.


 


1.16           “Person”
shall mean an individual, corporation, partnership, limited
liability company (LLC), 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.


 


1.17           “Phase
I Clinical Trial” shall mean a human clinical trial that is
intended to initially evaluate the safety and/or pharmacological
effect of a Licensed Human Therapeutic Product in subjects or that
would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its
foreign equivalent.


 


1.18           “Phase
II Clinical Trial” shall mean a human clinical trial in any
country that is intended to initially evaluate the effectiveness of
a Licensed Human Therapeutic 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.


 


1.19           “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 Licensed Human Therapeutic Product as a basis for an
NDA or would otherwise satisfy requirements of 21 CFR 312.21(c), or
its foreign equivalent.


 


1.20           
“Registration(s)” shall mean any and all permits,
licenses, authorizations, registrations or regulatory approvals
including an NDA required or granted by any Competent Authority as
a prerequisite to the development, manufacturing, packaging,
marketing and selling of any product.


 



 

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1.21           “Research
Field” shall mean the use of Licensed Research Products to
conduct pre-clinical and IND enabling studies in vitro and in vivo in mammals, other than humans,
to target and treat triple negative breast cancer or multiple
myeloma/secondary osteoporosis.


 


1.22           “Royalty
Term” shall mean, with respect to each Licensed Human
Therapeutic Product in each country, the longer of (i) 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 Licensed Human Therapeutic Product in
such country; or (ii) the term during which Licensed Human
Therapeutic Products made with, using or incorporating the Licensed
Technology Know-How Rights are offered for sale, sold or imported
in such country.


 


1.23           “Successful
Completion” means with respect to a specified human clinical
trial the achievement as determined by the sponsor of such trial of
the primary clinical endpoint identified in the protocol for such
trial.


 


1.24           
“Territory” shall mean worldwide.


 


1.25           “Third
Party” shall mean any Person other than MCIT, OXIS and their
respective Affiliates


 


1.26           “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           Each
party hereby represents and warrants to the other party as
follows:


 


2.1.1           Such
party 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 corporate power and authority and the legal right
to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate 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           MCIT
Representations and Warranties. MCIT hereby represents, warrants
and covenants on its and its Affiliates’ behalf
that:


 


2.2.1           To
its knowledge, (i) the inventors identified in the Licensed Patent
Rights represent all the inventors of the Licensor Patent Rights in
accordance with United States patent law; and (ii) the inventors
have assigned their full right, title and interest in the MCIT
Patent Rights to MCIT;


 


2.2.2           MCIT
is the sole owner of the MCIT Patent Rights and the MCIT Technology
Know-How Rights;


 


2.2.3           The
execution and delivery of this Agreement and its performance by
MCIT will not result in any breach or violation of, or constitute a
default under, any agreement, instrument, judgment or order to
which MCIT is bound.



 

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2.2.5           There
are no invention disclosures, patent applications, or issued
patents other than MCIT Patent Rights in which MCIT has an
ownership interest which discloses or claims any inventions which
are reasonably necessary for the use, manufacture and sale of
Licensed Human Therapeutic Products.


 


2.2.6           To
its knowledge, sale, offer for sale or importation of any Licensed
Human Therapeutic Product, or the practice of any MCIT Patent
Rights or use of any MCIT Technology Know-How does not infringe or
misappropriate any Third Party patent or other intellectual
property rights, it being acknowledged and agreed by OXIS that
neither MCIT nor OXIS has engaged outside patent counsel to conduct
a freedom to operate search with respect to any MCIT Patent Rights
or any MCIT Technology Know-How.


 


2.2.7           MCIT
has not received any claim in writing from any Third Party
contesting the validity, enforceability, licensability, use or
ownership of any MCIT Patent Rights or MCIT Technology
Know-How.


 


2.2.8           There
are no pending declaratory judgment actions, interferences,
oppositions, reissue proceedings or re-examinations involving the
MCIT Patent Rights or MCIT Technology Know-How.


 


2.3           OXIS
Representations and Warranties. OXIS hereby represents, warrants
and covenants on its and its Affiliates’ behalf
that:


 


2.3.1           Neither
OXIS nor its Affiliates shall use MCIT Patent Rights or MCIT
Technology Know-How other than as expressly set forth herein and
neither OXIS nor its Affiliates shall misappropriate MCIT Patent
Rights or MCIT Technology Know-How at any time.


 


2.3.2           OXIS
and its Affiliates shall comply with the intellectual property,
confidentiality and non-use provisions set forth
herein.


 


2.3.3           OXIS
and its Affiliates shall not attempt to reverse engineer MCIT
Technology Know-How or any Licensed Products manufactured by or on
behalf of MCIT.


 


2.3.4           The
execution and delivery of this Agreement and its performance by
OXIS will not result in any breach or violation of, or constitute a
default under, any agreement, instrument, judgment or order to
which OXIS is bound.


 


2.4           EXCEPT
AS SET FORTH IN SECTION 2.2, MCIT MAKES NO GUARANTEES OR
WARRANTIES, EITHER EXPRESS OR IMPLIED, TO OXIS AND SPECIFICALLY
EXCLUDES, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE OR USE WITH RESPECT TO MCIT
PATENT RIGHTS OR MCIT TECHNOLOGY KNOW-HOW AND ANY INFORMATION OR
DATA FURNISHED HEREUNDER OR UNDER THE RA, AND NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED AS:


 




 

(I)           A
WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, SOLD OR
OTHERWISE DISPOSED OF UNDER ANY LICENSE UNDER THIS AGREEMENT IS OR
WILL BE FREE FROM INFRINGEMENT OF VALID, ISSUED PATENTS OF THIRD
PARTIES;


 




 

(II)           A
REQUIREMENT THAT MCIT SHALL FILE ANY PATENT APPLICATION, SECURE ANY
PATENT OR MAINTAIN OR DEFEND ANY PATENT OR PATENT APPLICATION IN
FORCE;


 




 

(III)           GRANTING
BY IMPLICATION, ESTOPPEL OR OTHERWISE, ANY LICENSES OR RIGHTS UNDER
PATENTS OF MCIT, REGARDLESS OF WHETHER SUCH OTHER PATENTS ARE
DOMINANT OF OR SUBORDINATE TO ANY OTHER PATENTS;


 




 

(IV)           AN
OBLIGATION TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD
PARTIES FOR INFRINGEMENT; OR


 




 

(V)           CONFERRING
A RIGHT TO USE IN ADVERTISING, PUBLICITY, OR OTHERWISE ANY
TRADEMARK OR TRADENAME OF MCIT.


 


2.5           MCIT
MAKES NO REPRESENTATION OR WARRANTIES OF ANY KIND, EITHER EXPRESS
OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT
TO MANUFACTURE, USE, SALE, OFFER FOR SALE, IMPORT, TRANSFER, OR
OTHER DISPOSITION OF LICENSED PRODUCTS.


 



 

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2.6           NOTHING
HEREIN WILL BE CONSTRUED AS A WARRANTY AND/OR REPRESENTATION AS TO
THE SCOPE AND/OR VALIDITY OF ANY CLAIM OF ANY MCIT PATENT RIGHTS OR
THAT ANY MCIT PATENT RIGHT IS ENFORCEABLE.


 


3.           License
Grant.


 


3.1           Subject
to all terms of this Agreement, MCIT hereby grants
OXIS:


 


(i) a
fee-bearing, terminable, indivisible, non-transferable, right and
license, with the right to grant sublicenses, to use and consume
the Deliverables solely as necessary to conduct studies within the
Research Field; and


 


(ii) a
fee-bearing, royalty-bearing, terminable, indivisible,
non-transferable, exclusive right and license, with the right to
grant sublicenses, to sell Licensed Human Therapeutic Products in
the Territory within the Exclusive Field. MCIT shall not assert any
MCIT Patent Rights against OXIS or any permitted sublicensee so
long as such parties exercise the rights in the preceding sentence
as permitted. Nothing contained in this Agreement shall grant OXIS
any interest in MCIT Patent Rights or MCIT Technology Know-How or,
until exercise of the option under Section 4.4 and payment of all
amounts due thereunder, any license to use any of the MCIT Patent
Rights or MCIT Technology Know-How.


 


3.2           OXIS’
right to grant sublicenses of license in Section 3.1 above to its
Affiliates and to third parties is contingent upon (i) the
sublicensee agreeing 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 notifying MCIT of any grant of a sublicense and providing to
MCIT upon MCIT request a copy of any sublicense
agreement.


 


3.3           Subject
to all terms of this Agreement, and effective only upon exercise of
the Option under Section 4.4 and payment of all amounts due
thereunder, MCIT shall additionally grant to OXIS a fee-bearing,
royalty-bearing, terminable, indivisible, non-transferable,
worldwide right and license, without the right to sublicense, to
use the MCIT Patent Rights and MCIT Technology Know-How solely to
extent required to make or have made Licensed Human Therapeutic
Products for sale and use only in the Exclusive Field in the
Territory.


 


3.4           For
a period of one (1) year following the date of this Agreement, MCIT
shall provide such technical assistance to OXIS as OXIS reasonably
requests regarding the Licensed Products. OXIS shall pay to MCIT
its documented reasonable out-of-pocket costs of providing such
technical assistance.


 


3.5           MCIT
acknowledges and agrees that OXIS shall own all Registrations for
Licensed Human Therapeutic Products for sale in the Exclusive Field
in each country in the Territory. Additionally, MCIT acknowledges
and agrees that OXIS shall have the right to conduct pre-clinical
and clinical development activities for Licensed Human Therapeutic
Products in the Territory by using Licensed Research Products
incident to such research activities in vitro and in vivo in mammals (other than humans)
as permitted in Section 3.1(i) above. For the avoidance of doubt,
OXIS shall have no rights to use any Licensed Research Products to
treat humans in vivo. MCIT
hereby grants to OXIS the right to reference, use, and have full
access to all other Registrations and all other regulatory
documents that relate to Licensed Human Therapeutic Products,
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 sub-licensees and
Affiliates provided said sub-licensees and Affiliates comply fully
with all applicable terms herein. MCIT shall promptly notify OXIS
of any written or oral notices received from, or inspections by any
Competent Authority relating to any such Registrations, and shall
promptly inform OXIS of any responses to such written notices or
inspections and the resolution of any issue raised by such
Competent Authority. OXIS shall be entitled to attend any and all
meetings and participate in telephone calls with the Competent
Authorities, including without limitation any meeting preparation,
meeting co-ordination and preparation of minutes.


 


3.6           Notwithstanding
anything to the contrary herein, all rights not specifically and
expressly granted in the license above to OXIS shall be reserved
and remain always with MCIT.


 


4.           Financial
Considerations.


 


4.1           Technology
and License Fees.


 


4.1.1           As
consideration, inter alia,
for the licenses in Section 3.1 herein, OXIS shall pay MCIT a
non-refundable technology and license fee of FIVE HUNDRED THOUSAND
DOLLARS ($500,000) which shall be due and payable according to the
following payment schedule:


 


(a) TWO
HUNDRED FIFTY THOUSAND DOLLARS ($250,000) shall be paid to MCIT
immediately upon the Effective Date of this Agreement.


 



 

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(b) ONE
HUNDRED TWENTY-FIVE THOUSAND DOLLARS ($125,000) shall be paid to
MCIT thirty (30) calendar days after the Effective Date of this
Agreement.


 


(c) ONE
HUNDRED TWENTY-FIVE THOUSAND DOLLARS ($125,000) shall be paid to
MCIT sixty (60) calendar days after the Effective Date of this
Agreement.


 


4.2           Royalties.


 


4.2.1           Subject
to the Royalty Term and the terms and conditions of this Agreement,
OXIS shall pay to MCIT royalties, with respect to each Licensed
Human Therapeutic Product, equal to (a) THREE PERCENT (3.0%) of Net
Sales of such Licensed Human Therapeutic Product by OXIS and its
Affiliates, and (b) THIRTY PERCENT (30%) of Net Sub-licensing
Revenues for such Licensed Human Therapeutic Product.


 


4.2.2           If
a Licensed Human Therapeutic Product and its components are not
covered by any Valid Claim but are covered by Licensed Technology
Know-How Rights, then OXIS shall pay to MCIT royalties, with
respect to each such Licensed Human Therapeutic Product, equal to
(a) TWO AND ONE-HALF PERCENT (2.5%) of Net Sales of such Licensed
Human Therapeutic Product by OXIS and its Affiliates, and (b)
TWENTY-FIVE PERCENT (25%) of Net Sub-licensing Revenues for such
Licensed Human Therapeutic Product.


 


4.2.3           Third
Party Royalties. If OXIS, its Affiliates or sub-licensees is
required to pay royalties to any Third Party in order to exercise
its rights hereunder to sell, offer to sale or import any Licensed
Human Therapeutic Product, then OXIS shall have the right to credit
ONE PERCENT (1%) of such Third Party royalty payments against the
royalties owing to MCIT under Section 4.2.1 above with respect to
sales of such Licensed Human Therapeutic Product in such country;
provided, however, that OXIS shall not reduce the amount of the
royalties paid to MCIT under Section 4.2.1 above by reason of this
Section 4.2.2, with respect to sales of such Licensed Human
Therapeutic Product in such country, to less than ONE AND ONE-HALF
PERCENT (1.5%) of Net Sales of such Licensed Human Therapeutic
Product in such country.


 


4.3           OXIS
shall pay to MCIT the following milestone payments within THIRTY
(30) days following the first achievement of the applicable
milestone:


 


4.3.1           FIVE
HUNDRED THOUSAND DOLLARS ($500,000) upon dosing of the first
patient in a Phase I clinical trial for each Licensed Human
Therapeutic Product anywhere in the Territory.


 


4.3.2           SEVEN
HUNDRED FIFTY THOUSAND DOLLARS ($750,000) upon dosing of the first
patient in a Phase II clinical trial for each Licensed Human
Therapeutic Product anywhere in the Territory.


 


4.3.3           ONE
MILLION THOUSAND DOLLARS ($1,000,000) upon dosing of the first
patient in a Phase III clinical trial for each Licensed Human
Therapeutic Product anywhere in the Territory.


 


4.3.4           ONE
MILLION DOLLARS ($1,000,000) upon filing of an NDA or equivalent
for each Licensed Human Therapeutic Product anywhere in the
Territory.


 


4.3.5           ONE
MILLION DOLLARS ($1,000,000) upon the first marketing approval by a
competent regulatory authority for each Licensed Human Therapeutic
Product anywhere in the Territory.


 


4.4           Manufacturing
Rights to Licensed Human Therapeutic Products.


 


4.4.1           MCIT
hereby grants to OXIS the option to obtain a worldwide license to
make or have made Licensed Human Therapeutic Products for sale in
the Exclusive Field (“Option”).


 


4.4.2           The
Option shall expire THREE (3) YEARS from the Effective Date
(“Option Period”) and must be exercised in full prior
to the lapse of the foregoing Option Period.


 


4.4.3           OXIS
may exercise the Option, during the term of this Agreement, by
delivering to MCIT, prior to the lapse of the Option Period, (i) a
written notice of its election to exercise the Option; and (ii) the
sum of TEN MILLION DOLLARS ($10,000,000). Failure to deliver both
(i) and (ii) in the preceding sentence during the term of this
Agreement and prior to the lapse of the Option Period shall void
the Option.


 



 

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5.           Reports
and Payments.


 


5.1.           On
or before the last business day of January, April, July, and
October of each calendar year of this Agreement, OXIS shall submit
to MCIT a written report with respect to the preceding calendar
quarter (the “Payment Report”) stating:


 


(i) Net
Sales made by OXIS or any Affiliate during such
quarter;


 


(ii) In
the case of transfers of Licensed Human Therapeutic Products to an
Affiliate by OXIS for sale, rental, or lease of such Licensed Human
Therapeutic Products by the Affiliate to third parties, Net Sales
by OXIS to the Affiliate and Net Sales by the Affiliate to third
parties during such quarter;


 


(iii)
Net Sales by sublicensees during such quarter;


 


(iv)
Amounts accruing to, and received by, OXIS from its sublicensees
during such quarter; and,


 


(v) A
calculation under Section 4 of the amounts due to LICENSOR, making
reference to the applicable subsection thereof.


 



5.2.           

Within thirty (30)
days of the submission of each Payment Report, OXIS shall make
payments to MCIT of the amounts due for the calendar quarter
covered by the Payment Report. All amounts shall be paid in United
States Dollars. Payments shall be made by OXIS by bank wire
transfer to MCIT’s bank. Payment Reports shall be mailed to
the following address:






 


MultiCell
Immunotherapeutics, Inc.


68
Cumberland Street, Suite 301


Woonsocket,
RI 02895


Attn:
Chief Executive Officer


 



6.            

Payments.






 


6.1           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           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 Licensed Human Therapeutic 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 MCIT’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           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 sub-licensees, or any taxes required to be withheld
by OXIS, its Affiliates or sub-licensees, to the extent OXIS, its
Affiliates or sub-licensees 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 sub-licensees. 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.


 



 

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7.           Research
and Development Obligations.


 


7.1           OXIS
shall 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 Licensed
Human Therapeutic Products as OXIS determines are commercially
feasible in the Territory and as otherwise required to commence a
Phase I clinical trial for a Licensed Human Therapeutic Product on
or before the 3rd anniversary of the Effective Date, and shall use
its commercially reasonable efforts to obtain regulatory approval
to market, and following approval to commence marketing and market
each such Licensed Human Therapeutic Product in such countries in
the Territory as OXIS determines are commercially
feasible.


 



7.2           

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 Licensed Human
Therapeutic Products.






 


7.3           No
less often than every SIX (6) MONTH anniversary after the Effective
Date OXIS shall report in writing to MCIT on progress made toward
the objectives set forth above.


 


7.4           Notwithstanding
anything else to the contrary, OXIS shall be required to commence a
Phase I clinical trial for a Licensed Human Therapeutic Product
anywhere in the Territory on or before the 3rd anniversary of the
Effective Date.


 


8.           Patents.


 


8.1           If
OXIS determines that it desires a patent application to be made
covering Licensed Human Therapeutic Products, OXIS will appoint
qualified counsel after reasonable consultation with MCIT and to
whom MCIT has no reasonable objection, and in consultation with
patent counsel appointed by MCIT, OXIS will prepare and prosecute
such application in MCIT’s name and in countries designated
by OXIS. OXIS will handle the filing of the patent applications
with the appropriate patent offices. OXIS shall promptly provide
copies to MCIT of any proposed patent application filing. OXIS
shall in good faith take into consideration the advice and
suggestions of MCIT and its patent counsel with regard to each such
proposed patent application or communication. OXIS will reimburse
MCIT for reasonable expenses it has incurred and will pay
reasonable expenses incurred in the future in so filing and
prosecuting such applications, including attorneys' fees, taxes,
annuities, issue fees, working fees, maintenance fees and renewal
charges. Each party hereto agrees to cooperate with the other party
to execute all lawful papers and instruments, to make all rightful
oaths and declarations and to provide consultation and assistance
as may be necessary in the preparation, prosecution, maintenance,
and reinforcement of all such patent applications and patents. All
such patent applications and any letters patent issued thereupon
shall be added to MCIT Patent Rights and subject to the licenses
herein.


 



8.2           

Each party shall
notify the other party of any substantial infringement in the
Territory known to such party of any MCIT Patent Rights, and shall
provide the other party with the available evidence, if any, of
such infringement.





 


 


8.3           MCIT
shall have the right to exclusively determine the appropriate
course of action to enforce MCIT Patent Rights or otherwise abate
the infringement thereof, to take (or refrain from taking)
appropriate action to enforce MCIT Patent Rights, to defend any
declaratory judgments seeking to invalidate or hold the MCIT 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 MCIT Patent Rights, in each case in
MCIT’s own name. If MCIT does not, within one hundred twenty
(120) days of receipt of notice from OXIS, abate the infringement
or file suit to enforce the MCIT Patent Rights against at least one
infringing party in the Territory, OXIS shall have the right to
take whatever action it deems appropriate to enforce the MCIT
Patent Rights; provided, however, that, within thirty (30) days
after receipt of notice of OXIS’ intent to file such suit,
MCIT shall have the right to jointly prosecute such suit and to
fund up to one-half (1⁄2) 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 each party’s legal expenses, on a 50%/50%
basis by each party.


 


8.4           In
any suit to enforce and/or defend the MCIT Patent Rights pursuant
to this Section 8, 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.


 



 

8







 






 


9.           Confidentiality.


 



9.1           During
the term of this Agreement, and for a period of five (5) years
following the expiration or earlier termination hereof, each party
shall maintain in confidence all information of the other party
that is disclosed by the other party and identified as, or
acknowledged to be, confidential at the time of disclosure (the
“Confidential Information”), and shall not use,
disclose or grant the use of the Confidential Information except
(i) with respect to OXIS, as expressly permitted below; and (ii)
with respect to MCIT except on a need-to-know basis to those
directors, officers, affiliates, employees, permitted licensees,
permitted assignees and agents, consultants, clinical investigators
or contractors, to the extent such disclosure is reasonably
necessary in connection MCIT’s performing its obligations or
exercising its rights under this Agreement. To the extent that
disclosure is authorized by this Agreement, prior to disclosure,
each party hereto shall obtain agreement of any such Person to hold
in confidence and not make use of the Confidential Information for
any purpose other than those permitted by this Agreement. Each
party shall notify the other promptly upon discovery of any
unauthorized use or disclosure of the other party’s
Confidential Information.


 


9.1.1           Notwithstanding
anything else to the contrary herein, any disclosure by OXIS of
Confidential Information to any employee, officer or director of
OXIS is prohibited unless (i) said individual needs to know the
information in order for OXIS to perform its obligations or
exercise its rights under this Agreement; and (ii) said individual
is bound by written obligations of confidentiality, non-use and
intellectual property ownership to OXIS, no less restrictive as the
corresponding obligations binding OXIS hereunder and under the RA;
and


 


9.1.2           Notwithstanding
anything else to the contrary herein, any disclosure by OXIS of
Confidential Information to any Third Party including but not
limited to consultants, agents, independent contractors, investors,
or business partners is prohibited, except that OXIS is permitted
to disclose portions of Confidential Information to employees of
the California Pacific Medical Center Research Institute or the
University of Pittsburg who have a need to know the information in
order for OXIS to be able to exercise the rights licensed to OXIS
under Section 3.1(i) but only provided the minimum information is
disclosed as required for such purpose; and (ii) each such
recipient is, in each case, bound to OXIS by written obligations of
confidentiality, non-use and intellectual property ownership, no
less restrictive as the corresponding obligations binding OXIS
hereunder and under the RA.


 


9.2           The
confidentiality obligations contained in Section 9.1 above shall
not apply to the extent that (a) any receiving party (the
“Recipient”) is required (i) to disclose information by
law, regulation or order of a governmental agency or a court of
competent jurisdiction, or (ii) to disclose information to any
governmental agency for purposes of obtaining approval to test or
market a product, provided in either case that the Recipient shall
provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request
confidential treatment thereof; or (b) the Recipient can
demonstrate that (i) the disclosed information was public
knowledge at the time of such disclosure to the Recipient, or
thereafter became public knowledge, other than as a result of
actions of the Recipient in violation hereof; (ii) the
disclosed information was rightfully known by the Recipient (as
shown by its written records) prior to the date of disclosure to
the Recipient by the other party hereunder; (iii) the
disclosed information was disclosed to the Recipient on an
unrestricted basis from a source unrelated to any party to this
Agreement and not under a duty of confidentiality to the other
party; or (iv) the disclosed information was independently
developed by the Recipient without use of the Confidential
Information disclosed by the other party or breach of this
Agreement.


 


9.3           Disclosure
of Terms of this Agreement.


 


9.3.1           Except
as otherwise provided in Section 9.3.2 , MCIT and OXIS shall not
disclose any terms or conditions of this Agreement to any Third
Party without the prior consent of the other party hereto provided,
however, that each party hereto may indicate the existence of this
license with the other party and its terms and conditions in any of
its filings with U.S. Securities Exchange Commission
(“SEC”).


 


9.3.2           Each
party may issue a press release stating that they have entered into
this Agreement. Said party’s press release must be approved
by the other party in advance of publication, and such approval
will not be unreasonably withheld.


 


10.           Prohibition
Against Use of the Other Party’s Name.

 


10.1.           Neither
party will not use the other party’s the name, insignia,
symbols, or combination thereof, or the name of employee for any
purpose whatsoever without the other party’s prior written
consent, provided, however, that each party hereto may indicate the
existence of this license with the other party in any of its SEC
filings.

 



 

9







 






 


11.           Compliance
with Governmental Obligations.


 


11.1           Notwithstanding
any provision in this Agreement, MCIT disclaims any obligation or
liability arising under the license provisions of this Agreement if
OXIS is charged in a governmental action for not complying with or
fails to comply with governmental regulations in the course of
taking steps to bring any Licensed Human Therapeutic Product to a
point of practical application.


 


11.2.           OXIS
shall comply with all governmental requests directed to OXIS or
(upon reasonable notice from MCIT) to LICENSOR and provide all
information and assistance reasonably necessary to comply with
legitimate governmental requests.


 


11.3           OXIS
shall insure that research, development, and marketing under this
Agreement complies with all government regulations in force and
effect including, but not limited to, Federal, state, and municipal
legislation.


 


12.           Indemnification.


 


12.1           OXIS
shall defend, indemnify and hold MCIT and its directors, officers,
employees, agents and affiliates 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 (i) any breach of the representations,
warranties and covenants of OXIS in Section 2.2; (ii) any use of
the MCIT Patent Rights and/or MCIT Technology Know-How by OXIS,
whether authorized or not; (iii) any manufacture, storage,
transportation, sale or use or Licensed Human Therapeutic Products;
(iv) the use of any Licensed Research Products in vivo in humans; and (v) the
negligence or willful misconduct of OXIS in the performance of its
obligations under this Agreement.


 


12.2           MCIT
promptly shall notify OXIS of any liability or action in respect of
which MCIT 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 12 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 12, 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 12.
MCIT under this Section 12, 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.


 


12.3           OXIS
shall maintain product liability insurance with respect to the
research, development, manufacture and sales of Licensed Human
Therapeutic 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 Licensed Human Therapeutic Products, and
thereafter for so long as OXIS customarily maintains insurance
covering the research, development, manufacture or sale of its
similar products.


 


12.4           NOTWITHSTANDING
ANYTHING TO THE CONTRARY HEREIN, EXCEPT FOR OXIS’ VIOLATION
OF MCIT’S INTELLECTUAL PROPERTY RIGHTS OR EXCEEDING SCOPE OF
ANY LICENSE RIGHTS HEREIN, NO PARTY SHALL BE LIABLE FOR ANY
INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES,
WHETHER FORESEEABLE OR NOT, THAT ARE IN ANY WAY RELATED TO THIS
AGREEMENT OR THE BREACH THEREOF, ANY TRANSACTIONS RESULTING FROM
THIS AGREEMENT, LOSS OF GOODWILL OR PROFITS, LOST BUSINESS HOWEVER
CHARACTERIZED AND/OR FROM ANY OTHER CAUSE WHATSOEVER, EVEN THOUGH
THE PARTY MAY HAVE BEEN ADVISED OR MAY OTHERWISE KNOW OF THE
POSSIBILITY OF SUCH DAMAGES.


 


13.           Force
Majeure.


 


13.1.           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.


 



 

10







 






 


14.           Export
Control Laws.


 


14.1.           This
Agreement is made subject to any restrictions concerning the export
of products or technical information from the United States of
America which may be imposed from time to time by the government of
the United States of America. Furthermore, each party hereto agrees
that it will not export or re-export, directly or indirectly, any
technical information acquired from the other under this Agreement
or any products using such technical information to any country for
which the United States government or any agency thereof at the
time of export requires an export license or other governmental
approval, without first obtaining the written consent to do so from
the Department of Commerce or other agency of the United States
government when required by an applicable statute or
regulation.


 


15.           Termination.


 


15.1           Subject
to Sections 15.2 and 15.3 below, this Agreement shall expire on the
expiration of OXIS’ obligation to pay royalties to MCIT under
Section 4 above. The licenses granted under Section 3.1, and if the
Option is fully exercised as permitted herein, 3.3, shall be
effective at all times prior to such expiration.


 


15.2           OXIS
may terminate this Agreement, in its sole discretion, upon THIRTY
(30) DAYS prior written notice to MCIT.


 


15.3.           Except
as otherwise provided in Section 13, MCIT may terminate this
Agreement upon or after the breach of any provision of this
Agreement by OXIS if OXIS has not cured such breach within THIRTY
(30) DAYS after receipt of express written notice thereof by
MCIT.


 


15.4           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, 9, 10, 11, 12, 14, and 15
and any other provisions which, by their terms, survive termination
in order to give effect to their terms, shall survive the
expiration or termination of this Agreement.


 


 




 

11








 






 

 


16.           Miscellaneous.


 


16.1           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’s Chief Executive Officer at the address
indicated below, or to such other address as one party shall have
last furnished in writing to the other party, and (except as
otherwise provided in this Agreement) shall be effective upon
receipt by the receiving party.


 



If
to: 

MultiCell
Immunotherapeutics, Inc.






68
Cumberland Street, Suite 301


Woonsocket,
RI 02895


 



If
to: 

Oxis Biotech,
Inc.






1407
North Beverly Drive


Beverly
Hills, CA 90210


 


16.2           All
payments made to MCIT required or permitted under this Agreement
shall be made as follows by bank wire transfer:


 


	

ACCOUNT
NAME:

	
 


	

ACCOUNT
NUMBER:

	
 


	

BANK
NAME:

	
 


	

BANK
ADDRESS:

	
 


	

BANK
WIRE TRANSFER ROUTING NUMBER:

	
 







 


 


16.3           Neither
party shall assign its rights or obligations under this Agreement
without the prior written consent of the other party; provided,
however, that either party 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.


 


16.3           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.


 


16.4           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 San Francisco, 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.


 



 

12







 






 


16.5           OXIS
will inform MCIT within five (5) business days of any regulatory
approval for a Licensed Human Therapeutic Product, and will assist
MCIT to apply for applicable extension of exclusivity, whether by
patent extension, special protection certificate, data exclusivity,
or the like.


 


16.6           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.


 


16.7           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.


 


16.8           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.


 


16.9           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.


 


16.10           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 THEREOF, MCIT and OXIS have caused this Agreement to be
executed by their duly authorized representatives as of the day and
year first written above.


 


 


	


For MultiCell Immunotherapeutics, Inc.:

	
 

	


For Oxis Biotech, Inc.:


	

 


 


/s/ W.
Gerald Newmin

	
 

	

 


 


/s/
Anthony J. Cataldo


	

W.
Gerald Newmin

	
 

	

Anthony
J. Cataldo


	

 


 


Chairman
& Chief Executive Officer

	
 

	

 


 


Chairman
& Chief Executive Officer


	

Title

	
 

	

Title







 


 




 

13