AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
AMENDED
AND RESTATED EXCLUSIVE LICENSE AGREEMENT
THIS
AMENDED
AND RESTATED EXCLUSIVE
LICENSE AGREEMENT
(the
“Agreement”)
is
entered into as of April 2, 2007, having an effective date of April 5, 2007
(the
“Effective
Date”)
by and
between OXIS
INTERNATIONAL,
a
Delaware corporation (“OXIS”),
located at 0000 X. Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx XX 00000 and ALTEON,
INC. (FORMERLY KNOWN AS HAPTOGUARD, INC.,)
a
Delaware corporation located at 000 X. Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx,
XX
00000 (“Alteon”).
RECITALS
WHEREAS,
OXIS is
the owner of certain
Licensed Patents, Licensed Compounds, Licensed Know-How, Licensed Process,
and
Licensed Product (each as defined below), as described below;
WHEREAS,
Alteon
is a biopharmaceutical company that is interested in developing and
commercializing the Licensed Product;
WHEREAS,
OXIS
wishes to grant Alteon and Alteon desires to obtain an exclusive, worldwide
license under the Licensed Patents, Licensed Compounds, Licensed Know-How,
Licensed Process, and Licensed Product on the terms set forth
herein.
WHEREAS,
Alteon
and OXIS previously entered into an agreement, titled “Exclusive License
Agreement” which was made effective as of February 28, 2004 ( the "Prior
Exclusive License Agreement");
WHEREAS,
this Agreement is intended to cover the same intellectual property as described
in the Prior Exclusive License Agreement and evidenced by the Licensed Patents
Licensed Compounds, Licensed Know-How, Licensed Process and Licensed Product,
but, among other things, expands the scope of the previous licenses to also
include non cardiovascular indications;
WHEREAS,
the
Parties now desire to enter into this “Amended and Restated Exclusive License
Agreement” for the purpose of amending the Prior Exclusive License Agreement by
expanding the rights granted and making certain changes regarding the terms
and
conditions and rights and obligations of the Parties; and
WHEREAS,
the
Parties intend that this Agreement shall supersede the Prior Exclusive License
Agreement from and as of the Effective Date;
NOW
THEREFORE,
for good
and valuable consideration of the foregoing and the covenants and premises
contained in this Agreement, the parties agree as follows:
1.
|
DEFINITIONS
|
The
following capitalized terms shall have the meanings indicated for purposes
of
this Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
1
1.2 “ANDA”
shall
mean an Abbreviated New Drug Application filed pursuant to the requirements
of
the FDA, or the equivalent application in any other country or jurisdiction,
required before Commercial Sale of a drug product.
1.3 “Combination
Product” any
product that combines Licensed Product with any Alteon product or
technology.
1.4 “Confidential
Information”
shall
have the meaning in Section 7
1.5 “Disclosing
Party”
shall
have the meaning provided in Section 6.1.
1.6 “Disputes”
shall
have the meaning provided in Section 9.4.
1.7 “FDA”
shall
mean the United States Food and Drug Administration or any successor
agency.
1.8 “Field”
shall
mean any and all uses including but not limited to the therapeutic, diagnostic,
preventative, amerliorative, and/or prognostic for and in any indication,
assay,
disease and/or condition.
1.9 “First
Commercial Sale”
shall
mean, with respect to any Licensed Product, the first sale on a commercial
basis
in an arm's length transaction for end use of such Licensed Product in a
country
after the governing health regulatory authority of such country has granted
regulatory approval of such Licensed Product, to the extent such regulatory
approval is required in such country. Licensed Product distributed or used
for
clinical trial purposes shall not be considered sold, marketed or made publicly
available for sale and shall not constitute first commercial sale.
1.10 “Alteon
Indemnitee”
shall
have the meaning provided in Section 9.1(b).
1.11 “Generic
Competition”
shall
mean on a country by country basis the commercial sale of a generic product
containing the same compound as Licensed Product as an active
ingredient.
1.12 “Indemnifying
Party” shall
have the meaning provided in Section 9.1(c).
1.13 “Parenteral
Formulation”
shall
mean Licensed Product formulated sterilely for administration through a needle
or indwelling catheter to a human subject
1.14 “Licensed
Know-How”
shall
mean, with respect to the Field, all information, data, compositions, materials,
method, processes, protocols, reports, techniques relating
to [***************************************************
**********************************************************************************************************************************
**********************************************************************************************************************************
************************************************** ********************************************************************************
***].
**********************************************************************************************************************************
************************************************** ********************************************************************************
***].
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
2
1.15 “Licensed
Compound”
shall
mean a set of compounds [*****************************************
*****************************************************************************************************************]
including a set of cyclic organoselenium compounds
[*******************************************] for use in the Field.
1.16 “Licensed
Patents”
shall
mean any and all i) Patents covering the Licensed Compounds, Licensed Process,
Licensed Know-How of the Prior Exclusive License Agreement which have a Valid
Claim; and ii) [****************************************************************************].
1.17 “Licensed
Process”
shall
mean synthetic routes, materials, conditions, and/or processes relating to
and
for the manufacture of the Licensed Compounds and/or Licensed Product relating
to the Field as disclosed in the Licensed Patents .
1.18 “Licensed
Product”
shall
mean any products prepared, created, generated or synthesized by use of the
[****
**********************************************************************************************************************************
***] BXT-51072 and the organoselenium compounds and formulations thereof [*********************************
***] BXT-51072 and the organoselenium compounds and formulations thereof [*********************************
*****].
1.19 “Losses”
shall
have the meaning provided in Section 9.1(a).
1.20 “NDA”
shall
mean a New Drug Application filed pursuant to the requirements of the FDA,
or
the equivalent application in any other country or jurisdiction.
1.21 “Net
Sales”
shall
mean, except as specified in Section 3.6(c) hereof for the purposes set forth
in
such Section, the amount actually received by Alteon and its Affiliates for
sales by Alteon or an Affiliate in a given jurisdiction of Licensed Product
for
use in the Field to independent purchasers in arm's length transactions,
less
the following customary and reasonable items, actually allowed or granted
for
such Licensed Product (if not previously deducted from the amount invoiced):
(a) discounts,
credits, retroactive price reductions, rebates, refunds, charge backs,
allowances and adjustments, including Medicaid, managed care and similar
types
of rebates, rejections, market withdrawals, recalls and returns, and
administrative fees charged by hospital buying groups and managed care
organizations;
(b) trade,
quantity and cash discounts and rebates actually allowed or given;
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
3
(c) sales,
excise, turnover, value-added,
and
similar taxes assessed on the sale of the Product, and import and customs
duties;
(d) shipping
and insurance charges, postage, and freight out;
(e) government
imposed rebates or discounts; and
(f) payments
of actual fees or royalties to bona fide third parties in connection with
the
commercialization, licensing, or manufacture of Licensed Product
1.22 Sales
of
Licensed Product by and between Alteon and its Affiliates and sublicensees
are
not sales to Third Parties and shall be excluded from Net Sales calculations
for
all purposes. Sales of Product for use in conducting clinical trials of Licensed
Product in a country in order to obtain the regulatory approval of Licensed
Compounds and/or Product in such country shall be excluded from Net Sales
calculations for all purposes. Net Sales shall be determined in a manner
consistent for all products sold by or on behalf of Alteon and in accordance
with applicable U.S. generally accepted accounting principles.
1.23 “Non-Parenteral
Intravenous Formulation” shall
mean Licensed Product formulated ******************
******************************************************].
1.24 “OXIS
Indemnitee”
shall
have the meaning provided in Section 9.1(a).
1.25 “OXIS
Improvements” shall
mean any new invention related to active pharmaceutical ingredient production,
formulation or chemical structure of the Licensed Processes and/or Licensed
Compounds developed by OXIS whereby such improvements are covered under and/or
disclosed by the Patents.
1.26 “Patents”
shall
mean, with respect to the Field, (a) patents and patent applications,
existing as of February 28, 2004 as set for in Appendix A of the Prior Exclusive
License Agreement; (b) any and all corresponding foreign patents and patent
applications, whether now existing or hereafter filed, (c) provisionals,
substitutions, divisionals, reexaminations, reissues, renewals, extensions,
term
restorations, continuations, continuations-in-part, substitute applications
and
inventors’ certificates, arising from, or based upon, any of such patents or
patent applications, and (d) patents issuing from any such patent
applications.
1.27 “Phase
I Clinical Trial”
shall
mean a human clinical trial in any country conducted by Alteon or its Affiliate
to initially evaluate the safety of Licensed Product in human subjects or
that
would otherwise satisfy the requirements of 21 CFR 312.21(a) or the equivalent
laws, rules or regulations in a regulatory jurisdiction outside the United
States.
1.28 “Phase
II Clinical Trial”
shall
mean a human clinical trial in any country conducted by Alteon or its Affiliate
to initially evaluate the effectiveness of Licensed Product in human subjects
with the disease or indication under study or that would otherwise satisfy
the
requirements of 21 CFR 312.21(b) or the equivalent laws, rules or regulations
in
a regulatory jurisdiction outside the United States.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
4
1.29 “Phase
III Clinical Trial”
shall
mean the first patient dosed in a pivotal human clinical trial in any country
conducted by Alteon or its Affiliate the results of which could be used to
establish safety and efficacy of the Licensed Product as a basis for approval
of
an NDA for such Licensed Product or Additional Product or that would otherwise
satisfy the requirements of 21 CFR 312.21(c) or the equivalent laws, rules
or
regulations in a regulatory jurisdiction outside the United States.
1.30 “Receiving
Party”
shall
have the meaning provided in Section 6.1.
1.31 “Regulatory
Approval”
shall
mean approval of an NDA and satisfaction of any related applicable regulatory
registration and notification requirements (if any).
1.32 “Royalty
Term”
shall
mean, with respect to each country in which Licensed Product is sold, on
a
product-by-product basis, that time period beginning on the First Commercial
Sale of such Licensed Product covered by a Valid Claim in such country and
expiring, on a country-by-country basis, the expiration in such country of
the
last-to-expire Licensed Patent with a Valid Claim.
1.33 “Sublicense
Fee”
shall
mean *************************************************************
**********************************************************************************************************************************
**********************************************************************************************************************************
**********************************************************************************************************************************
**********************************************************************************************************************************
*****************************************].
**********************************************************************************************************************************
**********************************************************************************************************************************
**********************************************************************************************************************************
*****************************************].
1.34 “Sublicensee”
shall
mean any Third Party to which Alteon or its Affiliate has granted rights
in the
to the Licensed Patents covering the Licensed Product pursuant to the terms
of
this Agreement.
1.35 “Term”
shall
have the meaning provided in Section 8.1.
1.36 “Third
Party” shall
mean any entity other than OXIS or Alteon
or an
Affiliate of OXIS or Alteon.
1.37 “U.S.”
shall
mean the United States.
1.38 “Valid
Claim”
shall
mean a claim of an issued patent included within the Licensed Patents in
the
Field, which claim has not lapsed, been cancelled or become abandoned
irrevocably and has not been declared invalid or unenforceable by an unreversed
and unappealable decision or judgment of a court or other appropriate body
of
competent jurisdiction, and which has not been admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
5
2.
|
LICENSE;
|
2.1 License
Grant.
Subject
to the terms and conditions of this Agreement, OXIS hereby grants to Alteon
and
its Affiliates during the Term, with respect to the Field an exclusive, sole,
worldwide, royalty bearing license, with the right to grant sublicenses through
multiple tiers of sublicenses, in, to, and under the Licensed Patents, Licensed
Compounds, Licensed Know-How, Licensed Process, and Licensed Product to develop,
distribute, market, make, have made, use, have used, sell, have sold, offer
for
sale, and import Licensed Compounds, Licensed Processes, and Licensed
Products.
For the
avoidance of doubt, it is understood and acknowledged by the parties hereto
that
the Licensed Patents hereunder is identical to the Licensed Patents and all
reformulations disclosed in and covered by the Licensed Patents under the
Prior
Exclusive License Agreement.
2.2 Sublicenses.
In the
event that Alteon sublicenses any of its rights hereunder to a Sublicensee
pursuant to Section 2.1,
such
sublicense shall, as a condition to the effectiveness of such sublicense,
include terms and conditions consistent with the terms and conditions of
the
license granted under this Agreement (including, without limitation, Sections
3.8 and 3.9 hereof). Sublicenses, if any, granted hereunder, will be to Third
Parties in an arm's length transaction under written agreements (each, a
“Sublicense Agreement”), copies of which will be provided to OXIS, and
conditioned on such Sublicensees’ agreement to accept and abide with the
applicable terms and obligations of this Agreement or the Sublicense Agreement,
as the case may be.
2.3 Disclosure
of Licensed Know-How. The
parties hereto acknowledge that OXIS has provided Alteon with the Licensed
Know-How required to give effect to the transactions contemplated
herein.
2.4 Cross
Reference Letters. OXIS
agrees to provide Alteon within twenty (20) days of a written request from
Alteon with a cross-reference letter to any OXIS regulatory applications
and
approvals relating to the Licensed Compounds. The cross-reference letter
shall
be without limitation to clinical phase of the ongoing study. Any such
cross-reference letter shall remain in effect and may not be revoked by OXIS
unless this Agreement is terminated. OXIS shall be notified and be provided
with
copies of such cross reference letters for the Licensed Compounds. Alteon
shall
be responsible for OXIS’ reasonable fees and costs associated with the
preparation of such cross-reference letters and any required subsequent actions
relating thereto.
3.
|
CONSIDERATION
|
3.1 Upfront
Payment.
In
consideration for the Amended and Restated Exclusive License Agreement, Alteon
will pay OXIS a non-refundable payment in the amount of Five Hundred Thousand
US
Dollars ($500,000) to be paid as follows: [*********************************************************************************************************************************
********] Within Thirty days (30) from an affirmative Alteon shareholder approval of a financing by Alteon of at least Twenty million dollars (20,000,000 USD), Alteon shall pay OXIS for any amounts unpaid under this section. For the avoidance of doubt, it is hereby understood by the parties the payment of such $500,000 fee is in addition to the amounts previously paid in connection with the Prior Exclusive License Agreement.
********] Within Thirty days (30) from an affirmative Alteon shareholder approval of a financing by Alteon of at least Twenty million dollars (20,000,000 USD), Alteon shall pay OXIS for any amounts unpaid under this section. For the avoidance of doubt, it is hereby understood by the parties the payment of such $500,000 fee is in addition to the amounts previously paid in connection with the Prior Exclusive License Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
6
3.2
Equity Investment.
Within
14 days of the Effective Date, Alteon shall execute a share purchase agreement
substantially in the form of Exhibit X hereto, for the purchase by Alteon
and
issuance by OXIS of Common Shares of OXIS, at a [***********] to the per
share
of common stock [*************************************], but in any event
not
less than $[****] per share, and for a total investment sum of $500,000.
Such
issued shares shall be held by Alteon for not less than [*********] from
the
date of their issuance (it being understood that Alteon may not transfer
in any
manner such shares during this [********] period, except as may be required
by
law). During such [********] period, OXIS shall use its commercially reasonable
efforts to prepare a registration statement covering such shares (which may
be
also included in the context of [******************] so that upon the expiration
of such period, the shares may be sold free or restrictions. Notwithstanding
anything to the contrary, in the event that the equity investment by Alteon
contemplated by this Section 3.2 causes under applicable accounting standards
and guidelines a requirement to prepare, review or otherwise generate
consolidated financial statements reflecting the financing results of Alteon
and
OXIS, the parties hereto agree to use good faith efforts to restructure the
equity investment in a manner so that such principals of consolidation do
not
apply (e.g. the issuance of non-voting shares) while preserving the economic
benefit of the investment in OXIS.
3.3 Alteon
shall [******] at least [***********************************************************]
in the development program of [****] for the development, discovery, regulatory
advancement, intellectual property protection (which shall not include defenses
against suits brought by third-parties against [******] for infringement
or
other similar claims) and manufacture of the Licensed Product during the
first
[********] following the execution of the this Amended and Restated Exclusive
License Agreement [****************************].
[*************************************************************************************************]
hereunder. It is the express intent of the parties that such development
program(s) either under license under this Agreement or pursuant to any
Sublicense Agreement which may be entered into pursuant hereof be for
[********************************************************************************************************************************************************************************
***********************].
[*******************************************************************************************************************]
AND the effect of any Sublicense Agreement on the royalty rates are below
[***],
then [****] shall have a [************************], not to exceed [******]
following its receipt of such reasonable [************], to enter into such
[********************************************************************************************************************************************************************************
******************************************************************************]
3.4 Milestone
Payments. Alteon
will pay OXIS the amounts set forth below upon the first occurrence of each
of
the milestone events set forth below, each such payment to be made within
[********] days after achievement of such milestone event.
[***********************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
***************************************].
********************************************************************************************************************************************
********************************************************************************************************************************************
***************************************].
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
7
(1)
[*****************] [******************].
|
[******]
|
|
(2) [**************************************] [****************].
|
[*******]
|
|
(3) [****************************************************************************].
|
[*********]
|
|
(4) [*****************************************************************************
***].
|
[*******]
|
|
(5) First [******************************
[***********************************************].
|
[*******]
|
|
(6)
First [*****************************************************************************
***************************].
|
[*******]
|
3.5
[******]
the period as set forth in 3.3 of the [**************************],
[*************************] shall
[*********************************************]. [****] has not yet been
[******************************] within the [*******] set forth in Section
3.3
relating to the [********************************] at its sole option may
make a
payment to [********] [****************************] [*********************]
start at the end of such [**************] in the following amounts:
[********************************] [***************] [*******]
[*********************] [******************************] [*******] [*******]
[************] [****************].
3.6 Royalties.
(a) Upon
the [***********************************], Alteon shall pay to OXIS an
incremental, tiered annual royalty on a country by country basis equal to
the
applicable royalty rate set forth below of [*******] as follows:
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
8
Portion
of Annual [*******] of Licensed Product Royalty
Rate
[********************************]
[**************************************]
[**************************************]
[**************************************]
(b)
Notwithstanding
the royalty rates set forth above, in the event that (X) [*******] has NOT
exercised any of its rights to [************************************] AND
(Y)
Alteon is required to make actual payments of fees or royalties to bona fide
third parties in connection with the commercialization, licensing or manufacture
of Licensed Product (“Outside Payments”), then
[*****************************************************] as follows:
(i) Subject
to clause (iii) below, with respect to Outside Payments that are not related
to
the payment of royalties (the “Non-Royalty Outside Payments”), [*****
*********************************************************************************************];
(ii) Subject
to clause (iii) below, with respect to Outside Payments that are related
to the
payment of royalties (the “Royalty Outside Payments”),
[***************
*********************************************] as follows:
*********************************************] as follows:
(X)
[*****************************************************************************************************************************
*********************************]; and
*********************************]; and
(Y)[**********************************************************************
********************************************************************************************************************
**************************************].
**************************************].
(iii) Notwithstanding
clauses (i) and (ii) above of this Section 3.6(b), in no event shall the
royalty
rates payable to OXIS under this Section 3.6 be
[***************
********].
********].
(c) As
used
in this Section 3.6 only, Net Sales shall NOT include clause (f) of the
definition of Net Sales contained in Section 1.21 hereof.
3.7 [*******]
shall have the sole and exclusive right, and its sole discretion, to
[*************************] as follows (for the avoidance of doubt, it is
hereby
understood that each of the following provisions in this Section 3.7 shall
be
construed independent of the other so that the exercise of any right under
on
subsection of this Section 3.7 shall not limit or otherwise affect another
subsection of this Section 3.7):
(a)
Upon
[***************************************************************************
***************************************************************************************************
**********************];
***************************************************************************************************
**********************];
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
9
(b)
On or
before July 1, 2009, [********************************]:
(i) [********************************************************************************************************************
**************]; or
**************]; or
(ii) [****************************************************************************
****************]
(c) On
or
before July 1, 2010,
[**************************************************
**********************************************************************************];
(d) On
or
before July 1, 2012,
[**************************************************
**********************************************************************************];
(e) [*******]************************************************************
************************************************************].
3.8 Sublicense
Fee. (a) Subject
to [*******] as hereinafter described in Section 3.8(b) below, Alteon or
its
Affiliates shall pay to OXIS an amount equal to [***********] of the Sublicense
Fee received from any Sublicensee pursuant to the Sublicense Agreement.
[**********************************************************
*************************************************************************].
*************************************************************************].
(b)
[******]
Shall have the sole and exclusive right, and its sole discretion,
[*********************************************]:
[*******************************************************************************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
****************************************************************************************************** **************************************
********************************************************************************************************************************************
**********************************************************].
********************************************************************************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
********************************************************************************************************************************************
****************************************************************************************************** **************************************
********************************************************************************************************************************************
**********************************************************].
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
10
3.9 Calculation
and Payment of Royalties and Percentage of Sublicense Fees.
(a) Notwithstanding
anything in this Agreement to the contrary, during the Royalty Term for a
given
country, the applicable royalty payable on [*******************] in such
country
shall be [*******************] of the royalty rate payable under
Section 3.6 for so long as there is a [**********] covering such Licensed
Product in such country.
[****************************************************************************************************************
*******************************************************************************************************************************************
*******************************************************************************************************************************************
*******************].
*******************************************************************************************************************************************
*******************************************************************************************************************************************
*******************].
(b) Payments
pursuant to Sections 3.4, 3.6 and 3.8 and reports for the sale of Licensed
Product shall be calculated and reported for each calendar quarter. All payments
due to OXIS pursuant
to Sections 3.4, 3.6 and 3.8 shall be paid within [*****************] of
the end
of each calendar quarter, unless otherwise specifically provided herein.
Each
such payment shall be accompanied by a report
[*********************************************************************************************
********************************************************************************************************************************************
****************], in U.S. dollars, the method used to calculate such royalty and the exchange rates used, as applicable. All payments to OXIS including those with respect to the Sublicense Fee will be paid within thirty (30) days of receipt of payments from Sublicensee.
********************************************************************************************************************************************
****************], in U.S. dollars, the method used to calculate such royalty and the exchange rates used, as applicable. All payments to OXIS including those with respect to the Sublicense Fee will be paid within thirty (30) days of receipt of payments from Sublicensee.
3.10 Tax
Withholding. Any
tax
required to be withheld by Alteon or any Affiliate or Sublicensee under the
laws
of any foreign country for the account of OXIS under this Article 3 shall
be
deducted from the applicable payment to OXIS and promptly paid by Alteon
or said
Affiliate or Sublicensee for and on behalf of OXIS to the appropriate
governmental authority (provided that, if Alteon assigns its obligations
under
this Agreement to a non-U.S. Affiliate, the amount of any withholding taxes
deducted from payments by such Affiliate to OXIS shall not exceed the amount
of
any withholding taxes that would have been deducted by Alteon had Alteon
made
such payment to OXIS), and Alteon or the Affiliate shall furnish OXIS with
proof
of payment of such tax together with official or other appropriate evidence
issued by the appropriate governmental authority sufficient to enable OXIS
to
support a claim for income tax credit in respect of any sum so withheld.
3.11 Exchange
Rate; Manner and Place of Payment. All
payments hereunder shall be payable in U.S. dollars. For payments made on
sales
of Licensed Product, with respect to each quarter, for countries other than
the
U.S., whenever conversion of payments from any foreign currency shall be
required, such conversion shall be made at a rate of exchange equal to the
rate
of exchange for the currency of the country from which payments are payable
as
published in The
Wall Street Journal, Western Edition,
on the
last business day of the calendar quarter for which a payment is due. All
payments owed under this Agreement shall be made by wire transfer to a bank
and
account designated in writing by OXIS, unless otherwise specified in writing
by
OXIS.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
11
3.12 Prohibited
Payments.
Notwithstanding any other provision of this Agreement, if Alteon is prevented
from making any such payment by virtue of the statutes, laws, codes or
governmental regulations of the country from which the payment is to be made,
then such royalty may be paid by depositing funds in the currency in which
accrued to OXIS’s account in a bank acceptable to OXIS in the country whose
currency is involved.
3.13 Records;
Audits.
Alteon
shall, and shall cause its Affiliates and Sublicensees to, keep complete
and
accurate records pertaining to the sale of Licensed Product and payment of
Sublicense Fees in sufficient detail to permit OXIS to confirm the accuracy
of
payments due hereunder. Upon written request to Alteon by OXIS, and no more
than
[*******************], OXIS shall have the right to cause an independent,
certified public accountant reasonably acceptable to Alteon to audit such
records to confirm Net Sales and royalty payments and payments with respect
to
Sublicense Fees for any calendar year ending not more than three (3) years
prior
to the date OXIS requests such audit. OXIS agrees to treat, and to cause
such
accountant to treat, all such information as confidential and not to use
or
disclose any such information for any purpose except to determine compliance
with this Agreement. For the avoidance of doubt, Alteon, its Affiliates and
Sublicensees shall not be obligated to provide OXIS or such accountant with
access to any records or information other than that which is necessary to
confirm Net Sales, royalty payments or payments with respect to Sublicense
Fees
payable under this Agreement. Such audits may be exercised during normal
business hours upon reasonable prior written notice to Alteon. If any audit
or
examination shall reveal a deficiency of any payment due, Alteon shall make
payment to OXIS of such deficiency. Payment shall be made within ten (10)
days
following announcement of the results of the audit to Alteon and OXIS. The
parties shall promptly make any adjustments necessary to reflect the results
of
such audit. OXIS shall bear the full cost of such audit unless such audit
discloses a shortfall by more than [*******************] from the actual
amount
of any payment due under this Agreement, in which case, Alteon shall bear
the
full cost of such audit.
4.
|
INTELLECTUAL
PROPERTY
|
4.1 Prosecution
and Maintenance of Licensed Patents.
Alteon
shall control, prosecute and maintain all Patents included in the Licensed
Patents. Alteon shall provide OXIS with an opportunity to review and discuss
with Alteon prosecution strategy and to consult with Alteon on the content
of
patent filings with respect to Licensed Patents. Alteon shall be responsible
for
all costs, fees and expenses incurred from and after the Effective Date in
connection with the filing, prosecution and maintenance of such Licensed
Patents. Alteon undertakes to notify OXIS in writing in a timely manner if
it
does not desire to support the continued prosecution, appeals, or maintenance
of
any of the Patents included in the Licensed Patents. In the event Alteon
declines to maintain any of the Patents included in the Licensed Patents,
OXIS
may, at its own expense, continue to prosecute or maintain such Licensed
Patent,
in which case all rights with respect to such Patents shall be transferred
to
OXIS.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
12
4.2 Enforcement
of Licensed Patents.
Each
party shall promptly notify the other in writing of any alleged or threatened
infringement of any Patent included in the Licensed Patents of which such
party
becomes aware.
(a)
With
respect to any infringement or misappropriation in the United States, Europe
or
any other territory of any Patent included in the Licensed Patents, Alteon
shall
have the sole and exclusive first right, but not the obligation, to direct,
bring and control any action or proceeding in its own name, with respect
to such
infringement or misappropriation at its own expense and by counsel of its
own
choice, and OXIS shall have the right, at its own expense, to be represented
in
any such action by counsel of its own choice. If Alteon fails to bring such
an
action or proceeding, OXIS may commence such a proceeding and the fees and
expenses associated with such proceeding shall be borne equally by OXIS and
Alteon.
(b) In
the
event Alteon brings an infringement action in accordance with this
Section 4.2,
OXIS
shall cooperate fully, including if required to bring such action, the
furnishing of a power of attorney.
[*****************************************************************************************************************
*******************************************************************************************************************************************
*******************************************************************************************************************************************
**********************************].
*******************************************************************************************************************************************
*******************************************************************************************************************************************
**********************************].
4.3 Third
Party Infringement Claims.
Each
party shall promptly notify the other in writing of any allegation by a Third
Party that the activity of either of the parties pursuant to this Agreement
infringes or may infringe the intellectual property rights of such Third
Party.
Alteon shall have the sole and exclusive right to control, direct or defend
in
its own name any defense, action, appeal of any such claim, action, proceeding,
re-examination, opposition, at its own expense and by counsel of its own
choice
without the consent of OXIS. If Alteon fails to defend any such claim against
OXIS, and the failure to so defend would have an adverse effect on any Patent
within the Licensed Patents, then OXIS shall then have the right to assume
the
defense against such claim at its own expense and by counsel of its own choice.
Neither party shall have the right to settle any patent infringement litigation
under this Section 4.3 relating to the Patents in a manner that diminishes
the rights or interests of the other party without the consent of such other
party (which shall not be unreasonably withheld). During the pendency of
any
such proceeding or any appeal thereof, any payment hereunder to OXIS shall
be
paid by Alteon into an interest-bearing escrow account pending the outcome
of
such proceeding. Upon a favorable final resolution of such proceeding or
any
appeal thereof retaining the full rights, Alteon shall resume paying OXIS
the
full royalties, and all funds in such escrow account shall be paid to OXIS.
Upon
an unfavorable final resolution of such proceeding or any appeal thereof,
the
funds in such escrow account shall be applied toward the damage award in
such
action, if any, and the balance, if any, paid to OXIS.
4.4 Cooperation
of the Parties.
Each
party agrees to cooperate fully in the preparation, filing, and prosecution
of
any Licensed Patents under this Agreement and in the obtaining and maintenance
of any patent extensions, supplementary protection certificates and the like
with respect to any Patent claiming a Licensed Product being developed or
commercialized by Alteon or Sublicensees. Such cooperation includes, but
is not
limited to, promptly informing the other party of any matters coming to such
party’s attention that may affect the preparation, filing, prosecution or
maintenance of any Patents.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
13
5.
|
Joint
Development Committee.
|
(a)
Formation
of JDC.
Alteon
and OXIS shall form a separate Joint Development Committee (“JDC”). The JDC
shall be comprised of [*****] members[********] from Alteon; and [*****]
from
OXIS.
(b)
Meetings.
Meetings of each of the JDC may be called by either Party on
[*******************] written notice to the other unless such notice is waived
by the Parties. Such committees may be convened, polled or consulted from
time
to time by means of telecommunication, video communication, or correspondence.
The JDC will meet at least [*********], at sites to be designated by the
chairpersons of such committees or through teleconference or video conference,
as agreed upon by the JDC.
(c)
Agendas.
Each
Party will disclose to the other proposed agenda items along with appropriate
Information at least [*** ****************]in advance of each meeting of
the
JDC.
(d)
Responsibilities
of the JDC.
The JDC
will oversee the Parties’ efforts for development and will oversee and
coordinate the Parties’ efforts with respect to Development. The JDC will review
and comment on the Development Plans and Development Budgets and make
non-binding recommendations as may be requested by either OXIS or Alteon
with
respect to adjustment of Development, budget and timetables and the assessment
of whether a Licensed Product shall proceed to the next stage of Development.
OXIS will update the JDC periodically, but at least [******], of all Development
activities. The JDC will review and approve, with respect to Development,
the
addition of new indications, provided, however, that it is understood that
the
JDC shall act in a separate advisory capacity only and shall not at any time
be
deemed to be a committee or subcommittee of the Board of Directors or scientific
advisory board of either OXIS or Alteon. The JDC shall not at any time be
authorized to enter into agreements for itself or on behalf of either OXIS
or
Alteon.
(e)
All
decisions by the JDC that relate to Alteon/Oxis Development shall be made
by
[*****], after an open and informed discussion of the matters as to which
decisions are being made, including, but not limited to those matters relating
to the portion of the Development Plan and Budget directed to Alteon/Oxis
Development.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
14
·
|
All
publication submissions, regulatory filings, by either company
shall be
first submitted to this committee for approval which approval shall
not be
unreasonably withheld
|
·
|
Clinical
Development Responsibilities: Alteon will be responsible for all
clinical
development, patent and regulatory filings, process
development/manufacturing scale-up, supply of product (via third
party
contractor) and costs required to obtain regulatory approval in
the U.S.
and other Regulatory filings Oxis shall take all reasonable actions
to
permit Alteon development and commercialization to advance. OXIS
shall
provide any and all cross references letters to OXIS Drug Master
Files or
other regulatory files, for Product regulatory
filings
|
6.
|
CONFIDENTIALITY
|
6.1 Confidentiality.
The
parties agree that, during the Term, and for a period of five (5) years
thereafter, each party (the “Receiving
Party”)
will
maintain in confidence, and will not use, all Confidential Information disclosed
to it by the other party (the “Disclosing
Party”)
under
this Agreement, except to the extent expressly authorized by this Agreement
or
otherwise agreed in writing by the parties. The
parties agree that the financial terms of the Agreement will be considered
Confidential Information of both parties. The
Receiving Party shall use at least the same standard of care as it uses to
protect proprietary or confidential information of its own (but at least
reasonable care) to ensure that its employees, agents, consultants and other
representatives do not disclose or make any unauthorized use of the Disclosing
Party’s Confidential Information. Each party will promptly notify the other upon
discovery of any unauthorized use or disclosure of the other party’s
Confidential Information.
Public
Disclosures.
Subject
to the further provisions of this Section, neither Party shall originate
any
written publicity, news release or public announcement, whether to the public
or
press, concerning this Agreement, including the subject matter to which it
relates, performance under it or any of its terms, or any amendment hereto
save
only such announcements that are i) approved by both parties in which such
approval shall not be unreasonable withheld; and ii) required by law (or
the
applicable rules of any securities exchange or market on which a Party’s
securities are listed or traded) to be made or that are otherwise agreed
by the
Parties or expressly permitted in this Agreement. Such announcements shall
be
factual and as brief as reasonable under the circumstances. In addition,
each
Party agrees to submit to the other Party, for review and written approval,
any
question and answer sheet or similar materials (“Q & A”) prior to using such
materials as the basis for written or oral disclosures, which written or
oral
disclosures must, in any event, be consistent in content with the information
contained in the approved Q & A. Routine references to this Agreement and
the arrangements hereunder shall be allowed in the usual course of business,
and
shall be consistent with any approved Q & A relating thereto. Once
information has been approved for disclosure as part of an approved Q & A or
publication under this Section, either Party may use such approved information
in written publicity, news releases, public announcements and other future
communications with Third Parties. If a Party decides to make an announcement
or
any filing with a governmental agency or securities exchange or market as
required by law or the applicable rules of any securities exchange or market
on
which a Party’s securities are listed or traded, it will give the other Party at
least three (3) calendar days advance notice, where possible, of the text
of the
announcement or content of the filing so that the other Party will have an
opportunity to comment upon the announcement or filing. To the extent that
the
receiving Party reasonably requests that any information in the materials
proposed to be disclosed be maintained as confidential, the disclosing Party
shall use commercially reasonable efforts to request confidential treatment
of
such information pursuant to Rule 406 of the Securities Act of 1933 or Rule
25b-2 of the Securities Exchange Act of 1934, as applicable (or any other
applicable regulation relating to the confidential treatment of information),
except to the extent that the disclosing Party receives advice from its legal
counsel that such Confidential
Information is required to be disclosed under applicable laws or
regulations.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
15
6.2 Exceptions.
The
obligations of confidentiality contained in Section 6.1
will not
apply to the extent that it can be established by the Receiving Party by
competent written evidence that such Confidential Information:
(a) was
already known to the Receiving Party, other than under an obligation of
confidentiality, at the time of disclosure by the Disclosing Party;
(b) was
generally available to the public or otherwise part of the public domain
at the
time of its disclosure to the Receiving Party;
(c) became
generally available to the public or otherwise part of the public domain
after
its disclosure and other than through any act or omission of the Receiving
Party
in breach of this Agreement;
(d) was
independently discovered or developed by the Receiving Party without the
use of
Confidential Information of the Disclosing Party; or
(e) was
disclosed to the Receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation not to disclose such
information to others.
6.3 Authorized
Disclosure.
The
Receiving Party may disclose the Confidential Information of the Disclosing
Party to the extent such disclosure is reasonably necessary in the following
instances:
(a) filing,
prosecuting or maintaining the Licensed Patents in accordance with this
Agreement;
(b) practicing
the licenses granted hereunder or preparing and submitting regulatory filings
with respect to Licensed Products;
(c) prosecuting
or defending litigation or complying with applicable court orders or
governmental laws, rules or regulations including, but not limited to,
disclosures required by the FDA or the Securities and Exchange Commission;
or
(d) disclosure
to Affiliates, Sublicensees, employees, consultants, agents or other Third
Parties who have a need to know such information for purposes of this Agreement
or in connection with due diligence or similar investigations, and disclosure
to
potential Third Party investors in confidential financing documents, provided,
in each case, that any such Affiliate, Sublicensee, employee, consultant,
agent
or Third Party is subject to obligations of confidentiality and non-use
comparable to those set forth in this Section 6.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
16
Notwithstanding
the foregoing, in the event a party is required to make a disclosure of the
other party’s Confidential Information pursuant to Section 6.3 (c),
it
will, except where impracticable, give reasonable advance notice to the other
party of such disclosure and use efforts to secure confidential treatment
of
such information at least as diligent as such party would use to protect
its own
confidential information, but in no event less than reasonable efforts. In
any
event, the parties agree to take all reasonable action to avoid disclosure
of
Confidential Information hereunder. The parties will consult with each other
on
the provisions of this Agreement to be redacted in any filings made by the
parties with the Securities and Exchange Commission or as otherwise required
by
law and on any disclosure to Third Parties.
7.
|
REPRESENTATIONS
AND WARRANTIES
|
7.1 Representations
and Warranties of OXIS.
OXIS
represents and warrants to Alteon that, except for the Prior Exclusive License
Agreement:
(a) OXIS
has
as of the Effective Date, and will have during the Term, sufficient rights
and
power to grant the licenses to Alteon which it purports to grant herein free
and
clear of any and all liens and any requirements of charges, fees, rights,
conditions or restrictions of any kind and, as of the Effective Date;
(b)
has not
and will not grant, license, convey, assign, and/or transfer to any Third
Party
any rights to Licensed Patents, Licensed Compounds, Licensed Know-How, and
Licensed Products, inconsistent with the licenses and other rights granted
hereunder;
(c) is
the
sole owner, and has the entire right, title and interest in the Licensed
Patent,
Licensed Compounds, Licensed Products, and Licensed Know-How; and such Licensed
Patents are valid, in full force, and enforceable.
(d) there
are, as of the Effective Date, and during the Term shall be, no outstanding
liens, encumbrances, agreements or understandings of any kind, requirements
of
charges, fees, rights, conditions or restrictions of any kind, either written,
oral or implied, regarding the Licensed Patents or Licensed Products to which
OXIS or its Affiliates is a party or which are binding upon OXIS its Affiliates
which are inconsistent or in conflict with any provision of this Agreement;
(e) as
of the
Effective Date, OXIS or its Affiliates has received no written claim or
accusation that the practice of the Licensed Products or the manufacture,
use or
sale of Licensed Products infringes or may infringe any Third Party patent;
(f) as
of the
Effective Date, OXIS or its Affiliates has not received a written notification
of any interference proceeding, opposition proceeding, cancellation proceeding
or other protest proceeding relating to the Licensed Patents being instituted
against OXIS or its Affiliates; and
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
17
(g) no
obligations of any kind currently exist on the part of OXIS with respect
to the
Prior Exclusive License Agreement, and OXIS has materially complied with
all
terms and conditions of the Prior Exclusive License Agreement (except in
the
case where any such obligation is already qualified by materiality in which
case
this representation shall be deemed to apply without further
qualification).
7.2 Mutual
Representations and Warranties. Each
party hereby represents and warrants to the other party that:
(a) it
is
duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder;
(b) this
Agreement is a legal and valid obligation binding upon it and enforceable
in
accordance with its terms; and
(c) the
execution, delivery and performance of this Agreement do not conflict with
any
agreement, instrument or understanding, oral or written, to which it is a
party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over
it.
7.3 Representations
and Warranties of Alteon.
Alteon
represents and warrants that:
(a) the
merger and related transactions with relating to Alteon have been completed
as
contemplated by the original Agreement of Merger (the “Merger”);
(b) Alteon
is
the successor-in-interest to HaptoGuard, Inc. with respect to the Prior
Exclusive License Agreement and the transactions contemplated
therein;
(c) no
obligations of any kind currently exist on the part of Alteon with respect
to
the Prior Exclusive License Agreement, and Alteon has materially complied
with
all terms and conditions of the Prior Exclusive License Agreement (except
in the
case where any such obligation is already qualified by materiality in which
case
this representation shall be deemed to apply without further
qualification);
(d) with
respect to the Warrant (as defined in the Prior Exclusive License Agreement),
such Warrant has been duly and validly exercised by means of a deemed “cashless”
exercise in connection with the Merger and 551,800 shares of Alteon have
been
issued to OXIS in connection with such exercise; and
(e) Alteon
has not sublicensed or entered into any agreement, commitment or understanding
to sublicense (or engage in any other similar transaction) any of Licensed
Patents, Licensed Know-How, Licensed Processes or Licensed Product either
under
this Agreement or the Prior Exclusive License Agreement.
7.4 Disclaimer.
Except
as expressly set forth herein, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS
OR
IMPLIED, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE,
NON-INFRINGEMENT, MERCHANTIBILITY, AND FITNESS FOR A PARTICULAR
PURPOSE.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
18
7.5 Performance
by Affiliates.
The
parties recognize that each may perform some or all of its obligations under
this Agreement through Affiliates and/or Sublicensees; provided,
however,
that
each party shall remain responsible and be guarantor of the performance by
its
Affiliates and/or Sublicensees and shall cause its Affiliates and/or
Sublicensees to comply with the provisions of this Agreement in connection
with
such performance, and that such performance through Affiliates and/or
Sublicensees shall not adversely affect the rights of the other
party.
8.
|
TERM;
TERMINATION
|
8.1 Term.
The term
of this Agreement will commence as of the Effective Date of this Agreement
and,
unless sooner terminated as provided hereunder, will terminate upon the
expiration of the last Royalty Term (the “Term”).
Upon
expiration of the Royalty Term in a given jurisdiction, Alteon shall continue
to
have a license on the terms described in Section 2.1,
except
that such license shall be fully paid, perpetual, irrevocable and
nonexclusive.
8.2 Termination
by Alteon.
Alteon
shall have the right to terminate this Agreement for any reason or for no
reason
upon one hundred and eighty (180) days’ written notice to OXIS. Any payment
under Section 3
made
after the date Alteon notifies OXIS of termination under this Section
8.2
shall be
the pro rata amount due for the period prior to the effective date of such
termination.
8.3 Termination
by OXIS.
In the
event that Alteon fails to timely make any payment and such failure continues
for thirty (30) days following Notice by OXIS, OXIS shall have the right
at any
time to terminate this Agreement forthwith upon written notice to Alteon.
8.4 Termination
for Cause.
Each
party shall have the right to terminate this Agreement upon thirty (30) days’
written notice to the other upon the occurrence of any of the
following:
(a) Upon
or
after bankruptcy, insolvency, dissolution or winding up or assignment for
the
benefit of creditors of the other party (other than a dissolution or winding
up
for the purpose of reconstruction or amalgamation) or a petition is filed
for
any of the foregoing and is not removed within ninety (90) days; or
(b) Upon
or
after the breach of any material provision of this Agreement by the other
party,
including, with respect to Alteon, its Affiliates, (other than as provided
in
Section 8.3)
if the
breaching party has not cured such breach within the thirty (30) day period
following written notice of termination by the non-breaching party.
8.5 Effect
of Termination; Surviving Obligations.
(a) Upon
termination of this Agreement by OXIS pursuant to Section 8.3
or by
either party pursuant to Section 8.4,
all
rights and
obligations of the parties under this Agreement shall terminate (except that
if
OXIS terminates this Agreement only as to a particular country or countries
under Section 8.4
(b) then
the rights and obligations of the parties under this Agreement shall terminate
only as to such country or countries), except as set forth in this Section
8.5.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
19
(b) Upon
termination of this Agreement by Alteon pursuant to Section 8.2
(where
Alteon has not committed a breach of this Agreement permitting termination
by
OXIS under Section 8.3
or
8.4)
all
rights to the Licensed Patents, Licensed Compounds, Licensed Know-How, Licensed
Process, and Licensed Product and the Licensed Compounds shall revert to
OXIS.
(c) Expiration
or termination of this Agreement shall not relieve the parties of any obligation
accruing prior to such expiration or termination. Except as expressly set
forth
elsewhere in this Agreement, the obligations and the rights of the parties
shall
survive expiration or termination of this Agreement.
8.6 Rights
in Bankruptcy.
All
rights and licenses granted under or pursuant to this Agreement by either
party
to the other party are, and will otherwise be deemed to be, for purposes
of
Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The parties agree that the party not subject to bankruptcy proceedings,
as
licensee of such rights under this Agreement, will retain and may fully exercise
all of its rights and elections under the U.S. Bankruptcy Code. The parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against any party under the U.S. Bankruptcy Code, the other party will
be
entitled to a complete duplicate of (or complete access to, as appropriate)
any such intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession, will be promptly delivered
to them (a) upon any such commencement of a bankruptcy proceeding upon
written request therefor by the party not subject to bankruptcy proceedings,
unless the other party elects to continue to perform all of its obligations
under this Agreement, or (b) if not delivered under (a) above, following
the rejection of this Agreement by or on behalf of either party upon written
request therefor by the other party.
8.7 Remedies.
In the
event of any breach of any provision of this Agreement, in addition to the
termination rights set forth herein, each party shall have all other rights
and
remedies at law or equity to enforce this Agreement.
9.
|
INDEMNIFICATION;
DISPUTE RESOLUTION
|
9.1 Indemnification.
(a) Alteon
hereby agrees to save, defend, indemnify and hold harmless OXIS, its directors,
officers, employees, agents and Affiliates (and its directors, officers,
employees and agents) (each, a “OXIS
Indemnitee”)
from
and against any and all losses, damages, liabilities, expenses and costs,
including reasonable legal expenses and attorneys’ fees (“Losses”),
to
which a OXIS Indemnitee may become subject as a result of any claim, demand,
action or other proceeding by any Third Party to the extent such Losses arise
out of (a) the practice by Alteon of the license granted under
Section 2.1,
or
(b) the development, manufacture, handling, storage, sale or other
disposition of any Licensed Product by Alteon and its Affiliates and
Sublicensees, except to the extent such Losses result from the willful
misconduct of any OXIS Indemnitee.
(b) OXIS
hereby agrees to save, defend, indemnify and hold harmless Alteon, its
directors, officers, employees and agents, its Affiliates (and its directors,
officers, employees and agents) and its Sublicensees (and its directors,
officers, employees and agents) (each, a “Alteon
Indemnitee”)
from
and against any and all Losses to which a Alteon Indemnitee may become subject
as a result of any claim, demand, action or other proceeding by any Third
Party
to the extent such Losses arise out of the material breach by OXIS of any
of its representations, warranties or obligations hereunder, except
to
the extent such Losses result from the willful misconduct of any Alteon
Indemnitee.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
20
(c) In
the
event a party seeks indemnification under Section 9 9.1(a)
or 9
9.1
(b), it
shall inform the other party (the “Indemnifying
Party”)
of a
claim as soon as reasonably practicable after it receives notice of the claim,
shall permit the Indemnifying Party to assume direction and control of the
defense of the claim (including the right to settle the claim solely for
monetary consideration), and shall cooperate as requested (at the expense
of the
Indemnifying Party) in the defense of the claim.
9.2 Limitation
of Liability.
EXCEPT
FOR LIABILITY FOR BREACH OF CONFIDENTIALITY OR FOR INFRINGEMENT OR
MISAPPROPRIATION, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER
PARTY ANY INDIRECT, SPECIAL, INCIDENTIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES,
INCLUDING BUT NOT LIMITED TO, LOST PROFITS, ARISING FROM OR RELATING TO ANY
BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF
SUCH
DAMAGES. IN NO EVENT SHALL ALTEON’S LIABILITY HEREIN SHALL EXCEED IN THE
AGGREGATE THE AMOUNTS ACTUALLY PAID OR PAYABLE TO OXIS UNDER THS
AGREEMENT.
9.3 Insurance.
From
and
after such time as Alteon or any of its Sublicensees first commences human
clinical trials of Licensed Product, Alteon shall, or shall cause each such
Sublicensee to, at its own expense, maintain product liability insurance
in an
amount consistent with industry standards during the Term. Such liability
insurance shall name OXIS as a named co-insured, and Alteon shall provide
to
OXIS regularly, and no less frequently than annually. Certificates evidencing
OXIS coverage as a named co-insured and specifying the limits of such coverage.
9.4 Dispute
Resolution. All
disputes arising out of or related to this Agreement, including disputes
that
may involve the parent companies, subsidiaries and Affiliates of any party
performing hereunder (“Disputes”),
shall
be resolved in accordance with this Section 9 9.4.
(a) Any
Dispute shall be settled by binding arbitration by one arbitrator selected
by
the parties, or if they cannot agree, each party shall select an arbitrator
and
the two arbitrators shall select a third arbitrator. The decision of the
arbitrator(s) shall be final and binding on the parties. The arbitration
shall
be conducted in New York, New York. The arbitral tribunal shall exert its
best
efforts to conduct the proceedings so as to issue an award within nine (9)
months of the appointment of the arbitrator(s).
(b) The
merits of any Dispute shall be decided in accordance with the law governing
this
Agreement, without application of any principle of conflict of laws. Each
party
expressly waives any right it may have to a trial by jury of any Dispute,
and
also expressly waives any right it may have to seek or to be awarded special
or
punitive damages on account of any matter that is the subject of a Dispute.
Nothing herein shall limit or restrict a party’s ability to seek injunctive or
other equitable relief in the event of a breach or anticipated breach of
Section 6.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
21
(c) The
arbitral tribunal may grant any relief appropriate under the applicable law,
but
may not include any penalty or element of punitive or exemplary damages.
The
arbitral tribunal may award the costs and expenses of the arbitration. Any
party
may seek emergency, interim or provisional relief prior to the appointment
of an
arbitrator from any court of competent jurisdiction, without prejudice to
the
agreement to arbitrate herein contained. After appointment of an arbitrator,
any
request for such relief shall be addressed to the arbitrator, who shall have
the
power to enter an interim award granting any emergency, interim or provisional
relief to which a party may be entitled under applicable law.
(d) Any
award
of money shall be in U.S. dollars. The award of the tribunal may be entered
and
enforced in any court of competent jurisdiction. A court called upon to enforce
such an award may require a party resisting enforcement to pay the reasonable
attorney fees and costs of the party seeking enforcement.
(e) Any
duty
to arbitrate under this Agreement shall remain in effect and enforceable
after
termination of this Agreement for any reason.
(f) Each
party has the right before or during the arbitration to seek and obtain from
the
appropriate court provisional remedies, such as attachment, preliminary
injunction or replevin, to avoid irreparable harm, maintain the status quo,
or
preserve the subject matter of the arbitration. This Section 9.4
shall
not apply to any dispute, controversy or claim that concerns (i) the
validity or infringement of a patent, trademark or copyright; or (ii) any
antitrust, anti-monopoly or competition law or regulation, whether or not
statutory.
10.
|
MISCELLANEOUS
PROVISIONS
|
10.1 Governing
Law.
This
Agreement shall be governed by, and construed and enforced in accordance
with,
the laws of the State of New York, excluding its conflicts of laws
principles.
10.2 Entire
Agreement; Modification. This
Agreement (including the Exhibits hereto) is both a final expression of the
parties’ agreement and a complete and exclusive statement with respect to all of
its terms, provided, however, the parties hereby acknowledge the following
with
respect to the Prior Exclusive License Agreement: (a) all fees, royalties
or
other payments contemplated by the Prior Exclusive License Agreement have
been
either paid in accordance with the Prior Exclusive License Agreement; (b)
except
with respect to clause (c) below, to the extent that any non-payment right,
obligation or liability under the Prior Exclusive License Agreement exists
and
is continuing after giving effect to this Agreement, the parties agree to
waive
such obligations with respect to each party hereto and also not to assert
such
rights against the other party hereto; (c) to the extent that any existing
right, obligations or liabilities which may be subject to Section 9 of the
Prior
Exclusive License Agreement, the parties hereto agree that such rights shall
continue and survive as contemplated by this Agreement. This Agreement
supersedes all prior and contemporaneous agreements and communications, whether
oral, written or otherwise, concerning any and all matters contained herein.
No
rights or licenses with respect to any intellectual property of either party
are
granted or deemed granted hereunder or in connection herewith, other than
those
rights expressly granted in this Agreement. No trade customs, courses of
dealing
or courses of performance by the parties shall be relevant to modify, supplement
or explain any term(s) used in this Agreement. This Agreement may not be
modified or supplemented by any purchase order, change order, acknowledgment,
order acceptance, standard terms of sale, invoice or the like. This Agreement
may only be modified or supplemented in a writing expressly stated for such
purpose and signed by the parties to this Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
22
10.3 Relationship
Between the Parties.
The
parties’ relationship, as established by this Agreement, is solely that of
independent contractors. This Agreement does not create any partnership,
joint
venture or similar business relationship between the parties. Neither party
is a
legal representative of the other party, and neither
party
can assume or create any obligation, representation, warranty or guarantee,
express or implied, on behalf of the other party for any purpose whatsoever.
10.4 Non-Waiver.
The
failure of a party to insist upon strict performance of any provision of
this
Agreement or to exercise any right arising out of this Agreement shall neither
impair that provision or right nor constitute a waiver of that provision
or
right, in whole or in part, in that instance or in any other instance. Any
waiver by a party of a particular provision or right shall be in writing,
shall
be as to a particular matter and, if applicable, for a particular period
of time
and shall be signed by such party.
10.5 Assignment.
Except
as
expressly provided hereunder, neither this Agreement nor any rights or
obligations hereunder may be assigned or otherwise transferred by either
party
without the prior written consent of the other party (which consent shall
not be
unreasonably withheld); provided,
however,
that
either party may assign this Agreement and its rights and obligations hereunder
without the other party’s consent in connection with the transfer or sale of all
or substantially all of the business of such party to which this Agreement
relates to an Affiliate or Third Party provided the successor’s financial
strength is at least as great as the assignor’s., whether by merger, sale of
stock, sale of assets or otherwise. In
the
event of such transaction, however, intellectual property rights of the
acquiring party to such transaction (if other than one of the parties to
this
Agreement), which are not specific to Licensed Compound or Licensed Product,
shall not be included in the technology licensed hereunder. The rights and
obligations of the parties under
this
Agreement shall be binding upon and inure to the benefit of the successors
and
permitted assigns of the parties. Any assignment not in accordance with this
Agreement shall be void.
10.6 No
Third Party Beneficiaries. This
Agreement is neither expressly nor impliedly made for the benefit of any
party
other than those executing it.
10.7 Severability.
If, for
any reason, any part of this Agreement is adjudicated invalid, unenforceable
or
illegal by a court of competent jurisdiction, such adjudication shall not
affect
or impair, in whole or in part, the validity, enforceability or
legality
of any remaining portions of this Agreement. All remaining portions shall
remain
in full force and effect as if the original Agreement had been executed without
the invalidated, unenforceable or illegal part.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
23
10.8 Notices.
Any
notice to be given under this Agreement must be in writing and delivered
either
in person, by any method of mail (postage prepaid) requiring return receipt,
or
by overnight courier or facsimile confirmed thereafter by any of the foregoing,
to the party to be notified at its address(es) given below, or at any address
such party has previously designated by prior written notice to the other.
Notice shall be deemed sufficiently given for all purposes upon the earlier
of:
(a) the date of actual receipt; (b) if mailed, five (5) business days
after the date of postmark; or (c) if delivered by overnight courier with
guaranteed next day delivery, the next business day the overnight courier
regularly makes deliveries.
If
to
Alteon, notices must be addressed to:
Alteon,
Inc.
000
X.
Xxxxx Xxxxxx
Xxxxx
000
Xxxxxxxx,
XX 00000
Office:
(000) 000-0000
Fax: (000)
000-0000
Attention:
Chief Executive Officer
With
copies to:
Xxxxx
Xxxxx Zedek Xxxxxx , LLP
0000
Xxxxxxxx, 00xx Xxxxx
Xxx
Xxxx,
Xxx Xxxx 00000
Attention:
Xxxx X. Xxxxx, Esq
Telephone:
x000 000 0000
Facsimile:
+ 646 878 0801
If
to
OXIS, notices must be addressed to:
OXIS
International, Inc.
000
Xxxxxxx Xxxx Xxxxx, Xxxxx X
Xxxxxx
Xxxx, XX 00000
Phone:
000-000-0000
Attention:
Chief Executive Officer
10.9 Force
Majeure.
Each
party shall be excused from liability for the failure or delay in performance
of
any obligation under this Agreement other than failure to pay when due by
reason
of any event beyond such party’s reasonable control including but not limited to
Acts of God, fire, flood, explosion, earthquake, or other natural forces,
war,
terrorism, civil unrest, accident, destruction or other casualty,
any
lack or failure of transportation facilities, any lack or failure of supply
of
raw materials, any strike or labor disturbance, or any other event beyond
reasonable control of the parties similar to those enumerated above. Such
excuse
from liability shall be effective only to the extent and duration of the
event(s) causing the failure or delay in performance and provided that the
party
has not caused such event(s) to occur. Notice of a party’s failure or delay in
performance due to force majeure must be given to the other party within
ten
(10) calendar days after its occurrence. All delivery dates under this Agreement
that have been affected by force majeure shall be tolled for the duration
of
such force majeure. In no event shall any party be required to prevent or
settle
any labor disturbance or dispute.
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
24
10.10 Legal
Fees. If
any
party to this Agreement resorts to any legal action or arbitration in connection
with this Agreement,
the
prevailing party shall be entitled to recover reasonable fees of attorneys
and
other professionals in addition to all court costs and arbitrator’s fees which
that party may incur as a result.
10.11 Headings.
The
headings contained in this Agreement have been added for convenience only
and
shall not be construed
as
limiting or used in the interpretation of this Agreement.
10.12 Counterparts.
This
Agreement may be executed in two or more counterparts, each of which shall
be
deemed an original document,
and all
of which, together with this writing, shall be deemed one
instrument.
[REMAINDER
OF THIS PAGE INTENTIONALLY LEFT BLANK]
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
25
IN
WITNESS WHEREOF,
the
parties hereto have duly executed this AMENDED
AD RESTATED EXCLUSIVE LICENSE AGREEMENT,
including the Exhibit attached hereto and incorporated herein by
reference.
OXIS INTERNATIONAL. | ALTEON, INC. | |||
By: | /s/ Xxxxxx X. Xxxxxxx, M.D. | By: | /s/ Xxxx Xxxxxxxxx, M.D., Ph.D. | |
Name:
|
Xxxxxx X. Xxxxxxx, M.D. |
Name: |
Xxxx Xxxxxxxxx, M.D., Ph.D. |
|
Title: | CEO | Title: | President and CEO |
By: | ||||
Name: |
|
|||
Title: |
|
|||
|
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.
EXHIBIT
A
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|||
Portions
of this Exhibit were omitted and have been filed separately with the
Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 24b-2 under the Securities Exchange Act of
1934.