AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.1
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT***
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.
1
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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***.
2
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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 ***. .
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;
(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.
3
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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.
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.
4
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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.
|
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.
5
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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.
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 ***.
6
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH
THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
***
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. ***.
|
***
|
***
|
|
***
|
***
|
|
***
|
***
|
|
***
|
***
|
|
***
|
***
|
|
***
|
***
|
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:
Portion
of Annual *** of Licensed Product Royalty
Rate
*** ***
*** ***
*** ***
*** ***
7
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
(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:
(X) ***;
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
***;
(b) On
or before July 1, 2009, ***:
(i) ***;
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. ***.
8
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
(b)
*** shall have the sole and exclusive right, and its sole discretion,
***:
***.
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.
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.
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.
9
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
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.
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.
10
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
(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.
|
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.
11
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
(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.
|
·
|
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
|
12
|
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.
13
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 0.
14
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
(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).
15
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.
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.
16
|
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 3made
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.
(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.
17
(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.
18
(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 0.
19
(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.
20
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.
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.
21
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.
22
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]
23
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:
|
By:
|
|||
|
Name:
|
Name:
|
|||
|
Title:
|
Title:
|
|
|
||||
|
|
By:
|
|||
|
|
Name:
|
|||
|
|
Title:
|
***CONFIDENTIAL
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT.
EXHIBIT
A
***
