NON-EXCLUSIVE CABILLY PATENT LICENSE AGREEMENT
Exhibit 10.21
NON-EXCLUSIVE
CABILLY PATENT LICENSE AGREEMENT
[Cabilly
Coexpression Patents]
This
Non-Exclusive Cabilly Patent License Agreement ("Agreement") is
effective as of November 5, 2003 ("Effective Date") by
and between Genentech, Inc., a Delaware corporation having its principal place
of business at ▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter "Genentech") and
Peregrine Pharmaceuticals, Inc., a Delaware corporation having its principal
place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
(hereinafter "Licensee").
WHEREAS:
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A.
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Genentech
owns and controls certain patent rights relating to methods and
compositions in the field of antibodies (the "Licensed
Patents", as that term is defined
below);
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B.
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Licensee
is developing, and intends to commercialize, antibody products that bind
to the antigen phosphatidylserine ("PS") and wishes to acquire a
non-exclusive license for such products under the Licensed Patents;
and
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C.
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Genentech
is willing to grant such a non-exclusive license to Licensee on he terms
and conditions set forth below.
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NOW,
THEREFORE, in consideration of the promises and the mutual covenants recited
herein, the Parties agree as follows:
Article
I
DEFINITIONS
Unless
otherwise specifically set forth herein, the following terms shall have the
following meanings:
1.01.
"Affiliate" with respect to Licensee shall mean any corporation or other entity
which, directly or indirectly, controls, is controlled by or is under common
control with, a Party. For the purpose of this Section 1.01 "control" shall mean
(i) the ownership, directly or indirectly, of at least fifty percent (50%) of
the outstanding voting securities or other ownership interest of an entity, or
(ii) the possession, directly or indirectly, of the power to manage, direct or
cause the direction of the management and policies of the corporation or other
entity or the power to elect or appoint fifty percent (50%) or more of the
members of the governing body of the corporation or other entity.
1.02.
"Bulk Product" shall mean Licensed Product supplied in a form other than
Finished Product, which can be converted into Finished Product.
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1.03.
"Calendar Quarter" shall mean each three month period commencing January 1,
April 1, July 1 and October 1 of each year during the teen of this
Agreement.
1.04.
"Chimera Patents" shall mean (i) U.S. Patent No. 4,816,567; issued March 28,
1989 from U.S. patent application serial no. (USSN) 06/483,457, and (ii) any
claims directed to chimeric antibodies or any method of making or using chimeric
antibodies, which claims are found in any patent(s) issuing from divisionals,
continuations, or continuations-in-part o f any application from which U.S.
Patent No. 4,816,567 claims priority, (iii) any claims directed to chimeric
antibodies or any method o f making or using chimeric antibodies, which claims
are found in any patents that are reissues,
reexaminations, or extensions of any of the foregoing (i) and (ii), and (iv)
foreign counterparts of any of the foregoing (i), (ii), or (iii).
1.05.
"Cost of Product" shall mean the cost of acquisition, if purchased, or the cost
of manufacture, the latter being the sum of direct production costs and
manufacturing overhead costs determined in accordance with U.S. Generally
Accepted Accounting Principles ("GAAP") for Finished Product.
1.06.
"Designee" shall mean a corporation or other entity designated by and under
written contract to Licensee to exercise the rights of Licensee hereunder in
concert with, or in place of and to the exclusion of, Licensee in all or part of
the Territory.
1.07.
"Field of Use" shall mean the diagnosis, prevention or therapy of human or
veterinary disease.
1.08.
"Finished Product" shall mean any and all Licensed Product in a form for use by
an end user and not intended for further chemical or genetic manipulation or
transformation.
1.09.
"First Commercial Sale" shall mean the first sale of any Licensed Product by
Licensee or any of its Affiliates or Designees to a non-affiliated third party.
The sale shall be deemed to occur on the earlier of (i) the date the Licensed
Product is shipped to the third party, or (ii) the date of the invoice to the
third party for the Licensed Product.
1.10.
"Licensed Patents" shall mean (i) U.S. Patent No. 6,331,415, issued December 18,
2001, (ii) any patent(s) issuing from divisionals, continuations, or
continuations-in-part of any patent application from which U.S. Patent No.
6,331,415 claims priority, and (iii) patents that are reissues, reexaminations,
extensions, or foreign counterparts of any of the foregoing (i) or (ii),
provided, however, that Licensed Patents shall not include Chimera
Patents.
1.11.
"Licensed Product" shall mean any antibody that binds specifically to PS, the
making (or having made), using, selling, offering for sale or importing of
which, but for the license granted under this Agreement, would infringe a Valid
Claim of a patent included in Licensed Patents.
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1.12.
"Net Sales" shall mean the gross invoice or contract price to third party
customers for Finished Product. Finished Product used or consumed by Licensee or
its Affiliates or Designees as part of the delivery of services to customers for
which Licensee derives compensation
shall be considered Net Sales at the gross invoice or contract price of like
Finished Product which are sold to customers. If Licensed Product is sold in
combination with one or more active ingredients, Net Sales shall be calculated
by multiplying Net Sales of the combination product by the fraction A/(A+B)
where A is the sales price of the Finished Product in the combination when sold
separately and B is the total sales price of all other active ingredients in the
combination when sold separately. If the Finished Product and the other active
ingredients are not sold separately, the percentage of the total cost of the
combination product attributed to Cost of Product shall be multiplied times the
sales price of the combination product to arrive at Net Sales. For all Licensed
Product used or consumed by others than Licensee, Licensee shall be entitled to
deduct 5% from Net Sales in lieu of all other deductions such as taxes, shipping
charges, allowances and the like prior to calculating royalties
due.
Net Sales
for Bulk Products shall be calculated by doubling the gross invoice or contract
price of Bulk Products sold to non-affiliated customers.
The
method of calculating Net Sales of materials in a form other than Finished
Product or Bulk Product that can be converted into Finished Product shall be
established by the Parties prior to the first sale or transfer of any such
material by Licensee, its Affiliates or Designees to a nonaffiliated third
party.
1.13.
"Party" shall mean either Genentech or Licensee, and when used in the plural
shall mean both Genentech and Licensee.
1.14.
"Term" is defined in Section 7.01.
1.15.
"Territory" shall mean the entire world.
1.16.
"U.S." and "United States" shall mean the United States of America, including
its territories and possessions.
1.17.
"Valid Claim" shall mean any claim of an issued and unexpired patent within the
Licensed Patents that has not been disclaimed, abandoned or dedicated to the
public or held unenforceable, unpatentable or invalid by a decision of a court
or governmental agency of competent jurisdiction, which decision is unappealable
or unappealed within the time allowed for appeal.
Article
II
GRANT
2.01.
License.
Genentech hereby grants to Licensee and Licensee hereby accepts a
nonexclusive license under Licensed Patents during the Term to make (and
have made), use, sell, offer for sale, and import Licensed Product in the
Territory in the Field of Use. Licensee shall have a limited right to grant
sublicenses as provided in Section 2.02.
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2.02.
Right to Grant
Sublicenses. Licensee shall only have the right to grant sublicenses to
its Affiliates and Designees of the rights granted hereunder to Licensee to make
(and have made), use, sell, offer for sale, and import Licensed Product, in all
or part of the Territory; provided that Licensee shall always be responsible for
the payment of royalties on Net Sales of Licensed Product by any such
sublicensee and for all other acts of such sublicensee as if such acts were
those of the Licensee. A sublicense granted under this Section 2.02 shall not be
further sublicensable or sublicensed by the licensee thereof. Licensee shall
notify Genentech in writing promptly after the grant of a sublicense hereunder
including in such notice the name and address of the sublicensee.
2.03.
No Other
License. Licensee understands and agrees that no license under any patent
or patent application other than Licensed Patents, or under any know-how, is or
shall be deemed to have been granted under this Agreement, either expressly or
by implication. By way of example only, and without limitation, no license under
Chimera Patents is granted hereunder.
Article
III
FEES,
MILESTONES AND ROYALTIES
3.01.
License Grant
Fee. Licensee shall pay to Genentech a non-creditable, nonrefundable
license grant fee of [***]
in two (2) separate payments, a first payment of [***]
within ten (10) business days after the Effective Date, a second payment of
[***]
on the day that the first human patient is dosed with Licensed Product in a
clinical trial.
3.02.
Development Milestone
Fee. Within ten (10) business days after receipt by Licensee, its
Affiliates or Designee of the first marketing approval for a Licensed Product
from the United States Food and Drug Administration or any successor agency or
authority thereto ("FDA"), Licensee shall pay to Genentech a non-creditable,
non-refundable development milestone fee of [***].
3.03.
Earned
Royalties. Licensee shall pay to Genentech a royalty (a) of [***] of the
portion of aggregate annual Net Sales of all Licensed Product that is less than
or equal to [***],
and (b) of [***] of the portion of aggregate annual Net Sales of all Licensed
Product that is greater than [***].
3.04.
Sales To or Between
Licensee, Affiliates, and Designees. It is the intent of the Parties that
Net Sales shall be based on arm's length sales transactions to non-affiliated
third parties. No royalties shall be paid upon sales of Licensed Product to or
between any of Licensee, its Affiliates and Designees for further sale;
provided, however, that in such cases royalties shall be paid upon such further
sale of Licensed Product by Licensee, its Affiliates or Designees to
non-affiliated third parties.
[***] The
following portion has been omitted pursuant to a Confidential Treatment Request
under Rule 24b-2 of the Securities Exchange Act of 1934 and has been filed
separately with the Securities and Exchange Commission.
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3.05.
No Non-Monetary
Consideration. Without the prior written consent of Genentech, Licensee,
its Affiliates and Designees shall not solicit or accept any consideration for
the sale of any Licensed Product other than as will be accurately reflected in
Net Sales.
3.06.
No Credit Against
Royalties. Licensee shall not be entitled to deduct any portion of
royalties paid to any third party from the royalties due to Genentech pursuant
to this Agreement for any reason.
Article
IV
RECORDS,
REPORTS AND PAYMENTS
4.01.
Records
Retention. Licensee shall keep and shall cause its Affiliates and
Designees to keep true, complete and accurate records of all sales of all
Licensed Product in accordance with GAAP, or the equivalent, and in sufficient
detail to permit Genentech to confirm the accuracy of Licensee's royalty
calculations. At Genentech's request and expense, Licensee shall permit not more
than once in a twelve (12) month period an independent certified public
accountant appointed by Genentech and acceptable to Licensee to examine at
Licensee's principal place of business, upon reasonable notice and at reasonable
times, such records solely to the extent necessary to verify Licensee's
calculations. Licensee shall be responsible for providing access to such records
that in the ordinary course of business are in the possession or control of its
Affiliates and Designees. Such examination shall be limited to a period of time
no more than three (3) years immediately preceding the request for examination.
The report of any such examination shall be made simultaneously to Genentech and
Licensee and shall simply report the amount, if any, by which Licensee has
overpaid or underpaid its royalties. If Licensee's royalties are found to be in
error such that royalties to Genentech were underpaid, then Licensee shall
promptly pay the deficiency plus interest pursuant to Section 4.05 to Genentech;
and if royalties to Genentech were underpaid by more than five percent (5.0%),
then Licensee shall additionally reimburse Genentech for its reasonable costs
incurred in examining such records.
4.02.
Reports. Within
sixty (60) days after the end of each Calendar Quarter following the First
Commercial Sale of Licensed Product, Licensee shall furnish to Genentech a
written report of all sales of all Licensed Product subject to royalty under
Article III during such Calendar Quarter. Such report shall include, without
limitation, (i) the determination of Net Sales as specified in Section 1.12,
setting forth the amount of gross receipts, Net Sales, and any deduction taken
from gross receipts to arrive at Net Sales, for each of Finished Product and
Bulk.
Product separately; and (ii) the royalty payment then due. Concurrently
with each report pursuant to this Section 4.02, Licensee shall make the royalty
payment then due.
4.03.
Payments.
Payments shall be in United States dollars and, unless otherwise agreed in
writing, shall be made by wire transfer of immediately available funds to such
account of Genentech in such bank as Genentech may from time to time designate
in writing. All royalty payments shall be free and clear of any taxes, duties,
levies, fees or charges, except for withholding taxes. Licensee shall pay any
withholding tax due on behalf Genentech and such withholding taxes shall be
deducted from all payments due hereunder. The Parties shall cooperate
to take advantage of the benefit of any double taxation treaty(ies) that may be
applicable.
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4.04.
Currency
Conversion. Royalties due on Net Sales of Licensed Product made in
currency other than U.S. dollars shall be expressed in the currency of the
invoice issued in connection with the sale of such Licensed Product together
with the U.S. dollar equivalent of the royalty due, calculated using the average
rate of exchange published in Reuters during the applicable Calendar
Quarter.
4.05.
Interest. All
royalty payments not made when due shall bear interest, calculated from the date
such payment was due, at the annual rate of two percent (2.0%) over the prime
rate of interest as reported in the Wall Street Journal
on the day the payment was due.
Article
V
REPRESENTATIONS,
WARRANTIES, AND DISCLAIMERS
5.01.
Genentech represents and warrants that it has the right to grant the license
granted under this Agreement.
5.02.
Nothing in this Agreement is or shall be construed as:
(i) A
warranty or representation by Genentech as to the validity or scope of any claim
or patent or patent application within the Licensed Patents;
(ii) A
warranty or representation by Genentech that anything made, used, sold, or
otherwise disposed of under any license granted in this Agreement is or will be
free from infringement of any patent rights or other intellectual property right
of any third party;
(iii) A grant
by Genentech, whether by implication, estoppel, or otherwise, of any licenses or
rights other than that expressly granted under Section 2.01; or
(iv) An
obligation to bring or prosecute actions or suits against any third party for
infringement of any of the Licensed Patents.
5.03. NO
WARRANTY IS GIVEN WITH RESPECT TO THE LICENSED PATENTS, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND THE PARTIES
SPECIFICALLY DISCLAIM ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE LICENSED PATENTS, OR
NON-INFRINGEMENT OF THE PATENT OR OTHER RIGHTS OF ANY THIRD PARTY.
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Article
VI
LIABILITY
6.01.
Indemnification.
Licensee shall indemnify, defend and hold Genentech and its directors, officers,
employees and agents harmless from and against any and all liabilities, claims,
demands, expenses (including, without limitation, attorneys and professional
fees and other costs of litigation), losses or causes of action (each, a "Liability") arising
out of or relating in any way to (i) the possession, manufacture, use, sale or
other disposition of Licensed Product hereunder, whether based on breach of
warranty, negligence, product liability or otherwise, (ii) the exercise of any
right granted to Licensee pursuant to this Agreement, or (iii) any breach of
this Agreement by Licensee, except to the extent, in each case, that such
Liability is caused by the gross negligence or willful misconduct of Genentech
as determined by a court of competent jurisdiction; provided, however, that upon
receiving notice of any such Liability, Genentech shall promptly notify Licensee
and permit Licensee to handle and control the defense (including litigation and
settlement) of such Liability, at Licensee's sole expense, and Genentech shall
reasonably cooperate with the indemnifying Party in the defense of such
Liability, at Licensee's sole expense.
Article
VII
TERM AND
TERMINATION
7.01.
Term. The term
of this Agreement will commence on the Effective Date and remain in full force
and effect until the expiration of the last patent within the Licensed Patents
(the "Term"),
unless earlier terminated in accordance with this Article VII.
7.02.
Termination without
Breach. Licensee shall have the right to terminate this Agreement upon
ninety (90) days prior written notice to Genentech.
7.03.
Termination for
Breach. Genentech shall have the right to terminate this Agreement and
the licenses granted hereunder upon written notice to Licensee for a material
breach of this Agreement if Licensee has failed to cure such breach within
thirty (30) days following written notice thereof. Licensee's failure to pay
royalties and provide reports to Genentech under this Agreement when due shall
constitute a material breach.
7.04.
Insolvency.
Genentech may terminate this Agreement if, at any time, Licensee shall file in
any court pursuant to any statute of any individual state or country, a petition
in bankruptcy, insolvency or for reorganization or for an agreement among
creditors or for the appointment of a receiver or trustee of Licensee or of its
assets, or if Licensee proposes a written agreement of composition or extension
of its debts, or if Licensee shall be served with an involuntary petition
against it filed in any insolvency proceeding, and such petition shall not be
dismissed within sixty (60) days after the filing thereof, or if Licensee shall
propose or be a party to any dissolution or liquidation, or if Licensee shall
make an assignment for the benefit of creditors. Any termination pursuant to
this Section 7.04 shall be effective immediately upon notice of such
termination.
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7.05.
Effect of
Termination. Termination of this Agreement in whole or in part for any
reason shall not relieve Licensee of its obligations to pay all fees and
royalties that shall have accrued hereunder prior to the effective date of
termination. Termination of this Agreement by or as to Licensee shall result in
the termination of the licenses granted to Licensee and to all sublicensees of
Licensee pursuant to this Agreement. The provisions of Article IV, Article V,
Article VI, Article VIII and this Section 7.05 shall survive termination of the
Agreement for any reason.
Article
VIII
MISCELLANEOUS
PROVISIONS
8.01.
Relationship of the
Parties. Nothing in this Agreement is intended or shall be deemed to
constitute or give rise to a partnership, agency, distributorship,
employer-employee, joint venture, or fiduciary relationship between the Parties.
No Party shall incur any debts or make any commitments for the
other.
8.02.
Patent Prosecution,
Maintenance and Enforcement. Genentech shall be solely responsible, at
its sole discretion and expense, for the prosecution, defense, and maintenance
of Licensed Patents, and for enforcing Licensed Patents against actual or
suspected third party infringers.
8.03.
Assignment.
Neither Party shall assign any of its rights or obligations hereunder except:
(i) as incident to the merger, consolidation, reorganization or acquisition of
stock or assets affecting substantially all of the assets or voting control of
the assigning Party; (ii) to any corporation or other entity to which it may
transfer substantially all of its assets related to the Licensed Product; (iii)
to any wholly owned subsidiary if the assigning Party remains liable and
responsible for the performance and observance of all of the subsidiary's duties
and obligations hereunder; or (iv) with the prior written consent of the other
Party (which consent shall not be unreasonably withheld); provided however, that
assignment in the context of insolvency or bankruptcy of Licensee shall require
prior written consent of Genentech. This Agreement shall be binding upon the
successors and permitted assigns of the Parties, and the name of a Party
appearing herein shall be deemed to include the names of such Party's
successor's and permitted assigns to the extent necessary to carry out the
intent of this Agreement. Any assignment not in accordance with this Section
8.03 shall be void.
8.04.
Further Acts and
Instruments. Upon request by either Party, the other Party agrees to
execute, acknowledge and deliver such further instruments, and to do all such
other acts, as may be reasonably necessary or appropriate in order to carry out
the purposes and intent of this Agreement.
8.05.
Trade Names and
Trademarks. Except as otherwise provided herein, no right, expressed or
implied, is granted by this Agreement to use in any manner the name "Genentech"
or any other trade name or trademark of Genentech in connection with the
performance of this Agreement. Except as otherwise provided herein, no right,
expressed or implied, is granted by this
Agreement to use in any manner the name "Peregrine" or any other trade name or
trademark of Licensee in connection with the performance of this
Agreement.
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8.06. Entire Agreement.
This Agreement constitutes and contains the entire understanding
and agreement of the Parties with respect to the subject matter hereof, and
cancels and supersedes any and all prior negotiations, correspondence,
understandings and agreements, whether verbal or written, between the Parties
respecting the subject matter hereof. No waiver, modification, or amendment of
any provision of this Agreement shall be valid or effective unless made in
writing and signed by a duly authorized representative of each of the
Parties.
8.07.
Severability.
In the event any one or more of the provisions of this Agreement should for any
reason be held by any court or authority having jurisdiction over this Agreement
or either of the Parties to be invalid, illegal or unenforceable, such provision
or provisions shall be validly reformed to as nearly as possible approximate the
intent of the Parties and, if unreformable, shall be divisible and deleted in
such jurisdiction; elsewhere, this Agreement shall not be affected so long as
the Parties are still able to realize the principal benefits bargained for in
this Agreement.
8.08.
Waiver. The
waiver by a Party of any breach of or default under any of the provisions of
this Agreement or the failure of a Party to enforce any of the provisions of
this Agreement or to exercise any right hereunder shall not constitute or be
construed as a waiver of any other breach or default or as a waiver of any such
rights or provisions hereunder.
8.09.
Choice of Law.
This Agreement shall be governed by and interpreted in accordance with the laws
of the State of California without regard to conflict of laws provisions. This
Agreement shall be construed as if drafted equally by the Parties, and in
construing this Agreement no presumption shall operate in either Party's favor
as a result of the role of it or its counsel in drafting or negotiating the
terms or provisions hereof.
8.10.
Notices. Any notice, request, consent, or other document required or permitted
to be given under this Agreement or otherwise relating to this Agreement shall
be in writing and shall be deemed to have been sufficiently given if delivered
in person, transmitted by facsimile (with a confirming copy sent by overnight
courier), or sent by overnight courier or registered mail to the Party to whom
it is directed at its address shown below or such other address as such Party
shall have last given by notice to the other P arty. Any such notice, requests,
delivery, approval or consent shall be deemed received on the date of hand
delivery or transmission by facsimile (provided that such date is a business
day, otherwise it shall be deemed received on the next business day), one (1)
business day after dispatch by overnight courier, or five (5) business days
after dispatch of the registered mail.
If to
Licensee addressed to:
Peregrine
Pharmaceuticals, Inc.
▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn:
President
Facsimile:
(▇▇▇) ▇▇▇-▇▇▇▇
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If to Genentech, addressed
to:
Genentech,
Inc.
▇ ▇▇▇
▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇. ▇▇ ▇▇▇▇▇
Attn:
Corporate Secretary
Facsimile:
(▇▇▇) ▇▇▇-▇▇▇▇
8.11.
Confidentiality. Each
Party shall be free to disclose the existence of this Agreement (but not its
terms) to any third party. Neither Party shall disclose any of the terms
(including, but not limited to, the financial terms) of this Agreement to any
third party without the prior written consent of the other Party; provided,
however, that each Party shall be free to disclose any of the terms of this
Agreement (i) to the extent that a Party reasonably believes it is required to
do so by securities or other applicable laws, regulations, or rules (including
the regulations or rules of any relevant stock exchange), (ii) pursuant to a
legal proceeding or order of a court or governmental agency, (iii) to actual or
prospective sublicensees, (iv) to City of Hope National Medical Center (in the
case of Genentech), (v) to its accountants, attorneys and other professional
advisors, or (vi) in connection with a financing, merger, consolidation,
acquisition or a permitted assignment of this Agreement, provided that in the
case of any disclosure under (iii), (iv), (v), or (vi) above, the recipient(s)
are obligated and do so undertake to keep such terms of this Agreement
confidential to the same extent as said Party, and provided that in the case of
disclosure under (ii), the disclosing Party will use reasonable efforts to
secure confidential treatment of such terms of this Agreement required to be
disclosed.
8.12.
Counterparts.
This Agreement may be executed simultaneously in one or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
[signature
page follows]
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IN
WITNESS WHEREOF, Genentech and Licensee have caused this Agreement to be
executed by their duly authorized representatives.
GENENTECH,
INC.
By:
/s/ ▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇▇▇▇
Title: V.P. Business
Development
Date:
6-Nov-03
PEREGRINE
PHARMACEUTICALS, INC.
By: /s/
▇▇▇▇ ▇.
▇▇▇▇▇
Title: Chief Financial
Officer
Date: Nov. 4,
2003
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