UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): April 14, 2010
PEREGRINE PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-17085
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95-3698422
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(State
of other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Company
Identification
No.)
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14282
Franklin Avenue, Tustin, California 92780
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(Address
of Principal Executive Offices)
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Registrant’s
telephone number, including area code: (714)
508-6000
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Not
Applicable
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(Former
name or former address, if changed since last
report)
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Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425).
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o
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Soliciting
material pursuant to Rule 14A-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
8.01 Other Events.
Peregrine
Pharmaceuticals, Inc. (the “Company”) is filing this Current Report on Form 8-K
solely for the purpose of filing the attached Exhibits in response to a comment
letter dated March 8, 2010, received from the staff of the Securities and
Exchange Commission (“SEC”) regarding its review of the Company’s Form 10-K for
the fiscal year ended April 30, 2009. Certain information contained
in the attached Exhibits has been redacted pursuant to the Company’s requests
for confidential treatment, which requests have been submitted to the SEC on the
date of this filing.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No.
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Description
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10.17
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Exclusive
Patent License Agreement between The University of Texas System and
Peregrine Pharmaceuticals, Inc. effective as of August 18, 2005
*
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10.18
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Amendment
No. 1 to Exclusive Patent License Agreement between The University of
Texas System and Peregrine Pharmaceuticals, Inc. dated June 1, 2009
*
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10.19
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Exclusive
Patent License Agreement between The University of Texas System and
Peregrine Pharmaceuticals, Inc. effective as of August 1, 2001
*
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10.20
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Amendment
No. 1 to Exclusive Patent License agreement between The University of
Texas System and Peregrine Pharmaceuticals, Inc. dated June 1, 2009
*
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10.21
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Non-Exclusive
Cabilly Patent License Agreement between Genentech, Inc. and Peregrine
Pharmaceuticals, Inc. effective as of November 5, 2003
*
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10.22
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Commercial
License Agreement between Avanir Pharmaceuticals, Inc. and Peregrine
Pharmaceuticals, Inc. dated December 1, 2003 *
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10.23
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License
Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc.
dated July 1, 1998 *
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10.24
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License
Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc.
dated March 1, 2005 *
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* Portions
of the attached exhibits have been redacted in connection with the Company’s
request for confidential treatment which has been submitted to the Securities
and Exchange Commission in connection with the filing of this Current
Report.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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PEREGRINE
PHARMACEUTICALS, INC.
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Date:
April 14, 2010
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By:
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/s/ Paul J. Lytle | |
| Paul J. Lytle | |||
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Chief
Financial Officer and
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Corporate
Secretary
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Exhibit
Index
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Exhibit No.
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Description
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10.17
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Exclusive
Patent License Agreement between The University of Texas System and
Peregrine Pharmaceuticals, Inc. effective as of August 18, 2005
*
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10.18
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Amendment
No. 1 to Exclusive Patent License Agreement between The University of
Texas System and Peregrine Pharmaceuticals, Inc. dated June 1, 2009
*
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10.19
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Exclusive
Patent License Agreement between The University of Texas System and
Peregrine Pharmaceuticals, Inc. effective as of August 1, 2001
*
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10.20
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Amendment
No. 1 to Exclusive Patent License agreement between The University of
Texas System and Peregrine Pharmaceuticals, Inc. dated June 1, 2009
*
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10.21
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Non-Exclusive
Cabilly Patent License Agreement between Genentech, Inc. and Peregrine
Pharmaceuticals, Inc. effective as of November 5, 2003
*
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10.22
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Commercial
License Agreement between Avanir Pharmaceuticals, Inc. and Peregrine
Pharmaceuticals, Inc. dated December 1, 2003 *
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10.23
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License
Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc.
dated July 1, 1998 *
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10.24
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License
Agreement between Lonza Biologics PLC and Peregrine Pharmaceuticals, Inc.
dated March 1, 2005 *
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* Portions
of the attached exhibits have been redacted in connection with the Company’s
request for confidential treatment which has been submitted to the Securities
and Exchange Commission in connection with the filing of this Current
Report.
EXCLUSIVE
PATENT LICENSE AGREEMENT
BETWEEN
THE
UNIVERSITY OF TEXAS SYSTEM
AND
PEREGRINE
PHARMACEUTICALS, INC.
TABLE OF
CONTENTS
| RECITALS | PAGE 1 | |
| 1. | EFFECTIVE DATE | PAGE 1 |
| 2. | DEFINITIONS | PAGE 1 |
| 3. | WARRANTY: SUPERIOR-RIGHTS | PAGE 3 |
| 4. | LICENSE | PAGE 3 |
| 5. | PAYMENTS AND REPORTS | PAGE 4 |
| 6. | TERM AND TERMINATION | PAGE 7 |
| 7. | INFRINGEMENT BY THIRD PARTIES | PAGE 8 |
| 8. | ASSIGNMENT | PAGE 8 |
| 9. | PATENT MARKING | PAGE 8 |
| 10. | INDEMNIFICATION AND INSURANCE | PAGE 9 |
| 11. | USE OF NAME | PAGE 9 |
| 12. | CONFIDENTIAL INFORMATION | PAGE 10 |
| 13. | PATENTS AND INVENTIONS | PAGE 10 |
| 14. | ALTERNATE DISPUTE RESOLUTION | PAGE 11 |
| 15. | GENERAL | PAGE 11 |
| SIGNATURES | PAGE 13 |
EXCLUSIVE PATENT LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF TEXAS SYSTEM
AND
PEREGRINE
PHARMACEUTICALS, INC.
THIS
Agreement (AGREEMENT) is between the Board of Regents (BOARD) of The University
of Texas System (SYSTEM), an agency of the State of Texas, whose address is 201
West 7th
Street, Austin, Texas 78701, on behalf of The University of Texas Southwestern
Medical Center at Dallas (UT SOUTHWESTERN), a component institution of SYSTEM,
and Peregrine Pharmaceuticals, Inc. (LICENSEE), a Delaware corporation having a
principal place of business located at 14272 Franklin Avenue, Suite 100, Tustin,
California 92780.
A. BOARD
owns certain PATENT RIGHTS (as defined below) and TECHNOLOGY RIGHTS (as defined
below) related to LICENSED SUBJECT MATTER (as defined below), which were
developed at UT SOUTHWESTERN.
B. BOARD
desires to have the LICENSED SUBJECT MATTER developed and used for the benefit
of LICENSEE, INVENTORS (as defined below), BOARD, and the public as outlined in
BOARD’S Intellectual Property Policy.
C. LICENSEE
wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
NOW, THEREFORE, in
consideration of the mutual covenants and premises herein contained, the parties
agree as follows:
1. EFFECTIVE
DATE
This
AGREEMENT is effective August 18, 2005 (EFFECTIVE DATE).
2. DEFINITIONS
As used
in this AGREEMENT, the following terms have the meanings indicated:
2.1 AFFILIATE means any business
entity more than 50% owned by LICENSEE, any business entity which owns more than
50% of LICENSEE, or any business entity that is more than 50% owned by a
business entity that owns more than 50% of LICENSEE.
2.2 FDA means United States Food
and Drug Administration.
2.3 FIELD means all human
therapeutic and diagnostic uses.
2.4 INVENTOR(S) means Philip
Thorpe, Jin He, Melina Soares, Xianming Huang and Sophia Ran.
2.5 LICENSED PRODUCT means any
product or service which is covered by or is produced using LICENSED SUBJECT
MATTER pursuant to this AGREEMENT.
Page 1
of 13
2.6 LICENSED SUBJECT MATTER means
inventions, discoveries and processes covered by PATENT RIGHTS and/or TECHNOLOGY
RIGHTS within FIELD.
2.7
NET SALES means the
gross revenues received by LICENSEE, AFFILIATE and/or any sublicensee pursuant
to Paragraph 4.3 from the SALE of LICENSED PRODUCTS less, to the extent paid by
LICENSEE, AFFILIATE and/or any sublicensee: (a) cost of freight, postage, and
freight insurance; (b) sales taxes, value added taxes, excise taxes, and customs
duties; (c) cost of export licenses and any taxes, fees or other governmental
charges imposed upon the exportation or importation of LICENSED PRODUCTS; (d)
rebates accrued, incurred or paid and any price reductions required by law,
rule, regulation or any governmental agency; (e) rejected shipments, returns,
recalls and retroactive deductions; (f) customary cash, quantity, and trade
discounts; provided, however, that with respect to the deductions specified in
subsections (a) through (f) above, an amount shall be deducted only once
regardless of how many categories may apply to it. No deductions
shall be made for commissions paid to sales persons or agents or for the cost of
collections.
In the
event that LICENSED PRODUCTS are SOLD in the form of a combination product
containing one or more active ingredients other than LICENSED PRODUCTS, NET
SALES for such combination products shall be calculated by multiplying actual
NET SALES of the combination product by the fraction A/(A+B) where A is the
invoice price of the LICENSED PRODUCT if SOLD separately and B is the total
invoice price of any other active component or components in the combination if
sold separately by LICENSEE or sublicensee; provided, however that the resulting
value of such NET SALES of combination products shall not be less than 50% of
the value of the NET SALES of the LICENSED PRODUCTS had they been SOLD
separately. If, on a country-by-country basis, the LICENSED PRODUCT
and other active component or components in the combination are not SOLD
separately in any country by LICENSEE or sublicensee, NET SALES for purposes of
determining royalties on the combination product shall be calculated by
multiplying actual NET SALES of such combination product by the fraction C/(C+D)
where C is LICENSEE’S or sublicensee’s total actual cost of the LICENSED PRODUCT
and D is the total actual cost of the other active ingredient(s) included in the
combination product at such point; provided, however that the resulting value of
such NET SALES of combination products shall not be less than 50% of the value
of the actual cost of the LICENSED PRODUCTS.
2.8 PATENT RIGHTS means BOARD’S
rights in the patent applications listed on Exhibit 1, the inventions described
and claimed therein, and all patents anywhere in the world that issue from
these, and any divisionals, continuations, continuations-in-part (but solely to
the extent not containing new matter), extensions (including supplemental
protection certificates), substitutions, registrations, confirmations,
re-examinations, renewals and any patents issuing on any of the foregoing, as
well as extensions and reissues thereof.
2.9 PHASE 1 CLINICAL STUDIES means
human clinical trials in any country that satisfy the requirements of U.S. 21
CFR 312.21(a) or its non-U.S. equivalent.
2.10
PHASE 2 CLINICAL STUDIES means
human clinical trials in any country that satisfy the requirements of U.S. 21
CFR 312.21(b) or its non-U.S. equivalent.
2.11
PHASE 3 CLINICAL STUDIES means
human clinical trials in any country that satisfies the requirements of U.S. 21
CFR 312.21(c) or its non-U.S. equivalent.
2.12
SALE, SELL or SOLD means the
transfer or disposition of a LICENSED PRODUCT for value to a party other than
LICENSEE, AFFILIATE and/or any sublicensee. SALE does not include
transfer or disposition of a LICENSED PRODUCT, at or below cost, for charitable,
promotional, pre-clinical, clinical, regulatory or governmental
purposes.
Page 2 of
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2.13 TECHNOLOGY RIGHTS means
BOARD’S rights in technical information, know-how, processes, procedures,
compositions, devices, methods, formulas, protocols, techniques, software,
designs, drawings or data created by INVENTORS at UT SOUTHWESTERN before the
EFFECTIVE DATE and relating to using antibodies as treatment for viral disease
and cancer which are not covered by PATENT RIGHTS but which are necessary for
practicing the PATENT RIGHTS (UT SOUTHWESTERN file references UTSD:0892;
UTSD:0893; UTSD:0968).
3. WARRANTY:
SUPERIOR-RIGHTS
3.1
Except for the rights, if any, of the government of the United States of America
(GOVERNMENT), as set forth below, BOARD represents and warrants (1) that it is
the owner of the entire right, title, and interest in and to LICENSED SUBJECT
MATTER, (2) that it has the sole right to grant licenses thereunder, and (3) its
belief that it has not knowingly granted licenses thereunder to any other entity
that would restrict rights granted to LICENSEE except as stated
herein.
3.2 LICENSEE
understands that the LICENSED SUBJECT MATTER may have been developed under a
funding agreement with the GOVERNMENT and, if so, that the GOVERNMENT may have
certain rights relative thereto. This AGREEMENT is explicitly made
subject to the GOVERNMENT’S rights under any agreement and any applicable law or
regulation. If there is a conflict between any agreement, applicable
law or regulation and this AGREEMENT, the terms of the GOVERNMENT agreement,
applicable law or regulation shall prevail. LICENSEE agrees that
LICENSED PRODUCTS used or SOLD in the United States will be manufactured
substantially in the United States, unless a written waiver is obtained in
advance from the GOVERNMENT.
3.3
LICENSEE understands and acknowledges that BOARD, by this AGREEMENT, makes no
representation as to the operability or fitness for any use, safety, efficacy,
approvability by regulatory authorities, time and cost of development,
patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD,
by this AGREEMENT, also makes no representation as to whether there are any
patents now held, or which will be held, by others or by BOARD which may be
dominant or subordinate to PATENT RIGHTS, nor does BOARD make any representation
that the inventions contained in PATENT RIGHTS do not infringe any other patents
now held or that will be held by others or by BOARD.
3.4 LICENSEE,
by execution hereof, acknowledges, covenants and agrees that it has not been
induced in any way by BOARD, SYSTEM, UT SOUTHWESTERN or its employees to enter
into this AGREEMENT, and further warrants and represents that (1) it has
conducted sufficient due diligence with respect to all items and issues
pertaining to this AGREEMENT; and (2) LICENSEE has adequate knowledge and
expertise, or has utilized knowledgeable and expert consultants, to adequately
conduct the due diligence, and agrees to accept all risks inherent
herein.
4. LICENSE
4.1 BOARD
hereby grants to LICENSEE a worldwide, royalty-bearing, exclusive license under
LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer
for SALE and/or SELL LICENSED PRODUCTS for use within FIELD. This
grant is subject to the payment by LICENSEE to BOARD of all consideration as
provided herein, and is further subject to rights retained by BOARD
to:
a. publish
the general scientific findings from research related to LICENSED SUBJECT MATTER
subject to the terms of Article 12, Confidential Information;
Page 3 of
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b. use
LICENSED SUBJECT MATTER for research, teaching and other educationally-related
purposes; and
c. transfer
LICENSED SUBJECT MATTER to academic or research institutions for non-commercial
research use with prior written consent from LICENSEE, which consent will not be
unreasonably withheld or delayed.
4.2 LICENSEE
may extend the license granted herein to any AFFILIATE if the AFFILIATE consents
in writing to be bound by this AGREEMENT to the same extent as
LICENSEE. LICENSEE must deliver to BOARD a true and accurate copy of
such written agreement, and any modification or termination thereof, within 30
days after execution, modification or termination.
4.3
LICENSEE may grant sublicenses consistent with this AGREEMENT if LICENSEE is
responsible for all obligations under this AGREEMENT including the payment
obligations relating to sublicensees pursuant to Article 5 as if they were those
of LICENSEE, whether or not such payments are made by the sublicensee to
LICENSEE. LICENSEE must deliver to BOARD a true and correct copy of
each sublicense granted by LICENSEE, and any modification or termination
thereof, within 30 days after execution, modification, or
termination. If this AGREEMENT is terminated, BOARD and UT
SOUTHWESTERN agree to accept as successors to LICENSEE existing sublicensees in
good standing at the date of termination, provided that the sublicensees consent
in writing to be bound by all the terms and conditions of this
AGREEMENT.
5. PAYMENTS
AND REPORTS
5.1 In
consideration of rights granted by BOARD to LICENSEE under this AGREEMENT,
LICENSEE will pay BOARD the following:
a. a
non-refundable license documentation fee in the amount of $10,000.00, due and
payable within 30 days of LICENSEE’S receipt of a fully executed AGREEMENT from
BOARD;
b. an annual
license reissue fee in the amount of [***],
due and payable on each anniversary of the EFFECTIVE DATE beginning on the first
anniversary;
c.
a running royalty equal to [***] of NET SALES;
d.
milestone fees according to the table below, due and payable within 30 days of
each milestone event for a LICENSED PRODUCT:
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Milestone
Event
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Milestone
Fee
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Initiation
of PHASE 1 CLINICAL STUDIES
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[***]
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Initiation
of PHASE 2 CLINICAL STUDIES
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[***]
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Initiation
of PHASE 3 CLINICAL STUDIES
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[***]
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Filing
of a new drug application
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[***]
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Regulatory
Approval
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[***]
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[***] 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.
Page 4 of
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For the
purpose of this Section 5.1e, “Initiation” means the date the first patient is
dosed by or on behalf of LICENSEE;
e.
if LICENSEE is required to pay royalties to a third party under patents owned by
such third party to manufacture, have manufactured, use, import, offer for SALE
and/or SELL LICENSED PRODUCTS for use within FIELD, then LICENSEE may reduce the
royalty payment owed to BOARD on the same LICENSED PRODUCT under Section 5.1c by
[***]
of the royalty paid to such third party, but in no event shall such reduction,
alone or in combination with a reduction as described in Section 5.1f, result in
a royalty of [***]
of the royalties due pursuant to Section 5.1c;
f.
if LICENSEE is required to pay royalties on a LICENSED PRODUCT under any other
license agreement between BOARD and LICENSEE covering any patents naming Philip
Thorpe as inventor and developed at UT SOUTHWESTERN before the EFFECTIVE DATE,
then LICENSEE may reduce the royalty payment owed to BOARD on the same LICENSED
PRODUCT under Section 5.1c by [***]
paid to BOARD under such other license agreement, but in no event shall such
reduction, alone or in combination with a reduction as described in Section
5.1e, result in a royalty of less than [***]
of the royalties due pursuant to Section 5.1c;
g.
all out-of-pocket expenses paid by UT SOUTHWESTERN prior to the EFFECTIVE DATE
in filing, prosecuting and maintaining PATENT RIGHTS. All future
expenses will be paid in accordance with Paragraph 13.3;
h.
a sublicense fee of [***]
of all consideration received by LICENSEE from any sublicensee pursuant
to Paragraph 4.3 above, including but not limited to, marketing, distribution,
franchise, option, annual license or license renewal fees and bonus and
milestone payments, other than development milestones, and expressly excluding
any up-front cash payments, milestones payments for development milestone
events, including, but not limited to, those listed in Section 5.1d, royalties
on NET SALES and research and development money, within 30 days of LICENSEE’S
receipt of any such consideration. In the event any such
consideration is paid to LICENSEE in the form of equity securities, the value of
such equity securities will be calculated as the average market value of the
class of stock involved for 5 consecutive days preceding the transfer to
LICENSEE, if a public market exists for same, or if no public market exists the
price of such equity securities on the date of transfer to LICENSEE as
determined by the sublicensee's board of directors. In cases where
the sublicense or assignment agreement calls for payment to LICENSEE of a
premium over the market value, BOARD will also share [***]
of the premium paid to LICENSEE. In the event a sublicense
agreement includes the type of consideration covered under this Section 5.1h for
a combination of LICENSED SUBJECT MATTER and LICENSEE’S other technologies, the
amount due will be reasonably determined by the parties based on the relative
value of LICENSED SUBJECT MATTER and LICENSEE’S additional technology;
and
i.
a sublicense fee of [***]
of any up-front cash payment, including any initial license, license issuance or
documentation fees, or [***],
whichever is less, received by LICENSEE from any sublicensee pursuant to
Paragraph 4.3 above within 30 days of LICENSEE’s receipt of any such
consideration. For the avoidance of doubt, in the event that LICENSEE
does not receive any up-front cash payment in connection with any sublicense
agreement, [***]
shall be due by LICENSEE under this Section 5.1i. In the event a
sublicense agreement includes the type of consideration covered under this
Section 5.1i for a combination of LICENSED SUBJECT MATTER and LICENSEE’S other
technologies, the amount due will be reasonably determined by the parties based
on the relative value of LICENSED SUBJECT MATTER and LICENSEE’S additional
technology.
[***] 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.
Page 5 of
13
5.2 In the
event payments to BOARD due under Article 5 are late in excess of 30 days, a
penalty equal to the lesser of 5% and the maximum rate allowed by applicable law
of the amount due will be assessed and due additionally from LICENSEE for each
such late payment, provided, however, that in the event there is a bona fide
dispute as to whether such payment is due such 30 day period shall be
tolled.
5.3 No
multiple royalties shall be payable in the event that any LICENSED PRODUCT(S) or
the manufacture, use or sale thereof is covered by more than one patent or
patent application included in the PATENT RIGHTS.
5.4
During the term of this AGREEMENT and for 1 year thereafter, LICENSEE agrees to
keep, and to require each of its sublicensees to keep, complete and accurate
records of, respectively, its and its sublicensees’ SALES and NET SALES under
the license granted in this AGREEMENT in sufficient detail to enable the
royalties payable hereunder to be determined. LICENSEE agrees to
permit an independent accounting firm selected by BOARD and approved by
LICENSEE, such approval not to be unreasonably withheld, at BOARD’s request and
expense and with 14 days written notice, to examine its books, ledgers, and
records during regular business hours, but not more than once in any 12-month
period, for the purpose of and to the extent necessary to verify any report
required under this AGREEMENT. If the amounts due to BOARD are
determined to have been underpaid by 10% or more in any given calendar quarter,
LICENSEE will pay the cost of the examination and all overdue amounts with
accrued interest at the highest allowable rate, provided that such independent
accounting firm first agrees in writing to treat all information learned in
connection with such examination as LICENSEE’s confidential information, in
accordance with Article 12 hereof.
5.5
Within 30 days after March 31, June 30, September 30, and December 31 of each
year of the valid term of this AGREEMENT, beginning immediately after the first
SALE of a LICENSED PRODUCT, LICENSEE must deliver to BOARD a true and accurate
written report, even if no payments are due BOARD, giving the particulars of the
business conducted by LICENSEE and its sublicensee(s), if any exist, during the
preceding calendar quarter under this AGREEMENT as are pertinent to calculating
payments hereunder. Such reports will be on a per-country and
per-product basis and presented substantially in the form as shown in the
attached Exhibit 2. Simultaneously with the delivery of each report,
LICENSEE must pay to BOARD the amount due, if any, for the period of each
report.
5.6
On or before January 1 of each year, irrespective of having a first SALE or
offer for SALE, LICENSEE must deliver to BOARD a written progress report as to
LICENSEE’S (and any sublicensee’s) efforts and accomplishments during the
preceding year in diligently commercializing LICENSED SUBJECT MATTER and
LICENSEE’S (and sublicensee’s) commercialization plans for the upcoming
year.
5.7 All
amounts payable under this AGREEMENT by LICENSEE must be paid in United States
dollars without deductions for taxes, assessments, fees, or charges of any kind
(except such deductions as are expressly permitted in accordance with the
definition of NET SALES). Royalties accruing on SALES in countries
other than the United States must be paid in United States dollars in amounts
based on the rate of exchange as quoted in the Wall Street Journal (“WSJ”) as of
the last business day of the reporting period. If the WSJ does not
publish any such rate, a comparable rate publication will be agreed upon from
time to time by the parties, and with respect to each country for which such
rate is not published by the WSJ or in a comparable publication, the parties
will use the prevailing rate for bank cable transfers for such date, as quoted
by leading United States banks in New York City dealing in the foreign exchange
market.
Page 6 of
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5.8 All
payments must be payable to UT SOUTHWESTERN and sent to the address listed in
Paragraph 15.2.
6. TERM
AND TERMINATION
6.1 The term
of this AGREEMENT shall commence on the EFFECTIVE DATE, and this AGREEMENT shall
continue in full force and effect, on a country-by-country, LICENSED
PRODUCT-by-LICENSED PRODUCT basis, until the later of (i) the final abandonment
of all pending patent applications within the PATENT RIGHTS, or (ii) the
expiration of the last to expire patent within the PATENT RIGHTS.
6.2
Any time after 3 years from the EFFECTIVE DATE, BOARD and UT SOUTHWESTERN have
the right to terminate this license in any national political jurisdiction if
LICENSEE, within 90 days after receiving written notice from UT SOUTHWESTERN of
the intended termination, fails to provide written evidence reasonably
satisfactory to UT SOUTHWESTERN that LICENSEE or its sublicensee(s)
has:
a. SALES in
such jurisdiction; or
b. an
effective, ongoing and active research, development, manufacturing, marketing or
sales program as appropriate, directed toward obtaining regulatory approval,
and/or production and/or SALES in any jurisdiction in accordance with LICENSEE’S
business, legal, medical and scientific judgment and LICENSEE’S normal practices
and procedures for products having similar technical and commercial
potential.
6.3 This
AGREEMENT will earlier terminate:
a. automatically
if LICENSEE becomes bankrupt and/or if the business of LICENSEE is placed in the
hands of a receiver, assignee, or trustee, whether by voluntary act of LICENSEE
or otherwise; or
b. upon 7
days written notice from BOARD if LICENSEE becomes insolvent unless, before the
end of the 7 day period, LICENSEE provides BOARD with evidence of its solvency
(for the purposes of this Section 6.3b, the term “insolvent” means substantially
unable to pay its debts when they come due continuing for a period of 60 days or
longer, and expressly excludes the failure to pay such debts for any other
reason such as a billing discrepancy or a bona fide dispute); or
c. upon 30
days written notice from BOARD if LICENSEE breaches or defaults on its
obligation to make payments (if any are due) or reports, in accordance with the
terms of Article 5 hereunder, unless, before the end of the 30 day period,
LICENSEE has cured the breach or default and so notifies BOARD, stating the
manner of the cure; or
d. upon 90
days written notice if LICENSEE breaches or defaults on any other obligation
under this AGREEMENT, unless, before the end of the 90 day period, LICENSEE has
cured the breach or default and so notifies BOARD, stating the manner of the
cure; or
Page 7 of
13
e. at any
time by mutual written agreement between LICENSEE, UT SOUTHWESTERN and BOARD and
subject to any terms herein which survive termination unless otherwise agreed by
the parties in writing; or
f. at any
time by LICENSEE upon 90 days written notice to all parties and subject to any
terms herein which survive termination; or
g. under the
provisions of Paragraph 6.2 if invoked.
6.4 Unless
otherwise agreed by the parties in writing, if this AGREEMENT is terminated for
any reason:
a. nothing
herein will be construed to release either party of any obligation matured prior
to the effective date of the termination;
b. after the
effective date of the termination, LICENSEE will provide BOARD with a written
inventory of all LICENSED PRODUCTS in process of manufacture, in use or in
stock. LICENSEE, AFFILIATE or any sublicensee may SELL any such
LICENSED PRODUCTS within the 90 day period following such termination if
LICENSEE pays earned royalties thereon, and any other amount due pursuant to the
terms of Article 5; and
c. Each
party, as applicable, will be bound by the provisions of Articles 10
(Indemnification And Insurance), 11 (Use Of Name), and 12 (Confidential
Information) of this AGREEMENT.
7. INFRINGEMENT
BY THIRD PARTIES
7.1 LICENSEE,
at its expense, may enforce PATENT RIGHTS against infringement in the FIELD by
third parties and is entitled to retain recovery from such enforcement,
provided, however, that after LICENSEE recovers it reasonable out-of-pocket
legal expenses incurred in such enforcement, any recovery for actual damages or
a reasonable royalty in lieu thereof will be considered NET SALES and subject to
royalty payments pursuant to Section 5.1c. If LICENSEE does not file
suit against a substantial infringer of PATENT RIGHTS within 6 months of
knowledge thereof and has not entered into good faith negotiations to sublicense
such infringer, and such infringement has not otherwise ceased, then BOARD may
enforce PATENT RIGHTS on behalf of itself and LICENSEE at BOARD’S sole expense,
BOARD retaining all recoveries from such enforcement and/or reducing the license
granted hereunder to non-exclusive with respect to the relevant
patent(s).
7.2 In any
infringement suit or dispute, the parties agree to cooperate fully with each
other. At the request and expense of the party bringing suit, the
other party will permit access to all relevant personnel, records, papers,
information, samples, specimens, etc., during regular business
hours.
8. ASSIGNMENT
Except in
connection with a merger, consolidation, reorganization or acquisition, or the
sale of all, or substantially all, of LICENSEE’S assets to which this AGREEMENT
relates to a third party with written notice to UT SOUTHWESTERN, LICENSEE may
not assign this AGREEMENT without the prior written consent of BOARD, which will
not be unreasonably withheld.
9. PATENT
MARKING
LICENSEE
must permanently and legibly mark all products, packaging and documentation
manufactured or SOLD by it under this AGREEMENT with a patent notice as may be
permitted or required under Title 35, United States Code.
Page 8 of
13
10. INDEMNIFICATION
AND INSURANCE
10.1
LICENSEE agrees to hold harmless and indemnify BOARD, INVENTORS, SYSTEM, UT
SOUTHWESTERN, its Regents, officers, employees and agents (collectively,
“Indemnitees”) from and against any claims, demands, or causes of action
whatsoever, relating to this AGREEMENT, brought by any third party, including
without limitation those arising on account of any injury or death of persons or
damage to property caused by, or arising out of, or resulting from, the exercise
or practice of the license granted hereunder by LICENSEE, its AFFILIATES or
their officers, employees, agents or representatives. The obligations
of LICENSEE stated in this Paragraph 10.1 shall apply only if an Indemnitee
promptly notifies LICENSEE in writing following receipt of written notice of any
claim or suit brought against Indemnitee in respect of which Indemnitee intends
to invoke the provisions of this Paragraph 10.1. Subject to the
statutory duties of the Texas Attorney General, LICENSEE shall have the right to
control the defense of any such action, including the right to select counsel to
defend an Indemnitee and LICENSEE and to settle any claim or suit with the
approval of SYSTEM and UT SOUTHWESTERN, which approval will not be unreasonably
withheld, conditioned or delayed. LICENSEE shall keep the Indemnitee
informed on a regular basis of its defense of any claims pursuant to this
Paragraph 10.1.
10.2 Beginning
at the time when any LICENSED PRODUCT is being distributed or SOLD (including
for the purpose of obtaining regulatory approvals) by LICENSEE or by a
sublicensee, LICENSEE will, at its sole cost and expense, procure and maintain
commercial general liability insurance in amounts not less than $2,000,000 per
incident and $2,000,000 annual aggregate, and LICENSEE will use reasonable
efforts to have the BOARD, SYSTEM, UT SOUTHWESTERN, its officers, employees and
agents named as additional insureds. Such commercial general
liability insurance will provide (i) product liability coverage; (ii) broad form
contractual liability coverage for LICENSEE’S indemnification under this
AGREEMENT; and (iii) coverage for litigation costs. The minimum
amounts of insurance coverage required will not be construed to create a limit
of LICENSEE’S liability with respect to its indemnification under this
AGREEMENT.
10.3 LICENSEE
will provide BOARD with written evidence of such insurance upon BOARD’S
request. LICENSEE will provide BOARD with written notice of at least
15 days prior to the cancellation, non-renewal or material change in such
insurance.
10.4 LICENSEE
will maintain such commercial general liability insurance beyond the expiration
or termination of this AGREEMENT during (i) the period that any LICENSED PRODUCT
developed pursuant to this AGREEMENT is being commercially distributed or SOLD
by LICENSEE or by a sublicensee or agent of LICENSEE; and (ii) the 5 year period
immediately after such period.
11. USE
OF NAME
LICENSEE
may not use the name of UT SOUTHWESTERN, SYSTEM, INVENTORS or BOARD without
express written consent from the respective party except as required by
governmental law, rule or regulation. Consent for UT SOUTHWESTERN,
SYSTEM and/or BOARD should be requested in writing at least 5 business days in
advance and sent to:
Roy
Bode
Vice
President for Public Affairs
UT
Southwestern Medical Center at Dallas
5323
Harry Hines Blvd.
Dallas,
Texas 75390-8588
Email: Roy.Bode@UTSouthwestern.edu
Phone: 214-648-7500
Fax: 214-648-7503
Page 9 of
13
12. CONFIDENTIAL
INFORMATION
12.1 The
parties agree that all information forwarded to one by the other for the
purposes of this AGREEMENT (1) are to be received in strict confidence, (2) are
to be used only for the purposes of this AGREEMENT, and (3) are not to be
disclosed by the recipient party, its agents or employees without the prior
written consent of the other party, except to the extent that the recipient
party can establish competent written proof that such information:
a. was in
the public domain at the time of disclosure;
b. later
became part of the public domain through no act or omission of the recipient
party, its employees, agents, successors or assigns;
c. was
lawfully disclosed to the recipient party by a third party having the right to
disclose it;
d. was
already known by the recipient party prior to disclosure by the disclosing
party;
e. was
independently developed by the recipient; or
f. is
required by law or regulation to be disclosed, provided however, that the
disclosing party shall first give the other party written notice and adequate
opportunity to object to such order for disclosure or to request confidential
treatment.
12.2 Information
shall not be deemed to be available to the public or to be in the recipient’s
possession merely because it:
a. includes
information that falls within an area of general knowledge available to the
public or to the recipient (i.e., it does not include the specific information
provided by the other party); or
b. can be
reconstructed in hindsight from a combination of information from multiple
sources that are available to the public or to the recipient, if not one of
those sources actually taught or suggested the entire combination, together with
its meaning and importance.
12.3 Each
party’s obligation of confidence hereunder shall be fulfilled by using at least
the same degree of care with the other party’s confidential information as it
uses to protect its own confidential information, but in no event less than a
reasonable degree of care. This obligation shall exist while this
AGREEMENT is in force and for a period of 3 years thereafter.
13. PATENTS
AND INVENTIONS
13.1 BOARD, UT
SOUTHWESTERN and LICENSEE will select the patent attorney, patent agent and/or
law firm responsible for searching, filing, prosecuting and maintaining patent
applications and patents for LICENSED SUBJECT MATTER, such attorney, agent
and/or law firm to be reasonably acceptable to BOARD, UT SOUTHWESTERN and
LICENSEE.
Page 10 of
13
13.2 If after
consultation, both parties agree that a patent application should be filed for
LICENSED SUBJECT MATTER, BOARD will authorize the preparation and filing of the
appropriate patent application and such application will be considered PATENT
RIGHTS. If LICENSEE does not respond or make an effort to agree with
BOARD on the disposition of rights in the subject invention, then BOARD may file
an application at its own expense and LICENSEE will have no rights to such
invention or any patent application or resulting patents.
13.3 LICENSEE
will directly pay all costs for searching, filing, prosecuting and maintaining
PATENT RIGHTS that accrue after the EFFECTIVE DATE. Unless LICENSEE
is handling such matters internally using its own employees, consultants or
agents, LICENSEE will provide UT SOUTHWESTERN with evidence of payment of such
costs within 30 days of LICENSEE’S receipt of invoices. LICENSEE will
notify UT SOUTHWESTERN if it does not intend to pay any such costs at least 90
days prior to the deadline for such payment. If LICENSEE (1) notifies
BOARD that it does not intend to pay costs associated with any patent
application and/or patent under PATENT RIGHTS; or (2) fails to pay costs in a
timely manner, then LICENSEE will have no further rights under this AGREEMENT to
such patent application and/or patent.
13.4 LICENSEE
will arrange to provide UT SOUTHWESTERN a copy of all patent applications filed
for LICENSED SUBJECT MATTER for which LICENSEE has paid the cost as well as
copies of any patent related communications, including, but not limited to,
office actions, responses and, if applicable, invoices. The parties
each have the right to review and comment upon the wording of specifications,
claims and responses to office actions prior to their submission to the
appropriate patent office.
14. ALTERNATE
DISPUTE RESOLUTION
Any
dispute or controversy arising out of or relating to this AGREEMENT, its
construction or its actual or alleged breach will be decided by
mediation. If the mediation does not result in a resolution of such
dispute or controversy, it will be finally decided by an appropriate method of
alternate dispute resolution, including without limitation, arbitration,
conducted in the city of Dallas, Texas in accordance with the Commercial
Arbitration Rules and Mediation Procedures of the American Arbitration
Association. The arbitration panel will include members knowledgeable
in the evaluation of biotechnology. Judgment upon the award rendered
may be entered in the highest court or forum having jurisdiction, state or
federal. The provisions of this Article 14 will not apply to
decisions on the validity of patent claims or to any dispute or controversy as
to which any treaty or law prohibits such arbitration. The decision
of the arbitration must be sanctioned by a court of law having jurisdiction to
be binding upon and enforceable by the parties.
15. GENERAL
15.1 This
AGREEMENT constitutes the entire and only agreement between the parties for
LICENSED SUBJECT MATTER and all other prior negotiations, representations,
agreements, and understandings are hereby superseded. No agreements
altering or supplementing these terms may be made except by a written document
signed by both parties.
15.2
Any payments required by this AGREEMENT must be payable to UT SOUTHWESTERN and
sent to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTENTION: Director
for Technology Transfer
Page 11 of
13
15.3 Any
notice required by this AGREEMENT must be given by email or facsimile
transmission confirmed by personal delivery (including delivery by reputable
courier services such as Federal Express) or by prepaid, first class, certified
mail, return receipt requested, addressed in the case of BOARD and UT
SOUTHWESTERN to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTENTION: Director
for Technology Transfer
Email: TechnologyDevelopment@UTSouthwestern.edu
Phone: (214)
648-1888
Fax: (214)
648-1889
or in the
case of LICENSEE to:
Peregrine
Pharmaceuticals, Inc.
14272
Franklin Avenue, Suite 100
Tustin,
California 92780
ATTENTION: Steven
King, Ph.D.
Email: sking@peregrineinc.com
Phone: (714)
508-6000
Fax: (714)
838-5817
or other
addresses as may be given from time to time under the terms of this notice
provision.
15.4 LICENSEE
must comply with all applicable national, state and local laws and regulations
in connection with its activities pursuant to this AGREEMENT.
15.5 This
AGREEMENT will be construed and enforced in accordance with the laws of the
United States of America and of the State of Texas. The Texas state
courts of Dallas County, Texas (or, if there is exclusive federal jurisdiction,
the United States District Court for the Northern District of Texas) shall have
exclusive jurisdiction and venue over any dispute arising out of this AGREEMENT,
and LICENSEE hereby consents to the jurisdiction of such courts.
15.6 Failure
by either party to enforce a right under this AGREEMENT will not act as a waiver
of that right or the ability to later assert that right relative to the
particular situation involved.
15.7 Headings
are included herein for convenience only and shall not be used to construe this
AGREEMENT.
15.8 If any
part of this AGREEMENT is for any reason found to be unenforceable, all other
parts nevertheless remain enforceable.
THE
REMAINDER OF THIS PAGE IS INTENTIONALLY BLANK
Page 12 of
13
15.9 Neither
party shall be held liable or responsible to the other party nor be deemed to
have defaulted under or breached this AGREEMENT for failure or delay in
fulfilling or performing any term of this AGREEMENT when such failure or delay
is caused by or results from causes beyond the reasonable control of the
affected party, including, without limitation, fire, floods, earthquakes,
natural disasters, embargoes, war, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority.
IN WITNESS WHEREOF, the
parties hereto have caused their duly authorized representatives to execute this
AGREEMENT.
|
THE
UNIVERSITY OF TEXAS SYSTEM
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By /s/ John
A.
Roan
|
By /s/
Steven W.
King
|
|
John
A. Roan
|
Steven
W. King
|
|
Executive
Vice President for Business Affairs
|
President
and CEO
|
|
UT
Southwestern Medical Center at Dallas
|
|
|
Date
9-3-05
|
Date 29 August
2005
|
|
Approved
as to Content:
|
|
By /s/ Dennis
K.
Stone
|
|
Dennis
K. Stone, M.D.
|
|
Vice
President for Technology Development
|
|
UT
Southwestern Medical Center at Dallas
|
|
Date
9/2/05
|
Page 13 of
13
EXHIBIT 1
PATENT
RIGHTS
a. U.S.
Provisional Patent Application Number 60/396,263, filed July 15, 2002, now
lapsed, entitled “Antibodies and Peptides Binding to Anionic Phospholipids and
Aminophospholipids and Their Use in Viral Inhibition & Disease Treatment”
(UT SOUTHWESTERN file reference UTSD:0892 PZ1);
b. U.S.
Patent Application Number 10/642,120, filed August 15, 2003, entitled “Methods
For Treating Viral Infections Using Antibodies To Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0892 US);
c. U.S.
Patent Application Number 10/642,060, filed August 15, 2003, entitled
“Combinations and Kits for Treating Viral Infections Using Antibodies to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-1
US);
d. U.S.
Patent Application Number 10/642,119, filed August 15, 2003, entitled “Methods
for Treating Viral Infections Using Immunoconjugates to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0892-2 US);
e. U.S.
Patent Application Number 10/642,124, filed August 15, 2003, entitled
“Compositions for Treating Viral Infections Using Immunoconjugates to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-3
US);
f. U.S.
Patent Application Number 10/642,122, filed August 15, 2003, entitled
“Combinations and Kits for Treating Viral Infections Using Immunoconjugates To
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0892-4
US);
g. Australian
Patent Application Number 2003247869, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 AU);
h. Brazilian
Patent Application Number PI0312692-7, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 BR);
i. Canadian
Patent Application Number 2,491,310, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 CA);
j. Chinese
Patent Application Number 03816751.4, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 CN);
k. European
Patent Application Number 03764600.7, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 EP);
Exhibit 1
Page 1 of 3
l. Hong Kong
Patent Application, based upon European Patent Application Number 03764600.7,
effective filing date July 15, 2003, entitled “Selected Antibodies and Duramycin
Peptides Binding to Anionic Phospholipids and Aminophospholipids and Their Use
in Treating Viral Infections and Cancer” (UT SOUTHWESTERN file reference
UTSD:0893 HK);
m. Israeli
Patent Application Number 16526, effective filing date July 15, 2003, entitled
“Selected Antibodies and Duramycin Peptides Binding to Anionic Phospholipids and
Aminophospholipids and Their Use in Treating Viral Infections and Cancer” (UT
SOUTHWESTERN file reference UTSD:0893 IL);
n. Indian
Patent Application Number 416/DELNP/2005, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 IN);
o. Japanese
Patent Application Number 2004-521771, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 JP);
p. South
Korean Patent Application Number 2005-700602, effective filing date July 15,
2003, entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 KR);
q. Mexican
Patent Application Number PA/a/2005/000652, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 MX);
r. New
Zealand Patent Application Number 537690, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 NZ);
s. Singapore
Patent Application Number 200500378-5, effective filing date July 15, 2003,
entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 SG);
t. South
African Patent Application Number 2005/0363, effective filing date July 15,
2003, entitled “Selected Antibodies and Duramycin Peptides Binding to Anionic
Phospholipids and Aminophospholipids and Their Use in Treating Viral Infections
and Cancer” (UT SOUTHWESTERN file reference UTSD:0893 ZA);
u. U.S.
Patent Application Number 10/621,269, filed July 15, 2003, entitled “Selected
Antibody Compositions For Binding To Aminophospholipids” (UT SOUTHWESTERN file
reference UTSD:0893 US);
v. U.S.
Patent Application Number 10/620,850, filed July 15, 2003, entitled “Selected
Antibody Compositions and Methods For Binding To Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-1 US);
Exhibit 1
Page 2 of 3
w. U.S.
Patent Application Number 10/642,071, filed August 15, 2003, entitled “Cancer
Treatment Methods Using Selected Antibodies to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD: 893-2 US);
x. U.S.
Patent Application Number 10/642,058, filed August 15, 2003, entitled “Combined
Cancer Treatment Methods Using Selected Antibodies to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-3 US);
y. U.S.
Patent Application Number 10/642,118, filed August 15, 2003, entitled “Selected
Antibody CDRs for Binding To Aminophospholipids” (UT SOUTHWESTERN file reference
UTSD:0893-4 US);
z. U.S.
Patent Application Number 10/642,064, filed August 15, 2003, entitled “Liposomes
Coated with Selected Antibodies That Bind to Aminophospholipids” (UT
SOUTHWESTERN file reference UTSD:0893-5 US);
aa. U.S.
Patent Application Number 10/642,116, filed August 15, 2003, entitled
“Combinations and Kits For Cancer Treatment Using Selected Antibodies to
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0893-6
US);
bb. U.S.
Patent Application Number 10/642,099, filed August 15, 2003, entitled “Selected
Immunoconjugates for Binding To Aminophospholipids” (UT SOUTHWESTERN file
reference UTSD:0893-7 US);
cc. U.S.
Patent Application Number 10/642,065, filed August 15, 2003, entitled “Cancer
Treatment Methods Using Selected Immunoconjugates For Binding To
Aminophospholipids” (UT SOUTHWESTERN file reference UTSD:0893-8
US);
dd. International
Patent Application Number PCT/US03/21925, filed July 15, 2003, entitled
“Selected Antibodies & Duramycin Peptides Binding to Anionic Phospholipids
& Aminophospholipids & Their Use in Treating Viral Infections &
Cancer” (UT SOUTHWESTERN file reference UTSD:0893 WO);
ee. U.S.
Patent Application Number 10/642,059, filed August 15, 2003, entitled
“Compositions Comprising Cell-Impermeant Duramycin Derivatives” (UT SOUTHWESTERN
file reference UTSD:0968 US);
ff. U.S.
Patent Application Number 10/642,117, filed August 15, 2003, entitled
“Anti-Viral Treatment Methods Using Phosphatidylethanolamine-Binding Peptide
Derivatives” (UT SOUTHWESTERN file reference UTSD:0968-1 US);
gg. U.S.
Patent Application Number 10/642,121, filed August 15, 2003, entitled
“Compositions Comprising Phosphatidylethanolamine-Binding Peptides Linked to
Anti-Viral Agents” (UT SOUTHWESTERN file reference UTSD:0968-2 US);
and
hh. U.S.
Patent Application Number 10/642,100, filed August 15, 2003, entitled
“Anti-Viral Treatment Methods Using Phosphatidylethanolamine-Binding Peptides
Linked to Anti-Viral Agents” (UT SOUTHWESTERN file reference UTSD:0968-3
US).
Exhibit 1
Page 3 of 3
ROYALTY
REPORT
|
Period:
|
/ /
|
through
|
/ /
|
|
Licensee:_________________________________
|
Agreement
#: L0892.Peregrine$
|
|
If
license covers several product lines, please prepare a separate report for
each product line. Then combine all product lines into a
summary report.
|
|
Report
Type:
|
o Single
Product Line Report:
|
__________________________________________________
|
|
(Product
Name)
|
||
|
o Multi-Product
Summary Report (Page 1 of __ pages)
|
||
|
Country
|
Quantity
Produced
|
Gross
Sales
($)
|
*Less
Allowances
|
Net
Sales
($)
|
Royalty
Rate
|
Conversion
Rate
(if
applicable)
|
Royalties
Due
this
period(US$)
|
|
USA
|
|||||||
|
Canada
|
|||||||
|
Japan
|
|||||||
|
Other:
|
|||||||
|
Sublicensees:
|
|||||||
|
___________
|
|||||||
|
___________
|
|
Subtotal:
|
|
|
Less
Advanced Royalty Balance (if any):
|
|
|
TOTAL
ROYALTIES DUE THIS PERIOD:
|
* Please
indicate in the following space the specific types of deductions and the
corresponding amounts used to calculate Allowances:
|
Prepared
by --
|
Name:___________________________________________
|
|
Title:____________________________________________
|
|
|
Date:____________________________________________
|
Mail
completed report and royalty payment (make checks payable to: UT
SOUTHWESTERN) to:
UT
Southwestern Medical Center at Dallas
Office
for Technology Development
5323
Harry Hines Boulevard
Dallas,
Texas 75390-9094
ATTN: Director
for Technology Development
Exhibit 2
Page 1 of 1
Exhibit 10.18
AMENDMENT
No. 1 TO EXCLUSIVE PATENT LICENSE AGREEMENT
This
Amendment No. 1 to Exclusive Patent License Agreement (AMENDMENT ONE) is made
and entered into as of June 1, 2009 by and between Peregrine Pharmaceuticals,
Inc. (LICENSEE) and the Board of Regents (BOARD) of The University of Texas
System (SYSTEM).
RECITALS
A. LICENSEE
and BOARD entered into an Exclusive Patent License Agreement effective as of
August 18, 2005 (3G4 AGREEMENT).
B. LICENSEE
and BOARD wish to amend the terms of the 3G4 AGREEMENT to revise the royalty
provisions as set forth below.
NOW, THEREFORE, it is hereby
agreed as follows:
|
1.
|
Section
5.1c of the 3G4 AGREEMENT shall be revised to read in its entirety as
follows:
|
“c. a
running royalty equal to [***]
of NET SALES, provided however, if a royalty is payable on the same LICENSED
PRODUCT under any other license agreement between BOARD and LICENSEE covering
patents naming Philip Thorpe as inventor and developed at UT SOUTHWESTERN, then
LICENSEE shall pay either (i) the royalty on NET SALES of such LICENSED PRODUCT
under this AGREEMENT, or (ii) the royalty due on such LICENSED PRODUCT under
such other agreement, whichever is higher;”
|
2.
|
Section
5.1f of the 3G4 AGREEMENT shall be deleted in its entirety and subsequent
Sections 5.1g, 5.1h, and 5.1i shall be renumbered 5.1f, 5.1g and 5.1h
respectively.
|
|
3.
|
Except
as expressly provided in this AMENDMENT ONE, all other terms, conditions
and provisions of the 3G4 AGREEMENT shall continue in full force and
effect as provided therein.
|
|
4.
|
This
AMENDMENT ONE may be executed in counterparts, each of which shall be
deemed original, and in aggregate shall constitute one and the same
instrument. Transmission by facsimile, email or other form of
electronic transmission of an executed counterpart of this AMENDMENT ONE
shall be deemed to constitute due and sufficient delivery of such
counterpart.
|
[***] 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.
Page 1 of
2
IN WITNESS WHEREOF, LICENSEE and BOARD have entered into this AMENDMENT ONE effective as of the date first set forth above.
|
BOARD
OF REGENTS OF
THE
UNIVERSITY OF TEXAS SYSTEM
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By /s/ John A.
Roan
|
By /s/ Steven W.
King
|
|
John
A. Roan
|
Steven
W. King
|
|
Executive
Vice President for Business Affairs
|
President
and CEO
|
|
UT
Southwestern Medical Center at Dallas
|
|
|
Date
7/23/09
|
Date
7-10-09
|
|
Approved
as to Content:
|
|
By /s/ Dennis K.
Stone
|
|
Dennis
K. Stone, M.D.
|
|
Vice
President for Technology Development
|
|
UT
Southwestern Medical Center at Dallas
|
|
Date
7/21/09
|
Page 2 of
2
Exhibit 10.19
EXCLUSIVE
PATENT LICENSE AGREEMENT
BETWEEN
THE UNIVERSITY OF TEXAS SYSTEM
AND
PEREGRINE
PHARMACEUTICALS, INC.
THIS
Agreement (AGREEMENT) is between the Board of Regents (BOARD) of The University
of Texas System (SYSTEM), an agency of the State of Texas, whose address is 201
West 7th Street, Austin, Texas 78701, on behalf of the University of Texas
Southwestern Medical Center at Dallas (UT SOUTHWESTERN), a component institution
of SYSTEM, and Peregrine Pharmaceuticals, Inc. (LICENSEE), a Delaware
corporation having a principal place of business located at 14272 Franklin
Avenue, Suite 100, Tustin, California 92780.
RECITALS
A. BOARD
owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED SUBJECT
MATTER, which were developed at UT SOUTHWESTERN.
B. BOARD
desires to have the LICENSED SUBJECT MATTER developed and used for the benefit
of LICENSEE, INVENTORS, BOARD, and the public as outlined in BOARD’s
Intellectual Property Policy.
C. BOARD
and LICENSEE entered into a Patent License Agreement effective October 8, 1998
(PATENT AGREEMENT) and a Coagulation Patent License Agreement effective October
8, 1998 (COAGULATION PATENT AGREEMENT).
D. LICENSEE
wishes to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
NOW, THEREFORE, in
consideration of the mutual covenants and premises herein contained, the parties
agree as follows:
1. EFFECTIVE
DATE
This
AGREEMENT is effective August 1, 2001 (EFFECTIVE DATE).
2. DEFINITIONS
As used
in this AGREEMENT, the following terms have the meanings indicated:
2.1 AFFILIATE means any business
entity more than 50% owned by LICENSEE, any business entity which owns more than
50% of LICENSEE, or any business entity that is more than 50% owned by a
business entity that owns more than 50% of LICENSEE.
2.2 FIELD means all therapeutic
and diagnostic uses.
2.3 INVENTOR(S) means Philip
Thorpe and Sophia Ran.
Page 1 of
13
2.4 LICENSED PRODUCT means any
product or service comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
2.5 LICENSED SUBJECT MATTER means
inventions, discoveries and processes covered by PATENT RIGHTS and/or TECHNOLOGY
RIGHTS within FIELD.
2.6 NET SALES means the gross
revenues received by LICENSEE, its AFFILIATES and/or sublicensees from the SALE
of LICENSED PRODUCTS less sales and/or use taxes actually paid, import and/or
export duties actually paid, outbound transportation prepaid or allowed, and
amounts allowed or credited due to returns (not to exceed the original billing
or invoice amount).
In the
event that LICENSED PRODUCTS are SOLD in the form of a combination product
containing one or more active ingredients other than LICENSED PRODUCTS, NET
SALES for such combination products shall be calculated by multiplying actual
NET SALES of the combination product by the fraction A/(A+B) where A is the
invoice price of the LICENSED PRODUCT if SOLD separately and B is the total
invoice price of any other active component or components in the combination if
SOLD separately by LICENSEE or sublicensee; provided, however that the resulting
value of such NET SALES of combination products shall not be less than 50% of
the value of the NET SALES of the LICENSED PRODUCTS had they been SOLD
separately. If, on a country-by-country basis, the LICENSED PRODUCT and other
active component or components in the combination are not SOLD separately in any
country by LICENSEE or sublicensee, NET SALES for purposes of determining
royalties on the combination product shall be calculated by multiplying actual
NET SALES of such combination product by the fraction C/(C+D) where C is
LICENSEE’s or sublicensee’s total actual cost of the LICENSED PRODUCT and D is
the total actual cost of the other active ingredient(s) included in the
combination product at such point; provided, however that the resulting value of
such NET SALES of combination products shall not be less than 50% of the value
of the actual cost of the LICENSED PRODUCTS.
2.7 PATENT RIGHTS means BOARD’s
rights in information or discoveries covered in patents, and/or patent
applications, whether domestic or foreign, and all divisionals, continuations,
continuations-in-part, reissues, reexaminations or extensions thereof, and any
letters patent that issue thereon, as defined in Exhibit 1 attached
hereto.
2.8 SALE, SELL or SOLD means the
transfer or disposition of a LICENSED PRODUCT for value to a party other than
LICENSEE.
2.9 TECHNOLOGY RIGHTS means
BOARD’s rights in technical information, know-how, processes, procedures,
compositions, devices, methods, formulas, protocols, techniques, software,
designs, drawings or data created by INVENTORS at UT SOUTHWESTERN before the
EFFECTIVE DATE relating to cancer treatment using antibodies to
aminophospholipids which are not covered by PATENT RIGHTS but which are
necessary for practicing the PATENT RIGHTS.
3. WARRANTY:
SUPERIOR-RIGHTS
3.1 Except
for the rights, if any, of the Government of the United States of America
(“Government”), as set forth below, BOARD represents and warrants its belief
that (1) it is the owner of the entire right, title, and interest in and to
LICENSED SUBJECT MATTER, (2) it has the sole right to grant licenses thereunder,
and (3) it has not knowingly granted licenses thereunder to any other entity
that would restrict rights granted to LICENSEE except as stated
herein.
Page 2 of
13
3.2 LICENSEE
understands that the LICENSED SUBJECT MATTER may have been developed under a
funding agreement with the Government and, if so, that the Government may have
certain rights relative thereto. This AGREEMENT is explicitly made subject to
the Government’s rights under any pre-existing agreement and any applicable law
or regulation. If there is a conflict between any such agreement, applicable law
or regulation and this AGREEMENT, the terms of such Government agreement,
applicable law or regulation shall prevail.
3.3 LICENSEE
understands and acknowledges that BOARD, by this AGREEMENT, makes no
representation as to the operability or fitness for any use, safety, efficacy,
approvability by regulatory authorities, time and cost of development,
patentability, and/or breadth of the LICENSED SUBJECT MATTER. BOARD,
by this AGREEMENT, also makes no representation as to whether there are any
patents now held, or which will be held, by others or by BOARD which may be
dominant or subordinate to PATENT RIGHTS, nor does BOARD make any representation
that the inventions contained in PATENT RIGHTS do not infringe any other patents
now held or that will be held by others or by BOARD.
4. LICENSE
4.1 BOARD
hereby grants to LICENSEE a worldwide, royalty-bearing, exclusive license under
LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer
for SALE, and/or SELL LICENSED PRODUCTS for use within FIELD. This
grant is subject to the payment by LICENSEE to BOARD of all consideration as
provided herein, and is further subject to rights retained by BOARD
to:
a. publish
the general scientific findings from research related to LICENSED SUBJECT MATTER
subject to the terms of Article 13, Confidential Information; and
b. use
LICENSED SUBJECT MATTER for research, teaching and other educationally-related
purposes.
4.2 LICENSEE
may extend the license granted herein to any AFFILIATE if the AFFILIATE consents
in writing to be bound by this AGREEMENT to the same extent as
LICENSEE. LICENSEE must deliver to BOARD a true and accurate copy of
such written agreement, and any modification or termination thereof, within 30
days after execution, modification or termination.
4.3 LICENSEE
may grant sublicenses consistent with this AGREEMENT if LICENSEE is responsible
for all obligations under this AGREEMENT including the payment obligations
relating to sublicensees pursuant to Article 5 as if they were those of
LICENSEE, whether or not such payments are made by the sublicensee to
LICENSEE. LICENSEE must deliver to BOARD a true and correct copy of
each sublicense granted by LICENSEE, and any modification or termination
thereof, within 30 days after execution, modification, or
termination. If this AGREEMENT is terminated, BOARD and UT
SOUTHWESTERN agree to accept as successors to LICENSEE existing sublicensees in
good standing at the date of termination, provided that the sublicensees consent
in writing to be bound by all the terms and conditions of this
AGREEMENT.
5. PAYMENTS
AND REPORTS
5.1 In
consideration of rights granted by BOARD to LICENSEE under this AGREEMENT,
LICENSEE will pay BOARD the following:
Page 3 of
13
a. a
non-refundable license documentation fee in the amount of $22,500.00 due and
payable within 30 days of LICENSEE’s receipt of a fully executed AGREEMENT from
BOARD;
b. a
minimum yearly royalty of [***]
due and payable on January 1 of each year beginning January 1, 2002 and
creditable against royalties due under 5.1c for the respective
year;
c. a
running royalty equal to [***] of NET SALES for LICENSED PRODUCTS, provided
however, if LICENSEE pays royalties on a LICENSED PRODUCT under the COAGULATION
PATENT AGREEMENT or the PATENT AGREEMENT, such royalties are creditable toward
royalties due on the same LICENSED PRODUCT pursuant to this Section 5.1c, up to
a total credit of [***] of NET SALES for LICENSED PRODUCTS;
d. milestone
fees according to the table below, due and payable within 30 days of each
milestone event for a LICENSED PRODUCT:
|
Milestone
Event
|
Milestone
Fee
|
||
|
Initiation
of Phase I clinical trials
|
[***]
|
||
|
Initiation
of Phase II clinical trials
|
[***]
|
||
|
Initiation
of Phase III clinical trials
|
[***]
|
||
|
Filing
of a new drug application
|
[***]
|
||
|
Regulatory
Approval
|
[***]
|
For the
purpose of this Section, “Initiation” means the date the first patient is dosed
by or on behalf of LICENSEE;
e. a
sublicense fee of [***]
of all consideration, other than up-front cash payments, research and
development money, milestones payments for development milestone events,
including, but not limited to, those listed in Section 5.1d, and royalties on
NET SALES, received by LICENSEE from either (1) any sublicensee pursuant to
Section 4.3 herein above, or (2) any assignee pursuant to Article 9 hereinbelow,
including but not limited to, marketing, distribution, franchise, option,
license, or documentation fees, bonus and milestone payments other than
development milestones, and the value of any equity securities received by
LICENSEE less any amounts paid by LICENSEE for same, within 30 days of
LICENSEE’s receipt of any such consideration. The value of any equity securities
will be calculated as the average market value of the class of stock involved
for 5 consecutive days preceding the transfer to LICENSEE. In cases
where the sublicense agreement calls for payment to LICENSEE of a premium over
the market value, BOARD will also share [***]
of the premium paid to LICENSEE; and
f. a
sublicense fee of [***]
of any up-front cash payment or [***],
whichever is less, received by LICENSEE from either (1) any sublicensee pursuant
to Section 4.3 herein above, or (2) any assignee pursuant to Article 9
hereinbelow within 30 days of LICENSEE’s receipt of any such
consideration.
5.2 In
the event payments to BOARD due under Article 5 are late in excess of 30 days, a
penalty of 5% of the amount due will be assessed and due additionally from
LICENSEE for each such late payment.
[***] 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.
Page 4 of
13
5.3 During
the term of this AGREEMENT and for 1 year thereafter, LICENSEE agrees to keep,
and to require each of its sublicensees to keep, complete and accurate records
of, respectively, its and its sublicensees’ SALES and NET SALES under the
license granted in this AGREEMENT in sufficient detail to enable the royalties
payable hereunder to be determined. LICENSEE agrees to permit an
independent accounting firm selected by BOARD and approved by LICENSEE, such
approval not to be unreasonably withheld, at BOARD’s request and expense and
with 14 days written notice, to examine its books, ledgers, and records during
regular business hours, but not more than once in any calendar year, for the
purpose of and to the extent necessary to verify any report required under this
AGREEMENT. If the amounts due to BOARD are determined to have been
underpaid by 10% or more, LICENSEE will pay the cost of the examination and all
overdue amounts with accrued interest at the highest allowable rate, provided
that such independent accounting firm first agrees in writing to treat all
information learned in connection with such examination as LICENSEE’s
confidential information, in accordance with Article 13 hereof.
5.4 Within
30 days after March 31, June 30, September 30, and December 31, beginning
immediately after the first SALE of a LICENSED PRODUCT, LICENSEE must deliver to
BOARD a true and accurate written report, even if no payments are due BOARD,
giving the particulars of the business conducted by LICENSEE and its
sublicensee(s), if any exist, during the preceding 3 calendar months under this
AGREEMENT as are pertinent to calculating payments hereunder. This report will
include at least:
|
a.
|
the
total quantities of LICENSED PRODUCTS produced;
and
|
|
b.
|
the
total SALES by country, product, quantity and extended dollars SOLD, and
the conversion factor used to convert to United States dollars;
and
|
|
c.
|
the
calculation of royalties thereon;
and
|
|
d.
|
the
total royalties computed and due BOARD;
and
|
|
e.
|
all
other amount due BOARD herein.
|
Simultaneously
with the delivery of each report, LICENSEE must pay to BOARD the amount, if any,
due for the period of each report.
5.5 On
or before January 1 of each year, irrespective of having a first SALE or offer
for SALE, LICENSEE must deliver to BOARD a written progress report as to
LICENSEE’s (and any sublicensee’s) efforts and accomplishments during the
preceding year in using reasonable diligence to commercialize (as defined in
Section 7.2) LICENSED SUBJECT MATTER and LICENSEE’s (and sublicensee’s)
commercialization plans for the upcoming year.
5.6 All
amounts payable here by LICENSEE must be paid in United States dollars without
deductions for taxes, assessments, fees, or charges of any kind. Royalties
accruing on SALES in countries other than the United States must be paid in
United States dollars in amounts based on the rate of exchange as quoted in the
Wall Street Journal (WSJ) as of the last business day of the reporting
period. If the WSJ does not publish any such rate, a comparable rate
publication will be agreed upon from time to time by the parties, and with
respect to each country for which such rate is not published by the WSJ or in a
comparable publication, the parties will use the prevailing rate for bank cable
transfers for such date, as quoted by leading United States banks in New York
City dealing in the foreign exchange market. Checks must be payable
to UT SOUTHWESTERN and sent to:
|
|
UT
Southwestern Medical Center at
Dallas
|
|
|
Office
for Technology Development
|
|
|
5323
Harry Hines Boulevard
|
|
|
Dallas,
Texas 75390-9094
|
|
|
ATTN: Director
for Technology Development
|
Page 5 of
13
6. SPONSORED RESEARCH
If
LICENSEE desires to sponsor research for or related to the LICENSED SUBJECT
MATTER, and particularly when LICENSEE receives payments for sponsored research
pursuant to a sublicense agreement under this AGREEMENT, LICENSEE will in good
faith consider funding the research at UT SOUTHWESTERN.
7. TERM
AND TERMINATION
7.1 The
term of this AGREEMENT is from the EFFECTIVE DATE to the full end of the term or
terms for which PATENT RIGHTS have not expired or, if only TECHNOLOGY RIGHTS are
licensed and no PATENT RIGHTS are applicable, for a period of 20
years.
7.2 Any
time after 2 years from the EFFECTIVE DATE, BOARD and UT SOUTHWESTERN have the
right to terminate this license in any national political jurisdiction if
LICENSEE, within 90 days after receiving written notice from UT SOUTHWESTERN of
the intended termination, fails to provide written evidence satisfactory to UT
SOUTHWESTERN that LICENSEE or its sublicensee(s) has used reasonable diligence
to commercialize or is using reasonable diligence in actively attempting to
commercialize a licensed invention in such jurisdiction(s). The following
definitions apply to Article 7: (1) “commercialize” means having SALES of
LICENSED PRODUCTS in such jurisdiction; (2) “attempting to commercialize” means
having SALES of LICENSED PRODUCTS or an effective, ongoing and active research,
development, manufacturing, marketing or sales program as appropriate, directed
toward obtaining regulatory approval, and/or production and/or SALES of LICENSED
PRODUCTS in any jurisdiction in accordance with LICENSEE’s business, legal,
medical and scientific judgment and LICENSEE’s normal practices and procedures
for products having similar technical and commercial potential; and (3)
“reasonable diligence” means diligence that is, in LICENSEE’s good faith
judgment, commercially and scientifically reasonable with respect to the
relevant geographical region(s) and LICENSED PRODUCT(s), it being expressly
understood and agreed that it shall not constitute a failure of reasonable
diligence if LICENSEE does not attempt to commercialize, does not commercialize,
or ceases efforts to do so, in any region and with respect to any LICENSED
PRODUCT where such commercialization would require a license of rights from a
third party, which rights LICENSEE is unable to secure on commercially
reasonable terms after having made a good faith effort to do so.
7.3 This
AGREEMENT will earlier terminate:
|
a.
|
automatically
if LICENSEE becomes bankrupt or insolvent and/or if the business of
LICENSEE is placed in the hands of a receiver, assignee, or trustee,
whether by voluntary act of LICENSEE or otherwise;
or
|
|
b.
|
upon
30 days written notice from BOARD if LICENSEE breaches or defaults on its
obligation to make payments (if any are due) or reports, in accordance
with the terms of Article 5 hereunder, unless, before the end of the 30
day period, LICENSEE has cured the breach or default and so notifies
BOARD, stating the manner of the cure;
or
|
Page 6 of
13
|
c.
|
upon
90 days written notice if LICENSEE breaches or defaults on any other
material obligation under this AGREEMENT, unless, before the end of the 90
day period, LICENSEE has cured the breach or default and so notifies
BOARD, stating the manner of the cure;
or
|
|
d.
|
at
any time by mutual written agreement between LICENSEE, UT SOUTHWESTERN and
BOARD, upon 30 days written notice to all parties and subject to any terms
herein which survive termination;
or
|
|
e.
|
under
the provisions of Section 7.2 if invoked;
or
|
|
f
|
at
any time by LICENSEE upon 30 days written notice to all parties and
subject to any terms herein which survive
termination.
|
7.4 If
this AGREEMENT is terminated for any cause:
|
a.
|
nothing
herein will be construed to release either party of any obligation matured
prior to the effective date of the
termination;
|
|
b.
|
after
the effective date of the termination, LICENSEE will provide BOARD with a
written inventory of all LICENSED PRODUCTS in process of manufacture, in
use or in stock. LICENSEE may SELL any such LICENSED PRODUCTS
within the 90 day period following such termination if it pays earned
royalties thereon, and any other amount due pursuant to the terms of
Article 5; and
|
|
c.
|
LICENSEE
will be bound by the provisions of Articles 11 (Indemnification), 12 (Use
of Name), and 13 (Confidential Information) of this
AGREEMENT.
|
8. INFRINGEMENT
BY THIRD PARTIES
8.1 LICENSEE,
at its expense, may enforce any patent exclusively licensed hereunder against
infringement by third parties and it is entitled to retain recovery from such
enforcement. After LICENSEE recovers it reasonable out-of-pocket
legal expenses incurred in such enforcement LICENSEE must pay BOARD royalties
due under Article 5 on any monetary recovery if the monetary recovery is for
damages or a reasonable royalty in lieu thereof. If LICENSEE does not
file suit against a substantial infringer of a patent within 6 months of
knowledge thereof and has not entered into good faith negotiations to sublicense
such infringer, and such infringement has not otherwise ceased, then BOARD may
enforce any patent licensed hereunder on behalf of itself and LICENSEE at
BOARD’s sole expense, BOARD retaining all recoveries from such enforcement
and/or reducing the license granted hereunder to non-exclusive with respect to
the relevant patent(s).
8.2 In
any infringement suit or dispute, the parties agree to cooperate fully with each
other. At the request and expense of the party bringing suit, the
other party will permit access to all relevant personnel, records, papers,
information, samples, specimens, etc., during regular business
hours.
Page 7 of
13
9. ASSIGNMENT
Except in
connection with a merger, consolidation, reorganization or acquisition, or the
sale of all of substantially all of LICENSEE’s assets to which this AGREEMENT
relates to a third party, this AGREEMENT may not be assigned by LICENSEE without
the prior written consent of BOARD, which will not be unreasonably
withheld.
10. PATENT
MARKING
LICENSEE
must permanently and legibly mark all products, packaging and documentation
manufactured or SOLD by it under this AGREEMENT with a patent notice as may be
permitted or required under Title 35, United States Code.
11. INDEMNIFICATION
LICENSEE
agrees to hold harmless and indemnify BOARD, INVENTORS, SYSTEM, UT SOUTHWESTERN,
its Regents, officers, employees and agents (collectively, “Indemnitees”) from
and against any claims, demands, or causes of action whatsoever, including
without limitation those arising on account of any injury or death of persons or
damage to property caused by, or arising out of, or resulting from, the exercise
or practice of the license granted hereunder by LICENSEE, its AFFILIATES or
their officers, employees, agents or representatives, except to the extent that
such claims, demands, or causes of action are caused by, or arise out of, or
result from, the negligence or intentional misconduct of an
Indemnitee. The obligations of LICENSEE stated in this Article 11
shall apply only if an Indemnitee notifies LICENSEE in writing following receipt
of written notice of any claim or suit brought against Indemnitee in respect of
which Indemnitee intends to invoke the provisions of this Article
11. Subject to the statutory duties of the Texas Attorney General,
LICENSEE shall have the right to control the defense of any such action,
including the right to select counsel to defend an Indemnitee and LICENSEE, and
to settle any claim. LICENSEE shall keep the Indemnitee informed on a
current basis of its defense of any claims pursuant to this Article
11.
12. USE
OF NAME
LICENSEE
may not use the name of UT SOUTHWESTERN, SYSTEM, INVENTORS or BOARD without
express written consent from UT SOUTHWESTERN and/or SYSTEM.
13. CONFIDENTIAL
INFORMATION
13.1 BOARD
and LICENSEE each agree that all information forwarded to one by the other for
the purposes of this AGREEMENT (1) are to be received in strict confidence, (2)
are to be used only for the purposes of this AGREEMENT, and (3) are not to be
disclosed by the recipient party, its agents or employees without the prior
written consent of the other party, except to the extent that the recipient
party can establish competent written proof that such information:
|
a.
|
was
in the public domain at the time of
disclosure;
|
|
b.
|
later
became part of the public domain through no act or omission of the
recipient party, its employees, agents, successors or
assigns;
|
|
c.
|
was
lawfully disclosed to the recipient party by a third party having the
right to disclose it;
|
Page 8 of
13
|
d.
|
was
already known by the recipient party at the time of
disclosure;
|
|
e.
|
was
independently developed by the recipient;
or
|
|
f.
|
is
required by law or regulation to be disclosed, provided however, that the
disclosing party shall first give the other party written notice and
adequate opportunity to object to such order for disclosure or to request
confidential treatment.
|
13.2 Information
shall not be deemed to be available to the public or to be in the recipient’s
possession merely because it:
|
a.
|
includes
information that falls within an area of general knowledge available to
the public or to the recipient (i.e., it does not include the specific
information provided by the other party);
or
|
|
b.
|
can
be reconstructed in hindsight from a combination of information from
multiple sources that are available to the public or to the recipient, if
not one of those sources actually taught or suggested the entire
combination, together with its meaning and
importance.
|
13.3 Each
party’s obligation of confidence hereunder shall be fulfilled by using at least
the same degree of care with the other party’s confidential information as it
uses to protect its own confidential information. This obligation
shall exist while this AGREEMENT is in force and for a period of 3 years
thereafter.
14. PATENTS
AND INVENTIONS
LICENSEE,
with the written approval of UT SOUTHWESTERN, such approval will not be
unreasonably withheld, shall have the right, but not the obligation, to
designate patent counsel to prepare, file, prosecute and maintain all patent
applications and patents included in PATENT RIGHTS. If LICENSEE
declines to designate patent counsel, UT SOUTHWESTERN will designate patent
counsel to prepare, file, prosecute and maintain all patent applications and
patents included in PATENT RIGHTS. LICENSEE will be responsible for
all costs related to searching, filing, prosecuting and maintaining all patent
applications and patents included in PATENT RIGHTS and will directly pay
designated patent counsel for all such costs. If, after consultation,
both parties agree that additional patent applications should be filed for
PATENT RIGHTS, LICENSEE will direct approved patent counsel to prepare and file
the appropriate applications and such applications will be included in PATENT
RIGHTS (the parties agree to timely amend Exhibit 1 in writing when new matter
is added under PATENT RIGHTS). If LICENSEE does not intend to pay
patent costs for PATENT RIGHTS, LICENSEE will notify UT SOUTHWESTERN at least 90
days prior to the deadline for such payment. If LICENSEE notifies UT
SOUTHWESTERN that it does not intend to pay such costs, or if LICENSEE does not
respond or make an effort to reach agreement on the disposition of rights in the
subject invention, then UT SOUTHWESTERN may pay such costs or file such
application at its own expense and LICENSEE will have no further rights to such
invention. All communications between LICENSEE and patent counsel
regarding PATENT RIGHTS, including, but not limited to, patent applications,
status reports, filing deadline notices, declarations, office actions and
responses to office actions, will be copied to UT SOUTHWESTERN and to
BOARD. All parties have the right to review and comment upon the
wording of the specifications, claims and responses to Office Actions prior to
their submission to the appropriate patent office. LICENSEE will
instruct patent counsel to provide UT SOUTHWESTERN with copies of all invoices
providing detailed descriptions of all costs and expenses incurred by designated
patent counsel in connection with PATENT RIGHTS. LICENSEE will
provide evidence to UT SOUTHWESTERN of payment of such invoices within 60 days
of LICENSEE’S receipt thereof.
Page 9 of
13
15. GENERAL
15.1 This
AGREEMENT constitutes the entire and only agreement between the parties for
LICENSED SUBJECT MATTER and all other prior negotiations, representations,
agreements, and understandings are superseded hereby. No agreements
altering or supplementing the terms hereof may be made except by a written
document signed by both parties.
15.2 Any
notice required by this AGREEMENT shall be effective upon receipt and shall be
given by facsimile transmission confirmed by personal delivery (including
delivery by reputable messenger services such as Federal Express) or by prepaid,
first class, certified mail, return receipt requested, addressed in the case of
BOARD and UT SOUTHWESTERN to:
|
|
UT
Southwestern Medical Center at
Dallas
|
|
|
Office
for Technology Development
|
|
|
5323
Harry Hines Boulevard
|
|
|
Dallas,
Texas 75390-9094
|
|
|
ATTENTION: Ray
Wheatley, M.S.
|
|
|
Phone: (214)
648-1888
|
|
|
Fax: (214)
648-1889
|
with
copies to:
|
|
Board
of Regents
|
|
|
The
University of Texas System
|
|
|
201
West 7th Street
|
|
|
Austin,
Texas 78701
|
|
|
ATTENTION: Office
of General Counsel
|
|
|
Phone: (512)
499-4462
|
|
|
Fax: (512)
499-4523
|
or in the
case of LICENSEE to:
Peregrine
Pharmaceuticals, Inc.
14272
Franklin Avenue, Suite 100
Tustin,
California
ATTENTION: Steven
King, Ph.D.
Phone: 714-508-6000
Fax: 714-838-4094
or other
addresses as may be given from time to time under the terms of this notice
provision.
15.3 LICENSEE
must comply with all applicable national, state and local laws and regulations
in connection with its activities pursuant to this AGREEMENT.
15.4 This
AGREEMENT will be construed and enforced in accordance with the laws of the
United States of America and of the State of Texas. The Texas state
courts of Dallas County, Texas (or, if there is exclusive federal jurisdiction,
the United States District Court for the Northern District of Texas) shall have
exclusive jurisdiction and venue over any dispute arising out of this AGREEMENT,
and LICENSEE hereby consents to the jurisdiction of such courts.
Page 10 of
13
15.5 Failure of either party to enforce a right under this AGREEMENT will not act as a waiver of that right or the ability to later assert that right relative to the particular situation involved.
15.6 Headings
are included herein for convenience only and shall not be used to construe this
AGREEMENT.
15.7 If
any part of this AGREEMENT is for any reason found to be unenforceable, all
other parts nevertheless remain enforceable.
IN WITNESS WHEREOF, parties
hereto have caused their duly authorized representatives to execute this
AGREEMENT.
|
BOARD
OF REGENTS OF THE
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
UNIVERSITY
OF TEXAS SYSTEM
|
|
|
By
/s/ John
A.
Roan
|
By /s/ Edward
Legere
|
|
John
A. Roan
|
Edward
Legere
|
|
Executive
Vice President for Business Affairs
|
President
and CEO
|
|
UT
Southwestern Medical Center at Dallas
|
|
|
Date
8-13-01
|
Date
08/08/01
|
|
Approved
as to Content:
|
|
By /s/ Dennis K.
Stone
|
|
Dennis
K. Stone, M.D.
|
|
Vice
President for Technology Development
|
|
UT
Southwestern Medical Center at Dallas
|
|
Date
10Aug2001
|
Page 11 of
13
EXHIBIT
1
PATENT
RIGHTS
(a) U.S.
Patent Application Number 60/092,672, filed July 13, 1998, entitled “Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549PZ1);
(b) U.S.
Patent Application Number 60/110,608, filed December 2, 1998, entitled “Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549PZ2);
(c) U.S.
Patent Application Number 09/351,543, filed July 12, 1999, entitled “ Cancer
Treatment Methods Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549);
(d) U.S.
Patent Application Number 09/351,862, filed July 12, 1999, entitled “ Cancer
Treatment Kits Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549-1);
(e) International
Patent Application Number PCT/US99/15600, filed July 12, 1999, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549PCT);
(f) Australian
Patent Application Number 54585/99, filed December 22, 2000, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 AU);
(g) Canadian
Patent Application Number 2,333,147, filed January 3, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 CA);
(h) European
Patent Application Number 99940802.4, filed January 11, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 EU);
(i) Japanese
Patent Application Number 2000-558843, filed January 12, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 JP);
(j) Brazilian
Patent Application Number PI 9911882-3, filed January 5, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 BR);
(k) Israeli
Patent Application Number 140700, filed January 3, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 IL);
(l) Mexican
Patent Application Number 2001/000457, filed January 12, 2001, entitled “ Cancer
Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 MX);
Page 12 of
13
(m) New
Zealand Patent Application Number 508950, filed December 12, 2000, entitled “
Cancer Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 NZ); and
(n) Singapore
Patent Application Number 2000 07409-6, filed December 15, 2000, entitled “
Cancer Treatment Using Antibodies to Aminophospholipids” (UT SOUTHWESTERN File
Reference UTSD:0549 SG).
Page 13 of
13
Exhibit 10.20
AMENDMENT
No. 1 TO EXCLUSIVE PATENT LICENSE AGREEMENT
This
Amendment No. 1 to Exclusive Patent License Agreement (AMENDMENT ONE) is made
and entered into as of June 1, 2009 by and between Peregrine Pharmaceuticals,
Inc. (LICENSEE) and the Board of Regents (BOARD) of The University of Texas
System (SYSTEM).
RECITALS
A. LICENSEE
and BOARD entered into an Exclusive Patent License Agreement effective as of
August 1, 2001 (ANTI-PS AGREEMENT).
B. LICENSEE
and BOARD wish to amend the terms of the ANTI-PS AGREEMENT to revise the royalty
provisions as set forth below.
NOW, THEREFORE, it is hereby
agreed as follows:
|
1.
|
Section
5.1c of the ANTI-PS AGREEMENT shall be revised to read in its entirety as
follows:
|
“c. a
running royalty equal to [***]
of NET SALES, provided however, if a royalty is payable on the same LICENSED
PRODUCT under any other license agreement between BOARD and LICENSEE covering
patents naming Philip Thorpe as inventor and developed at UT SOUTHWESTERN, then
LICENSEE shall pay either (i) the royalty on NET SALES of such LICENSED PRODUCT
under this AGREEMENT, or (ii) the royalty due on such LICENSED PRODUCT under
such other agreement, whichever is higher;”
|
2.
|
Section
5.1f of the ANTI-PS AGREEMENT shall be revised to read in its entirety as
follows:
|
“f. a
sublicense fee of [***] of
any up-front cash payment or [***],
whichever is less, received by LICENSEE from either (1) any sublicensee pursuant
to Section 4.3 herein above, or (2) any assignee pursuant to Article 9 herein
below within 30 days of LICENSEE’s receipt of any such
consideration.”
|
3.
|
Article
5.1 of the ANTI-PS AGREEMENT shall be amended by the addition of the
following Section 5.1g:
|
“g. if
LICENSEE is required to pay royalties to a third party under patents owned by
such third party to manufacture, have manufactured, use, import, offer for SALE
and/or SELL LICENSED PRODUCTS, then LICENSEE may reduce the royalty payment owed
to BOARD on the same LICENSED PRODUCT under Section 5.1c by an amount equal to
[***] of
the royalty paid to such third party, but in no event shall such reduction,
result in a royalty of less than [***] of
the royalties due pursuant to Section 5.1c;”
[***] 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
Page 1 of
2
|
4.
|
Except
as expressly provided in this AMENDMENT ONE, all other terms, conditions
and provisions of the ANTI-PS AGREEMENT shall continue in full force and
effect as provided therein.
|
|
5.
|
This
AMENDMENT ONE may be executed in counterparts, each of which shall be
deemed original, and in aggregate shall constitute one and the same
instrument. Transmission by facsimile, email or other form of
electronic transmission of an executed counterpart of this AMENDMENT ONE
shall be deemed to constitute due and sufficient delivery of such
counterpart.
|
IN WITNESS WHEREOF, LICENSEE
and BOARD have entered into this AMENDMENT ONE effective as of the date first
set forth above.
|
BOARD
OF REGENTS OF
THE
UNIVERSITY OF TEXAS SYSTEM
|
PEREGRINE
PHARMACEUTICALS, INC.
|
|
By /s/ John A.
Roan
|
By /s/ Steven W.
King
|
|
John
A. Roan
|
Steven
W. King
|
|
Executive
Vice President for Business Affairs
|
President
and CEO
|
|
UT
Southwestern Medical Center at Dallas
|
|
|
Date
7/23/09
|
Date
7-10-09
|
|
Approved
as to Content:
|
|
By /s/ Dennis K.
Stone
|
|
Dennis
K. Stone, M.D.
|
|
Vice
President for Technology Development
|
|
UT
Southwestern Medical Center at Dallas
|
|
Date
7/21/09
|
Page 2 of
2
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 1 DNA Way, South San Francisco, CA 94080 (hereinafter "Genentech") and
Peregrine Pharmaceuticals, Inc., a Delaware corporation having its principal
place of business at 14272 Franklin Ave, Suite 100, Tustin, CA 92780
(hereinafter "Licensee").
WHEREAS:
|
A.
|
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);
|
|
B.
|
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
|
|
C.
|
Genentech
is willing to grant such a non-exclusive license to Licensee on he terms
and conditions set forth below.
|
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.
1
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.
2
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.
3
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.
4
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.
5
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.
6
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.
7
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.
8
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.
14272
Franklin Ave, Suite 100
Tustin,
CA 92780
Attn:
President
Facsimile:
(714) 838-5817
9
If to Genentech, addressed
to:
Genentech,
Inc.
1 DNA
Way
South San
Francisco. CA 94080
Attn:
Corporate Secretary
Facsimile:
(650) 952-9881
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]
10
IN
WITNESS WHEREOF, Genentech and Licensee have caused this Agreement to be
executed by their duly authorized representatives.
GENENTECH,
INC.
By:
/s/ Joseph J.
McCracken
Title: V.P. Business
Development
Date:
6-Nov-03
PEREGRINE
PHARMACEUTICALS, INC.
By: /s/
Paul J.
Lytle
Title: Chief Financial
Officer
Date: Nov. 4,
2003
11
Exhibit 10.22
COMMERCIAL LICENSE AGREEMENT
THIS
COMMERCIAL LICENSE AGREEMENT (this "Agreement") is
entered into as of the 1st day of December, 2003 by and between Avanir
Pharmaceuticals, a California corporation ("Avanir"), and Peregrine
Pharmaceuticals, Inc., a Delaware corporation ("Peregrine").
RECITALS
WHEREAS, Avanir, through its
wholly-owned subsidiary Xenerex Biosciences ("Xenerex"), has certain expertise
and technology relating to the creation of chimeric antibodies;
WHEREAS, Peregrine and Xenerex
have entered into a collaborative arrangement (the "Collaboration") as
evidenced by a Materials Transfer and Antibody Generation Agreement With
Commercial Option, made effective as of October 28, 2002 ("Materials Transfer
Agreement");
WHEREAS, the Materials
Transfer Agreement was directed to a Project (as defined therein) pursuant to
which Xenerex, using Xenerex's proprietary antibody technology and know how,
created a chimeric antibody by combining the marine variable regions of the 3G4
antibody with a fully-human constant region identified by Xenerex, and Xenerex
then transferred the completed chimeric antibody and the chimeric antibody
producing cell line to Peregrine;
WHEREAS, pursuant to the
Materials Transfer Agreement, (a) the chimeric antibody and the chimeric
antibody producing cell line created by Xenerex pursuant to the Project are
jointly-owned by both Peregrine and Xenerex until final ownership rights are
determined in a definitive commercial agreement, (b) Xenerex granted to
Peregrine the option to acquire an exclusive worldwide license to such chimeric
antibody and cell line; and (c) Xenerex and Peregrine agreed to act in good
faith and use commercially reasonable efforts to execute a final license
agreement; and
WHEREAS, Peregrine and Avanir
(on behalf of Xenerex) are entering into this Agreement the licenses granted
herein;
NOW, THEREFORE, in
consideration of the foregoing and the covenants and promises contained in this
Agreement, the parties agree as follows:
ARTICLE
1.
DEFINITIONS
As used
in this Agreement, any capitalized terms not defined in this Agreement will have
the meanings set forth for such terms in the Material Transfer Agreement, and
the following terms will have the following meanings:
1.1. "Affiliate" means any company
or entity controlled by, controlling, or under common control with a party to
this Agreement and will include without limitation any company fifty percent
(50%) or more of whose voting stock or participating profit interest is owned or
controlled, directly or indirectly, by a party, and any company which owns or
controls, directly or indirectly, fifty percent (50%) or more of the voting
stock of a party.
1
1.2. "Antibody" means the
chimeric antibody and the chimeric antibody producing cell line created
by Xenerex, pursuant to the Project and fragments, or direct or indirect
derivatives or mimetics or chimeric constructs thereof, and samples of
biochemical, biological, clonal, or synthetic chemical materials or sequence
data relating thereto and regardless of whether such chimeric antibodies or cell
lines were subsequently modified by Peregrine, Peregrine's Affiliate or any
Third Party.
1.3. "Biologies License
Application" or "BLA" means an application filed with the FDA, as
defined
in the United States Food, Drug & Cosmetics Act and the regulations
promulgated thereunder and any corresponding U.S. or equivalent foreign
application, registration or certification.
1.4. "Cost" means all labor, material and
overhead costs incurred in connection with the procurement,
manufacture (if applicable) and testing as determined in accordance with
generally accepted accounting principles.
1.5. "FDA" means the
United States Food and Drug Administration and other governmental agencies
around the world charged with responsibility for approving the sale of drugs,
biologics, or diagnostics.
1.6. "First Commercial
Sale" means, in any country, the first commercial sale, where sale
means
delivery, billing out or invoicing, whichever comes first, of a Licensed Product
by Peregrine, its Affiliates or sublicensees to any person or entity other than
Peregrine, its Affiliates or sublicensees following Regulatory Approval in the
country in which the sale is to be made.
1.7. "Licensed Products"
means all products incorporating the Antibody.
1.8. "Net Revenues" means
(a) the worldwide gross amount received by Peregrine or its Affiliates
for sales of the Licensed Products (whether in the form of royalties or sales
revenues) and fees for services utilizing the Antibody, less (b) transportation
charges, commissions, prompt payment discounts, credits allowed for defective or
returned goods actually paid or allowed, insurance and sales and other taxes
based on sales prices when included in gross sales, but not including taxes
assessed on income derived from such sales. However, in the ease of a
disposition of Licensed Products to an Affiliate where there is no subsequent
sale to a Third Party, Net Revenues will be the sales price of such items
generally available to unaffiliated Third Parties making similar quantity
commitments.
In the
event that Licensed Products are sold in the form of a combination product
containing one or more active ingredients other than Licensed Products, Net
Revenues for such combination products shall be calculated by multiplying actual
Net Revenues of the combination product by the fraction A/(A+B) where A is the
invoice price of the Licensed Product if sold separately and B is the total
invoice price of any other active component or components in the combination if
sold separately by Peregrine or its Affiliates or sublicensees; provided,
however that the resulting value of such Net Revenues of combination products
shall not be less than 50% of the value of the Net Revenues of the Licensed
Products had they been sold separately. If, on a country-by-country basis, the
Licensed Products and other active component or components in the combination
are not sold separately in any country by Peregrine or its Affiliates or
sublicensees, Net Revenues for purposes of determining royalties on the
combination product shall be calculated by multiplying actual Net Revenues of
such combination product by the fraction C/(C+D) where C is Peregrine's or its
Affiliates' or sublicensees' total actual cost of the Licensed Product and D is
the total actual cost of the other active
ingredient(s) included in the combination product at such point; provided,
however that the resulting value of such Net Revenues of combination products
shall not be less than 50% of the value of the actual cost of the Licensed
Products.
2
1.9. "Phase III Clinical
Trial" means a clinical trial, in any country, involving patients with
the
disease or condition of interest, designed to obtain sufficient efficacy and
safety data to support product registration in the country in which the testing
is completed.
1.10. "Regulatory Approval"
means final regulatory approval required to market a Licensed Product for a
disease or condition in accordance with the applicable laws and regulations of a
given country.
1.11. "Third Party" means
any person or entity other than Peregrine, Avanir and their respective
Affiliates.
ARTICLE
2.
LICENSE
GRANT
2.1. GRANT BY AVANIR TO PEREGRINE.
Subject to the terms of this Agreement, Avanir hereby grants to Peregrine an
exclusive, worldwide royalty-bearing license under any and all patents,
copyrights, trademarks, trade secrets, know-how and other intellectual property
and other proprietary rights Avanir has or may have in and to the Antibody to
manufacture, have manufactured, use, sell, offer to sell and import Licensed
Products. In connection with the foregoing, Avanir agrees to provide to
Peregrine data it has directly relating to the Antibody or the Project, as set
forth in Exhibit A attached hereto, provided, however, that Avanir does not
agree to provide any information about Avanir's proprietary antibody generation
technology and know-how included therein or to undertake any efforts to create,
discover or acquire any new information or data not already in its possession
and control.
2.2. SUBLICENSING. Peregrine will
have the right to grant sublicenses of the license rights
provided in Section
2.1 to Affiliates and to Third Parties who are capable of fulfilling the
development or commercialization responsibilities of Peregrine as set forth in
Section 2.3,
subject to Avanir's prior consent, such consent not to be unreasonably withheld
or delayed. Each such sublicense will be consistent with the terms of this
Agreement and will provide for the termination or direct assumption of each such
sublicense at Avanir's option upon the termination of this Agreement. Peregrine
will furnish Avanir a copy of each sublicense agreement with a Third Party. In
considering whether or not to terminate or assume any sublicense Avanir will
give due consideration to the terms of the sublicense, the past performance
under the sublicense agreement and any other commercially significant
consideration which Avanir considers, in the exercise of its reasonable
judgment, to be relevant. Except as specifically provided above, Peregrine will
have no rights to sublicense all or any part of the license granted to Peregrine
pursuant to this Agreement. Any transfer or extension of rights under the
license granted under this Agreement, in whole or in part, by Peregrine to any
Third Party will be deemed and considered to be a sublicense under this Section 2.2, even if
not so designated in the relevant legal documents. Peregrine shall make all
payments due to Avanir by reason of any Net Revenues by any such sublicensee and
shall ensure each sublicensee's compliance with all terms of this Agreement
applicable to Peregrine (including all terms of this Agreement identified as
applicable to sublicensees), and Peregrine will cause any such sublicensee to
agree in writing (i) to keep accurate books and records and permit Avanir to
review the information concerning such books and records in accordance with the
terms of this Agreement and (ii) to comply with all other terms of this
Agreement applicable to Peregrine (including all terms of this Agreement
identified as applicable to sublicensees).
3
2.3. DUE DILIGENCE. Peregrine will use
commercially reasonable efforts consistent with prudent
business judgment to develop, manufacture, market and sell the Licensed
Products. Peregrine will promptly give Avanir notice if Peregrine intends to
abandon permanently the commercial development of Licensed Products whereupon
any license will automatically and immediately terminate.
2.4. OBLIGATION TO INFORM. Peregrine will keep Avanir
reasonably informed in a timely manner as to the progress of the development and
commercialization of Licensed Products Peregrine determines, from time to time,
to pursue; and beginning on July 1, 2004, Peregrine will annually provide Avanir
with a written report summarizing Peregrine's activities related to development
of Licensed. Products and status of clinical trials and government approvals
necessary for marketing Licensed Products, provided that Peregrine shall not be
obligated to provide such a report more than once in any 12 month period. All
such reports will be the Confidential Information of Peregrine.
2.5. CARE AND USE OF MATERIALS; COMPLIANCE
WITH LAWS. Each
party acknowledges that the materials to be used and generated under this
Agreement are experimental in nature and may have unknown characteristics and
therefore will use prudence and reasonable care in the use, handling, storage,
transportation, disposition and containment of any such materials and will use,
handle, store, transport, dispose of and contain such materials in compliance
with all applicable laws.
ARTICLE
3.
COMMERCIAL
TERMS
3.1. LICENSE FEE. Upon execution of this
Agreement, Peregrine will pay to Avanir a non-refundable license fee of
[***].
3.2. ROYALTIES. In consideration for the
license granted under Section 2.1, and
without regard to whether Avanir or X.enerex has any patent covering the
Antibody, Peregrine will pay to Avanir within 45 days after the end of each
calendar quarter royalties equal to (a) [***] of Net Revenues or, (b) [***] of
Peregrine's Net Revenues that are paid to Peregrine by non-Affiliate
sublicensees in the event that Peregrine sublicenses its rights hereunder
pursuant to Section
2.2 above to a Third Party.
3.3. ROYALTY TERM. The royalties payable under
Section 3.2
will be paid until ten years from First Commercial Sale of a Licensed Product,
as determined on a country-by-country basis.
[***] 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.
4
3.4. MILESTONE PAYMENTS. Avanir
will be entitled to receive and Peregrine will be obligated to pay additional
amounts based upon the achievement of certain milestones (regardless of whether
such milestone is achieved by Peregrine or any of its sublicensees) for Licensed
Products as follows:
(a) [***]
upon treatment of the first patient in Phase 111 Clinical Trials in any country
for the first Licensed Product; and
(b) [***]
upon the first Regulatory Approval of a BLA in any country for the first
Licensed Product.
ARTICLE
4.
PAYMENTS;
RECORDS; AUDIT
4.1. PAYMENTS. All amounts payable
to Avanir under this Agreement will be paid in U.S.
Dollars no later than 45 days after the date upon which such amount becomes
owed. Each payment of royalties will be accompanied by a statement of the amount
of Net Revenues during such period, and all other information necessary to
determine the appropriate amount of such payments. Peregrine will be liable for
interest on any overdue payments equal to the annual prime rate listed at such
time in the Wall Street Journal plus 3% or the maximum annual rate allowable by
law, whichever is lower, commencing 30 days after the date such payments become
owed, until paid.
4.2. REPORTS Peregrine will make
written reports and royalty payments to Avanir within. 45 days after the close
of the calendar quarter to which they relate, beginning with the calendar
quarter in which the date of First Commercial Sale of a Licensed Product occurs.
These reports will show on a consolidated basis in reasonably specific detail
for each Licensed Product, (i) the Net Revenues during the corresponding
calendar quarter and the calculation of payments due to Avanir from such Net
Revenues; (ii) the royalties payable in US dollars, if any, which will have
accrued hereunder based upon Net Revenues of Licensed Products; (iii) the
withholding taxes, if any, required by law to be deducted in respect of such
royalties; (iv) the dates of the First Commercial Sale of each Licensed Product
in each country if it has occurred during the corresponding calendar quarter;
(e) the exchange rates used in determining the royalty amount expressed in. US
dollars. Concurrently with the making of each such report, Peregrine will make
any payment due to Avanir of royalties for the period covered by such
report.
4.3. EXCHANGE RATE. The rate of
exchange to be used in computing the amount of currency
equivalent in United States Dollars due Avanir will be made at the period-end
rate of exchange published for the last business day of the royalty period by
the United States edition of The Wall Street Journal.
[***]
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.
5
4.4. RECORDS AND AUDIT. During the term of this
Agreement and for a period of three years
thereafter, Peregrine will keep complete and accurate records pertaining to the
sale or other disposition
of the Licensed Products commercialized by it, in sufficient detail to permit
Avanir to confirm
the accuracy of all payments due hereunder. Avanir will have the right to cause
an independent
accounting firm of national standing to audit such records to confirm Net
Revenues and royalty payments made by Peregrine to Avanir hereunder; provided, however, that such
auditor will not disclose Peregrine's Confidential Information to Avanir, except
to the extent such disclosure is necessary to verify the amount of royalty
payments due under this Agreement. Such audits may be exercised no more than
once per year, within three years after the royalty period to which such records
relate, upon reasonable advance notice to Peregrine and during normal business
hours. Avanir will hear the full cost of such audit unless such audit discloses
an underpayment of more than 5% from the amount of payments due to Avanir for
such year ("Audit Difference Period"). In such case, Peregrine will bear the
full cost of such audit pertaining to the Audit Difference Period in addition to
paying any identified underpayment. In the event such audit reveals an
overpayment by Peregrine, the amount of such overpayment shall, at Peregrine's
option, be refunded to Peregrine or credited to royalties due and payable by
Peregrine to Avanir for the subsequent calendar quarter. The terms of this Section 4.4 will
survive any termination or expiration of this Agreement for a period of two
years.
4.5. NON-MONETARY CONSIDERATION. In
the event Peregrine or its Affiliates receives
any non-monetary consideration in lieu of royalties payable in cash in
connection with the Licensed Products, Peregrine's royalty obligations to Avanir
under Article 3
will be based on the monetary value of such other consideration. In such case,
Peregrine will disclose the terms of such arrangement to Avanir and the parties
will endeavor in good faith to agree on such monetary value. In the event that
the parties do not so agree, the parties will submit the matter to an
independent accounting firm of national standing to determine such value. The
cost of such determination will be borne equally by the parties.
ARTICLE
5.
OWNERSHIP;
PATENTS
5.1. OWNERSHIP. Except as may be
expressly set forth in this Agreement, the ownership of
intellectual property as between the parties to this Agreement will be as set
forth in the Material. Transfer Agreement.
5.2. PATENT PROSECUTION. Peregrine
will have sole right and responsibility for preparing,
filing, prosecuting and maintaining patents and patent applications worldwide
relating to the Licensed Products and conducting any interferences,
reexaminations, or requesting reissues or patent term extensions with respect
thereto, in each case in its name and sole discretion and at Peregrine's
expense. Peregrine will keep Avanir reasonably informed as to the status of such
patent matters and will provide Avanir copies of any documents received by
Peregrine from such patent offices including notice of all interferences,
reexaminations, oppositions or requests for patent term extensions. Avanir will
cooperate with and assist Peregrine in connection with such activities, at
Peregrine's request and expense. Peregrine may also determine whether to file
any patents covering the Antibody, in its name and sole discretion and at
Peregrine's expense. Avanir will cooperate with and assist Peregrine in
connection with such activities, at Peregrine's request and expense. In the
event that Peregrine determines not to file any patent applications for the
Antibody, Peregrine will notify Avanir of such fact no later than six months
before the deadline to file such patent application, and Avanir will have the
right to prepare, file, prosecute and maintain patents and patent applications
worldwide relating to the Antibody and conduct any interferences,
reexaminations, or request reissues or patent term extensions
with respect thereto. Peregrine will cooperate with and assist Avanir in
connection with such activities, at Avanir's request and expense.
6
5.3. INFRINGEMENT OF THIRD PARTY PATENT
RIGHTS.
(a) Joint Strategy. In the event
that the manufacture, use or sale of the Licensed Products becomes the subject
of a claim of infringement of a patent, copyright or other proprietary right
anywhere in the world, and without regard to which party is charged with said
infringement, and the venue of such claim, the parties will promptly confer to
discuss the claim.
(b) Defense. Unless the parties
otherwise agree, Peregrine will assume the responsibility
for the conduct of the defense of any such claim. In any event, Avanir will have
the right, but not the obligation, to participate in any such suit at its sole
option and at its own expense. Each party will reasonably cooperate with the
party conducting the defense of the claim including, if required to conduct such
defense, furnishing a power of attorney. Neither party will enter into any
agreement, license or settlement that affects the other party's rights or
interests without such other party's written consent, which consent will not be
unreasonably withheld.
ARTICLE
6.
CONFIDENTIALITY
6.1. CONFIDENTIALITY. Except to the
extent expressly authorized by this Agreement or otherwise agreed in writing by
the parties, each party agrees that, for the won of this Agreement and for five
years thereafter, the confidentiality obligations of Section 4 of the Material
Transfer Agreement will apply and govern the parties' use of Confidential
Information (as defined in the Materials Transfer Agreement) as if such Section
was fully set forth herein.
6.2. EMPLOYEES; AGENTS. Each party
will ensure that each of its employees, consultants,
other agents, Affiliates and sublicensees who have access to Confidential
Information is bound in writing to obligations of confidentiality and non-use at
least equivalent in scope to those set forth in Sections 6.1 and 6.2 of the
Materials Transfer Agreement.
6.3. PUBLICITY. Any disclosures of
the teens of this Agreement will be consistent with the
disclosure in the press release. Except as expressly provided in this Agreement,
neither party may disclose the existence or tei His of this Agreement without
the prior written consent of the other party; provided, however, that either
party may make such disclosure to the extent required by law and that either
party may make a disclosure of the existence and terms of this Agreement to its
attorneys, advisors, investors, prospective investors, lenders and other
financing sources, and to strategic partners or licensees for the Licensed
Products under circumstances that reasonably ensure the confidentiality
thereof.
7
ARTICLE
7.
REPRESENTATIONS AND
WARRANTIES
7.1. REPRESENTATIONS AND WARRANTIES OF
AVANIR.
(a) Corporate Power. Avanir is
duly organized and validly existing under the laws of California and has full
corporate power and authority to enter into this Agreement on behalf of itself
and on behalf of Xenerex, and to carry out its obligations under this
Agreement.
(b) Due Authorization. Avanir is
duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder. The person executing this Agreement on Avanir's behalf
has been duly authorized to do so by alt requisite corporate
action.
(c) Binding Agreement. This
Agreement is a legal and valid obligation binding upon Avanir and enforceable in
accordance with its terms. The execution, delivery and performance of this
Agreement by Avanir does 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 material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
(d) Grant of Rights. Avanir has
not, and will not during the term of this Agreement, grant any right to any
Third Party which would conflict with the rights granted to Peregrine
hereunder.
7.2. REPRESENTATIONS AND WARRANTIES OF
PEREGRINE.
(a) Corporate Power. Peregrine is
duly organized and validly existing under the laws of Delaware and has full
corporate power and authority to enter into this Agreement and to carry out the
provisions of this Agreement.
(b) Due Authorization. Peregrine
is duly authorized to execute and deliver this Agreement and to perform its
obligations hereunder. The person executing this Agreement on Peregrine behalf
has been duly authorized to do so by all requisite corporation
action.
(c) Binding Agreement. This
Agreement is a legal and valid obligation binding upon Peregrine and enforceable
in accordance with its terms. The execution, delivery and performance of this
Agreement by Peregrine does 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 material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
7.3. DISCLAIMER AND LIMITATION OF
LIABILITY. THE ANTIBODY IS PROVIDED AS IS AND AVANIR EXPRESSLY DISCLAIMS
ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES OR
ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN ALL CASES WITH
RESPECT THERETO. NEITHER PEREGRINE NOR AVANIR WILL BE LIABLE WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER THEORY FOR COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES,
TECHNOLOGY OR RIGHTS OR FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES. EXCEPT FOR
BREACHES OF ITS CONFIDENTIALITY OBLIGATIONS SET FORTH IN ARTICLE 6 ABOVE
NEITHER AVANIR OR XENEREX WILL BE LIABLE FOR ANY AMOUNTS AGGREGATING IN EXCESS
OF ONE HALF OF THE AMOUNTS PAID TO IT HEREUNDER.
8
ARTICLE 8.
INDEMNIFICATION
8.1. INDEMNIFICATION. Peregrine
hereby agrees to save, defend and hold Avanir and its Affiliates, officers,
directors, agents and employees (collectively, "Avanir Indemnities") harmless
from and against any and all third party claims, suits, actions, demands,
liabilities, expenses and/or losses, including reasonable legal expenses and
attorneys' fees (collectively, "Claims") resulting from the development,
clinical study, manufacturing, testing, use, handling, storage, or sale of the
Licensed Products by Peregrine and its Affiliates and sublicensees or directly
or indirectly from actions by Peregrine in connection with this Agreement. The
parties hereby agree that the risk of toxicity, immunogenicity, teratogenicity
or other "drug risk" associated with the Licensed Products will be with and for
the account of Peregrine and will be included under the foregoing
indemnification of Avanir by Peregrine.
8.2. CONTROL OF DEFENSE. Avanir
will give notice to Peregrine of any Claims that may be subject to
indemnification within 30 days, after learning of such Claim, and Peregrine will
have the exclusive right to assume the defense of such Claims with counsel of
its choosing. If such defense is assumed by Peregrine with counsel so selected,
Peregrine will not be obligated to pay the fees and expenses of any separate
counsel retained by Avanir with respect to such Claims, unless representation
presents a conflict due to actual or potential differing interests between
Avanir and any other party represented by such counsel in such proceeding, and
will have the right to settle such Claim on such terms and conditions it deems
advisable; provided, however,
that Peregrine will obtain Avanir's consent to any settlement which
requires payment or other action by Avanir or is likely to have a material
adverse effect on Avanir's business. The obligation of Peregrine stated in.
Section 8.1
above will apply only if Avanir notifies Peregrine in writing within 30 days
following receipt of written notice of any Claim brought against Avanir in
respect of which Avanir intends to invoke the provisions of Section
8.1.
ARTICLE
9.
TERM;
TERMINATION
9.1. TERM. Except as otherwise
provided in this Article 9, (a) the
term of license set forth in Sections 2.1 and
2.2 with
respect to Licensed Products will commence upon the date of this Agreement first
set forth above and will expire on the expiration date of the last to expire
royalty obligation, and (b) upon such expiration of this Agreement, Peregrine
will have an irrevocable, fully paid, royalty free, nonexclusive license to use
the Antibody for any purpose whatsoever.
9.2. TERMINATION FOR CONVENIENCE.
Peregrine will have the right to terminate this
Agreement at any time upon 30 day's written notice to Avanir.
9.3. TERMINATION FOR BANKRUPTCY.
Either party may terminate this Agreement by notice
in writing to the other party if the other party becomes insolvent, suspends
business, makes a general assignment for the benefit of creditors, suffers
execution to be levied against it or is subject to or takes or attempts to take
the benefit of any law for the release of the bankrupt or insolvent, whether
voluntarily or otherwise, and such proceedings are not dismissed within 90 days
of the commencement of any
such proceeding. The party with respect to which the event referred to in this
Section 9.3 has occurred will immediately notify the other party in writing of
the occurrence of such event. The parties acknowledge that all licenses granted
hereunder are and shall be deemed to be, for the purposes of Section 365(n) of
the United States Bankruptcy Code, as amended (the "Code"), licenses of rights
to intellectual property as defined under Section 101 of the Code. Each party
hereby agrees that the Antibody and all intellectual property rights thereto
shall and do hereby constitute "intellectual property" as such term is defined
and used for all purposes as set forth at 11 U.S.C. §101(35A). The parties
further agree that Peregrine, as licensee of such rights under this Agreement,
shall retain and may fully exercise all of its rights and elections under the
Code.
9
9.4. EFFECT OF TERMINATION; ACCRUED
RIGHTS; SURVIVING OBLIGATIONS.
(a) Upon
termination of this Agreement for any reason under the terms and conditions
hereof: (i) the licenses granted hereunder will immediately terminate, (ii)
Peregrine will discontinue its use of the Antibody, and destroy any and all
materials comprising the Antibody (including any DNA sequences encoding such
Antibody) in its possession, and (iii) upon the consent of Avanir and a given
sublicensee, each such sublicensee of Peregrine hereunder will become a licensee
of Avanir; provided that Peregrine and its Affiliates will retain the right to
sell Licensed Products existing on the date of such termination, which sales
will be subject to the royalty payment provisions set forth herein.
(b) Termination
of this Agreement for any reason under the terms and conditions of this
Agreement will not affect obligations of either party incurred prior to
termination or the right of either party to recover damages from any breach
thereof or affect Peregrine's obligations to pay to Avanir any royalties that
have accrued as of the date of such termination.
(c) In
the event Avanir terminates the licenses granted under this Agreement for
nonpayment of royalties by Peregrine, all amounts then owing by Peregrine
will immediately become due and payable.
(d) Upon
termination of this Agreement by either party under the terms and conditions of
this Agreement, neither party will incur any liability whatsoever for any
damage, loss or expenses of any kind suffered or incurred by the other arising
from or incident to any termination of this Agreement (or any part thereof) by
such party which complies with the terms of the Agreement whether or not such
party is aware of any such damage, loss or expenses.
(e) Termination
is not the sole remedy under this Agreement and, whether or not termination is
effected; all other remedies will remain available.
(f) Upon
termination of this Agreement for any reason under the terms and conditions of
this Agreement, Avanir, may in its sole discretion, terminate any or all
licenses or sublicenses granted by Avanir to Peregrine pursuant to this
Agreement, together with any sublicenses by Peregrine hereunder.
(g) If
this Agreement terminates any time after royalties on Licensed Products are
payable, Peregrine will make a written report to Avanir, for each Licensed
Product, within 90 days after the date on which Peregrine, its Affiliates or
sublicensees last sell such Licensed Products stating in such report
the same
information required by yearly reports for all such Licensed Products made, sold
or otherwise disposed of which were not previously reported to
Avanir.
The terms
of Sections 4.4, 5.1.
and 5.2 and Articles 6, 7, 8, 9,
10 and 11 will survive termination of this Agreement for as long as necessary to
permit their full discharge. Promptly after termination of this Agreement each
party will return or dispose of any know-how of the other in the accordance with
the instructions of the other, including without limitation any compounds,
assays or other biological or chemical materials.
10
ARTICLE
10.
GOVERNING
LAW; DISPUTE RESOLUTION
10.1. GOVERNING LAW. This Agreement
will be governed by and construed in accordance with the laws of the State of
California, applicable to contracts entered into, and wholly to be performed
within the State of California (regardless of the choice of law principles of
California or any other jurisdiction).
10.2.
LEGAL COMPLIANCE. The
parties will review in good faith and cooperate in taking such actions to ensure
compliance of this Agreement with all applicable laws.
10.3. DISPUTE RESOLUTION. Any
dispute under this Agreement will be finally settled by binding arbitration,
conducted in accordance with the rules of the American Arbitration Association
by three arbitrators appointed in accordance with said rules. The costs of the
arbitration, including administrative and arbitrators' fees, will be shared
equally by the parties to the arbitration. The prevailing party in any
arbitration, as determined by the arbitration panel, will be entitled to an
award against the other party in the amount of the prevailing party's costs and
reasonable attorneys' fees. The arbitration will be held in San Diego,
California, if brought by Peregrine, or Irvine, California, if brought by
Avanir. A disputed performance or suspended perfoimances pending the resolution
of the arbitration must be completed within 30 days following the final decision
of the arbitrators. Any arbitration subject to this Section 10.3 will be
completed within six months from the filing notice of a request for such
arbitration.
ARTICLE
11.
GENERAL
PROVISIONS
11.1. NOTICES. All notices required
or permitted to be given under this Agreement will be in writing and will be
deemed effectively given upon personal delivery, or the day after delivery to a
recognized overnight courier, to the following address:
If to
Peregrine:
Peregrine
Pharmaceuticals, Inc.
14272
Franklin Avenue, Suite 100
Tustin,
CA 92780-7017
Attention:
Steven King
11
Cc: Mark
Ziebell
Falk,
Shaff & Ziebell LLP
18881 Von
Karman Ave, Suite 1400
Irvine,
CA 92612
If to
Avanir:
Avanir
Pharmaceuticals 11388
Sorrento
Valley Road
San
Diego, CA 92121
Attention:
J. David Hansen
President
and Chief Operating Officer
Any party
may, by written notice to the other, designate a new address to which notices to
the party giving the notice will thereafter be sent.
11.2.
FORCE MAJEURE. No party
will be liable for any delay or failure of performance to the extent such delay
or failure is declared to be caused by circumstances beyond its reasonable
control and that by the exercise of due diligence it is unable to prevent such
delay or failure, provided that the party claiming excuse uses its reasonable
best efforts to overcome the same. Notwithstanding the foregoing, should an
event force majeure persist for 180 days or more, the non-declaring party will
be entitled to terminate this Agreement without cost or liability.
11.3.
ENTIRETY OF AGREEMENT.
This Agreement and the Materials Transfer Agreement set forth the entire
agreement and understanding of the parties relating to the subject matter
contained in this Agreement and merges all prior discussions and agreements
between them, and no party will be bound by any representation other than as
expressly stated in this Agreement, or by a written amendment to this Agreement
signed by authorized representatives of each of the parties.
11.4.
NON-WAIVER. The failure
of a party in any one or more instances to insist upon strict performance of any
of the terms and conditions of this Agreement will not be construed as a waiver
or relinquishment, to any extent, of the right to assert or rely upon any such
terms or conditions on any future occasion.
11.5.
DISCLAIMER OF AGENCY.
This Agreement will not constitute any party the legal representative or agent
of another, nor will any party have the night or authority to assume, create, or
incur any Third Party liability or obligation of any kind, express or implied,
against or in the name of or on behalf of another except as expressly set forth
in this Agreement.
11.6.
SEVERANCE. In the event
that any provision of this Agreement becomes or is declared by a court of
competent jurisdiction to be illegal, unenforceable or void, this Agreement will
continue in full force and effect without such provision, and the parties will
discuss in good faith appropriate revised arrangements.
12
11.7.
AFFILIATES;
ASSIGNMENT. Except as otherwise provided in this Agreement,
neither party may assign its rights or delegate its duties under this Agreement
without the prior written consent
of the other party, riot to be unreasonably withheld; provided, however, that
either party may assign this Agreement to any Affiliate or to any successor by
merger or sale of substantially all of its business unit to which this Agreement
relates in a manner such that the assignor will remain liable and responsible
for the performance and observance of all its duties and obligations hereunder.
References to a party will include any Affiliate of that party to whom such an
assignment or delegation has been made or ratified. Subject to the restrictions
contained in the preceding sentence, this Agreement will be binding upon the
successors and assigns of the parties. Any attempted delegation or assignment
not in accordance with this Section 11.7 will be
of no force or effect.
11.8. HEADINGS. The headings
contained in this Agreement have been added for convenience only and will not be
construed as limiting.
11.9. COUNTERPARTS. This Agreement
may be executed in two counterparts, each of which will be an original and both
of which will constitute together the same document.
[Signature
Page Follows]
13
IN
WITNESS WHEREOF, the parties to this Agreement have duly executed this
Agreement.
|
AVANIR
PHARMACEUTICALS
|
PEREGRINE
PHARMACEUTICALS, INC
|
|
|
By:
/s/ J. David Hansen
|
By:
/s/ Steven King
|
|
|
(Signature)
|
(Signature)
|
|
|
J.
David Hansen
|
Steven
King
|
|
|
Printed
Name
|
Printed
Name
|
|
|
Sr.
Vice President
|
President
|
|
|
Title
|
Title
|
|
|
12/01/03
|
12-5-03
|
|
|
Date
|
Date
|
14
EXHIBIT
A
Information
to support the filing of an IND
|
I.
|
Copies
of all laboratory notebooks and development
reports
|
|
II.
|
List
of materials used, including animal derived components, including
certification and testing
|
|
III.
|
Vector
and Gene Construction
|
A. Source
and function of the component parts of the vector
|
|
1.
|
Name
|
|
|
2.
|
Origin
of Replication
|
|
|
3.
|
Promoters
|
|
|
4.
|
Enhancers
|
|
|
5.
|
Antibiotic
resistance genes/ selection genes
|
|
|
6.
|
Other
regulatory elements
|
|
|
7.
|
Function
of replicons, if applicable
|
|
|
8.
|
Open
reading frames
|
|
|
9.
|
Genetic
markers critical for characterization of production
cells
|
|
|
10.
|
Sequence
of the vector
|
|
|
11.
|
Restriction
enzyme map of the vector
|
B. Details
of the Gene
|
|
1.
|
Any
names and/or laboratory codes
|
|
|
2.
|
Rational
for choosing this gene
|
|
|
3.
|
Restriction
enzyme map of the gene
|
|
|
4.
|
Complete
nucleotide and amino acid sequences including the heavy
chain
|
|
|
5.
|
Origins
describing from what cell line and
type
|
|
|
6.
|
Isolation
strategy of the gene
|
|
|
7.
|
Open
reading frames
|
|
|
8.
|
Designate
any important sequence features
|
C. Details
of the antibody
|
|
1.
|
Structural
identity of human sequences (i.e. is it a kappa or lambda constant region,
IgG or IgG 4 ,
etc.?)
|
|
|
2.
|
molecular
mass
|
D. Detailed
description of how the gene and vector were constructed
IV. Host
Cells
|
|
A.
|
Source
(name, origin, history, identification characteristics,
etc.)
|
|
|
B.
|
Pheno-
and geno- types
|
|
|
C.
|
Any
extraneous sequences produced by this cell line including any
immunoglobulin heavy or light chains that it synthesizes and/or
secretes
|
|
|
E.
|
Methods
of cell culture, concentration of cells at passage and passage
numbers
|
15
V. Fusion Strategy
|
A.
|
Mechanisms
of gene/vector transfer into host
cells
|
|
C.
|
Are
the genes integrated or
extra-chromosomal
|
|
D.
|
Demonstration
that the construction is actually identical to that
desired
|
|
E.
|
Constitutive
or controlled expression
|
VI. Sub-cloning and Isolation
Strategy
|
A.
|
Detailed
methodology of candidate cell line
isolation
|
|
B.
|
Description
of amplification process
|
|
C.
|
Selection
methodology
|
|
E.
|
Detailed
methodology for establishment of the cell
line
|
|
F.
|
Any
extraneous sequences produced as a result of the
sub-cloning
|
VII.
Confirmation/comparison to known 3G4 sequence
|
A.
|
Sequencing
methodology
|
|
B.
|
Results
for identification and authenticity
|
16
Exhibit 10.23
LICENSE
AGREEMENT
between
LONZA
BIOLOGICS PLC
and
PEREGRINE
PHARMACEUTICALS INC
1
INDEX
|
ARTICLE
|
TITLE
|
PAGE
|
|
1.
|
Definitions
and Interpretation
|
3
|
|
2.
|
Supply
of Materials and Know-How
|
7
|
|
3.
|
Ownership
of Property and Intellectual Property
|
7
|
|
4.
|
Licences
|
7
|
|
5.
|
Payments
|
9
|
|
6.
|
Royalty
Procedures
|
10
|
|
7.
|
Liability
and Warranties
|
11
|
|
8.
|
Confidentiality
|
12
|
|
9.
|
Patents
|
13
|
|
10.
|
Term
and Termination
|
14
|
|
11.
|
Assignment
|
15
|
|
12.
|
Governing
Law and Jurisdiction
|
16
|
|
13.
|
Force
Majeure
|
16
|
|
14.
|
Illegality
|
16
|
|
15.
|
Entire
Agreement/Amendment/Waiver/Press Releases/Cost
|
17
|
|
16.
|
Notice
|
17
|
|
17.
|
Interpretation
|
18
|
|
SCHEDULE
|
||
|
1
|
Patent
Rights
|
20
|
2
THIS
AGREEMENT is made with effect from the first day of July 1998
BETWEEN
LONZA
BIOLOGICS PLC of 228 Bath Road, Slough, Berkshire SLI 4DY, England (hereinafter
referred to as "Biologics"), and
PEREGRINE
PHARMACEUTICALS INC, (formerly known as TECHNICLONE CORPORATION) of 14282
Franklin Avenue, Tustin, CA 92780-7017, USA (hereinafter referred to as
"Licensee")
WHEREAS
A. Biologics
is the proprietor of a system for gene expression utilising glutamine
synthetase, and
B. The
Licensee wishes to take a Licence under Intellectual Property (as hereinafter
defined) of which Biologics is the proprietor to commercially exploit a Product
(as hereinafter defined) in the form hereunder.
NOW
THEREFORE the parties hereby agree as follows:
1. Definitions
and Interpretation
"Affiliate"
means any company, partnership or other entity which directly or indirectly
controls, is controlled by or is under common control with the relevant party to
this Agreement. "Control" means the ownership of more than fifty percent (50%)
of the issued share capital or the legal power to direct or cause the direction
of the general management and policies of the party in question.
"Cell
Lines" means those cell lines referred to in Clause 2.1.1(b) of the REA of which
Biologics is the proprietor or is otherwise entitled to use in accordance with
the terms set out herein.
"Competing
Contract Manufacturer" means any party who undertakes or performs more than
fifty percent (50%) of its business as a third party manufacturer of monoclonal
antibodies and/or
therapeutic proteins or any product of a similar nature to that to which this
Agreement relates.
3
"Effective
Date" means the date first above written.
"First
Commercial Sale" means the date of the first sale or other disposal of Product
for consideration by the Licensee pursuant to a New Drug Application that has
been approved by the Food & Drug Administration or the equivalent in the
appropriate jurisdiction.
"Intellectual
Property" means Materials Know-How and Patent Rights.
"Know-How"
means unpatented technical and other information including but without prejudice
to the generality of the foregoing ideas, concepts, inventions, discoveries,
data, formulae, specifications, procedures for experiments and tests and other
protocols, results of experimentation and testing, fermentation and purification
techniques and assay protocols.
"Materials"
means the System and the Vectors, but excluding any gene proprietary to Licensee
inserted into the System for the purposes of producing Product.
"Materials
Know-How" means Know-How specifically relating to the Materials of which
Biologics is the proprietor.
"Net
Selling Price" means all monies received by or on behalf of Licensee in respect
of the sale of Product in the Territory less the following items to the extent
that they are paid or allowed and included in the invoice price:
(a) normal
discounts actually granted;
(b) credits
allowed for Product or other goods returned or not accepted by
customers;
(c) packaging,
transportation and prepaid insurance charges on shipments or deliveries to
customers;
4
(d) taxes
actually incurred and paid by Licensee in connection with the sale or delivery
of Product or other goods to customers;
(e) cost
of radio isotopes, including cost of radio labelling services, which are added
to Product prior to sale; and
(f) cost
of any other component that is added to the final antibody and that is necessary
for Product to produce its desired effect, including cost of conjugation
services which are added to Product.
Upon any
sale or other disposal of Product by or on behalf of Licensee other than a bona
fide arms length transaction exclusively for money or upon any use of the
Product for purposes which do not result in a disposal of such Product in
consideration of sales revenue customary in the country of use, such sale, other
disposal or use shall be deemed to constitute a sale at the then current maximum
selling price in the country in which such sale, other disposal or use
occurs.
For the
avoidance of doubt, the supply of Product free of charge or at cost as
commercial samples or for use in clinical studies or to third parties for
research, development or evaluation purposes shall not be included in this
provision
"Patent
Rights" means the patents and applications short particulars of which are set
out in Schedule 1 hereto and all patents and applications thereof of any kind
throughout the world whether national or regional including but without
prejudice to the generality of the foregoing, author certificates, inventor
certificates, improvement patents, utility certificates and models and
certificates of addition and including any divisions, renewals, continuations,
extensions of reissue thereof.
"Phase I
Clinical Studies" means a limited series of studies in patients or healthy
volunteers whose primary purpose is to evaluate the safety and pharmacokinetics
of a Product in any indication.
"Phase II
Clinical Studies" means the initial trials of a Product in a clinical
development programme on a limited number of patients for the primary purpose of
evaluating safety, dose ranging and efficacy in the proposed therapeutic
indications.
5
"Product"
means DNA/histone directed antibody of human or chimeric origin, in combination
with radio isotope or another component, of which antibody Licensee is the
proprietor and which is obtained by the expression of any one gene or of any
combination of genes by use of the Materials. For the avoidance of doubt, save
as expressly provided by Clause 4.4, this Agreement shall not entitle Licensee
to exploit the rights granted hereunder in respect of more than one antibody
without the prior written consent of Biologics.
"REA"
means the Research Evaluation Agreement dated 25 April 1995 between Biologics'
predecessor in title, Celltech Therapeutics Limited, and Licensee's predecessor
in title, Cancer Therapeutics, Inc., as updated and consolidated in that certain
Research Evaluation Agreement between the parties dated
"Strategic
Partner" means a party with whom Licensee has entered into a contractual
relationship to identify a therapeutic target for, or to collaborate in the
performance of research and development of, or to provide for the further
commercialisation of, a Product or a product of which the Strategic Partner is
the Proprietor. In no event may any entity that is primarily a Competing
Contract Manufacturer or a company which does not have independent operations
that will be materially relied on by Licensee for development of the relevant
Product be deemed a Strategic Partner for the purposes of this
Agreement.
"Subsidiary"
means Avid Bioservices Inc., and each other Affiliate of Licensee
"System"
means the glutamine synthetase gene expression system of which Biologics is the
proprietor, as the same is described in the Intellectual Property.
"Territory"
means worldwide.
"Valid
Claim" means a claim within the Patent Rights (including any re-issued and
unexpired patents) which has not been held unenforceable or invalid by the
decision of a court or other governmental agency of competent jurisdiction
unappealable or unappealed within the time allowed for appeal and which has not
been admitted to be invalid or unenforceable through re-issue or disclaimer or
otherwise.
6
"Vectors"
means those vectors containing the System referred to in clause 2.1.1 (a) of the
REA.
"Year"
means a twelve (12) month period from the Effective Date hereof or an
anniversary of the Effective Date.
2. Supply
of Materials and Know-How
|
|
2.1
|
Following
the signature of this Agreement by both parties and receipt of the payment
specified in Clause 5.1 hereof Licensee shall be entitled to retain and
use, in accordance with this Agreement, the Materials and Materials
Know-How supplied by Biologics under the REA prior to 1st June 2004. For
the avoidance of doubt, this Agreement does not impair the rights of
Licensee under the REA to use the Materials and Materials Know-How in
accordance with the terms of the
REA.
|
3. Ownership
of Property and Intellectual Property
|
|
3.1
|
It
is hereby acknowledged and agreed that any and all property and
Intellectual Property in the Materials is vested in Biologics, and any and
all property and intellectual property in the Products and any gene
belonging to the Licensee that is inserted into the System is vested in
Licensee.
|
3.2 The
provisions of this Clause 3 shall survive termination of this
Agreement.
4. Licences
|
|
4.1
|
Biologics
hereby grants to Licensee a worldwide non-exclusive licence to use the
System, the Cell Lines, the Materials, and the Intellectual Property to
develop, manufacture, market and sell
Product.
|
|
|
4.2
|
The
Licensee hereby undertakes not to make any modifications or adaptations to
the Materials or the Cell Lines during the subsistence of this
Agreement.
|
|
|
4.3
|
Subject to the provisions of this
Clause 4.3, Licensee shall be entitled to grant one or more sublicences to
the rights granted by Clause 4.1 to third parties for the purposes of any
such third party manufacturing, or assisting in the manufacture of, a
Product for Licensee provided
always:
|
7
4.3.1 Licensee
shall ensure such sublicensee's use of the Materials, the Cell Lines, the
Intellectual Property and the Product is undertaken solely for the purpose of
establishing a manufacturing process for Product, or producing Product, for
Licensee; and
4.3.2 The
sublicensee shall not, by virtue of this Agreement, be granted any right or
licence, either express or implied, under any patent or proprietary right vested
in Biologics or otherwise, to use the Materials, the Intellectual Property or
the Product other than for the purposes of establishing a manufacturing Process
for Product or producing Product for Licensee and Licensee agrees to ensure that
such sublicensee shall not assign, transfer, further sublicense or otherwise
make over the benefit or the burden of the rights granted to it pursuant to this
Agreement; and
4.3.3 Any
sublicence granted shall be expressly subject and subordinate to the terms of
this Agreement, and it shall be Licensee's responsibility to ensure the strict
adherence by any sublicensee hereunder to the terms and conditions of this
Agreement; and
4.3.4 Prior
to the grant of any sublicence pursuant to this Clause 4 (other than a
sublicence to any Affiliate of Licensee), Licensee shall obtain the written
consent of Biologics (such consent not to be unreasonably withheld or delayed),
to the grant of such sublicence. Licensee shall notify Biologics of any
sublicence to any Affiliate of Licensee within thirty (30) days of signature of
such sublicence.
|
|
4.4
|
Notwithstanding
the fact that the rights granted in Clause 4.1 relate only to a single
molecule which falls within the definition of Product, the Licensee shall
be entitled to conduct Phase I and Phase II Clinical Studies on more than
one (1) antibody which antibodies otherwise satisfy the definition of
Product. These additional rights are granted on the understanding that
they are exploited in every other way in accordance with, and are subject
to, the terms of this Agreement (including specifically Clause 5 below)
and on the understanding Licensee shall identify in writing to Biologics
the specific Product antibody it intends to proceed to develop beyond
Phase II Clinical Studies prior to embarking on such further
development.
|
8
|
|
4.5
|
Licensee
may provide plasmid vectors containing the DNA sequence encoding Product
and cell lines containing those plasmid vectors (hereafter "Licensee
Materials"), but not the Materials themselves, to one or more third
parties for analysis and testing purposes associated with the manufacture
of Product (for example in relation to the integrity of the DNA sequence),
subject to the following provisos:
|
(a) Licensee
shall obtain the written consent of Biologics prior to any disclosure to a third
party, such consent not to be unreasonably withheld or delayed; and
(b) Licensee
shall have obtained from each such third party an agreement that such third
party shall not use the Licensee Materials for any purpose except as set out
above in this clause 4.5, shall not disclose the Licensee Materials to any other
third party and shall destroy the Licensee Materials upon the conclusion of its
engagement.
5. Payments
|
|
5.1
|
In
consideration of the licence granted to Licensee pursuant to Clause 4.1
hereof, Licensee shall pay Biologics as
follows:
|
|
5.1.1
|
[***]
within thirty (30) days of execution of this Agreement;
and
|
|
5.1.2
|
a
royalty of [***]
of the Net Selling Price in respect of Product manufactured by Biologics,
Licensee or any of Licensee's Affiliates, including Avid Bioservices
Inc.
|
|
|
5.2
|
In
consideration for the right to sublicense the rights granted by Clause 4.1
pursuant to Clause 4.3 to a Strategic Partner, Licensee shall pay
Biologics as follows:
|
[***] 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.
9
|
5.2.1
|
[***]
per sublicence per annum during which the sublicence in question subsists,
beginning upon completion of patient recruitment for Phase II clinical
trials; and
|
|
5.2.2
|
a
royalty of [***]
of the Net Selling Price of Product Manufactured by such Strategic
Partner.
|
|
|
5.3
|
In
consideration for the right to sublicense the rights granted by Clause 4.1
pursuant to Clause 4.3 to parties other than those expressly permitted
under clauses 5.1 and 5.2 above, Licensee shall pay Biologics as
follows:
|
|
5.3.1
|
[***]
per sublicence per annum during which the sublicence in question subsists,
which sum shall fall due on the commencement date of the relevant
sublicence and on each anniversary of the commencement date of the
relevant sublicence; and
|
|
5.3.2
|
a
royalty of [***]
of the Net Selling Price of Product manufactured by a
sublicensee.
|
|
|
5.4
|
Notwithstanding
the foregoing provisions of this Clause 5, no amount shall be payable
pursuant to Clause 5.2.2 or 5.3.2 with respect to a sub-licence if such
sub-licence is not for the purpose of manufacturing, and does not permit
or result in the manufacture of, Product for
sale.
|
6. Royalty
Procedures
|
|
6.1
|
Licensee
shall keep true and accurate records and books of account containing all
data necessary for the calculation of royalties payable to Biologics. Such
records and books of account shall, upon reasonable notice having been
given by Biologics, be open at all reasonable times during business hours
for inspection by Biologics or its duly authorised
representative.
|
|
|
6.2
|
Subsequent to the commencement of
Product sales, Licensee shall prepare a statement in respect of each
calendar quarter which shall show for the quarter in question details of
the sales of Product and the royalty due and payable to Biologics
thereon.
|
10
Such
statement shall be submitted to Biologics within thirty (30) days of the end of
the calendar quarter to which it relates together with a remittance for the
royalties due to Biologics.
6.3 All
sums due under this Agreement:
|
6.3.1
|
shall
be made in pounds sterling to Biologics. Payments due to Biologics in
currencies other than pounds sterling shall first be calculated in the
relevant local currency before being calculated at the rate of exchange
ruling at the close of business on the day payment is due or made,
whichever is earlier, provided always that where payment is made after the
date provided therefore herein conversion shall be at the rate ruling at
the date of payment if this is more favourable to Biologics. The rate of
exchange shall be the mean value of the Pound Spot Rate in London first
published in the Financial Times on the day following the day for
determining such rates.
|
|
6.3.2
|
are
exclusive of any Value Added Tax or of any other applicable taxes, levies,
imposts, duties and fees of whatever nature imposed by or under the
authority of any government or public authority which shall be paid by
Licensee. The parties agree to co-operate in all respects necessary to
take advantage of such double taxation agreements as may be
available.
|
|
|
6.4
|
Where
Biologics does not receive payment of any sum by the due date, interest
shall accrue thereafter on the sum due and owing to Biologics at the rate
of two percent (2%) over the base rate from time to time of Midland Bank
plc, interest to accrue on a day to day basis without prejudice to
Biologics' right to receive payment on the due
date.
|
7. Liability
and Warranties
|
|
7.1
|
Biologics
gives no representation or warranty that the Patent Rights which are
patent applications will be granted or if granted will be valid nor that
the exercise of the rights granted to Licensee hereunder will not infringe
other patent rights or intellectual property rights vested in Biologics or
any third party.
|
11
|
|
7.2
|
The
Licensee hereby acknowledges that in order to exploit the rights contained
herein the Licensee may require licences under Biologics patent rights
other than those herein licensed or under third party patent rights
(including those vested in Affiliates of Biologics) that may be infringed
by the use by the Licensee of the rights licensed herein and it is hereby
agreed that it shall be the Licensee's responsibility to satisfy itself as
to the need for such licences and if necessary to obtain such licences. No
licence is granted save as expressly provided herein and no licence in
addition thereto shall be deemed to have arisen or be implied by way of
estoppel or otherwise.
|
|
|
7.3
|
Licensee
shall indemnify and hold harmless Biologics and its officers, servants and
agents at all times in respect of any and all losses, damages, costs and
expenses suffered or incurred as a result of any contractual, tortious or
other claims or proceedings by third parties against Biologics arising in
any way out of the exercise by Licensee of any of the rights granted to it
under this Agreement, and in particular, product liability claims or
proceedings.
|
|
|
7.4
|
Any
condition or warranty other than those relating to title which might
otherwise be implied or incorporated within this Agreement by reason of
statute or common law or otherwise is hereby expressly
excluded.
|
|
|
7.5
|
The
terms of this Clause 7 shall survive termination of the Agreement for
whatever reason.
|
8. Confidentiality
|
|
8.1
|
Licensee expressly acknowledges
that the Materials Know-How and any other Know-How with which it is
supplied by Biologics pursuant to this Agreement is supplied in
circumstances imparting an obligation of confidence and Licensee agrees to
keep such Know How or Materials Know-How secret and confidential and to
respect Biologics' proprietary rights therein and to use the same for the
sole purpose of this Agreement and not during the period of this Agreement
or at any time for any reason whatsoever to disclose or permit to be
disclosed such Know How or Materials Know-How to any third party. Licensee
shall procure that only its employees shall have access to the Know How or
Materials Know-How on a need to know basis and that all such employees
shall be informed of their secret and confidential nature and shall be
subject to the same obligations as Licensee pursuant to this Clause 8.1,
subject to applicable law.
|
|
|
8.2
|
Licensee
hereby undertakes and agrees to keep the Materials and the Cell Lines
secure and safe from loss, damage, theft, misuse and unauthorised access
and shall procure that the Materials and the Cell Lines shall be made
available only to employees of Licensee and other permitted persons under
clause 4.5 above on a need to know basis and subject to the same
obligations of confidence as provided in Clause 8.1 hereof, and to use the
same for the sole purpose of this
Agreement.
|
12
|
|
8.3
|
Both
parties undertake and agree not to at any time for any reason whatsoever
disclose or permit to be disclosed to any third party or otherwise make
use of or permit to be made use of any trade secrets or confidential
information relating to the business affairs or finances of the other or
of any suppliers, agents, distributors, licensees or other customers of
the other which comes into their possession pursuant to this
Agreement.
|
|
|
8.4
|
The
obligations of confidence referred to in this Clause 8 shall not extend to
any information which:
|
|
8.4.1
|
is
or shall become generally available to the public otherwise than by reason
of a breach by the recipient party of the provisions of this Clause
8;
|
|
8.4.2
|
is
known to the recipient party and is at its free disposal prior to its
receipt from the other;
|
|
8.4.3
|
is
subsequently disclosed to the recipient party without obligations of
confidence by a third party owing no such obligations in respect thereof;
and
|
|
8.4.4
|
Biologics
or Licensee may be required to disclose to a government agency for the
purpose of any statutory, regulatory or similar legislative requirement
applicable to the production of Product or to meet the requirements of any
Stock Exchange to which the parties may be subject but only to the extent
such disclosure is required, and subject to obligations of secrecy
wherever possible.
|
|
|
8.5
|
The
obligations of both parties under this Clause 8 shall survive the expiry
or termination of this Agreement for whatever
reason.
|
|
9.
|
Patents
|
|
9.1
|
Biologics
hereby undertakes and agrees that at its own cost and expense it
will:
|
|
9.1.1
|
prosecute
or procure prosecution of such of the Patent Rights which are patent
applications diligently to grant so as to secure the best commercial
advantage obtainable so far as it is reasonable to do so with reference to
Biologics' commercial considerations;
and
|
|
9.1.2
|
pay
or procure payment of all renewal fees in respect of the Patent Rights
valid and subsisting for the full term thereof and in particular will
procure such renewal of the registrations thereof as may be necessary from
time to time so far as it is reasonable to do so with particular reference
to commercial considerations.
|
13
|
|
9.2
|
Licensee
shall promptly notify Biologics in writing of any infringement or improper
or unlawful use of or of any challenge to the validity of the Patent
Rights and/or Materials Know-How that shall become known to the senior
executives of Licensee. Biologics undertakes and agrees to take all such
steps and proceedings and to do all other acts and things as may in
Biologics' sole discretion be necessary to restrain any such infringement
or improper or unlawful use or to defend such challenge to validity and
Licensee shall permit Biologics to have the sole conduct of any such steps
and proceedings including the right to settle them whether or not Licensee
is a party to them. Licensee hereby agrees to co-operate fully with
Biologics at its own cost and expense lending its name to the proceedings
as may be necessary.
|
Biologics
shall be entitled to retain any and all monies received from such
proceedings.
|
10.
|
Term
and Termination
|
|
10.1
|
Unless
terminated earlier in accordance with the provisions of this Clause 10 or
Clause 13 or 14, this Agreement shall continue in force in each country of
the world, until expiry of the last to expire of a period of fifteen (15)
years from the date of First Commercial Sale or until expiry of the last
Valid Claim, whichever is later always provided that this Agreement shall
terminate before the expiry of the said fifteen (15) year period and after
the expiry of the last Valid Claim if Biologics makes publicly available
the Materials and the Materials
Know-How.
|
|
10.2
|
Licensee
may terminate this Agreement by giving sixty (60) days notice in writing
to Biologics.
|
|
10.3
|
Either
Biologics or Licensee may terminate this Agreement forthwith by notice in
writing to the other upon the occurrence of any of the following events
:
|
|
10.3.1
|
if
the other commits a breach of this Agreement which in the case of a breach
capable of remedy shall not have been remedied within thirty (30) days of
the r eceipt by the other of a notice identifying the breach and requiring
its remedy.
|
|
10.3.2
|
if
the other is unable to pay its debts or enters into compulsory or
voluntary liquidation (other than for the purpose of effecting a
reconstruction or amalgamation in such manner that the company resulting
from such reconstruction or amalgamation if a different legal entity shall
agree to be bound by and assume the obligations of the relevant party
under this Agreement) or compounds with or convenes a meeting of its
creditors or has a receiver appointed over all or any part of its assets
or takes or suffers any similar action in consequence of a debt, or ceases
for any reason to carry on
business.
|
14
|
10.4
|
If
at any time during this Agreement Licensee directly or indirectly opposes
or assists any third party to oppose the grant of letters patent or any
patent application within any of the Patent Rights or disputes or directly
or indirectly assists any third party to dispute the validity of any
patent within any of the Patent Rights or any of the claims thereof,
Biologics shall be entitled at any time thereafter to terminate all or any
of the licences granted hereunder forthwith by notice to
Licensee.
|
|
10.5
|
If
this Agreement is terminated for any reason any and all licences granted
hereunder shall terminate with effect from the date of termination and
Licensee shall destroy all Materials and Cell Lines forthwith and shall
certify such destruction immediately thereafter in writing to Biologics.
Licensee shall be permitted to sell such stocks of Product as have been
manufactured or are being manufactured on or prior to the date of
termination of this Agreement, and shall account to Biologics for
royalties on the sale of such products in accordance with clause 5
above.
|
|
10.6
|
Termination
for whatever reason or expiration of this Agreement shall not affect the
accrued rights of the parties arising in any way out of this Agreement as
at the date of termination. The right to recover damages against the other
and all provisions which are expressed to survive this Agreement shall
remain in full force and
effect.
|
|
11.
|
Assignment
|
|
11.1
|
Neither
party shall be entitled to assign, transfer, charge or in any way make
over the benefit and/or the burden of this Agreement without the prior
written consent of the other which consent shall not be unreasonably
withheld or delayed, save that Biologics shall be entitled without the
prior written consent of the Licensee to assign, transfer, charge,
sub-contract, deal with or in any other manner make over the benefit
and/or burden of this Agreement to an Affiliate or to any 50/50 joint
venture company of which Biologics is the beneficial owner of fifty
percent (50%) or more of the issued share capital thereof or to any
company with which that party may merge or to any company to which that
party may transfer its assets and undertaking, provided in each case of an
assignment of burdens, that all intellectual property and other property
and rights of Biologics necessary to enable such assignee or transferee to
specifically perform the obligations of Biologics hereunder
shallalso
be so assigned or transferred. Notwithstanding the foregoing, Licensee
shall have the right to assign its rights and obligations hereunder in
connection with a sale of all or substantially all of the assets involved
in the line of business that includes the Product (including a sale of all
or substantially all of its assets) without the prior written consent of
Biologics.
|
|
11.2
|
This
Agreement shall be binding upon the successors and assigns of the parties
and the name of a party appearing herein shall be deemed to include the
names of its successors and assigns provided always that nothing herein
shall permit any assignment by either party except as expressly provided
herein.
|
15
|
12.
|
Governing
Law and Jurisdiction
|
|
12.1
|
The
validity, construction and performance of this Agreement shall be governed
by English law.
|
|
12.2
|
All
disputes, claims or proceedings between the parties relating to the
validity, construction or performance of this Agreement shall be subject
to the exclusive jurisdiction of the High Court of Justice in England to
which the parties hereto irrevocably
submit.
|
|
12.3
|
Each
of the parties irrevocably consents to award or grant of any relief in any
such proceedings before the High Court of Justice in England. Either party
shall have the right to take proceedings in any other jurisdiction for the
purposes of enforcing a judgement or order obtained from the High Court of
Justice in England.
|
|
13.
|
Force
Majeure
|
Neither
party shall be in breach of this Agreement if there is any total or partial
failure of performance by it of its duties and obligations under this Agreement
occasioned by any act of God, fire, act of government or state, war, civil
commotion, insurrection, embargo, prevention from or hindrance in obtaining any
raw materials, energy or other supplies, labour disputes of whatever nature and
any other reason beyond the control of either party. If either party is unable
to perform its duties and obligations under this Agreement as a direct result of
the effect of one of the reasons set out in this Clause 13 such party shall give
written notice to the other of such inability stating the reason in
question. The operation of this Agreement shall be suspended during the period
(and only during the period) in which the reason continues. Forthwith upon the
reason ceasing to exist the party relying upon it shall give written advice to
the other of this fact. If the reason continues for a period of more than ninety
(90) days and substantially affects the commercial basis of this Agreement the
party not claiming under this Clause 13 shall have the right to terminate this
Agreement by giving sixty (60) days written notice of such termination to the
other party.
|
14.
|
Illegality
|
If any
provision or term of this Agreement or any part thereof shall become or be
declared illegal, invalid or unenforceable for any reason whatsoever including
but without limitation by reason of the provisions of any legislation or other
provisions having the force of law or by reason of any decision of any Court or
other body or authority having jurisdiction over the parties hereto or this
Agreement including the EC Commission or the European Court of Justice, such
terms or provisions shall be divisible from this Agreement and shall be deemed
to be deleted from this Agreement in the jurisdiction in question provided
always that if any such deletion substantially affects or alters the commercial
basis of this Agreement either party shall have the right to terminate this
Agreement by giving sixty (60) days written notice of such termination to the
other party.
16
|
15.
|
Entire
Agreement/Amendment/Waiver/Press
Releases/Costs
|
|
15.1
|
This
Agreement embodies and sets forth the entire agreement and understanding
of the parties and supersedes all prior oral and written agreements,
understanding or arrangements relating to the subject matter of this
Agreement. Neither party shall be entitled to rely on any agreement,
understanding or arrangement which is not expressly set forth in this
Agreement.
|
|
15.2
|
This
Agreement shall not be amended, modified, varied or supplemented except in
writing signed by duly authorised representatives of the
parties.
|
|
15.3
|
No
failure or delay on the part of either party hereto to exercise any right
or remedy under this Agreement shall be construed or operated as a waiver
thereof nor shall any single or partial exercise of any right or remedy
underthis
Agreement preclude the exercise of any other right or remedy or preclude
the further exercise of such right or remedy as the case may be. The
rights and remedies provided in this Agreement are cumulative and are not
exclusive of any rights or remedies provided by
law.
|
|
15.4
|
The
text of any press release or other communication to be published by or in
the media whether or a scientific nature or otherwise and concerning the
subject matter of this Agreement shall require the prior written approval
of Biologics.
|
|
15.5
|
Each
of the parties hereto shall be responsible for its respective legal and
other costs incurred in relation to the preparation of this
Agreement.
|
|
16.
|
Notice
|
|
16.1
|
Any
notice or other document to be given under this Agreement shall be in
writing and shall be deemed to have been duly given if left at or sent by
registered post, courier, facsimile or other electronic media to a party
or delivered in person to a party at the address or facsimile number set
out below for such party or such other address as the party may from time
to time designate by written notice to the
other(s):
|
Address
of Biologics
Lonza
Biologics plc, 228 Bath Road, Slough, Berkshire SL1 4DX
Facsimile
: 01753 777001
Address
of Licensee
Peregrine
Pharmaceuticals Inc, 14282 Franklin Avenue, Tustin, CA 92780-7017
Facsimile
: 001 714 838 4094
17
|
16.2
|
All
such notices and documents shall be in the English language. Any such
notice or other document shall be deemed to have been received by the
addressee seven (7) working days following the date of despatch of the
notice or other document by post or, where the notice or other document is
sent by hand or is given by facsimile or other electronic media,
simultaneously with the transmission or delivery. To prove the giving of a
notice or other document it shall be sufficient to show that it was
despatched.
|
|
17.
|
Interpretation
|
|
17.1
|
The
headings in this Agreement are inserted only for convenience and shall not
affect the construction
hereof.
|
|
17.2
|
Where
appropriate words denoting a singular number only shall include the plural
and vice versa.
|
|
17.3
|
Reference
to any statute or statutory provision includes a reference to the statute
or statutory provision as from time to time amended, extended or
re-enacted.
|
18
AS
WITNESS the hands of the duly authorised representatives of the parties
hereto
|
Signed
for and on behalf of
|
|
| LONZA BIOLOGICS PLC | /s/ LONZA BIOLOGICS PLC |
| TITLE: Finance Director | |
| DATE: 05 OCT 2004 | |
|
Signed
for and on behalf of
|
|
| PEREGRINE PHARMACEUTICALS INC | /s/ Paul Lytle |
|
TITLE:
CFO
|
|
| DATE: 15 Sept 04 | |
19
SCHEDULE 1
PATENT
RIGHTS
|
Biologics
Ref:
|
LBP07
(formerly known as PA 98)
|
|
Priority
Dates:
|
01.04.85
and 03.09.85
|
|
Title:
|
Transformed
Myeloma Cell-Line and a Process for the Expression of a
|
|
Gene
Coding for a Eukaryotic Polypeptide employing same
|
|
|
Inventors:
|
John
Henry Kenten
|
|
|
Michael
Alan Boss
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Australia
|
*584417
|
01.04.02
|
||
|
Bulgaria
|
77296
|
-
|
||
|
Canada
|
*1319120
|
15.06.10
|
||
|
Europe+
|
*216846
|
01.04.06
|
||
|
Japan
|
501959/86
|
-
|
||
|
United
Kingdom
|
*2183662
|
01.04.06
|
||
|
USA
|
07/701374
|
-
|
||
|
Russia
(formerly a USSR application)
|
4028654.13
|
+ includes Austria,
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Swede and
Switzerland.
20
|
Biologics
Ref:
|
PA
108
|
|
Priority
Date:
|
23.01.86
|
|
Title:
|
Recombinant
DNA Sequences, Vectors containing them and Method for
the
|
|
use
thereof
|
|
|
Inventors:
|
Richard
Harris Wilson (Glasgow University)
|
|
|
Christopher
Robert Bebbington
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
or
* Patent Number
|
||||
|
Australia
|
*599081
|
23.01.03
|
||
|
Canada
|
528011
|
-
|
||
|
Europe+
|
*256055
|
23.01.07
|
||
|
Japan
|
500891/87
|
-
|
||
|
USA
|
*5122464
|
16.06.09
|
||
|
USA
(Divisional)
|
07/852390
|
-
|
+ includes
Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Swede and
Switzerland.
21
|
Biologics
Ref:
|
LBP09
(formerly known as PA 140)
|
|
Priority
Date:
|
23.07.87
|
|
Title:
|
Recombinant
DNA Product and Processes using it
|
|
Inventors:
|
Christopher
Robert Bebbington
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Europe+
|
*323997
|
22.07.08
|
||
|
Japan
|
506088/88
|
|||
|
USA
|
07/339615
|
+ includes Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Sweden, Switzerland and United Kingdom
22
|
Biologics
Ref:
|
LBP10
(formerly known as PA 177)
|
|
Priority
Date:
|
18.04.88
|
|
Title:
|
Recombinant
DNA Methods, Vectors and Host Cells
|
|
Inventors:
|
Christopher
Robert Bebbington
|
|
|
Geoffrey
Thomas Yarranton
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Australia
|
*624616
|
18.04.05
|
||
|
Canada
|
597034
|
|||
|
Europe+
|
89303964.4
|
|||
|
Japan
|
505128/89
|
|||
|
USA
|
07/460154
|
+ includes Austria,
Belgium, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain, Sweden,
Switzerland and United Kingdom
23
Exhibit 10.24
LICENSE
AGREEMENT
between
LONZA
BIOLOGICS PLC
and
PEREGRINE
PHARMACEUTICALS INC
INDEX
| ARTICLE | TITLE | PAGE |
| 1. | Definitions and Interpretation | 3 |
| 2. | Supply of Materials and Know-How | 6 |
| 3. | Ownership of Property and Intellectual Property | 6 |
| 4. | Licences | 7 |
| 5. | Payments | 8 |
| 6. | Royalty Procedures | 9 |
| 7. | Liability and Warranties | 10 |
| 8. | Confidentiality | 11 |
| 9. | Patents | 12 |
| 10. | Term and Termination | 13 |
| 11. | Assignment | 14 |
| 12. | Governing Law and Jurisdiction | 14 |
| 13. | Force Majeure | 15 |
| 14. | Illegality | 15 |
| 15. | Entire Agreement/Amendment/Waiver/Press Releases/Cost | 15 |
| 16. | Notice | 16 |
| 17. | Interpretation | 17 |
| SCHEDULE | ||
| 1 |
Patent
Rights
|
18 |
2
THIS
AGREEMENT is made with effect from the 1st day
of March 2005
BETWEEN
LONZA
BIOLOGICS PLC of 228 Bath Road, Slough, Berkshire SL1 4DX, England (hereinafter
referred to as "Biologics"), and
PEREGRINE
PHARMACEUTICALS INC, of 14282 Franklin Avenue, Tustin, CA 92780-7017, USA
(hereinafter referred to as "Licensee")
WHEREAS
|
A.
|
Biologics
is the proprietor of a system for gene expression utilising glutamine
synthetase, and
|
|
B.
|
The
Licensee wishes to take a Licence under Intellectual Property (as
hereinafter defined) of which Biologics is the proprietor to commercially
exploit a Product (as hereinafter defined) in the form
hereunder.
|
NOW
THEREFORE the parties hereby agree as follows:
1. Definitions and
Interpretation
"Affiliate"
means any company, partnership or other entity which directly or indirectly
controls, is controlled by or is under common control with the relevant party to
this Agreement. "Control" means the ownership of more than fifty percent (50%)
of the issued share capital or the legal power to direct or cause the direction
of the general management and policies of the party in question.
"Cell
Lines" means those cell lines referred to in Clause 2.1.1(b) of the REA of which
Biologics is the proprietor or is otherwise entitled to use in accordance with
the terms set out herein.
"Competing
Contract Manufacturer" means any party who undertakes or performs more than
fifty percent (50%) of its business as a third party manufacturer of monoclonal
antibodies
and/or therapeutic proteins or any product of a similar nature to that to which
this Agreement relates.
3
"Effective
Date" means the date first above written.
"First
Commercial Sale" means the date of the first sale or other disposal of Product
for consideration by the Licensee pursuant to a New Drug Application that has
been approved by the Food & Drug Administration or the equivalent in the
appropriate jurisdiction.
"Intellectual
Property" means Materials Know-How and Patent Rights.
"Know-How"
means unpatented technical and other information including but without prejudice
to the generality of the foregoing ideas, concepts, inventions, discoveries,
data, formulae, specifications, procedures for experiments and tests and other
protocols, results of experimentation and testing, fermentation and purification
techniques and assay protocols.
"Materials"
means the System and the Vectors, but excluding any gene proprietary to Licensee
inserted into the System for the purposes of producing Product.
"Materials
Know-How" means Know-How specifically relating to the Materials of which
Biologics is the proprietor.
"Net
Selling Price" means all monies received by or on behalf of Licensee in respect
of the sale of Product in the Territory less the following items to the extent
that they are paid or allowed and included in the invoice price:
|
(a)
|
normal
discounts actually granted;
|
|
(b)
|
credits
allowed for Product or other goods returned or not accepted by
customers;
|
|
(c)
|
packaging,
transportation and prepaid insurance charges on shipments or deliveries to
customers;
|
|
(d)
|
taxes
actually incurred and paid by Licensee in connection with the sale or
delivery of Product or other goods to
customers;
|
|
(e)
|
cost
of radio isotopes, including cost of radio labelling services, which are
added to Product prior to sale;
and
|
|
(f)
|
cost
of any other component that is added to the final antibody and that is
necessary for Product to produce its desired effect, including cost of
conjugation services which are added to
Product.
|
4
Upon any
sale or other disposal of Product by or on behalf of Licensee other than a bona
fide arms length transaction exclusively for money or upon any use of the
Product for purposes which do not result in a disposal of such Product in
consideration of sales revenue customary in the country of use, such sale, other
disposal or use shall be deemed to constitute a sale at the then current maximum
selling price in the country in which such sale, other disposal or use
occurs.
For the
avoidance of doubt, the supply of Product free of charge or at cost as
commercial samples or for use in clinical studies or to third parties for
research, development or evaluation purposes shall not be included in this
provision
"Patent
Rights" means the patents and applications short particulars of which are set
out in Schedule 1 hereto and all patents and applications thereof of any kind
throughout the world whether national or regional including but without
prejudice to the generality of the foregoing, author certificates, inventor
certificates, improvement patents, utility certificates and models and
certificates of addition and including any divisions, renewals, continuations,
extensions of reissue thereof.
"Phase I
Clinical Studies" means a limited series of studies in patients or healthy
volunteers whose primary purpose is to evaluate the safety and pharmacokinetics
of a Product in any indication.
"Phase II
Clinical Studies" means the initial trials of a Product in a clinical
development programme on a limited number of patients for the primary purpose of
evaluating safety, dose ranging and efficacy in the proposed therapeutic
indications.
"Product"
means the chimeric monoclonal antibody that binds to the phospholipid
phosphatidylserine, known as TarvacinTM, of which antibody Licensee is the
proprietor and which is obtained by the expression of any one gene or of any
combination of genes by use of the Materials. For the avoidance of doubt, save
as expressly provided by Clause 4.4, this Agreement shall not entitle Licensee
to exploit the rights granted hereunder in respect of more than one antibody
without the prior written consent of Biologics.
"REA"
means the Research Evaluation Agreement dated 25 April 1995 between Biologics'
predecessor in title, Celltech Therapeutics Limited, and Licensee's predecessor
in title, Cancer Therapeutics, Inc., as updated and consolidated in that certain
Research Evaluation Agreement between the parties dated 15 September,
2004.
5
"Strategic
Partner" means a party with whom Licensee has entered into a contractual
relationship to identify a therapeutic target for, or to collaborate in the
performance of research and development of, or to provide for the further
commercialisation of, a Product or a product of which the Strategic Partner is
the Proprietor. In no event may any entity that is primarily a Competing
Contract Manufacturer or a company which does not have independent operations
that will be materially relied on by Licensee for development of the relevant
Product be deemed a Strategic Partner for the purposes of this
Agreement.
"Subsidiary"
means Avid Bioservices Inc., and each other Affiliate of Licensee
"System"
means the glutamine synthetase gene expression system of which Biologics is the
proprietor, as the same is described in the Intellectual Property.
"Territory"
means worldwide.
"Valid
Claim" means a claim within the Patent Rights (including any re-issued and
unexpired patents) which has not been held unenforceable or invalid by the
decision of a court or other governmental agency of competent jurisdiction
unappealable or unappealed within the time allowed for appeal and which has not
been admitted to be invalid or unenforceable through re-issue or disclaimer or
otherwise.
"Vectors"
means those vectors containing the System referred to in clause 2.1.1 (a) of the
REA.
"Year"
means a twelve (12) month period from the Effective Date hereof or an
anniversary of the Effective Date.
2. Supply of Materials and
Know-How
|
2.1
|
Following
the signature of this Agreement by both parties Licensee shall
beentitled
to retain and use, in accordance with this Agreement, the Materials and
Materials Know-How supplied by Biologics under the REA. For the avoidance
of doubt, this Agreement does not impair the rights of Licensee under the
REA to use the Materials and Materials Know-How in accordance with the
terms of the REA.
|
3. Ownership of Property and Intellectual
Property
|
3.1
|
It
is hereby acknowledged and agreed that any and all property and
IntellectualProperty
in the Materials is vested in Biologics, and any and all property and
intellectual property in the Products and any gene belonging to the
Licensee that is inserted into the System is vested in
Licensee.
|
|
3.2
|
The
provisions of this Clause 3 shall survive termination of this
Agreement.
|
6
4. Licences
|
4.1
|
Biologics
hereby grants to Licensee a worldwide non-exclusive licence to use the
System,
the Cell Lines, the Materials, and the Intellectual Property to develop,
manufacture, offer for sale, import, market and sell
Product.
|
|
4.2
|
The
Licensee hereby undertakes not to make any modifications or adaptations to
the Materials or the Cell Lines during the subsistence of this
Agreement.
|
|
4.3
|
Subject
to the provisions of this Clause 4.3, Licensee shall be entitled to grant
oneor
more sublicences to the rights granted by Clause 4.1 to third parties for
the purposes of any such third party manufacturing, or assisting in the
manufacture of, a Product for Licensee provided
always:
|
4.3.1
Licensee shall ensure such sublicensee's use of the Materials, the Cell Lines,
the Intellectual Property and the Product is undertaken solely for the purpose
of establishing a manufacturing process for Product, or producing Product, for
Licensee; and
4.3.2 The
sublicensee shall not, by virtue of this Agreement, be granted any right or
licence, either express or implied, under any patent or proprietary right vested
in Biologics or otherwise, to use the Materials, the Intellectual Property or
the Product other than for the purposes of establishing a manufacturing Process
for Product or producing Product for Licensee and Licensee agrees to ensure that
such sublicensee shall not assign, transfer, further sublicense or otherwise
make over the benefit or the burden of the rights granted to it pursuant to this
Agreement; and
4.3.3 Any
sublicence granted shall be expressly subject and subordinate to the terms of
this Agreement, and it shall be Licensee's responsibility to ensure the strict
adherence by any sublicensee hereunder to the terms and conditions of this
Agreement; and
4.3.4
Prior to the grant of any sublicence pursuant to this Clause 4 (other than a
sublicence to any Affiliate of Licensee), Licensee shall obtain the written
consent of Biologics (such consent not to be unreasonably withheld or delayed),
to the grant of such sublicence. Licensee shall notify Biologics of any
sublicence to any Affiliate of Licensee within thirty (30) days of signature of
such sublicence.
|
4.4
|
Notwithstanding
the fact that the rights granted in Clause 4.1 relate only to a single
molecule which falls within the definition of Product, the Licensee shall
be entitled to conduct Phase I and Phase II Clinical Studies on more than
one (1) antibody which antibodies otherwise satisfy the definition of
Product. These additional rights are granted on the understanding that
they are exploited in every other way in accordance with, and are subject
to, the terms of this Agreement (including specifically Clause 5 below)
and on the understanding Licensee shall identify in writing to Biologics
the specific Product antibody it intends to proceed to develop beyond
Phase II Clinical Studies prior to embarking on such further
development.
|
7
|
4.5
|
Licensee
may provide plasmid vectors containing the DNA sequence
encodingProduct
and cell lines containing those plasmid vectors (hereafter "Licensee
Materials"), but not the Materials themselves, to one or more third
parties for analysis and testing purposes associated with the manufacture
of Product (for example in relation to the integrity of the DNA sequence),
subject to the following provisos:
|
(a) Licensee
shall obtain the written consent of Biologics prior to any disclosure to a third
party, such consent not to be unreasonably withheld or delayed;
and
(b) Licensee
shall have obtained from each such third party an agreement that such third
party shall not use the Licensee Materials for any purpose except as set out
above in this clause 4.5, shall not disclose the Licensee Materials to any other
third party and shall destroy the Licensee Materials upon the conclusion of its
engagement.
|
5.
|
Payments
|
|
5.1
|
In
consideration of the licence granted to Licensee pursuant to Clause 4.1
hereof,
|
Licensee
shall pay Biologics as follows:
|
|
5.1.1
|
where
Biologics manufactures the Product, a royalty of [***] of the Net Selling
Price; or
|
|
|
5.1.2
|
where
Licensee, any of Licensee's Affiliates, including Avid Bioservices Inc. or
Licensee's Strategic Partner manufactures the Product under a sublicence
granted in accordance with Clause
4.3:
|
|
5.1.2.1
|
[***]
commencing upon completion of patient recruitment for phase II clinical
trials; and
|
|
5.1.2.2
|
a
royalty of [***] of the Net Selling
Price.
|
[***]
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.
8
|
5.2
|
In
consideration for the right to sublicense the rights granted by Clause
4.1pursuant
to Clause 4.3, to parties other than those expressly permitted under
clauses
5.1.1 and 5.1.2 above Licensee shall pay Biologics as
follows:
|
|
|
5.2.1
|
[***] per
sublicence per annum during which the sublicence in question subsists,
which sum shall fall due on the commencement date of the relevant
sublicence and on each anniversary of the commencement date of the
relevant sublicence; and
|
|
|
5.2.2
|
a
royalty of [***] of the Net Selling Price of Product
Manufactured by a sublicensee.
|
|
5.3
|
Notwithstanding
the foregoing provisions of this Clause 5, no amount shall bepayable
pursuant to Clause 5.2.1 or 5.2.2 with respect to a sub-licence if such
sub-licence is not for the purpose of manufacturing, and does not permit
or result in the manufacture of, Product for
sale.
|
|
6.
|
Royalty
Procedures
|
|
6.1
|
Licensee
shall keep true and accurate records and books of account containing
alldata
necessary for the calculation of royalties payable to Biologics. Such
records and books of account shall, upon reasonable notice having been
given by Biologics, be open at all reasonable times during business hours
for inspection by Biologics or its duly authorised
representative.
|
|
6.2
|
Subsequent
to the commencement of Product sales, Licensee shall prepare astatement
in respect of each calendar quarter which shall show for the quarter in
question details of the sales of Product and the royalty due and payable
to Biologics thereon.
|
Such
statement shall be submitted to Biologics within thirty (30) days of the end of
the calendar quarter to which it relates together with a remittance for the
royalties due to Biologics.
[***]
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.
9
|
6.3
|
All
sums due under this Agreement:
|
|
|
6.3.1
|
shall
be made in pounds sterling to Biologics. Payments due to Biologics in
currencies other than pounds sterling shall first be calculated in the
relevant local currency before being calculated at the rate of exchange
ruling at the close of business on the day payment is due or made,
whichever is earlier, provided always that where payment is made after the
date provided therefore herein conversion shall be at the rate ruling at
the date of payment if this is more favourable to Biologics. The rate of
exchange shall be the mean value of the Pound Spot Rate in London first
published in the Financial Times on the day following the day for
determining such rates.
|
|
|
6.3.2
|
are
exclusive of any Value Added Tax or of any other applicable taxes, levies,
imposts, duties and fees of whatever nature imposed by or under the
authority of any government or public authority which shall be paid by
Licensee. The parties agree to co-operate in all respects necessary to
take advantage of such double taxation agreements as may be
available.
|
|
6.4
|
Where
Biologics does not receive payment of any sum by the due date, interest
shall accrue thereafter on the sum due and owing to Biologics at the rate
of two percent (2%) over the base rate from time to time of Midland Bank
plc, interest to accrue on a day to day basis without prejudice to
Biologics' right to receive payment on the due
date.
|
|
7.
|
Liability and
Warranties
|
|
7.1
|
Biologics
gives no representation or warranty that the Patent Rights which
arepatent
applications will be granted or if granted will be valid nor that the
exercise of the rights granted to Licensee hereunder will not infringe
other patent rights or intellectual property rights vested in Biologics or
any third party.
|
|
7.2
|
The
Licensee hereby acknowledges that in order to exploit the rights
containedherein
the Licensee may require licences under Biologics patent rights other than
those
herein licensed or under third party patent rights (including those vested
in
Affiliates
of Biologics) that may be infringed by the use by the Licensee of the
rights
licensed herein and it is hereby agreed that it shall be the Licensee's
responsibility to satisfy itself as to the need for such licences and if
necessary to obtain such licences. No licence is granted save as expressly
provided herein and no licence in addition thereto shall be deemed to have
arisen or be implied by way of estoppel or
otherwise.
|
10
|
7.3
|
Licensee
shall indemnify and hold harmless Biologics and its officers,
servantsand
agents at all times in respect of any and all losses, damages, costs and
expenses suffered or incurred as a result of any contractual, tortious or
other claims or proceedings by third parties against Biologics arising in
any way out of the exercise by Licensee of any of the rights granted to it
under this Agreement, and in particular, product liability claims or
proceedings.
|
|
7.4
|
Any
condition or warranty other than those relating to title which might
otherwisebe
implied or incorporated within this Agreement by reason of statute or
common law or otherwise is hereby expressly excluded.
|
|
7.5
|
The
terms of this Clause 7 shall survive termination of the Agreement
forwhatever
reason.
|
|
8.
|
Confidentiality
|
|
8.1
|
Licensee
expressly acknowledges that the Materials Know-How and any other Know-How
with which it is supplied by Biologics pursuant to this Agreement is
supplied in circumstances imparting an obligation of confidence and
Licensee agrees to keep such Know How or Materials Know-How secret and
confidential and to respect Biologics' proprietary rights therein and to
use the same for the sole purpose of this Agreement and not during the
period of this Agreement or at any time for any reason whatsoever to
disclose or permit to be disclosed such Know How or Materials Know-How to
any third party. Licensee shall procure that only its employees shall have
access to the Know How or Materials Know-How on a need to know basis and
that all such employees shall be informed of their secret and confidential
nature and shall be subject to the same obligations as Licensee pursuant
to this Clause 8.1, subject to applicable
law.
|
|
8.2
|
Licensee hereby
undertakes and agrees to keep the Materials and the Cell Lines secure and
safe from loss, damage, theft, misuse and unauthorised access and shall
procure that the Materials and the Cell Lines shall be made available only
to employees of Licensee and other permitted persons under clause 4.5
above on a need to know basis and subject to the same obligations of
confidence as provided in Clause 8.1 hereof, and to use the same for the
sole purpose of this
Agreement.
|
|
8.3
|
Both parties
undertake and agree not to at any time for any reason whatsoever disclose
or permit to be disclosed to any third party or otherwise make use of or
permit to be made use of any trade secrets or confidential information
relating to the business affairs or finances of the other or of any
suppliers, agents, distributors, licensees or other customers of the other
which comes into their possession pursuant to this
Agreement.
|
11
|
8.4
|
The obligations of
confidence referred to in this Clause 8 shall not extend to any
information which :
|
|
|
8.4.1
|
is
or shall become generally available to the public otherwise than by reason
of a breach by the recipient party of the provisions of this Clause
8;
|
|
|
8.4.2
|
is
known to the recipient party and is at its free disposal prior to its
receipt from the other;
|
|
|
8.4.3
|
is
subsequently disclosed to the recipient party without obligations of
confidence by a third party owing no such obligations in respect thereof;
and
|
|
|
8.4.4
|
Biologics
or Licensee may be required to disclose to a government agency for the
purpose of any statutory, regulatory or similar legislative requirement
applicable to the production of Product or to meet the requirements of any
Stock Exchange to which the parties may be subject but only to the extent
such disclosure is required, and subject to obligations of secrecy
wherever possible.
|
|
8.5
|
The obligations of
both parties under this Clause 8 shall survive the expiry or termination
of this Agreement for whatever
reason.
|
9. Patents
|
9.1
|
Biologics
hereby undertakes and agrees that at its own cost and expense it
will:
|
|
|
9.1.1
|
prosecute
or procure prosecution of such of the Patent Rights which are patent
applications diligently to grant so as to secure the best commercial
advantage obtainable so far as it is reasonable to do so with reference to
Biologics' commercial considerations;
and
|
|
|
9.1.2
|
pay
or procure payment of all renewal fees in respect of the Patent Rights
valid and subsisting for the full term thereof and in particular will
procure such renewal of the registrations thereof as may be necessary from
time to time so far as it is reasonable to do so with particular reference
to commercial considerations.
|
|
9.2
|
Licensee
shall promptly notify Biologics in writing of any infringement or improper
or unlawful use of or of any challenge to the validity of the Patent
Rights and/or Materials Know-How that shall become known to the senior
executives of Licensee. Biologics undertakes and agrees to take all such
steps and proceedings and to do all other acts and things as may in
Biologics' sole discretion be necessary to restrain any such infringement
or improper or unlawful use or to defend such challenge to validity and
Licensee shall permit Biologics to have the sole conduct of any such steps
and proceedings including the right to settle them whether or not Licensee
is a party to them. Licensee hereby agrees to co-operate fully with
Biologics at its own cost and expense lending its name to the proceedings
as may be necessary. Biologics shall be entitled to retain any and all
monies received from such
proceedings.
|
12
|
10.
|
Term
and Termination
|
|
10.1
|
Unless
terminated earlier in accordance with the provisions of this Clause 10 or
Clause
13 or 14, this Agreement shall continue in force in each country of the
world, until expiry of the last to expire of a period of fifteen (15)
years from the date of First Commercial Sale or until expiry of the
last Valid Claim, whichever is later always provided that this Agreement
shall terminate before the expiry of the said fifteen (15) year period and
after the expiry of the last Valid Claim if Biologics makes publicly
available the Materials and the Materials
Know-How.
|
|
10.2
|
Licensee
may terminate this Agreement by giving sixty (60) days notice in writing
to Biologics.
|
|
10.3
|
Either
Biologics or Licensee may terminate this Agreement forthwith by notice in
writing to the other upon the occurrence of any of the following events
:
|
|
10.3.1
|
if
the other commits a breach of this Agreement which in the case of a breach
capable of remedy shall not have been remedied within thirty (30) days of
the receipt by the other of a notice identifying the breach and requiring
its remedy.
|
|
10.3.2
|
if
the other is unable to pay its debts or enters into compulsory or
voluntary liquidation (other than for the purpose of effecting a
reconstruction or amalgamation in such manner that the company resulting
from such reconstruction or amalgamation if a different legal entity shall
agree to be bound by and assume the obligations of the relevant party
under this Agreement) or compounds with or convenes a meeting of its
creditors or has a receiver appointed over all or any part of its assets
or takes or suffers any similar action in consequence of a debt, or ceases
for any reason to carry on
business.
|
|
10.4
|
If
at any time during this Agreement Licensee directly or indirectly opposes
or assists any third party to oppose the grant of letters patent or any
patent application within any of the Patent Rights or disputes or directly
or indirectly assists any third party to dispute the validity of any
patent within any of the Patent Rights or any of the claims thereof,
Biologics shall be entitled at any time thereafter to terminate all or any
of the licences granted hereunder forthwith by notice to
Licensee.
|
|
10.5
|
If
this Agreement is terminated for any reason any and all licences granted
hereunder shall terminate with effect from the date of termination and
Licensee shall destroy all Materials and Cell Lines forthwith and shall
certify such destruction immediately thereafter in writing to Biologics.
Licensee shall be permitted to sell such stocks of Product as have been
manufactured or are being manufactured on or prior to the date of
termination of this Agreement, and shall account to Biologics for
royalties on the sale of such products in accordance with clause 5
above.
|
13
|
10.6
|
Termination
for whatever reason or expiration of this Agreement shall not affect the
accrued rights of the parties arising in any way out of this Agreement as
at the date of termination. The right to recover damages against the other
and all provisions which are expressed to survive this Agreement shall
remain in full force and
effect.
|
|
11.
|
Assignment
|
Neither
party shall be entitled to assign, transfer, charge or in any way make over the
benefit and/or the burden of this Agreement without the prior written consent of
the other which consent shall not be unreasonably withheld or delayed, save that
Biologics shall be entitled without the prior written consent of the Licensee to
assign, transfer, charge, sub-contract, deal with or in any other manner make
over the benefit and/or burden of this Agreement to an Affiliate or to any 50/50
joint venture company of which Biologics is the beneficial owner of fifty
percent (50%) or more of the issued share capital thereof or to any company with
which that party may merge or to any company to which that party may transfer
its assets and undertaking, provided in each case of an assignment of burdens,
that all intellectual property and other property and rights of Biologics
necessary to enable such assignee or transferee to specifically perform the
obligations of Biologics hereunder shall also be so assigned or transferred.
Notwithstanding the foregoing, Licensee shall have the right to assign its
rights and obligations hereunder in connection with a sale of all or
substantially all of the assets involved in the line of business that includes
the Product (including a sale of all or substantially all of its assets) without
the prior written consent of Biologics.
|
|
11.2
|
This
Agreement shall be binding upon the successors and assigns of the parties
and the name of a party appearing herein shall be deemed to include the
names of its successors and assigns provided always that nothing herein
shall permit any assignment by either party except as expressly provided
herein.
|
|
12.
|
Governing
Law and Jurisdiction
|
|
|
12.1
|
The
validity, construction and performance of this Agreement shall be governed
by English law.
|
|
|
12.2
|
All
disputes, claims or proceedings between the parties relating to the
validity, construction or performance of this Agreement shall be subject
to the exclusive jurisdiction of the High Court of Justice in England to
which the parties hereto irrevocably
submit.
|
|
|
12.3
|
Each
of the parties irrevocably consents to award or grant of any relief in any
such proceedings before the High Court of Justice in England. Either party
shall have the right to take proceedings in any other jurisdiction for the
purposes of enforcing a judgement or order obtained from the High Court of
Justice in England.
|
14
|
13.
|
Force
Majeure
|
Neither
party shall be in breach of this Agreement if there is any total or partial
failure of performance by it of its duties and obligations under this Agreement
occasioned by any act of God, fire, act of government or state, war, civil
commotion, insurrection, embargo, prevention from or hindrance in obtaining any
raw materials, energy or other supplies, labour disputes of whatever nature and
any other reason beyond the control of either party. If either party is unable
to perform its duties and obligations under this Agreement as a
direct result of the effect of one of the reasons set out in this Clause
13 such party shall give written notice to the other of such inability stating
the reason in question. The operation of this Agreement shall be suspended
during the period (and only during the period) in which the reason continues.
Forthwith upon the reason ceasing to exist the party relying upon it shall give
written advice to the other of this fact. If the reason continues for a period
of more than ninety (90) days and substantially affects the commercial basis of
this Agreement the party not claiming under this Clause 13 shall have the right
to terminate this Agreement by giving sixty (60) days written notice of such
termination to the other party.
|
14.
|
Illegality
|
If any
provision or term of this Agreement or any part thereof shall become or be
declared illegal, invalid or unenforceable for any reason whatsoever including
but without limitation by reason of the provisions of any legislation or other
provisions having the force of law or by reason of any decision of any Court or
other body or authority having jurisdiction over the parties hereto or this
Agreement including the EC Commission or the European Court of Justice, such
terms or provisions shall be divisible from this Agreement and shall be deemed
to be deleted from this Agreement in the jurisdiction in question provided
always that if any such deletion substantially affects or alters the commercial
basis of this Agreement either party shall have the right to terminate this
Agreement by giving sixty (60) days written notice of such termination to the
other party.
|
15.
|
Entire
Agreement/Amendment/Waiver/Press
Releases/Costs
|
|
|
15.1
|
This
Agreement embodies and sets forth the entire agreement and understanding
of the parties and supersedes all prior oral and written agreements,
understanding or arrangements relating to the subject matter of this
Agreement. Neither party shall be entitled to rely on any agreement,
understanding or arrangement which is not expressly set forth in this
Agreement.
|
|
|
15.2
|
This
Agreement shall not be amended, modified, varied or supplemented except in
writing signed by duly authorised representatives of the
parties.
|
15
|
|
15.3
|
No
failure or delay on the part of either party hereto to exercise any right
or remedy under this Agreement shall be construed or operated as a waiver
thereof nor shall any single or partial exercise of any right or remedy
under this Agreement preclude the exercise of any other right or remedy or
preclude the further exercise of such right or remedy as the case may be.
The rights and remedies provided in this Agreement are cumulative and are
not exclusive of any rights or remedies provided by
law.
|
|
|
15.4
|
The
text of any press release or other communication to be published by or in
the media whether or a scientific nature or otherwise and concerning the
subject matter of this Agreement shall require the prior written approval
of Biologics.
|
|
|
15.5
|
Each
of the parties hereto shall be responsible for its respective legal and
other costs incurred in relation to the preparation of this
Agreement.
|
|
16.
|
Notice
|
|
|
16.1
|
Any
notice or other document to be given under this Agreement shall be in
writing and shall be deemed to have been duly given if left at or sent by
registered post, courier, facsimile or other electronic media to a party
or delivered in person to a party at the address or facsimile number set
out below for such party or such other address as the party may from time
to time designate by written notice to the
other(s):
|
Address
of Biologics
Lonza
Biologics plc, 228 Bath Road, Slough, Berkshire SL1 4DX
Facsimile
: 01753 777001
Address
of Licensee
Peregrine
Pharmaceuticals Inc, 14282 Franklin Avenue, Tustin, CA 92780-7017
Facsimile
: 001 714 838 4094
|
|
16.2
|
All
such notices and documents shall be in the English language. Any such
notice or other document shall be deemed to have been received by the
addressee seven (7) working days following the date of despatch of the
notice or other document by post or, where the notice or other document is
sent by hand or is given by facsimile or other electronic media,
simultaneously with the transmission or delivery. To prove the giving of a
notice or other document it shall be sufficient to show that it was
despatched.
|
16
|
17.
|
Interpretation
|
|
|
17.1
|
The
headings in this Agreement are inserted only for convenience and shall not
affect the construction hereof.
|
|
|
17.2
|
Where
appropriate words denoting a singular number only shall include the plural
and vice versa.
|
|
17.3
|
Reference
to any statute or statutory provision includes a reference to the statute
or statutory provision as from time to time amended, extended or
re-enacted.
|
AS
WITNESS the hands of the duly authorised representatives of the parties
hereto
|
Signed
for and on behalf of
|
|
| LONZA BIOLOGICS PLC | /s/ LONZA BIOLOGICS PLC |
| TITLE: Director | |
| DATE: 14Mar2005 | |
|
Signed
for and on behalf of
|
|
| PEREGRINE PHARMACEUTICALS INC | /s/ Paul Lytle |
|
TITLE:
CFO
|
|
| DATE: 3/1/05 | |
17
SCHEDULE
1
PATENT
RIGHTS
|
Biologics
Ref:
|
LBP07
(formerly known as PA 98)
|
|
Priority
Dates:
|
01.04.85
and 03.09.85
|
|
Title:
|
Transformed
Myeloma Cell-Line and a Process for the Expression of a
|
|
Gene
Coding for a Eukaryotic Polypeptide employing same
|
|
|
Inventors:
|
John
Henry Kenten
|
|
|
Michael
Alan Boss
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Australia
|
*584417
|
01.04.02
|
||
|
Bulgaria
|
77296
|
-
|
||
|
Canada
|
*1319120
|
15.06.10
|
||
|
Europe+
|
*216846
|
01.04.06
|
||
|
Japan
|
501959/86
|
-
|
||
|
United
Kingdom
|
*2183662
|
01.04.06
|
||
|
USA
|
07/701374
|
-
|
||
|
Russia
(formerly a USSR application)
|
4028654.13
|
+ includes Austria,
Belgium, France, Germany, Italy, Luxembourg, Netherlands, Swede and
Switzerland.
18
|
Biologics
Ref:
|
PA
108
|
|
Priority
Date:
|
23.01.86
|
|
Title:
|
Recombinant
DNA Sequences, Vectors containing them and Method for
the
|
|
use
thereof
|
|
|
Inventors:
|
Richard
Harris Wilson (Glasgow University)
|
|
|
Christopher
Robert Bebbington
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
or
* Patent Number
|
||||
|
Australia
|
*599081
|
23.01.03
|
||
|
Canada
|
528011
|
-
|
||
|
Europe+
|
*256055
|
23.01.07
|
||
|
Japan
|
500891/87
|
-
|
||
|
USA
|
*5122464
|
16.06.09
|
||
|
USA
(Divisional)
|
07/852390
|
-
|
+ includes
Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Swede and
Switzerland.
19
|
Biologics
Ref:
|
LBP09
(formerly known as PA 140)
|
|
Priority
Date:
|
23.07.87
|
|
Title:
|
Recombinant
DNA Product and Processes using it
|
|
Inventors:
|
Christopher
Robert Bebbington
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Europe+
|
*323997
|
22.07.08
|
||
|
Japan
|
506088/88
|
|||
|
USA
|
07/339615
|
+ includes Austria, Belgium, France, Germany, Italy, Luxembourg, Netherlands, Sweden, Switzerland and United Kingdom
20
|
Biologics
Ref:
|
LBP10
(formerly known as PA 177)
|
|
Priority
Date:
|
18.04.88
|
|
Title:
|
Recombinant
DNA Methods, Vectors and Host Cells
|
|
Inventors:
|
Christopher
Robert Bebbington
|
|
|
Geoffrey
Thomas Yarranton
|
|
Territory
|
Patent
Application
|
Patent
Expiry Date
|
||
|
|
or
* Patent Number
|
|||
|
Australia
|
*624616
|
18.04.05
|
||
|
Canada
|
597034
|
|||
|
Europe+
|
89303964.4
|
|||
|
Japan
|
505128/89
|
|||
|
USA
|
07/460154
|
+ includes Austria,
Belgium, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain, Sweden,
Switzerland and United Kingdom
21