LICENSE AGREEMENT between LONZA BIOLOGICS PLC and PEREGRINE PHARMACEUTICALS INC
Exhibit 10.24
between
LONZA
BIOLOGICS PLC
and
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
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18 |
2
THIS
AGREEMENT is made with effect from the 1st day
of March 2005
BETWEEN
LONZA
BIOLOGICS PLC of 000 Xxxx Xxxx, Xxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx (hereinafter
referred to as "Biologics"), and
PEREGRINE
PHARMACEUTICALS INC, of 00000 Xxxxxxxx Xxxxxx, Xxxxxx, XX 00000-0000, XXX
(hereinafter referred to as "Licensee")
WHEREAS
A.
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Biologics
is the proprietor of a system for gene expression utilising glutamine
synthetase, and
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B.
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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.
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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)
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normal
discounts actually granted;
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(b)
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credits
allowed for Product or other goods returned or not accepted by
customers;
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(c)
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packaging,
transportation and prepaid insurance charges on shipments or deliveries to
customers;
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(d)
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taxes
actually incurred and paid by Licensee in connection with the sale or
delivery of Product or other goods to
customers;
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(e)
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cost
of radio isotopes, including cost of radio labelling services, which are
added to Product prior to sale;
and
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(f)
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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.
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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
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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.
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3. Ownership of Property and Intellectual
Property
3.1
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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.
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3.2
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The
provisions of this Clause 3 shall survive termination of this
Agreement.
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6
4. Licences
4.1
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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.
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4.2
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The
Licensee hereby undertakes not to make any modifications or adaptations to
the Materials or the Cell Lines during the subsistence of this
Agreement.
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4.3
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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:
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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
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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.
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7
4.5
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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:
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(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.
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Payments
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5.1
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In
consideration of the licence granted to Licensee pursuant to Clause 4.1
hereof,
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Licensee
shall pay Biologics as follows:
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5.1.1
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where
Biologics manufactures the Product, a royalty of [***] of the Net Selling
Price; or
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5.1.2
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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:
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5.1.2.1
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[***]
commencing upon completion of patient recruitment for phase II clinical
trials; and
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5.1.2.2
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a
royalty of [***] of the Net Selling
Price.
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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.
8
5.2
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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:
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5.2.1
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[***] 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
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5.2.2
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a
royalty of [***] of the Net Selling Price of Product
Manufactured by a sublicensee.
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5.3
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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.
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6.
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Royalty
Procedures
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6.1
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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.
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6.2
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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.
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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
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All
sums due under this Agreement:
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6.3.1
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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.
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6.3.2
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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.
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6.4
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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.
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7.
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Liability and
Warranties
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7.1
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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.
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7.2
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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.
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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.
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7.4
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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.
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7.5
|
The
terms of this Clause 7 shall survive termination of the Agreement
forwhatever
reason.
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8.
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Confidentiality
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8.1
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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.
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8.2
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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.
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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.
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11
8.4
|
The obligations of
confidence referred to in this Clause 8 shall not extend to any
information which :
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8.4.1
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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;
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8.4.2
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is
known to the recipient party and is at its free disposal prior to its
receipt from the other;
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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
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8.4.4
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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.
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8.5
|
The obligations of
both parties under this Clause 8 shall survive the expiry or termination
of this Agreement for whatever
reason.
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9. Patents
9.1
|
Biologics
hereby undertakes and agrees that at its own cost and expense it
will:
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9.1.1
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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
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9.1.2
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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.
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9.2
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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.
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12
10.
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Term
and Termination
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10.1
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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.
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10.2
|
Licensee
may terminate this Agreement by giving sixty (60) days notice in writing
to Biologics.
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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
:
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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.
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10.3.2
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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.
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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.
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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.
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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.
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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.
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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.
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12.
|
Governing
Law and Jurisdiction
|
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12.1
|
The
validity, construction and performance of this Agreement shall be governed
by English law.
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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.
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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.
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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, 000 Xxxx Xxxx, Xxxxxx, Xxxxxxxxx XX0 0XX
Facsimile
: 01753 777001
Address
of Licensee
Peregrine
Pharmaceuticals Inc, 00000 Xxxxxxxx Xxxxxx, Xxxxxx, XX 00000-0000
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/ Xxxx Xxxxx |
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:
|
Xxxx
Xxxxx Xxxxxx
|
|
Xxxxxxx
Xxxx Xxxx
|
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
|
||
Xxxxx
|
000000/00
|
-
|
||
Xxxxxx
Xxxxxxx
|
*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:
|
Xxxxxxx
Xxxxxx Xxxxxx (Glasgow University)
|
|
Xxxxxxxxxxx
Xxxxxx Xxxxxxxxxx
|
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:
|
Xxxxxxxxxxx
Xxxxxx Xxxxxxxxxx
|
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:
|
Xxxxxxxxxxx
Xxxxxx Xxxxxxxxxx
|
|
Xxxxxxxx
Xxxxxx 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