EXHIBIT 10.9
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
ALZA Contract # 20001780
INTERIM DEVELOPMENT
AGREEMENT
This INTERIM DEVELOPMENT
AGREEMENT (“Agreement”) is entered into as of this
8th day of November, 2000 between ALZA CORPORATION
(“ALZA”) and BIOMEDICINES, INC.
(“BioMedicines”).
RECITALS
A.
ALZA and BioMedicines have entered
into discussions with respect to the development of a product
utilizing proprietary technology of ALZA for the controlled
delivery of BioMedicines’ proprietary Interferon Omega
recombinant protein and have signed a Confidentiality Agreement
dated May 10, 2000 (the “Confidentiality Agreement”) in
that regard.
B.
The parties wish to commence the
development of such product while negotiating the definitive
agreement covering the development, manufacture and marketing of
such product.
NOW THEREFORE,
in consideration of the mutual
covenants and agreements provided herein, the parties hereby agree
as follows:
1.
DEFINITIONS
. For the purposes of this
Agreement, the following terms shall have the respective meanings
set forth below:
1.1
“Confidential
Information” shall
mean (i) in the case of BioMedicines, information disclosed by
BioMedicines to ALZA on or after the Effective Date hereof
concerning Drug (as defined herein) as such, or the use or
manufacture thereof, owned by or licensed to BioMedicines prior to
the date of the Confidentiality Agreement or developed by
BioMedicines after the date of the Confidentiality Agreement
outside the Program (as defined herein) and without reference to or
use of any Program Information (as defined herein) or ALZA
Confidential Information, and (ii) in the case of ALZA, information
disclosed by ALZA to BioMedicines on or after the Effective Date
hereof concerning the System, or the use or manufacture thereof, or
otherwise useful to the Program, owned by or licensed to ALZA prior
to the date of the Confidentiality Agreement or developed by ALZA
after the date of the Confidentiality Agreement outside the Program
and without reference to or use of any Program Information or
BioMedicines Confidential Information. Confidential
Information will not include any information which is (i) now in
the public domain or subsequently enters the public domain without
fault on the part of the receiving party; (ii) known by the
receiving party from its own sources, as evidenced by the receiving
party’s written records made prior to the date of the
Confidentiality Agreement; or (iii) received from any third party
not under any obligation to keep such information
confidential.
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1.2
“Development
Costs” shall mean
the costs of the Program incurred by ALZA pursuant to this
Agreement and determined in accordance with Exhibit A
hereto.
1.3
“Drug”
shall mean BioMedicines’
proprietary Interferon Omega recombinant protein in its pure form
or in the formulation originally provided to ALZA by BioMedicines
hereunder.
1.4
“Effective
Date” shall mean
November 8, 2000.
1.5
“Product”
shall mean the product developed
under the Program which combines Drug with System or another
product combining Drug with System that is substantially identical
to the Product.
1.6
“Program”
shall mean all activities undertaken
on or after the Effective Date by either or both parties in
accordance with the terms hereof for the development of a Product,
including regulatory and clinical activities.
1.7
“Program
Information” shall
mean any Technical Information and Regulatory Data developed or
acquired by either party under or as a result of the
Program.
1.8
“Regulatory
Data” shall mean
regulatory filings (but not any Program Information owned by ALZA
or any of ALZA’s Confidential Information contained therein,
which shall remain the property of ALZA) resulting from the Program
and clinical study results resulting from activities under the
Program.
1.9
“System”
shall mean an implantable osmotic
system which is intended to function by releasing the active agent
or agents on a controlled basis. The term “System” will
include anything incorporated in or used in connection with, or
which is an attribute of, the Product, or the development thereof,
including anything which affects or may affect the
pharmacodynamics, pharmacokinetics, stability or absorption of a
therapeutic agent or the formulation, stabilization or use of a
therapeutic agent in the System (in each case other than the Drug
itself, any formulation of the Drug itself provided to ALZA by
BioMedicines created by BioMedicines not under or as a result of
the Program or any other therapeutic agent not physically
incorporated into or onto the System).
1.10
“Technical
Information” shall
mean know-how, ideas, trade secrets, inventions (including patents
covering such inventions), data, technology and information,
including improvements and modifications to any thereof, processes
and analytical methodology used in development, testing, analysis
and manufacture, and medical, clinical, toxicological and other
scientific data developed or acquired by either party under or as a
result of the Program. Notwithstanding the foregoing,
Technical Information will not include trademarks or Regulatory
Data.
2.
PRODUCT DEVELOPMENT
PROGRAM .
2.1
Promptly after execution of this
Agreement and receipt from BioMedicines of Drug and the materials
described in Section 2.3, the parties will commence the
Program. In connection with the Program, the parties will
make available appropriate scientific,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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engineering and other personnel to perform tasks
under the Program. The parties will use diligent efforts to
carry out the Program, will participate in periodic conferences to
review its status and will cooperate in the prompt preparation and
review of, and discussion concerning, work plans and cost estimates
and revisions thereto as further described in
Section 2.2.
2.2
The initial work plan for, and the
initial cost estimate for ALZA’s activities under the Program
is attached hereto as Exhibit B. The parties understand and
agree that it is difficult to accurately predict the activities
that will be necessary to develop the Product, or the cost thereof,
and significant uncertainties exist in any product development
effort. As a result, any such work plan and cost estimate
will be diligently reviewed and revised from time to time in order
that it remain a faithful best-estimate of work to be done by the
parties under the Program and, with regard to ALZA’s
activities, the Development Costs thereof.
2.3
In connection with the Program,
BioMedicines will provide to ALZA, at no charge to ALZA, such
quantities of Drug which ALZA may reasonably require to carry out
its duties hereunder. BioMedicines will provide ALZA with a
Material Safety Data Sheet for the Drug and will complete and
return ALZA’s Safety and Environmental Evaluation
Questionnaire prior to commencement of the Program.
BioMedicines will also provide ALZA with all relevant information
available and known to BioMedicines concerning the safety,
handling, use, disposal and environmental effects of the Drug or as
may be necessary to conduct the Program. ALZA will provide
BioMedicines with all relevant information available and known to
ALZA concerning the safety, handling, use, disposal and
environmental effects on the System or as may be necessary to
conduct the Program.
BioMedicines will indemnify, defend
and hold ALZA harmless from and against all liabilities, claims,
demands, damages, losses, costs, expenses or money judgments
(including reasonable attorneys’ fees) incurred by or
rendered against ALZA and resulting from the use, storage or
handling of the Drug under the Program, except to the extent that
ALZA has not complied with written materials provided in advance by
BioMedicines as described above. Notwithstanding the
foregoing, BioMedicines shall not be required to indemnify ALZA for
actions by ALZA that represent willful misconduct, gross negligence
or a material violation of the law.
2.4
BioMedicines will pay to ALZA, on a
monthly basis, all Development Costs incurred by ALZA in connection
with the activities carried out under the Program. ALZA will
invoice BioMedicines on or before the fifteenth day of each month
for the preceding month’s Development Costs. All
payments will be made within 30 days after the date of the
invoice. Notwithstanding the foregoing, BioMedicines will not
be obligated to pay Development Costs in excess of those provided
for in approved work plans and cost estimates, and ALZA will not be
obligated to perform any work which would result in Development
Costs exceeding such approved cost estimates.
2.5
Each party will, for the term of
this Agreement and for [ * ] after its expiration or
termination for any reason, keep confidential and not disclose to
others, and use only as permitted hereunder in connection with the
Program, (a) all clinical study results resulting from activities
under the Program (unless such results fall within the exceptions
set forth in subsections (i), (ii) and (iii) in the last sentence
of Section 1.1 above), (b) all of the other
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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party’s Confidential Information and (c)
all Program Information (other than such clinical study results)
owned by the other party. Notwithstanding the foregoing, such
information may be (i) disclosed to government and regulatory
agencies where such information may be required to be included in
patent applications or regulatory filings permitted under the terms
of this Agreement; (ii) provided to third parties under agreements
including appropriate confidentiality provisions for consulting,
market research, manufacturing, development, and clinical testing
with respect to the Product and similar activities under the
Program; (iii) published if and to the extent such publication has
been approved in writing by each of the parties (provided, however,
results of clinical studies of the Product may be published without
the prior written approval of both parties if and to the extent any
such publication has been reviewed to ensure that no Confidential
Information or Program Information (other than the results of
clinical studies of the Product) has been disclosed and each party
has been given at least 60 days to file a patent application to
protect any patentable invention owned by it which would otherwise
be disclosed in such publication); or (iv) disclosed to the extent
required by applicable laws or regulations or as ordered by a court
or other regulatory body having competent jurisdiction. In
each of the foregoing cases, the other party will use diligent
efforts to limit the disclosure and maintain confidentiality to the
extent reasonably possible.
2.6
As part of the Program, BioMedicines
may conduct clinical studies of the Product, at its sole cost and
expense. In such instances:
(a)
ALZA will have the right to review
and comment upon all proposed protocols, forms of informed consent
forms, investigator brochures and all forms of investigator
agreements and contract research organization agreements (other
than with respect to the financial arrangements under such
agreements) for any clinical studies to be conducted by or on
behalf of BioMedicines with respect to the Product. ALZA
agrees to provide its comments to BioMedicines in writing as soon
as reasonably practicable but in any event within 30 days of
receipt of such documents. BioMedicines will make such
changes in any such documents as may be reasonably requested by
ALZA in writing with respect to the use of the System or any
reference to or description of ALZA or to otherwise protect the
rights or intellectual property interests of ALZA as described
herein.
(b)
Clinical supplies shall be supplied
by ALZA on a Development Cost basis and shall be manufactured in
accordance with current Good Manufacturing Practices as defined
from time to time by the Act (as defined in Section 2.8) or
any successor laws or regulations governing the manufacture of
clinical supplies of Product in the United States
(“GMPs”).
(c)
In order to assist in obtaining
patent protection for the Product outside the United States, unless
otherwise agreed in writing by ALZA, prior to conducting any
clinical study, BioMedicines will obtain from each participating
subject or patient, a confidentiality agreement in the form
attached hereto as Exhibit C and will deliver an executed copy
thereof to ALZA. If ALZA requires BioMedicines to obtain such
an agreement, ALZA shall pay the cost of any translation thereof as
required by applicable law or regulations.
(d)
Within a reasonable time after
completion or termination of each clinical study, BioMedicines will
deliver a final report concerning the study to ALZA.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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Publication of any data or information derived
from the study, or any reports thereof, will be subject to the
mutual agreement of the parties, (provided, however, results of
clinical studies of the Product may be published without the prior
written approval of both parties if and to the extent any such
publication has been reviewed to ensure that no Confidential
Information or Program Information (other than the results of
clinical studies of the Product) has been disclosed and each party
has been given at least 60 days to file a patent application to
protect any patentable invention owned by it which would otherwise
be disclosed in such publication).
(e)
If and to the extent that any
clinical studies are undertaken pursuant to this Agreement,
BioMedicines will indemnify, defend and hold ALZA harmless from and
against any and all liabilities, claims, demands, damages, losses,
costs, expenses or money judgments (including reasonable
attorneys’ fees) incurred by or rendered against ALZA, and
which arise out of or result from the clinical studies or the use,
design or labeling of the Product in connection therewith, except
as may arise from the gross negligence or willful misconduct of
ALZA. ALZA will give BioMedicines prompt notice in writing,
in the manner set forth in Section 5.3 below, of any claim or
demand made against ALZA for which ALZA may be entitled to
indemnity under this Section 2.6.
(f)
If and to the extent that any
clinical studies are undertaken pursuant to this Agreement, ALZA
will indemnify, defend and hold BioMedicines harmless from and
against any and all liabilities, claims, demands, damages, losses,
costs, expenses or money judgments (including reasonable
attorneys’ fees) incurred by or rendered against
BioMedicines, which arise out of or result from the gross
negligence or willful misconduct of ALZA or the failure by ALZA to
deliver clinical supplies manufactured in accordance with GMPs as
described in Section 2.6(b). BioMedicines will give ALZA
prompt notice in writing, in the manner set forth in
Section 5.3 below, of any claim or demand made against
BioMedicines for which BioMedicines may be entitled to indemnity
under this Section 2.6.
2.7
As part of the Program, ALZA will
have the right, but not the obligation, to review and comment upon
all regulatory filings proposed to be made by BioMedicines with
respect to the Product, and BioMedicines will include any changes
reasonably requested by ALZA with respect to the use of the System
or any reference to or description of ALZA or to otherwise protect
the rights or intellectual property interests of ALZA as described
herein. Such changes must be provided within 10 business days
after ALZA’s receipt of the proposed filing from
BioMedicines. ALZA will have the right, but not the
obligation, to participate in any meetings to be held with
regulatory authorities with respect to the Product, and
BioMedicines will promptly provide ALZA with copies of all
correspondence from or to regulatory authorities concerning the
Product. If ALZA does elect to participate in any meeting,
then ALZA shall promptly inform BioMedicines of its decision and
agrees to coordinate its activities with BioMedicines in
preparation for said meeting(s). Notwithstanding the
foregoing, unless otherwise agreed subsequently, BioMedicines shall
be responsible for the conduct of all meetings with regulatory
authorities regarding the Product.
2.8
Each party will promptly notify the
other party of any information that it obtains or develops
regarding the efficacy or safety of the Product or the System but
only insofar as such System-related information bears on the safety
or efficacy of the Product. ALZA and BioMedicines also agree
to exchange adverse drug reaction reports in a manner and time
frame
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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that will allow compliance with regulatory
reporting requirements, including any requirements of the U.S.
Food, Drug and Cosmetic Act, 21 U.S.C. 312 et seq., and regulations
promulgated thereunder (the “Act”) (and, if applicable,
the ICH guidelines) and ongoing safety review of the Product.
After execution of this Agreement but prior to the initiation of
any clinical trial of the Product, the parties will agree in
writing upon standard operating procedures for reporting adverse
events to regulatory authorities and to each other.
BioMedicines agrees and acknowledges that ALZA may provide
information it obtains under this Section 2.8 to ALZA’s
other clients developing and/or marketing other products
incorporating the System or similar delivery systems.
2.9
Prior to [ * ] , BioMedicines
will not conduct (by itself or with a third party) any material
development or commercialization activities with respect to any
product (other than the Product) which incorporates any [ *
] into any drug delivery system for the controlled or sustained
release of such [ * ] and intended for commercialization in
any subterritory in which BioMedicines retains exclusive
commercialization rights to the Product (as described in Exhibit D
attached hereto). Prior to [ * ] , ALZA will not
conduct (by itself or with any third party) any material
development or commercialization activities with respect to any
product (other than the Product) which incorporates any [ *
] ) into any [ * ] drug delivery system and intended for
commercialization in any subterritory in which BioMedicines retains
exclusive commercialization rights to the Product (as described in
Exhibit D attached hereto) so long as BioMedicines is using
diligent efforts to carry out the Program and is not otherwise in
material breach of this Agreement. Thereafter, neither party
will conduct (by itself or with a third party) any material
development or commercialization activities with respect to any
product (other than the Product) incorporating [ * ] drug
delivery system and intended for commercialization in any
subterritory in which BioMedicines retains exclusive
commercialization rights to the Product (as described in Exhibit D
attached hereto).
3.
OWNERSHIP .
3.1
Technical Information will be (a)
the property of BioMedicines if and to the extent (i) [ * ]
or (ii) [ * ] , and (b) the property of ALZA [ * ]
. [ * ] will be the property of BioMedicines, subject
to the confidentiality obligations set forth in
Section 2.5.
3.2
Each party has the right, with
respect to Program Information owned by the other party under
Section 3.1, to use such information to carry out the Program
during the term of this Agreement. Each party has the right,
with respect to Program Information owned by it under
Section 3.1, to disclose and to license such Program
Information to third parties; provided, however, that during the
term of this Agreement, no such use will be inconsistent with the
terms of this Agreement.
3.3
In addition, if BioMedicines
terminates this Agreement or determines not to proceed with the
Program for any reasons other than (i) an uncured material breach
of this Agreement by ALZA or (ii) the failure of the parties to
enter into a definitive development and commercialization agreement
on the terms in Exhibit D attached hereto (unless such failure is
based on BioMedicines’ failure to negotiate such an agreement
in good faith), BioMedicines hereby grants ALZA a worldwide,
royalty-free, nonexclusive license in perpetuity to use
all
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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Regulatory Data (including the right to
cross-reference the Regulatory Data contained in the regulatory
filings made in connection with the Program).
3.4
Nothing in this Agreement shall
provide or imply under any circumstance (i) the right of
BioMedicines to use or license the System from ALZA; (ii) the right
of ALZA to use or license [ * ] from BioMedicines; or (iii)
the right of either party to otherwise use or license any
intellectual property owned by the other party except as
specifically provided in this Agreement concerning Program
Information.
3.5
Each party agrees to enter promptly
into good faith negotiations with the other party for a definitive
development and commercialization agreement, consistent with the
terms set forth on Exhibit D attached hereto, and such additional
terms and conditions as the parties will agree, covering the
development and manufacture by ALZA and marketing by BioMedicines
of the Product.
4.
TERM AND TERMINATION
.
4.1
This Agreement will remain in effect
until such time as work is no longer being carried out under the
Program in accordance with mutually approved work plans and cost
estimates.
4.2
BioMedicines may terminate this
Agreement at any time upon not less than sixty (60) days’
written notice to ALZA. ALZA may terminate this Agreement
upon not less than thirty (30) days’ written notice to
BioMedicines but only if BioMedicines fails to pay any amounts due
to ALZA under this Agreement within thirty (30) days after the date
of invoice or if BioMedicines is not proceeding diligently with the
Program in accordance with Section 2.1 hereof.
4.3
Termination of this Agreement will
be without prejudice to ALZA’s right to receive from
BioMedicines (i) payment of all Development Costs incurred prior to
the effective date of the termination and (ii) all Program
Information owned by it. Termination of this Agreement by
BioMedicines will be without prejudice to BioMedicines’ right
to receive from ALZA all Program Information owned by it.
After termination of this Agreement by BioMedicines or termination
by ALZA due to a breach of this Agreement by BioMedicines,
BioMedicines will reimburse ALZA, within thirty (30) days after
invoice, for any uncancellable obligations and expenses incurred by
ALZA prior to such termination in connection with the Program and
all costs incurred by ALZA in terminating the Program.
4.4
Upon termination of this Agreement,
ALZA will return all unused Drug to BioMedicines, if requested by
BioMedicines in writing within thirty (30) days after termination,
or otherwise will dispose of it at BioMedicines’
expense.
5.
MISCELLANEOUS
.
5.1
This Agreement will be governed by
and construed in accordance with the laws of the State of
California, excluding any choice of law rules which may direct the
application of the laws of another jurisdiction.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 406 OF THE SECURITIES EXCHANGE ACT OF 1933, AS
AMENDED.
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5.2
This Agreement will not be amended
or modified except in a writing signed by each of the parties
hereto.
5.3
All notices, requests and other
communications required or permitted to be given hereunder or with
respect hereto will be in writing, and may be given by (i) personal
delivery, (ii) registered first-class United States mail, postage
prepaid by the sender, return receipt requested, (iii) overnight
delivery service, charges prepaid by the sender, or (iv) via
facsimile and, in each case, addressed to the other party at the
address for such party as set forth below, and will be effective
upon receipt in the case of (i) (iii) or (iv) above, and five days
after mailing in the case of (ii) above.
If to ALZA:
ALZA Corporation
1900 Charleston Road
Mountain View, CA
94043
Fax #: 650-564-7848
Attention: General
Counsel
If to BioMedicines:
BioMedicines, Inc.
1301 Marina Village
Parkway
Suite 200
Alameda, CA 94501
Fax #: 510-814-0170
Attention: Vice President,
Chemical Development
Any party may change its address at which notice
is to be received by written notice provided pursuant to this
Section 5.3.
5.4
Each party will be responsible for
assuring that all applicable rules, laws and regulations are met in
the performance of its respective duties hereunder.
5.5
This Agreement, together with the
exhibits hereto, sets forth the entire agreement and understanding
between the parties with respect to the subject matter hereof, and
supersedes all prior agreements and understandings between the
parties with respect to the subject matter hereof, whether oral or
in writing; provided, however, that the provisions of the
Confidentiality Agreement (other than with respect to the term of
confidentiality which is hereby amended to e
