EXHIBIT 10.18
COLLABORATIVE RESEARCH AGREEMENT
This COLLABORATIVE RESEARCH AGREEMENT is entered into as of May 31, 1996 by and
between PFIZER INC., a Delaware corporation, having an office at 000 Xxxx 00xx
Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 and its Affiliates ("Pfizer"), and MEGABIOS
CORP. ("MEGABIOS"), a California corporation, having an xxxxxx xx 000X Xxxxxx
Xxxx, Xxxxxxxxxx, XX 00000.
WHEREAS, Megabios has expertise in lipid-based gene delivery and expression; and
WHEREAS, Megabios has filed the patent applications set forth in Exhibit A
attached to and made part of this Agreement with respect to gene therapy and
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lipid-based delivery of genes to vascular endothelium; and
WHEREAS, Pfizer has the capability to undertake research for the discovery and
evaluation of agents for treatment of disease and also the capability for
clinical analysis, manufacturing and marketing with respect to cancer;
WHEREAS, the parties plan to seek patent protection for all Products which make
up the subject matter of this Agreement and the License and Royalty Agreement
("License Agreement") between the parties of even date;
NOW, THEREFORE, the parties agree as follows:
1. Definitions
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Whenever used in this Agreement, the terms defined in this Section 1 shall have
the meanings specified.
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1.1 "Affiliate" means any corporation or other legal entity owning,
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directly or indirectly, fifty percent (50%) or more of the voting capital shares
or similar voting securities of Pfizer or Megabios; any corporation or other
legal entity fifty percent (50%) or more of the voting capital shares or similar
voting rights of which is owned, directly or indirectly, by Pfizer or Megabios
or any corporation or other legal entity fifty percent (50%) or more of the
voting capital shares or similar voting rights of which is owned, directly or
indirectly, by a corporation or other legal entity which owns, directly or
indirectly, fifty percent (50%) or more of the voting capital shares or similar
voting securities of Pfizer or Megabios.
1.2 "Annual Commitment" means the maximum amount to be paid to
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Megabios by Pfizer to fund the Research Program for any Commitment Year.
1.3 "Annual Research Plan" means the written plan describing the
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research and budgets in the Area to be carried out during each Commitment Year
by Pfizer and Megabios pursuant to this Agreement. Each Annual Research Plan
will be attached to and made a part of this Agreement as Exhibit B.
1.4 "Research Program" is the collaborative research program in the
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Area conducted by Pfizer and Megabios pursuant to the Annual Research Plans in
effect during the Contract Period.
1.5 "Effective Date" is May 31, 1996.
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1.6 "Contract Period" means the period beginning on the Effective
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Date and ending on the date on which this Agreement terminates or expires
pursuant to Section 9.
1.7 "Commitment Year" means a twelve-month period commencing on the
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Effective Date and each anniversary of that date during the Contract Period.
1.8 "Area" means research and development with respect to
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angiogenesis inhibition for cancer gene therapy indications with targeting to
vascular
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endothelium in human beings as is set forth in the Annual Research Plans.
"Angiogenesis inhibition" includes [*_______________________________________]
genes to inhibit or to kill cells.
1.9 "Technology" means and includes all materials, technology,
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technical information know-how, expertise and trade secrets within the Area.
1.10 "Megabios Technology" means Technology that is or was:
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(a) developed by employees of or consultants to Megabios alone
or jointly with third parties prior to the Effective Date; or
(b) acquired by purchase, license, assignment or other means
from third parties by Megabios prior to the Effective Date, excluding Technology
licensed by Megabios from Stanford University (see Section 7 below).
1.11 "Joint Technology" means Technology that is or was:
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(a) developed by employees of or consultants to Pfizer or
Megabios solely or jointly with each other during the Contract Period; or
(b) acquired by purchase, license, assignment or other means
from third parties by Megabios or Pfizer during the Contract Period as agreed by
the parties pursuant to Section 7 below.
1.12 "Pfizer Technology" means Technology that is or was:
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(a) developed by employees of or consultants to Pfizer alone or
jointly with third parties prior to the Effective Date; or
(b) acquired by purchase, license, assignment or to other
means from third parties by Pfizer prior to the Effective Date.
1.13 "Megabios Confidential Information" means all information about
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any element of the Megabios or Joint Technology which is disclosed by Megabios
to Pfizer and designated "Confidential" in writing by Megabios at the time of
disclosure to Pfizer to the extent that such information as of the date of
disclosure to Pfizer is not (i) known to Pfizer other than by virtue of a prior
confidential
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELTY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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disclosure to Pfizer by Megabios; or (ii) disclosed in published literature, or
otherwise generally known to the public through no fault or omission of Pfizer;
or (iii) obtained from a third party free from any obligation of confidentiality
to Megabios.
1.14 "Pfizer Confidential Information" means all information about any
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element of Pfizer or Joint Technology which is disclosed by Pfizer to Megabios
and designated "Confidential" in writing by Pfizer at the time of disclosure to
Megabios to the extent that such information as of the date of disclosure to
Megabios is not (i) known to Megabios other than by virtue of a prior
confidential to Megabios by Pfizer; or (ii) disclosed in published literature,
or otherwise generally known to the public through no fault or omission of
Megabios; or (iii) obtained from a third party free from any obligation of
confidentiality to Pfizer.
1.15 "Valid Claim" means a claim within Patent Rights so long as such
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claim shall not have been disclaimed by either Pfizer or Megabios or both, as
the case may be, or shall not have been held invalid in a final decision
rendered by a tribunal of competent jurisdiction from which no appeal has been
or can be taken.
1.16 "Patent Rights" shall mean:
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(a) the Valid Claims of Megabios' patent applications listed
in Exhibit A, and patents issuing on them, including any division, continuation,
continuation-in-part renewal, extension, reexamination, reissue or foreign
counterpart thereof; and
(b) all inventions deemed patentable within Pfizer Technology,
Megabios Technology and Joint Technology including all the Valid Claims of
patent applications, whether domestic or foreign, claiming such patentable
inventions, including all continuations, continuations-in-part, divisions, and
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renewals, all letters patent granted thereon, and all reissues, reexaminations
and extensions thereof.
1.17 "Product" means a particular DNA sequence coding for the
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expression of a protein in a particular formulation of lipids, useful in the
treatment or management of a disease state in human beings, the manufacture, use
or sale of which would infringe a Valid Claim within Patent Rights in the
absence of a license.
1.18 "DNA Manufacture" means manufacture or purification of plasmid
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DNA by any current or future manufacturing method which uses proprietary
technology or know-how of Megabios.
1.19 "Major Market" means France, Japan, Italy, Spain, Germany and
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England.
2. COLLABORATIVE RESEARCH PROGRAM
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2.1.1 Purpose. Megabios and Pfizer shall conduct the Research
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Program throughout the Contract Period. All Technology in the Area developed in
the Research Program will become part of the Joint Technology. Technology to be
acquired in any manner from third parties shall be acquired in accordance with
Section 7. The objective of the Research Program is to discover and develop
Products.
2.1.2 Annual Research Plan. The Annual Research Plan for the first
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Commitment Year is described in the attached Exhibit B. For each Commitment Year
after the first, the Annual Research Plan shall be prepared by the Research
Committee for submission to and approval by Pfizer and Megabios no later than
ninety (90) days before the end of the prior Commitment Year. Each new Annual
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Research Plan for each succeeding Commitment Year shall be appended to Exhibit B
and made part of this Agreement.
2.1.3 Exclusivity. Megabios agrees that during the Contract
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Period, and in the Area as defined by the Annual Research Plan, neither Megabios
nor any of its Affiliates shall conduct research itself or sponsor any other
research, or engage in any research sponsored by any third party without
Pfizer's consent.
2.2 Research Committee
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2.2.1 Purpose. Pfizer and Megabios shall establish a Research
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Committee (the "Research Committee"):
(a) to review and evaluate progress under each Annual
Research Plan;
(b) to prepare the Annual Research Plan for each Commitment
Year; and
(c) to coordinate and monitor publication of research
results obtained from and the exchange of information
and materials that relate to the Research Program. (This
function shall survive the termination of this
Agreement.)
2.2 Membership. Pfizer and Megabios each shall appoint, in its sole
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discretion, four members to the Research Committee. Substitutes may be appointed
at any time.
The members initially shall be:
Pfizer Appointees: Xx. Xxxxx Xxxxxxxxx
Xx. Xxxx Xxxxx
Xx. Xxxxxx XxxXxx
Dr. Xxxxxxx Xxxxx
Megabios Appointees: Xx. Xxxxxx Xxxxxxxx
Xx. Xxxx Xxxxxx
Xx. Xxxxxx Xxxxxxx
Ms. Xxxxx Xxxxxxx
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2.2.3 Chair. The Research Committee shall be chaired by two
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co-chairpersons, one appointed by Pfizer and the other appointed by Megabios.
2.2.4 Meetings. The Research Committee shall meet at least
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quarterly, at places and on dates selected by each party in turn.
Representatives of Pfizer or Megabios or both, in addition to members of the
Research Committee, may attend such meetings at the invitation of either party.
2.2.5 Minutes. The Research Committee shall keep accurate
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minutes of its deliberations which record all proposed decisions and all actions
recommended or taken. Drafts of the minutes shall be delivered to all Research
Committee members within five (5) business days after each meeting. The party
hosting the meeting shall be responsible for the preparation and circulation of
the draft minutes. Draft minutes shall be edited by the co-chairpersons and
shall be issued in final form only with their approval and agreement.
2.2.6 Decisions. All decisions of the Research Committee shall
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be made by consensus.
2.2.7 Expenses. Pfizer and Megabios shall each bear all expenses
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of their respective members related to their participation on the Research
Committee.
2.3 Reports and Materials
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2.3.1 Reports. During the Contract Period, Pfizer and Megabios
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each shall furnish to the Research Committee:
(a) summary written reports within fifteen (15) days after
the end of each three-month period commencing on the Effective Date, describing
its progress under the Annual Research Plan; and
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(b) comprehensive written reports within thirty (30) days
after the end of each Commitment Year, describing in detail the work
accomplished by it under the Annual Research Plan during the Commitment Year and
discussing and evaluating the results of such work.
2.3.2 Materials. Megabios and Pfizer shall, during the Contract
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Period, as a matter of course as described in the Annual Research Plan, or upon
each other's written or oral request, furnish to each other samples of
biochemical, biological or synthetic chemical materials which are part of Pfizer
Technology, Megabios Technology or Joint Technology and which are necessary for
each party to carry out its responsibilities under the Annual Research Plan. To
the extent that the quantities of materials requested by either party exceed the
quantities set forth in the Annual Research Plan, the requesting party shall
reimburse the other party for the reasonable costs of such materials if they are
furnished.
2.4 Laboratory Facilities and Personnel. Megabios shall provide suitable
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laboratory facilities, equipment and personnel for the work to be done by
Megabios in carrying out the Research Program.
2.5 Diligent Efforts. Pfizer and Megabios each shall use reasonably
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diligent efforts to achieve the objectives of the Research Program. Megabios
will use reasonably diligent efforts to achieve the objectives listed in each
Annual Research Plan attached as Exhibit B and Pfizer will use reasonably
diligent efforts to assist Megabios in each Annual Research Plan attached as
Exhibit B in the pursuit of those objectives and in the establishment of a
development plan for the Products, if any.
2.6 Key Investigators. If [*_________________________________________]
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association with Megabios ends for any reason and the parties are unable to
agree on a successor
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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acceptable to Pfizer within one hundred and eighty (180) days of Pfizer may
terminate this Agreement pursuant to Section 9.3.1.
3. Funding the Research Program.
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3.1 The maximum Annual Commitment for each Commitment Year is as
follows:
Commitment Year Annual Commitment
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1 [* ]
2 [* ]
3 [* ]
4 [* ]
3.2 Pfizer shall make all payments quarterly in advance for research
and development activities scheduled to be performed by Megabios during any
three (3) month quarterly period, against Megabios' invoice for such three (3)
month quarterly period at the agreed upon rate of [*____] per FTE. Any payments
for expenses incurred from studies conducted by a third-party or from
consultantships in connection with the Research Program will be paid by Pfizer
directly to the third party. Megabios shall submit invoices from third-parties
to Pfizer for payment. Adjustments as necessary to reflect the research and
development activities actually performed by Megabios shall be made within
ninety (90) days of the end of each three (3) month quarterly period and shall
be reflected in Megabios' next invoice.
3.3 Each payment shall be paid by Pfizer in U.S. currency by check or
by other mutually materially acceptable means on the first day of the quarter or
thirty (30) days after receipt of invoice, whichever is later.
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
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3.4 Megabios shall keep for three (3) years from the conclusion of
each Commitment Year complete and accurate records of its expenditures under the
Research Program. The records shall conform to good accounting principles as
applied to a similar company similarly situated. Pfizer shall have the right at
its own expense during the term of this Agreement and during the subsequent
three-year period to appoint an independent certified public accountant
reasonably acceptable to Megabios to inspect said records to verify the accuracy
of such expenditures, pursuant to each Annual Research Plan. Upon reasonable
notice by Pfizer, Megabios shall make its records available for inspection by
the independent certified public accountant during regular business hours at the
place or places where such records are customarily kept, to verify the accuracy
of the expenditures. This right of inspection shall not be exercised more than
once in any calendar year and not more than once with respect to records
covering any specific period of time. All information concerning such
expenditures, and any information learned in the course of any audit or
inspection, shall be deemed to be Megabios Confidential Information, except to
the extent that it is necessary for Pfizer to reveal the information in order to
enforce any rights it may have pursuant to this Agreement or if disclosure is
required by law. The failure of Pfizer to request verification of any
expenditures before or during the three-year period shall be considered
acceptance by Pfizer of the accuracy of such expenditures, and Megabios shall
have no obligation to maintain any records pertaining to such report or
statement beyond such three-year period. The results of such inspection, if any,
shall be binding on the parties.
4. Treatment of Confidential Information
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4.1 Confidentiality
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4.1.1 Pfizer and Megabios each recognize that the other's
Confidential Information constitutes highly valuable, confidential information.
Subject to the terms and conditions of the License Agreement, the obligations
set forth in Section 4.3 and the publication rights set forth in Section 4.2,
Pfizer and Megabios each agree that during the term of this Agreement and for
five (5) years thereafter, it will keep confidential, and will cause its
Affiliates to keep confidential, all Megabios Confidential Information or Pfizer
Confidential Information, as the case may be, that is disclosed to it, or to any
of its Affiliates pursuant to this Agreement. Neither Pfizer nor Megabios nor
any of their respective Affiliates shall use such Confidential Information
except as expressly permitted in this Agreement.
4.1.2 Pfizer and Megabios each agree that any disclosure of
the other's Confidential Information to any officer, employee or agent of the
other party or of any of its Affiliates shall be made only if and to the extent
necessary to carry out its responsibilities under this Agreement and shall be
limited to the maximum extent possible consistent with such responsibilities.
Pfizer and Megabios each agree not to disclose the other's Confidential
Information to any third parties under any circumstance without written
permission from the other party. Each party shall take such action, and shall
cause its Affiliates to take such action, to preserve the confidentiality of
each other's Confidential Information as it would customarily take to preserve
the confidentiality of its own Confidential Information. Each party, upon the
other's request, will return all the Confidential Information disclosed to the
other party pursuant to this Agreement, including all copies and extracts of
documents, within sixty (60) days of the request upon the termination of this
Agreement except for one (1) copy which may be kept for the purpose of complying
with continuing obligations under this Agreement.
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4.1.3 Megabios and Pfizer each represent that all of its
employees, and any consultants to such party, participating in the Research
Program who shall have access to Pfizer Technology, Megabios Technology or Joint
Technology and Pfizer Confidential Information and Megabios Confidential
Information are bound by agreement to maintain such information in confidence.
4.2 Publication. Notwithstanding any matter set forth with
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particularity in this Agreement to the contrary, results obtained in the course
of the Research Program may be submitted for publication following scientific
review by the Research Committee and subsequent approval by Megabios' and
Pfizer's managements, which approval shall not be unreasonably withheld. After
receipt of the proposed publication by both Pfizer's and Megabios' managements
written approval or disapproval shall be provided within thirty (30) days for a
manuscript, within fourteen (14) days for an abstract for presentation at or
inclusion in the proceedings of a scientific meeting, and within fourteen (14)
days for a transcript of an oral presentation to be given at a scientific
meeting.
4.3 Publicity. Except as required by law, neither party may disclose
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the terms of this Agreement nor the research described in it without the written
consent of the other party, which consent shall not be unreasonably withheld.
4.4 Disclosure of Inventions. Each party shall promptly inform the
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other about all inventions in the Area that are conceived, made or developed in
the course of carrying out the Research Program by employees of, or consultants
to, either of them solely, or jointly with employees of, or consultants to the
other.
4.5 Restrictions on Transferring Materials. Pfizer and Megabios
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recognize that the biological synthetic chemical and biochemical materials
which are part of Pfizer Technology, Megabios Technology or Joint Technology,
represent valuable commercial assets. Therefore, throughout the Contract Period
and for five (5) years thereafter, Megabios and Pfizer agree not to transfer
such materials
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to any third party, unless prior written consent for any such transfer is
obtained from the other party; provided, however, that, this provision to the
contrary notwithstanding, Pfizer and Megabios shall each be free to transfer as
it sees fit materials included in its own Technology.
5. Intellectual Property Rights. The following provisions relate to
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rights in the intellectual property developed by Megabios or Pfizer, or both,
during the course of carrying out the Research Program.
5.1 Ownership. All Megabios Confidential Information and Megabios
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Technology shall be owned by Megabios. All Pfizer Confidential Information and
Pfizer Technology shall be owned by Pfizer. All Joint Technology and Patent
Rights described in Section 1.l6(b) shall be owned jointly by Megabios and
Pfizer.
5.2 Grants of Research Licenses. Megabios and Pfizer each grants to
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the other a nonexclusive, irrevocable, worldwide, royalty-free, perpetual
license, including the right to grant sublicenses to Affiliates, to make and use
Confidential Information, Technology and Patent Rights (other than that
pertaining to DNA Manufacture) for all research purposes other than the sale or
manufacture for sale of products or processes.
6. Provisions Concerning the Filing, Prosecution and Maintenance of
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Patent Rights. The following provisions relate to the filing, prosecution and
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maintenance of Patent Rights during the term of this Agreement:
6.1 Filing, Prosecution and Maintenance by Megabios. With respect to
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Patent Rights in which Megabios' employees or consultants, alone or together
with Pfizer employees, or consultants are named as inventors, Megabios shall
have the exclusive right and obligation:
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(a) to file applications letters patent on any invention
deemed patentable included in Patent Rights; provided, however, that Megabios
shall consult with Pfizer regarding countries in which such patent applications
should be filed and shall file patent applications in those countries where
Pfizer requests that Megabios file such applications; and, further provided,
that Megabios, at its option and expense, may file in countries where Pfizer
does not request that Megabios file such applications;
(b) to take all reasonable steps to prosecute all pending and
new patent applications included within Patent Rights;
(c) to respond to oppositions, nullity actions, re-examinations,
revocation actions and similar proceedings filed by third parties against the
grant of letters patent for such applications;
(d) to maintain in force any letters patent included in Patent
Rights by duly filing all necessary papers and paying any fees required by the
patent laws of the particular country in which such letters patent were granted;
and
(e) to cooperate fully with, and take all necessary actions
requested by, Pfizer in connection with the preparation, prosecution and
maintenance of any letters patent included in Patent Rights.
Megabios shall notify Pfizer in a timely manner of any decision to abandon a
pending patent application or an issued patent included in Patent Rights.
Thereafter, Pfizer shall have the option, at its expense, of continuing to
prosecute any such pending patent application or of keeping the issued patent in
force.
6.1.1 Copies of Documents. Megabios shall provide to Pfizer
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copies of all patent applications that are part of Patent Rights prior to
filing, for the purpose of obtaining substantive comment of Pfizer patent
counsel. Megabios shall also provide to Pfizer copies of all documents relating
to prosecution of all such patent applications in a timely manner and shall
provide to Pfizer every six
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(6) months a report detailing their status. Pfizer shall provide to Megabios
every six (6) months a report detailing the status of all patent applications
that are a part of Patent Rights in which Pfizer employees or consultants alone
are named as inventors.
6.1.2 Reimbursement of Costs for Filing, Prosecuting and
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Maintaining Patent Rights. Within thirty (30) days of receipt of invoices from
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Megabios, Pfizer shall reimburse Megabios for all the costs of filing,
prosecuting, responding to opposition and maintaining patent applications and
patents in countries where Pfizer requests that patent applications be filed,
prosecuted and maintained. Such reimbursement shall be in addition to Funding
Payments. However, Pfizer may, upon sixty (60) days notice, request that
Megabios discontinue filing or prosecution of patent applications in any country
and discontinue reimbursing Megabios for the costs of filing, prosecuting,
responding to opposition or maintaining such patent application or patent in any
country. Megabios shall pay all costs in those countries in which Pfizer does
not request that Megabios file, prosecute or maintain patent applications and
patents, but in which Megabios, at its option, elects to do so.
6.1.3 Pfizer shall have the right to file on behalf of and as
an agent for Megabios all applications and take all actions necessary to obtain
patent extensions pursuant to 35 USC Section 156 and foreign counterparts for
Patent Rights described in this Section 6.1 licensed to Pfizer. Megabios agrees,
to sign, at Pfizer's expense, such documents and take such further actions as
may be requested by Pfizer in this regard.
6.2 Filing, Prosecution and Maintenance by Pfizer. With respect to
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Patent Rights in which Pfizer employees or consultants alone are named as
inventors, Pfizer shall have those rights and duties ascribed to Megabios in
Section 6.1; provided, however, that Pfizer shall be responsible for all costs.
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6.3 Neither party may disclaim a Valid Claim within Patent Rights
without the consent of the other.
7. Acquisition of Rights from Third Parties. During the Contract Period,
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Megabios and Pfizer shall each promptly notify each other of any and all
opportunities to acquire in any manner from third parties, technology or patents
or information which may be useful in or may relate to the Research Program.
Megabios and Pfizer shall decide if such rights should be acquired in connection
with the Research Program and, if so, whether by Megabios, Pfizer or both. If
acquired as part of the Research Program such rights shall become part of the
Confidential Information, Technology or Patent Rights, whichever is appropriate
of the acquiring party or Joint Technology, as the case may be, if the parties
do not agree on how to acquire such technology, either party may acquire the
technology at its own expense and the technology will not become part of the
Confidential Information, Technology or Patent Rights. The parties agree that
the Technology licensed by Megabios from Stanford University prior to the
Effective Date shall be subject to this Section 7. It shall not be part of the
Research Program or be licensed to Pfizer unless separately agreed by both
parties.
8. Other Agreements. Concurrently with the execution of this Agreement,
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Megabios and Pfizer shall enter into the License Agreement appended to and made
part of this Agreement as Exhibit C and the Stock Purchase Agreement appended to
and made a part of this Agreement as Exhibit D. This Agreement, the Stock
Purchase Agreement and the License Agreement are the sole agreements with
respect to the subject matter and supersede all other agreements and
understandings between the parties with respect to same.
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9. Term Termination and Disengagement.
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9.1 Term. Unless sooner terminated or extended, this Agreement shall
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expire on the fourth anniversary of the Effective Date.
9.2 Events of Termination. The following events shall constitute
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events of termination ("Events of Termination").
(a) any material written representation or warranty by Megabios
or Pfizer, or any of its officers, made under or in connection with this
Agreement shall prove to have been incorrect in any material respect when made.
(b) Megabios or Pfizer shall fail in any material respect to
perform or observe any material term, covenant or understanding contained in
this Agreement or in any of the other documents or instruments delivered
pursuant to, or concurrently with, this Agreement, and any such failure shall
remain unremedied for ninety (90) days after written notice to the failing
party.
9.3 Termination
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9.3.1 Upon the occurrence of any Event of Termination, the
party not responsible may, by notice to the other party, terminate this
Agreement.
9.3.2 If Pfizer terminates this Agreement pursuant to
Section 9.3.1, the License Agreement shall continue according to its terms. If
Megabios terminates this Agreement pursuant to Section 9.3.1, the License
Agreement shall terminate immediately.
9.4 Termination by Pfizer.
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After this Agreement has been in effect for a period of eighteen
(18) months, Pfizer may terminate this Agreement, with or without cause, upon
six (6) months notice to Megabios. If Pfizer terminates this Agreement pursuant
to this Section, it will make the payments which would
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otherwise have been due for such six (6) month period and will retain all rights
and duties set forth in the License Agreement.
9.5 Termination of this Agreement by either party, with or without
cause, will not terminate the licenses granted pursuant to Section 5.2.
9.6 Expiration or termination of this Agreement for any reason shall
be without prejudice to:
(a) the rights and obligations of the parties provided in
Sections 4 and 12;
(b) Megabios' right to receive all payments accrued under
Section 3; or
(c) any other remedies which either party may otherwise have.
10. Representations and Warranties. Megabios and Pfizer each represents
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and warrants as follows:
10.1 It is a corporation duly organized, validly existing and is in
good standing under the laws of the State of California and the State of
Delaware, respectively, is qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which the conduct of its business or
the ownership of its properties requires such qualification and has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.
10.2 The execution, delivery and performance by it of this Agreement
have been duly authorized by all necessary corporate action and do not and will
not (a) require any consent or approval of its stockholders, (b) violate any
provision of any law, rule, regulations, order, writ, judgment, injunctions,
decree, determination award presently in effect having applicability to it or
any
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provision of its certificate of incorporation or by-laws or (c) result in a
breach of or constitute a default under any material agreement, mortgage, lease,
license, permit or other instrument or obligation to which it is a party or by
which it or its properties may be bound or affected.
10.3 This Agreement is a legal, valid and binding obligation of it
enforceable against it in accordance with its terms and conditions, except as
such enforceability may be limited by applicable bankruptcy, insolvency,
moratorium, reorganization or similar laws, from time to time in effect,
affecting creditor's rights generally.
10.4 It is not under any obligation to any person, or entity,
contractual or otherwise, that is conflicting or inconsistent in any respect
with the terms of this Agreement or that would impede the diligent and complete
fulfillment of its obligations.
10.5 It has good and marketable title to or valid leases or licenses
for; all of its properties, rights and assets necessary for the fulfillment of
its responsibilities under the Research Program, subject to no known claim of
any third party other than any relevant lessors or licensors.
11. Covenants of Megabios and Pfizer Other Than Reporting Requirements.
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Throughout the Contract Period, Megabios and Pfizer each shall:
11.1 maintain and preserve its corporate existence, rights, franchises
and privileges in the jurisdiction of its incorporation, and qualify and remain
qualified as a foreign corporation in good standing in each jurisdiction in
which such qualification is from time to time necessary or desirable in view of
their business and operations or the ownership of their properties
11.2 comply in all material respects with the requirements of all
applicable laws, rules, regulations and orders of any government authority to
the extent
20
necessary to conduct the Research Program, except for those laws, rules,
regulations, and orders it may be contesting in good faith.
12. Indemnification. Each party will indemnify the other for damages,
---------------
settlements costs legal fees and other expenses incurred in connection with a
claim against a party based on any action or omission of the other party, its
agents or employees related to the obligations of the other party under this
Agreement: provided, however, that the foregoing shall not apply (i) if the
claim is found to be based upon the negligence, recklessness or willful
misconduct of the party seeking indemnification or (ii) if such party fails to
give the other prompt notice of any claim it receives and such failure
materially prejudices the indemnifying party with respect to any claim or action
to which its obligation pursuant to this Section applies. The indemnifying
party, in its sole discretion shall choose legal counsel, shall control the
defense of such claim or action and shall have the right to settle same on such
terms and conditions it deems advisable.
13. Notices. All notices shall be in writing mailed via certified mail,
-------
return receipt requested, courier, or facsimile transmission addressed as
follow, or to such other address as may be designated from time to time:
If to Pfizer: To Pfizer at its address as set forth
at the beginning of this Agreement
Attention: President Central Research
with copy to: Office of the General Counsel.
If to Megabios Megabios at its address as set forth at the
beginning of this Agreement
Attention: President
Notices shall be deemed given as of the date received.
21
14. Governing Law. This Agreement shall be governed by and construed in
-------------
accordance with the laws of the State of New York.
15. Miscellaneous
-------------
15.1 Binding Effect. This Agreement shall be binding upon and inure
--------------
to the benefit of the parties and their respective legal representatives,
successors and permitted assigns.
15.2 Headings. Paragraph headings are inserted for convenience of
--------
reference only and do not form a part of this Agreement
15.3 Counterparts. This Agreement may be executed simultaneously
------------
two or more counterparts, each of which shall be deemed an original.
15.4 Amendment Waiver. This Agreement may be amended, modified
----------------
superseded or canceled, and any of the terms may be waived, only by a written
instrument executed by each party or, in the case of waiver, by the party or
parties waiving compliance. The delay or failure of any party at any time or
times to require performance of any provisions shall in no manner affect the
rights at a later time to enforce the same. No waiver by any party of any
condition or of the breach of any term contained in this Agreement, whether by
conduct, or otherwise, in any one or more instances, shall be deemed to be, or
considered as, a further or continuing waiver of any such condition or of the
breach of such term or any other term of this Agreement.
15.5 No Third Party Beneficiaries. No third party including any
----------------------------
employee of any party to this Agreement, shall have or acquire any rights by
reason of this Agreement. Nothing contained in this Agreement shall be deemed to
constitute the parties' partners with each other or any third party.
22
15.6 Assignment and Successors. This Agreement may not be assigned by
-------------------------
either party, except that each party may assign this Agreement and the rights
and interests of such party, in whole or in part, to any of its Affiliates, any
purchaser of all or substantially all of its assets or to any successor
corporation resulting from any merger or consolidation of such party with or
into such corporations.
15.7 Force Majeure. Neither Pfizer nor Megabios shall be liable for
-------------
failure of or delay in performing obligations set forth in this Agreement, and
neither shall be deemed in breach of its obligations, if such failure or delay
is due to natural disasters or any causes reasonably beyond the control of
Pfizer or Megabios.
15.8 Severability. If any provision of this Agreement is or becomes
------------
invalid or is ruled invalid by any court of competent jurisdiction or is deemed
unenforceable, it is the intention of the parties that the remainder of the
Agreement shall not be affected.
23
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives.
PFIZER INC
By ___________________________
MEGABIOS CORP
By /s/ Xxxxxxxx X. XxXxxx
---------------------------
cc: Pfizer Inc. Xxxxx Xxxxxxxx, Xxxxxx. XX 00000
24
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives.
PFIZER INC
By /s/
---------------------------
MEGABIOS CORP
By ___________________________
cc: Pfizer Inc. Xxxxx Xxxxxxxx, Xxxxxx. XX 00000
Exhibit A
1. UCSF Patent Applications Licensed to Megabios [* ]
1. US Serial Number [* ]
2. US Serial Number [* ]
3. WO Serial Number [* ]
and foreign counterparts [* ]
4. US Serial Number [* ]
2. Megabios Patent Applications: [* ]
1. US Serial Number [* ]
2. WO Serial Number [* ]
3. Megabios Patent Applications: [* ]
1. US Serial Number [* ]
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
EXHIBIT B
ANNUAL RESEARCH PLAN - YEAR 1
1. OVERALL PURPOSE. The overall purpose of this collaboration is to discover
----------------
and develop gene therapy products to treat non-small cell lung carcinoma via
angiogenesis inhibition, using Megabios; proprietary gene delivery technology to
target therapeutic gene(s) to the vascular endothelium of the lung. The
following outline of activities to be undertaken by Megabios defines the scope
of the collaboration between the two parties. This outline may be amended with
the consent of the Research Committee.
2. RESEARCH PLAN - YEAR 1. The goals and tasks of the collaboration in year 1
----------------------
are outlined below.
2.1 PROJECT TEAM 1 - CLONING AND FUNCTIONAL STUDIES [* ]
-----------------------------------------------
PROJECT TEAM GOALS
[* ]
[* ]
[* ]
Megabios' DNA:lipid delivery technology is sufficiently flexible to
allow rapid examination of many different genes for expression in endothelial
cells. A major advantage is the cassette-like nature of the delivery systems, in
which the gene component is largely interchangeable. As such, the preparation of
several versions of MB 102, each incorporating the gene for a distinct
anti-angiogenic factor, to "screen" for the relative therapeutic utility of the
several genes is feasible.
Our goal is [*________________________________________________________________]
and this inhibit angiogenesis. [*
]
The path to be followed here will be to [*__________________________]
which will be selected by the Research Committee. [*
]
OBJECTIVE 1.[* ]
[* ]
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
3. BUDGET FOR YEAR 1
-----------------
3.1 FULL TIME EQUIVALENTS AT MEGABIOS
---------------------------------
Megabios will allocate [* ] Full Time Equivalents ("FTEs") to the project in
year 1. Pfizer will reimburse Megabios at a rate of [*________] per FTE per
year.
3.2 ANTICIPATED ADDITIONAL COSTS
----------------------------
In addition to funding [* ] FTEs at Megabios, Pfizer will reimburse third
parties for certain specific additional cost as outlined below:
Estimated Maximum Additional costs
----------------------------------
Cost of [*________________________________________] at Megabios (headcount and
cost of materials are covered in FTE calculation):
Additional external costs
-------------------------
Costs for [* ] $ [* ]
Costs covering [* ]
[* ]
$ [* ]
$ [* ]
$ [* ]
$ [* ]
TOTAL ADDITIONAL EXTERNAL COSTS $ [* ]
[*]=CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
