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EXHIBIT 99.2
COLLABORATIVE RESEARCH AGREEMENT
This COLLABORATIVE RESEARCH AGREEMENT (The "Agreement") is entered into as of
the Effective Date by and between PFIZER INC, a Delaware corporation, having an
office at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, XX 00000 and its Affiliates
("Pfizer"), and ATRIX LABORATORIES, INC. ("ATRIX"), a Delaware corporation,
having an office at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, XX 00000-0000. Pfizer and
ATRIX are sometimes collectively referred to herein as the "Parties" and
individually as a "Party."
WHEREAS, ATRIX has expertise in the development and manufacturing of drug
delivery systems and biomaterials, and products using the same for medical,
veterinary and dental applications; and
WHEREAS, ATRIX has filed the patent applications described in Exhibit A attached
to and made part of this Agreement; and
WHEREAS, the Parties plan to seek patent protection for all Products which make
up the subject matter of this Agreement and the License Agreement; and
WHEREAS, the Parties will also execute a License Agreement with respect to the
commercialization of the subject matter of this Agreement on the same date that
this Agreement is executed; 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 such agents;
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS. Whenever used in this Agreement, the terms defined in this
Section 1 shall have the meanings specified. The capitalized terms used
in this
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Agreement and not defined elsewhere in it or in this Section 1 shall
have the meanings specified in the License Agreement.
1.1 "AFFILIATE" means any corporation or other legal entity
owning, directly or indirectly, fifty percent (50%) or more of
the voting capital shares or similar voting securities of
Pfizer or ATRIX; 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 ATRIX 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 ATRIX.
1.2 "AREA" means research or development with respect to delivery
systems for Pfizer Compounds.
1.3 "ATRIGEL(R) SYSTEM" means the biodegradable, polymeric drug
delivery system in all embodiments claimed in the "ATRIX
Patent Rights".
1.4 "ATRIX CONFIDENTIAL INFORMATION" means all information about
ATRIX or the Program Technology which is disclosed by ATRIX to
Pfizer and designated "Confidential" in writing by ATRIX 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 as of the date of disclosure to Pfizer as
shown by its prior written records, other than by virtue of a
prior confidential disclosure to Pfizer by ATRIX; or (ii) then
or thereafter 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 ATRIX.
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1.5 "ATRIX PATENT RIGHTS" means all patents set forth in Exhibit A
and all patent applications within the ATRIX Technology,
whether domestic or foreign, including all continuations,
continuations-in-part, divisions, and renewals, all letters
patent granted thereon, and all reissues, re-examinations and
extensions thereof.
1.6 "ATRIX TECHNOLOGY" means all technology, technical
information, know-how, expertise and trade secrets owned or
controlled by ATRIX as of the Effective Date of this
Agreement, that relates to and/or is useful in developing the
Atrigel(R) System, the bioerodible mucoadhesive disc
(BEMA(TM)) system, the mucoadhesive gel (MCA(TM)) system, the
solvent microparticulate (SMP(TM)) system and/or other drug
delivery technology owned or controlled by ATRIX.
1.7 "COMPOUND" means any proprietary compound, its derivatives,
metabolites, and intermediates, owned or controlled by Pfizer,
that Pfizer provides pursuant to any Research Plan or any
Exploratory Development Program Plan.
1.8 "CONTRACT PERIOD" means the period beginning on the Effective
Date and ending on the [ ** ] of said date.
1.9 "EFFECTIVE DATE" is August 8, 2000.
1.10 "EXPLORATORY DEVELOPMENT PROGRAM" means the research and
development program in the Area commencing upon completion of
any Feasibility Program. Each Exploratory Development Program
will have its own Exploratory Development Research Plan which
will be developed and agreed to by ATRIX and Pfizer
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1.11 "EXPLORATORY DEVELOPMENT PROGRAM PLAN" means the written plan
describing the research, xxxxxxx, budget, and payment terms in
the Area to be carried out by Pfizer and ATRIX during any
Exploratory Development Program.
1.12 "FEASIBILITY PROGRAM" means the initial phase of the Research
Program for any Compound in the Area. Each Feasibility Program
will have its own Feasibility Program Plan, which will be
developed and agreed to by ATRIX and Pfizer.
1.13 "FEASIBILITY PROGRAM PLAN" means the written plan describing
the research, xxxxxxx, budget, and payment terms in the Area
to be carried out by Pfizer and ATRIX during any Feasibility
Program.
1.14 "INVENTIONS" means all patentable inventions, discoveries,
improvements or other technological information relating to
the Area, which are made or conceived during the term of this
Agreement, and as a direct result of either Party's work under
the terms of this Agreement. Inventions shall not include any
modification, improvement, or discovery relating solely to
ATRIX Technology, ATRIX Patent Rights or Program Technology.
1.15 "LICENSE AGREEMENT" means the License and Royalty Agreement
attached to this Agreement as Exhibit C entered into by and
between Pfizer and ATRIX as of the Effective Date.
1.16 "PFIZER CONFIDENTIAL INFORMATION" means all information about
Pfizer or the Program Technology which is disclosed by Pfizer
to ATRIX and designated "Confidential" in writing by Pfizer at
the time of disclosure to ATRIX to the extent that such
information is not (i) known to ATRIX as of the date of
disclosure to ATRIX as shown by its prior written records,
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other than by virtue of a prior confidential disclosure to
ATRIX by Pfizer; or (ii) then or thereafter disclosed in
published literature, or otherwise generally known to the
public through no fault or omission of ATRIX; or (iii)
obtained from a third party free from any obligation of
confidentiality to Pfizer.
1.17 "PFIZER PATENT RIGHTS" means all patents and patent
applications within the Area, whether domestic or foreign,
including all continuations, continuations-in-part, divisions,
and renewals, all letters patent granted thereon, and all
reissues, re-examinations and extensions thereof. Pfizer
Patent Rights include all patents and patent applications
claiming any Invention.
1.18 "PFIZER TECHNOLOGY" means all technology, technical
information, know-how, expertise, and trade secrets in the
Area owned or controlled by Pfizer as of the Effective Date of
this Agreement.
1.19 "PRODUCT" means a Pfizer Compound in combination with the
ATRIX Technology, for use in the treatment of disease states
in humans or animals, the manufacture, use, sale, offer for
sale or import of which would infringe a Valid Claim within
ATRIX Patent Rights or Pfizer Patent Rights if made, used,
sold, offered for sale or imported by an unlicensed third
party.
1.20 "PROGRAM TECHNOLOGY" means technology:
(a) developed by employees of or consultants to Pfizer or
ATRIX solely or jointly with each other during the
Contract Period solely in connection with the
performance of any Research Program or Exploratory
Development Program; or
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(b) acquired by purchase, license, assignment or other
means from third parties by ATRIX or Pfizer during
the Contract Period solely for use in the performance
of any Research Plan or Exploratory Development
Program Plan.
1.21 "RESEARCH PLAN" means the written plan describing the
research, xxxxxxx, budget, and payment terms in the Area to be
carried out by Pfizer and ATRIX pursuant to this Agreement.
Each Research Plan will be developed and agreed to by ATRIX
and Pfizer and it will be attached to and made a part of this
Agreement as Exhibit B.
1.22 "RESEARCH PROGRAM" means the collaborative research program in
the Area conducted by Pfizer and ATRIX pursuant to each
Research Plan.
1.23 "TERM" The initial term of this Agreement begins on the
Effective Date and will continue until the [ ** ] anniversary
of the Effective Date. This Agreement will automatically renew
for an [ ** ] upon Pfizer's written notification to ATRIX at
least ninety (90) days prior to termination of the initial
term, unless ATRIX notifies Pfizer in writing of its intent
not to renew the Agreement.
1.24 "VALID CLAIM" means a claim within Pfizer Patent Rights and
ATRIX Patent Rights so long as such claim shall not have been
disclaimed by ATRIX (in the case of ATRIX Patent Rights) or by
Pfizer (in the case of Pfizer Patent Rights) and 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.
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2. COLLABORATIVE RESEARCH PROGRAM.
2.1 Feasibility Program.
2.1.1 Purpose. ATRIX and Pfizer shall conduct the Research
Program throughout the Contract Period during which,
from time to time, Pfizer may submit a Compound and a
proposed Feasibility Program Plan to ATRIX for
formulation and feasibility testing. ATRIX and Pfizer
will collaborate in feasibility studies defined in
the separate Feasibility Program Plans relating to
the Area. Pfizer shall have the right to bring forth
any Compound it chooses including those Compounds
related to human health and animal health programs,
provided that the development of such compounds will
not cause ATRIX to violate or breach any prior
agreement with any third party which is in effect as
of the Effective Date.
2.1.2 Feasibility Program Plan. Pfizer may, from time to
time, propose a Feasibility Program Plan for a
Compound. Upon agreement by the Parties, with respect
to Feasibility Program Plans for each succeeding
Compound, each such plan shall be appended to Exhibit
B and made part of this Agreement.
2.1.3 Non-Exclusivity. Subject to the provisions of Section
2.2.1, ATRIX agrees that during the Contract Period,
Pfizer can propose the addition of any Compound to
the Research Program for any indication, without
restriction with the exception of the exclusions
listed in Exhibit C attached to and made a part of
this Agreement; provided, however, that Pfizer shall
consider ATRIX's work load with respect to other
Compounds previously submitted in determining the
timing and number of new Compounds submitted.
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2.2 Exploratory Development Program
2.2.1 Purpose. Pfizer may advance any Compound as
formulated in a Feasibility Program ("Formulated
Compound") to an Exploratory Development Program.
Within sixty (60) days of Pfizer's notification to
ATRIX of its intent to advance a Formulated Compound,
Pfizer will submit a separate Exploratory Development
Plan to ATRIX for each Formulated Compound to be
advanced to an Exploratory Development Program.
2.2.2 Clinical Supplies. If Pfizer chooses to have clinical
supplies of a Formulated Compound manufactured during
an Exploratory Development Program, ATRIX shall
manufacture such clinical supplies and Pfizer will
pay ATRIX [ ** ]
2.3 Research Committee
2.3.1 Purpose. Pfizer and ATRIX shall establish a Research
Committee (the "Research Committee"):
(a) to review and evaluate progress under each
Research Plan;
(b) to prepare Research Plans, and any
amendments to them: 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).
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2.3.2 Membership. Pfizer and ATRIX each shall appoint, in
its sole unfettered discretion, three members to the
Research Committee. Substitutes may be appointed at
any time. The members initially shall be:
Pfizer Appointees: [ ** ]
[ ** ]
[ ** ]
ATRIX Appointees: [ ** ]
[ ** ]
[ ** ]
2.3.3 Chair. The Research Committee shall be chaired by two
co-chairpersons, one appointed by Pfizer and the
other appointed by ATRIX.
2.3.4 Meetings. The Research Committee shall meet at least
quarterly, at places selected by each Party in turn
and on dates mutually agreed by the Parties. The
location of the first meeting of the Research
Committee shall be at ATRIX. Representatives of
Pfizer or ATRIX or both, in addition to members of
the Research Committee, may attend such meetings at
the invitation of either Party.
2.3.5 Minutes. The Research Committee shall keep accurate
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 choosing
the location for the meeting shall be responsible for
the preparation
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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.
2.3.6 Decisions. All technical decisions of the Research
Committee shall be made by consensus. In the event of
a deadlock the co-chairpersons shall attempt to
resolve the deadlock, but if unsuccessful, shall
refer the matter to senior management of ATRIX and
Pfizer, respectively, for resolution.
2.3.7 Expenses. Pfizer and ATRIX shall each bear all
expenses related to the participation of the each
Party's designated members of the Research Committee.
2.4 Reports and Materials.
2.4.1 Reports. During the Contract Period, Pfizer and ATRIX
each shall furnish to the Research Committee;
(a) A summary written report within fifteen (15)
days after the end of each quarter as well
as at the completion of each Research Plan,
commencing on the Effective Date, describing
the progress under such Research Plan; and
(b) A comprehensive written report within thirty
(30) days after the end of each year,
describing in detail the work accomplished
by it under any Research Plan during the
year and discussing and evaluating the
results of such work
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2.4.2 Materials. ATRIX and Pfizer shall, during the
Contract Period, as a matter of course as described
in any Research Plan, or upon each other's written or
oral request, furnish to each other samples of
biochemical, biological or synthetic chemical
materials in the Area, provided that such Research
Plan provides funding therefore. To the extent that
the quantities of materials requested by either Party
exceed the quantities set forth in any Research Plan,
the requesting party shall reimburse the other party
for the reasonable costs of such materials if they
are furnished.
2.5 Laboratory Facilities and Personnel. ATRIX shall provide
suitable laboratory facilities, equipment and personnel for
the work to be done by ATRIX in carrying out each Research
Program.
2.6 Diligent Efforts. Pfizer and ATRIX each shall use reasonably
diligent efforts to achieve the objectives of each Research
Program.
3. FUNDING THE RESEARCH PROGRAM AND OTHER PAYMENTS.
3.1 Pfizer will pay all costs and expenses of all studies outlined
in each Research Plan pursuant this Agreement, including but
not limited to research and development expenses, clinical
study expenses, and expenses related to the preparation and
submission of regulatory filing as directed by the Research
Committee.
3.1.1 Full Time Equivalent Employee Rate. Atrix will charge
Pfizer a full time equivalent employee ("FTE") rate
of [ ** ] per FTE per year for the first two years of
this Agreement. For ensuing years, Atrix may increase
this FTE rate [ ** ], whichever is lower.
3.1.2 Capital Expenditure. ATRIX shall give Pfizer
reasonable notice of any anticipated capital expenses
required to perform tasks
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described in each Research Plan including, but not
limited to laboratory equipment, renovations of
laboratories and expansions of buildings. The
Research Committee may make recommendations to Pfizer
regarding such capital expenses; however, Pfizer
will, at its sole discretion, have the final decision
whether to pay for such capital expenses. If Pfizer
determines not to pay for such capital expenses,
Atrix shall not be obligated to perform its
obligations under that Research Plan which
necessitate such capital expenses.
3.1.3 Additional Payment. Upon approval of any Exploratory
Development Plan for an Exploratory Development
Program, Pfizer will make a payment to ATRIX in the
amount of [ ** .] This payment will be fully
creditable against costs and expenses associated with
such Exploratory Development Program. If for any
reason, ATRIX does not spend the entire amount of
such payment, ATRIX shall credit the balance to
Pfizer. Pfizer shall pay ATRIX for any expenses
incurred by ATRIX in connection with such Exploratory
Development Program in excess of such payment within
thirty (30) days of Pfizer's receipt and acceptance
of ATRIX's invoice.
3.2 Each payment shall be paid by Pfizer in U.S. currency by wire
transfer to an account designated by ATRIX or by other
mutually acceptable means.
3.3 ATRIX shall keep for three (3) years from the conclusion of
each year that this Agreement is valid, complete and accurate
records of its expenditures and payments received by it. 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
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an independent certified public accountant reasonably
acceptable to ATRIX to inspect said records for the sole
purpose of verifying that ATRIX has devoted to the Research
Program the FTE's required to verify the accuracy of such
expenditures, pursuant to each Research Plan. Upon reasonable
notice by Pfizer, ATRIX 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, for the sole purpose of
verifying that ATRIX has devoted to the Research Plan the
FTE's required pursuant to each Research Plan. 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 all information learned in
the course of any audit or inspection, shall be deemed to be
ATRIX Confidential Information. The failure of Pfizer to
request verification of any expenditure before or during the
three-year period shall be considered acceptance by Pfizer of
the accuracy of such expenditures, and ATRIX 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;
provided that if ATRIX disputes the results of such
inspection, the matter shall be referred to an independent
firm of certified public accountants chosen by agreement of
Pfizer and ATRIX for resolution of such dispute. Any decision
by the said firm of independent certified public accountants
shall be binding on the Parties.
4. TREATMENT OF CONFIDENTIAL INFORMATION.
4.1 CONFIDENTIALITY.
4.1.1 Pfizer and ATRIX each recognize that the other's
Confidential Information constitutes highly valuable,
confidential information. Subject to the terms and
conditions of the License Agreement, the
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obligations set forth in Section 4.3 and the
publication rights set forth in Section 4.2, Pfizer
and ATRIX each agree that during the term of this
Agreement and for [ ** ] years thereafter, it will
keep confidential, and will cause its Affiliates to
keep confidential, all ATRIX 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 ATRIX nor any of their respective Affiliates
shall use such Confidential Information of the other
Party except as expressly permitted in this
Agreement.
4.1.2 Pfizer and ATRIX 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 rights and obligations
under this Agreement and shall be limited to the
maximum extent possible consistent with such
responsibilities. Pfizer and ATRIX each agree not to
disclose the other's Confidential Information to any
third parties under any circumstance without written
permission from the other Party except to the extent
necessary to exercise its rights pursuant to this
Agreement or to comply with applicable law. 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 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 archival
purposes.
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4.1.3 ATRIX 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 Confidential Information and ATRIX
Confidential Information are bound by agreement to
maintain such Confidential Information in confidence.
4.2 PUBLICATION. Notwithstanding any matter set forth with
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 ATRIX's and
Pfizer's managements, which approval shall not be unreasonably
withheld. After receipt of the proposed publication by both
Pfizer's and ATRIX's 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 (including disclosure
required by applicable federal securities regulations) and the
rules of any stock exchange upon which either Party's
securities are or may be listed, neither Party may disclose
the terms of this Agreement without the prior written consent
of the other Party, which consent shall not be unreasonably
withheld; provided, however, that, upon execution of this
Agreement, Atrix will issue a press release with respect to
its contents; and, further provided, that copies of this
Agreement may be disclosed in confidence by ATRIX to
prospective investors, banks and other sources of financing.
4.4 DISCLOSURE OF INVENTIONS. Each Party shall promptly inform the
other about all Inventions that are conceived, made or
developed in the course
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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.
(a) Pfizer and ATRIX recognize that the biological,
synthetic chemical and biochemical materials, which
are part of Pfizer Technology, Pfizer Patent Rights,
ATRIX Technology, Atrix Patent Rights or Program
Technology, represent valuable commercial assets.
Therefore, subject to the terms and conditions of the
License Agreement, throughout the Contract Period and
for [ ** ] years thereafter, ATRIX and Pfizer agree
not to transfer the materials included in Program
Technology and Inventions and, in the case of Pfizer,
the materials included in ATRIX Technology and Atrix
Patent Rights and, in the case of ATRIX, the
materials included in Pfizer Technology and Pfizer
Patent Rights to any third party unless (i) prior
written, consent for any such transfer is obtained
from the other Party to this Agreement, or (ii) such
transfer is pursuant to a subcontractor for work
related to the Research Program and such
subcontractor is obligated to hold such materials in
confidence.
5. INTELLECTUAL PROPERTY RIGHTS. The following provisions relate to rights
in the intellectual property developed by ATRIX or Pfizer, or both,
during the course of carrying out the Research Program.
5.1 OWNERSHIP. [ ** ]
5.2 GRANTS OF LICENSES.
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5.2.1 ATRIX and Pfizer each grants to the other a
nonexclusive, irrevocable, worldwide, royalty-free,
perpetual license (the "Research License"), including
the right to grant sublicenses to Affiliates, to make
and use ATRIX Confidential Information, Pfizer
Confidential Information, Inventions, Program
Technology, ATRIX Technology, Pfizer Technology,
ATRIX Patent Rights, and Pfizer Patent Rights for all
research purposes (consistent with the purpose and
intent of this Agreement) other than the sale or
manufacture for sale of Products or processes.
5.2.2 Pfizer grants to ATRIX a nonexclusive, irrevocable,
worldwide, royalty-free, perpetual license, including
the right to grant sublicenses, to manufacture, use,
sell, offer to sale and import products under all
Inventions; provided, however, such rights are
limited to a license to use, sell, offer for sale and
import products with compounds other than the
Compounds.
6. ACQUISITION OF RIGHTS FROM THIRD PARTIES. During the Contract Period,
ATRIX 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 the Parties mutually agree may be
useful in or may relate to the Research Program. In each case, Pfizer
and ATRIX shall jointly decide if such rights should be acquired in
connection with the Research Program and, if so, whether by ATRIX,
Pfizer or both. If acquired such rights shall become part of ATRIX
Confidential Information, Pfizer Confidential Information, ATRIX
Technology, Pfizer Technology, ATRIX Patent Rights, Pfizer Patent
Rights, whichever is appropriate, of the acquiring party or Program
Technology, as the case may be. [ ** ]
7. OTHER AGREEMENTS. Concurrently with the execution of this Agreement,
ATRIX and Pfizer shall enter into the License Agreement appended to and
made part of this Agreement. This Agreement and the License Agreement
are the sole
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agreements with respect to the subject matter and supersede all other
agreements and understandings between the Parties with respect to same.
8. TERM, TERMINATION AND DISENGAGEMENT.
8.1 EVENTS OF TERMINATION. The following events shall constitute
events of termination ("Events of Termination"):
(a) any written representation or warranty by ATRIX or
Pfizer, or any of their respective officers, made
under or in connection with this Agreement shall
prove to have been incorrect in any material respect
when made and concerning which the declaring Party
knew or should have known the correct version.
(b) ATRIX or Pfizer shall fail in any material respect to
perform or observe any 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
sixty (60) days after written notice to the failing
Party.
8.2 TERMINATION.
8.2.1 Upon the occurrence of any Event of Termination, the
Party not responsible may, by thirty (30) days notice
to the other Party, terminate this Agreement.
8.2.2 If Pfizer terminates this Agreement pursuant to
Section 8.2.1, the License Agreement shall continue
according to its terms. If ATRIX terminates this
Agreement pursuant to Section 8.2.1, the License
Agreement shall terminate immediately.
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8.2.3 During the Contract Term, Pfizer may discontinue a
Research Program described in a Research Plan. The
Termination of any Research Plan will not terminate
this Agreement.
8.3 TERMINATION BY PFIZER.
8.3.1 After this Agreement has been in effect for a period
of thirty (30) months, Pfizer may terminate this
Agreement with six (6) months written notice given on
or after the last day of the thirtieth month, with or
without cause, to ATRIX. If Pfizer terminates this
Agreement pursuant to this Section, Pfizer will make
the payments, which would otherwise have been due for
such six (6) month period; provided, however, if
ATRIX has non-cancellable obligations (pursuant to a
Research Plan or otherwise as approved pursuant to
this Agreement), then any such termination by Pfizer
shall not terminate Pfizer's obligations to continue
to reimburse or pay ATRIX for such obligations. Such
termination shall not terminate Pfizer's right and
obligations pursuant to the License Agreement.
8.4 Termination of this Agreement by either Party, with or without
cause, will not terminate such portions of the Research
Licenses granted pursuant to Section 5.2. which by their terms
extend beyond termination of this Agreement.
8.5 Termination of this Agreement for any reason shall be without
prejudice to:
(a) any rights and obligations of the Parties which
provides for, by virtue of this Agreement, survival
after beyond the Contract Term;
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(b) ATRIX's right to receive all payments accrued under
Section 3; or
(c) any other remedies which either Party may otherwise
have.
8.6 Expiration or termination of this Agreement shall not relieve
the Parties of any obligation accruing prior to such
expiration or termination. Except as set forth below or
elsewhere in this Agreement, the obligations and rights of the
Parties under Articles 3, 4, 5, 6, 8, 11 and 13 shall survive
expiration or termination of this Agreement.
8.7 Within thirty (30) days following the expiration or
termination of this Agreement, each Party shall return to the
other Party, or destroy, upon the written request of the other
Party, any and all Confidential Information of the other Party
in its possession and upon a Party's request, such destruction
(or delivery) shall be confirmed in writing to such Party by a
responsible officer of the other Party. Notwithstanding the
provisions of this Section 8.7, either Party may retain one
(1) copy of such Confidential Information for the sole purpose
of determining its continuing confidentiality obligation to
the other Party under this Agreement.
9. REPRESENTATIONS AND WARRANTIES. ATRIX and Pfizer each represents and
warrants as follows:
9.1 It is a corporation duly organized, validly existing and is in
good standing under the laws of the State of Delaware, 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.
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9.2 The execution, delivery and performance by it of this
Agreement have been duly authorized by all necessary corporate
action and do not (a) require any consent or approval of its
stockholders, (b) violate any provision of any law, rule,
regulations, order, writ, judgement, injunctions, decree,
determination award presently in effect having applicability
to it or any provision of its certificate of incorporation or
by-laws, or (c) as of the Effective Date, result in a breach
of or constitute a material 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.
9.3 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.
9.4 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 fulfilment of its
obligations.
9.5 To the best of its knowledge and belief as of the Effective
Date, it has good and marketable title to or valid leases or
licenses for, all of its properties, rights and assets
necessary for the fulfilment of its responsibilities under the
Research Program.
10. COVENANTS OF ATRIX AND PFIZER OTHER THAN REPORTING REQUIREMENTS.
Throughout the Contract Period, ATRIX and Pfizer each shall:
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10.1 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.
10.2 comply in all material respects with the requirements of all
applicable laws, rules, regulations and orders of any
government authority to the extent necessary to conduct the
Research Program, except for those laws, rules, regulations,
and orders it may be contesting in good faith.
11. INDEMNIFICATION. Pfizer will indemnify, defend and hold ATRIX and its
Affiliates and their respective directors, officers, employees and
agents (the "ATRIX Indemnitees") harmless from and against any damages,
liabilities, settlements, costs, legal fees and other expenses incurred
in connection with a claim against the ATRIX Indemnitees based on any
action or omission of Pfizer, its agents or employees related to the
obligations of Pfizer under this Agreement; provided, however, that the
foregoing shall not apply (i) if the claim is found in a final
judgement to be based upon the negligence, recklessness or wilful
misconduct of ATRIX, or (ii) if ATRIX fails to give Pfizer prompt
notice of any claim it receives within fifteen (15) days of such
receipt and such failure materially prejudices Pfizer with respect to
any claim or action to which Pfizer's obligation pursuant to this
Section applies. Pfizer, 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; provided, however, Pfizer shall obtain ATRIX's prior written
consent to such part of any settlement which contemplates payment or
other action by ATRIX or has a material adverse effect on ATRIX's
business (which material adverse effect shall include but not be
limited to, an admission by the ATRIX Indemnitees of any issue, fact,
allegation or any other aspect of the claim being settled); provided,
further, that an ATRIX Indemnitee shall have the right to retain its
own counsel,
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if representation of such ATRIX Indemnitee by the counsel retained by
Pfizer would be inappropriate due to actual or potential differing
interests between Pfizer and any other Party represented by such
counsel in such proceeding.
12. 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: Pfizer Global Research & Development
Xxxxxxx Xxxxx Xxxx
Xxxxxx, XX 00000
Attn: Executive Vice President, SOM
Cc: Asst. General Counsel
If to ATRIX: To ATRIX at its address as set forth in
the beginning of this Agreement.
Attn: Xxxxxxx X. Xxx, PhD., MBA, Vice
President, New Business Development
with copy to: Xxxxxxxx & Xxxxxxxx LLP
0000 Xxxxxxxx Xxxxx
000 Xxxxxxxxxxx Xxxxxx
Xxxxxx, XX 00000-0000
Attn: Xxxxxx X. Xxxxxx, Esq.
Either Party may by like notice specify or change an address to which notices
and communications shall thereafter be sent. Notices sent by facsimile, computer
mail or other electronic means shall be effective upon confirmation of receipt,
notices sent by mail or overnight delivery service shall be effective upon
receipt, and notices given personally shall be effective when delivered.
13. MISCELLANEOUS.
13.1 GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of the State of New
York.
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13.2 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.
13.3 HEADINGS. Paragraph headings are inserted for convenience of
reference only and do not form a part of this Agreement.
13.4 COUNTERPARTS. This Agreement may be executed simultaneously in
two or more counterparts, each of which shall be deemed an
original.
13.5 AMENDMENT; WAIVER. This Agreement may be amended, modified,
superseded or cancelled, 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.
13.6 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.
13.7 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
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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.
13.8 FORCE MAJEURE. Neither Pfizer nor ATRIX 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 ATRIX; provided that the Party whose performance is
delayed or prevented shall continue to use good faith diligent
efforts to mitigate, avoid or end such delay or failure in
performance as soon as practicable.
13.9 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.
13.10 COMPLIANCE WITH LAW. In exercising their rights under this
Agreement, the Parties shall fully comply with the
requirements of any and all applicable laws, regulations,
rules and orders of any governmental body having jurisdiction
over the exercise of rights under this Agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.
PFIZER INC ATRIX LABORATORIES, INC.
By /s/ Xxxxxx X. Xxxxx, Xx. By /s/ Xxxxx X. Xxxxxxx
--------------------------- ------------------------------
Name: Xxxxxx X. Xxxxx, Xx. Name: Xxxxx X. Xxxxxxx
Title: Senior Vice President Title: Chairman and Chief Executive
Officer
cc: Pfizer Inc, Legal Division, Xxxxxx, XX 00000
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EXHIBIT A
ATRIX PATENT RIGHTS
[ ** ]
A-1
27
EXHIBIT B
RESEARCH PLAN
B-1
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EXHIBIT C
EXCLUSIONS
[ ** ]
C-1
