EXHIBIT 10.11
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AGREEMENT
Pfizer Inc, with an address at 000 Xxxx 00xx Xxxxxx, Xxx Xxxx, XX 00000 and its
Affiliates ("Pfizer"), and Bentley Pharmaceuticals, Inc., with an address at 00
Xxxxxxxxx Xxxx, Xxxxx Xxxxx, Xxxxx Xxxxxxx, XX 00000-0000, and its Affiliates
("BENTLEY"), enter into this Agreement for the feasibility of developing
formulations for delivering Pfizer compounds, as set forth in the protocol(s)
("Protocol") attached as Exhibit A, and in the purchase orders ("Purchase
Orders") attached to and made a part of this Agreement from time to time on the
following terms and conditions:
1. SCOPE OF WORK: BENTLEY will exercise reasonable commercial efforts to
perform the work described in the Protocol and the related Purchase
Orders at the price agreed upon by both parties and set forth in the
Protocol and Purchase Orders.
2. DEFINITIONS: When used in this Agreement, the following terms will have
the meanings set forth below:
2.1. "Affiliates" means any corporation, firm, partnership or other
entity, which directly or indirectly controls, is controlled by,
or is under common control with either of the parties.
2.2. "BENTLEY Confidential Information" means all information about any
element of the BENTLEY Technology which is disclosed by BENTLEY to
Pfizer and designated "Confidential" in writing by BENTLEY 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 BENTLEY; 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 BENTLEY.
2.3. "BENTLEY Technology" means all technology and technical
information, whether patented or not, that is:
(a) developed by employees of or consultants to BENTLEY alone
or jointly with third parties prior to the Effective Date
or since that date in the course of activities not
described in the Protocol or Purchase Orders; or
(b) developed by employees of BENTLEY in the course of
activities described in the Protocol and Purchase Orders
that do not pertain to the Compounds; or
(c) acquired by purchase, license, assignment or other means
from third parties by BENTLEY.
2.4. "BENTLEY Patent Rights" means all patentable inventions derived
from the BENTLEY Technology, but not the Pfizer Technology,
including all applications for letters patent, whether domestic or
foreign, claiming such patentable inventions, including all
continuations, continuations-in-part, divisions, renewals and
patents of addition thereof, all letters patent granted thereon,
and all reissues, re-examination certificates and extensions
thereof.
2.5. "Compounds" means any Pfizer compound, its derivatives,
metabolites, and intermediates, including those that Pfizer
provides to BENTLEY pursuant to the Protocol. See 5.1(c)
2.6. "Effective Date" means October 29, 2001.
2.7. "Pfizer Confidential Information" means all information about any
element of Pfizer Technology which is disclosed by Pfizer to
BENTLEY and designated "Confidential" in writing by Pfizer at the
time of disclosure to BENTLEY to the extent that such information
is not (i) known to BENTLEY as of the date of disclosure to
BENTLEY as shown by its prior written records, other than by
virtue of a prior confidential disclosure to BENTLEY by Pfizer; or
(ii) then or thereafter disclosed in published literature, or
otherwise generally known to the public through no fault or
omission of BENTLEY; or (iii) obtained from a third party free
from any obligation of confidentiality to Pfizer.
2.8. "Pfizer Technology" means technology and technical information
that is or was developed by employees of or consultants to Pfizer
alone or jointly with third parties prior to the Effective Date.
Pfizer Technology includes but is not limited to information
relating to Compounds. Pfizer Technology does not include
technology made with Bentley Technology prior to the Effective
Date.
2.9. "Pfizer Patent Rights" means all patentable inventions derived
from the Pfizer Technology or the Program Technology, but not the
BENTLEY Technology, including all applications for letters patent,
whether domestic or foreign, claiming such patentable inventions,
including all continuations, continuations-in-part, divisions,
renewals and patents of addition thereof, all letters patent
granted thereon, and all reissues, re-examination certificates and
extensions thereof.
2.10. "Program Technology" means technology:
(a) developed by employees of or consultants to Pfizer or
BENTLEY solely or jointly with each other during the Term
of this Agreement in connection with the work pursuant to
the Protocol or Purchase Orders; or
(b) acquired by purchase, license, assignment or other means
from third parties by BENTLEY or Pfizer during the Term of
this Agreement for use in the performance of the work
pursuant to the Protocol or Purchase Orders.
3. TERM: The term of this Agreement will begin on the Effective Date and
continue to the later of (a) the first anniversary of the Effective Date
and (b) the completion of the work described in the Protocol or Purchase
Orders.
4. PAYMENT: For work done pursuant to any Protocol or Purchase Order,
Bentley shall submit to Pfizer an invoice listing relevant Purchase Order
number and Pfizer shall pay BENTLEY the sum set forth in such invoice or
dispute the invoice in writing to Bentley within thirty (30) days
following receipt of such invoice.
5. JOINT WORKING COMMITTEE.
5.1. Purpose. Pfizer and BENTLEY shall establish a joint working
committee (the "JWC"):
(a) to review and evaluate progress of work under the Protocol;
(b) to coordinate and monitor the exchange of information and
materials that relate to the Protocol;
(c) to accept or reject Compounds prior to their inclusion in a
Protocol.
(d) to review and approve any revision to the Protocol or any
Purchase Order issued pursuant to the Agreement.
5.2. Membership. Each of Pfizer and BENTLEY each shall appoint, in
their respective sole discretion, three members to the JWC.
Substitutes may be appointed at any time.
The members initially shall be:
Pfizer Appointees:
Xxxxx Xxxxxxxx, Assistant Director Drug Delivery Technology
Assessment (Pfizer Co-Chair)
Xxxxxxxx X. Xxxxx, Pharmaceutical Sciences Portfolio Head
Xxxx Huatan, Principal Scientist
Xxxxxxx Xxxxxxxxx, Principal Scientist
BENTLEY Appointees:
Xxxxxx X. Xxxxxx, Vice President, Pharmaceutical Research (Bentley
Co-Chair)
Xxxxx X. Xxxxxx, Chief Executive Officer
Xxxxxx X. Xxxxx, MD., Chief Science Officer and Medical Director
Xxxx Xxxxxxxxxxx, Project Management Director (may act from time
to time as a substitute member)
5.3. Chair. The JWC shall be chaired by two co-chairpersons, one
appointed by Pfizer and the other appointed by BENTLEY.
5.4. Meetings. The JWC shall meet at least quarterly, at places and on
dates selected by each party in turn. Representatives of Pfizer or
BENTLEY or both, in addition to members of the JWC, may attend
such meetings at the invitation of either party.
5.5. Minutes. The JWC 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 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.
5.6. Decisions. All decisions of the JWC shall be made by consensus.
5.7. Expenses. Pfizer and BENTLEY shall each bear all expenses of their
respective members related to their participation on the JWC.
6. TREATMENT OF CONFIDENTIAL INFORMATION.
6.1. Confidentiality.
(a) Pfizer and BENTLEY each recognize that the other's
Confidential Information constitutes highly valuable,
confidential information. Subject to the obligations set
forth hereunder and the publication rights set forth in
Section 6.2, Pfizer and BENTLEY each agree that during the
term of this Agreement and for seven (7) years thereafter,
it will keep confidential, and will cause its Affiliates to
keep confidential, all BENTLEY 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 BENTLEY nor any of their
respective Affiliates shall use such Confidential
Information of the other party except as expressly
permitted in this Agreement.
(b) Pfizer and BENTLEY 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 BENTLEY 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.
(c) BENTLEY 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, BENTLEY Technology or Joint Technology and
Pfizer Confidential Information and BENTLEY Confidential
Information are bound by agreement to maintain such
Confidential Information in confidence.
6.2. Publication. Either party may submit for publication or present
results obtained in the course of the work performed pursuant to
this Agreement following scientific review by the JWC and
subsequent approval by the management of both BENTLEY and Pfizer,
which approval shall not be unreasonably withheld. After both such
managements receive the proposed publication, they shall give
written approval or disapproval within thirty (30) days for a
manuscript and within fourteen (14) days for any other proposed
presentation.
6.3. Publicity. Except as required by law (including disclosure
required by applicable federal securities regulations), neither
party may disclose the terms of this Agreement without the written
consent of the other party, which consent shall not be
unreasonably withheld; provided, however, that, upon agreement of
the parties, the parties will issue a press release with respect
to its contents; and, further provided, that copies of this
Agreement may be disclosed in confidence by BENTLEY to prospective
investors, banks and other sources of financing and as required by
law.
7. INTELLECTUAL PROPERTY:
7.1. Pfizer will own all Pfizer Technology , Pfizer Patent Rights, and
Program Technology.
7.2. BENTLEY will own all BENTLEY Technology and Bentley Patent Rights.
7.3. Grants of Research and Post-Agreement Licenses.
(a) Pfizer hereby grants BENTLEY a nonexclusive, worldwide,
royalty-free license or sublicense, as the case may be,
including the right to grant sublicenses to Affiliates, to
make and use Pfizer Confidential Information, Pfizer
Technology, Compounds, and Pfizer Patent Rights during the
term of this Agreement solely for the performance of the
work described in the Protocol or Purchase Orders.
(b) BENTLEY hereby grants Pfizer a non-exclusive license with
the right to grant sublicenses to Affiliates, to make and
use all BENTLEY Confidential Information, BENTLEY
Technology and BENTLEY Patent Rights solely for research
purposes, including the performance of the work described
in the Protocol or Purchase Orders. Such license shall not
permit Pfizer to sell, or make for sale any products or
processes.
7.4. Pfizer shall not commercialize the Program Technology until
BENTLEY and Pfizer have executed a separate license agreement to
manufacture, use, sell, offer for sale and import BENTLEY
Technology and/or BENTLEY Patent Rights that are part of the
Program Technology.
8. COMPOUNDS: BENTLEY shall use Compounds only to perform the work described
in the Protocol and Purchase Orders under the terms and conditions of
this Agreement, shall keep confidential the results of such work with
respect to such Compounds, and shall return to Pfizer or destroy any
portions of such Compounds remaining at the conclusion of the work.
9. REPORTS: At the conclusion of the work described in the Agreement,
Protocol and Purchase Orders, each party will provide a comprehensive
summary report to the other including Xxxxx cell data and plans for any
additional work by Pfizer with Bentley Technology.
10. NOTICES: Any notices permitted or required pursuant to this Agreement
shall be deemed effective if made in writing and sent, postage prepaid,
return receipt requested, or by overnight delivery as follows:
IF TO PFIZER: Pfizer Inc
Pfizer Global Research & Development
Xxxxxxx Xxxxx Xxxx
Xxxxxx, XX 00000
Attn: Exec. VP, Research
cc: Assistant General Council-Research
Progress Reports should be sent to:
Xx. Xxxxx Xxxxxxxx
Pfizer Global Research & Development
Xxxxxxx Xxxxx Xxxx
Xxxxxx, XX 00000
cc: Xx. Xxxxxxxx X. Xxxxx
Invoices should be sent to:
Pfizer Inc
North American Shared Services
X.X. Xxx 00000
Xxxxxxxx, XX 00000-0000
IF TO BENTLEY: Bentley Pharmaceuticals, Inc.
00 Xxxxxxxxx Xxxx, Xxxxx Xxxxx
Xxxxx Xxxxxxx, XX 00000-0000
Attn: General Counsel
cc: President
11. INDEMNIFICATION: Pfizer shall defend, indemnify and hold harmless
BENTLEY, its employees, directors, trustees and officers, from and
against any and all liability which it may incur by reason of Pfizer's
use of the Compounds. BENTLEY shall indemnify Pfizer, its employees,
consultants, directors and officers for any claims for injuries to
persons or damages, which occur on BENTLEY's premises or premises under
the exclusive control of BENTLEY.
12. ENTIRE AGREEMENT: This Agreement, Protocols, Purchase Orders and Invoices
issued by either party pursuant to it, sets forth the entire agreement
between Pfizer and BENTLEY as to its subject matter. None of the terms of
this agreement shall be amended except in writing signed by both parties.
13. BREACH: If either party breaches this agreement, the other may terminate
it if the breaching party does not cure the breach within thirty (30)
days of written notice of the same. The right of termination shall be an
addition to any other rights the terminating party may have, at law or
equity, pursuant to this Agreement.
14. TERMINATION: Either party retains the right to terminate this Agreement,
with or without cause, at any time, and will provide the other a written
thirty (30) days notice of termination the other. No termination under
this Article "Termination" or Article "Breach" shall prejudice BENTLEY's
right to payment for work performed or expenses incurred prior to
termination.
15. FORCE MAJEURE: Neither Pfizer nor BENTLEY 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 BENTLEY.
16. COMPLIANCE WITH LAWS: Both Pfizer and BENTLEY shall comply in all
material respects with the requirements of all applicable laws, rules,
regulations and orders of any government authority in handling or
disposing of the Compounds.
17. CHOICE OF LAW: This Agreement shall be construed in accordance with the
laws of the State of New York.
AGREED: AGREED:
BENTLEY PHARMACEUTICALS, INC. PFIZER INC
By: /s/ XXXXX XXXXXX By: /s/ B.W. CUE
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Name: Xxxxx Xxxxxx Name: B.W. Cue
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Title: Chairman and CEO Title: V.P. of Pharmaceutical Science
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Date: 25 October 2001 Date: November 1, 2001
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