RESEARCH/MANUFACTURING AGREEMENT
Exhibit
10.1
THIS
RESEARCH/MANUFACTURING AGREEMENT (“Agreement”), effective as of the last date of
signature by the parties below (“Effective Date”), is by and between Schering
Corporation, acting through its Schering-Plough Research Institute division,
0000 Xxxxxxxxx Xxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000-0000 (hereinafter
“SPRI”); and Albany Molecular Research, Inc., 00 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxx
Xxxx 00000-0000 (together with its subsidiaries and affiliates hereinafter
collectively referred to as “AMRI”).
WHEREAS,
SPRI is engaged in the development of pharmaceutical products; and,
WHEREAS,
AMRI is engaged in the business of providing synthetic chemical research and
analysis, chemistry consulting, medicinal chemical synthesis, computational
chemistry services, manufacturing of specialty chemical products, process
development, cGMP synthesis, analytical method development, validation and
release testing, stability studies, and related services, and undertakes such as
an independent company, understanding that neither AMRI nor its employees nor
agents shall be considered an employee of SPRI; nor a participant in any
programs, insurance or other benefits extended to SPRI’s employees;
and,
WHEREAS,
AMRI hereby represents and warrants to SPRI that this undertaking does not
conflict with its duties and obligations under any other agreement to which it
is a party, including any agreement with any other company or institution or any
policies applicable to them; and,
WHEREAS,
SPRI proposes to engage AMRI for the specific purpose of providing chemical
research, analysis, manufacturing of specialty chemical products or related
services which AMRI may offer on a project-by-project basis.
NOW,
THEREFORE, IT IS AGREED AS FOLLOWS:
A.
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AMRI
Services:
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1.
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SPRI may engage AMRI to perform chemistry
services, which may include consulting, chemical synthesis, chemical
process research, analytical methods development, validation or release
testing, and other related services
(collectively, the “Services”) in connection with one or more projects
(each a “Project” and collectively, the “Projects”) during the Term (as
hereinafter defined) as mutually agreed by the Parties from time to time
pursuant to one or more written Research Project Appendices in the form of
Appendix 1 attached hereto (each a “Research Project Appendix” and
collectively, the “Research Project Appendices”). AMRI shall
not commence work on any Project or provide any Services until the parties
enter into a Research Project Appendix, which will set forth (i) the
Services to be performed by AMRI (including deliverables to be provided to
SPRI in connection therewith), (ii) the timing for the Project (including
relevant deadlines and delivery dates for deliverables), (iii) the cost
and payment schedule with respect to such Services, (iv) any individuals
designated to have management responsibility for the Project or otherwise
required to perform the Services, and (v) to the extent necessary and
appropriate, additional provisions applicable to the Services to be
provided pursuant to the Research Project Appendix which shall not be
inconsistent with the terms of this Agreement and which are not otherwise
set forth in this Agreement. Any terms or conditions included
in a Research Project Appendix other than those described in this Section
A.1. shall be deemed to conflict with this Agreement and shall have no
force or effect. References in this Agreement to this
“Agreement” shall be deemed to include any Research Project Appendix
entered into pursuant hereto, subject to the preceding
sentence. The parties expressly agree that the terms hereof
cannot be altered by course of
dealings.
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1
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2.
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Anything to the contrary contained in this
Agreement notwithstanding, AMRI acknowledges and agrees that there is no
minimum number of Projects for which SPRI is obligated to engage the
services of AMRI and this Agreement shall not be construed as limiting in
any way SPRI’s right to contract for any services with any other
party.
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3.
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In no event shall this Agreement be construed as
obligating SPRI to pay any amounts for Services performed under this
Agreement unless (i) SPRI actually engages AMRI to perform Services
pursuant to this Agreement, (ii) such engagement is evidenced by a
Research Project Appendix in the form of Appendix 1 entered into pursuant
to this Agreement by the parties prior to the commencement of any such
engagement, and (iii) AMRI complies with the procedures set forth in
Section F.2. herein. AMRI acknowledges and agrees that verbal
authorization or instructions from SPRI or any of its affiliates to
commence work or Services shall not be sufficient and shall have no force
or effect and that any work or Services performed by AMRI prior to
execution by the parties of a Research Project Appendix for the engagement
shall be at the sole risk and expense of AMRI. The parties
expressly agree that this provision cannot be altered by course of
dealings.
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4.
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SPRI will define and the parties shall
mutually agree upon the parameter of the Projects and define the time
frame in which the Services are to be
provided as requested. Such Projects shall include, but not be
limited to, the following:
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a)
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Product Development
Assistance: AMRI shall be available to SPRI to advise on
design and synthesis of organic compounds, to perform process chemistry
and analytical services, and/or to complete the manufacture of organic
compounds, subject to mutually acceptable Research Project Appendices
governing the requested projects. Such Research Project
Appendices will specify the work to be undertaken, the conditions and
timing under which work is to be completed, and the amount of AMRI’s
compensation.
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b)
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Technical
Assistance: AMRI shall be available to SPRI to perform
synthetic chemical research, medicinal chemistry, process development, and
process optimization studies. The chemistry and scope of work
is to be defined under mutual agreement between AMRI and
SPRI.
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c)
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Technical
Consultations: AMRI shall be available to SPRI at such
times as are requested by SPRI for technical consultations with SPRI’s
Research and Development personnel via telephone. AMRI shall be
available for consultation at mutually agreed upon sites, provided that
the extent of this activity will be set by mutual agreement of SPRI and
AMRI. SPRI shall reimburse AMRI for [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/]
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2
[CONFIDENTIAL TREATMENT REQUESTED BY AMRI –
01].
B.
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Specific Duties of
AMRI:
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1.
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In
assuming responsibility for undertaking this Agreement, AMRI
will:
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a)
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Perform
chemistry consulting, computational services, synthetic chemical research,
medicinal chemistry, process development and process optimization studies,
and manufacturing of specialty chemicals for any Projects entered
into.
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b)
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Provide
technical consultation, technical assistance and product development
assistance, as defined, for any Projects entered
into.
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c)
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Develop
or utilize existing analytical methods which will allow determination of
the identity and quantification of the purity of any compounds
delivered.
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d)
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Provide
Services and/or compounds as
expeditiously as possible.
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e)
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Provide
to SPRI Certificates of Analysis to include, as appropriate, elemental
analysis, optical rotation, HPLC analysis, NMR spectra, and an IR spectrum
on any compounds provided.
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f)
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Perform
experiments using standard and accepted good laboratory practices and
current Good Manufacturing Practices, techniques, and record keeping
procedures, as appropriate to each
project.
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g)
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Interact
with SPRI’s scientists as is deemed appropriate in the conduct of a fully
integrated drug discovery project team
effort.
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h)
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Interact
with and communicate with SPRI, to its satisfaction, and upon all
requests, regarding any Projects.
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i)
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Provide
written research reports to SPRI describing the results and including full
experimental procedures, due upon mutually agreed upon interim dates and
upon the completion of individual
Projects.
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j)
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Retain
experimental records and laboratory notebooks containing experimental
descriptions and data generated from this work for a period of seven (7)
years. After this time and on request by SPRI, AMRI shall
provide to SPRI all experimental records and laboratory notebooks, or
copies thereof, containing information from the Projects for retention in
SPRI’s archives.
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3
C.
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SPRI’s
Obligations: SPRI will:
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1.
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Provide
research samples, chromatographic information, and appropriate structural
characterization spectra of relevant compounds to AMRI, as agreed to by
SPRI.
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2.
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Provide
intermediates to AMRI where (and if) AMRI and SPRI mutually agree to be
appropriate for project conduct and
completion.
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3.
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Agree
to pay AMRI for the Services to be performed by AMRI as set forth in
Section F.2. herein and agreed upon in the applicable Research Project
Appendix.
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D.
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Confidentiality:
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1.
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With
respect to any and all information indicated as being or which reasonably
appears to be or is marked to be confidential, including, but not limited
to, chemical synthesis or process data, proprietary chemicals, preclinical
and clinical data and program results, or any other information or data
acquired or generated by AMRI as a result of this Agreement or from
performance of the Services to be rendered hereunder (“SPRI Confidential
Information”), AMRI agrees that it will not, and will not permit any of
its employees, consultants, or representatives to, use said information
other than for the purposes of this Agreement, it will not, and will not
permit any of its employees, consultants, or representatives to, disclose
any of said information to a third party except as is required pursuant to
the purposes of this Agreement, and it will not, and will not permit any
of its employees, consultants, or representatives to, publish or submit
for publication said information without SPRI’s prior
approval. AMRI shall only disclose SPRI Confidential
Information to AMRI’s employees, consultants or representatives who have
entered into written confidentiality and non-use agreements with AMRI
having terms substantially similar to those set forth in this
Agreement.
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2.
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AMRI
agrees to utilize all reasonable efforts to create confidentiality
firewalls between different groups of its employees working on different
Projects under this Agreement so that SPRI Confidential Information from
one Project is not disclosed to AMRI employees working on a different
Project.
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3.
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AMRI’s
obligation with regard to confidential information, which is a Trade
Secret (as defined herein) shall continue at all times from and after the
date of this Agreement, and with regard to confidential information which
is not a Trade Secret, shall continue for a period of five (5) years from
the date of termination of this Agreement. For purposes of
this Agreement, the term “Trade Secrets” shall
mean: information including, but not limited to, technical or
nontechnical data, a formula pattern, compilation, program, device,
method, technique, drawing, process, financial data, or list of actual or
potential customers or suppliers
which:
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(i)
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Derives
economic value, actual or potential, from not being generally known to
other persons who can obtain economic value from its disclosure or use;
and
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4
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(ii)
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Is
the subject of efforts that are reasonable under the circumstances to
maintain its secrecy or
confidentiality.
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SPRI
shall promptly identify the information that SPRI considers Trade Secrets in
order for AMRI to perform the obligations hereunder. If information
is not designated by SPRI as a Trade Secret upon disclosure, it shall be treated
by AMRI as confidential.
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4.
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The
foregoing obligations shall not apply to information which is or lawfully
becomes generally available to the public through no fault of AMRI, which
is lawfully acquired from third parties who have a right to disclose such
information, or which by mutual agreement is released from a confidential
status.
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E.
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Term and
Termination:
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1.
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This
Agreement shall commence on the date first set forth above and shall
terminate after three (3) years, unless earlier terminated by either party
hereto (the “Term”). The Term of this Agreement may be extended
by mutual written agreement of the
parties.
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2.
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The
representations and warranties contained in this Agreement (including the
recitals hereto), as well as those rights and/or obligations contained in
the terms of this Agreement which by their intent or meaning have validity
beyond the term hereof, including without limitation Sections D, I, and
K.3. hereof, shall survive the expiration or termination of this
Agreement.
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3.
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This
Agreement may be terminated prior to the expiration of the term only under
the following Conditions:
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a)
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By
either party, if the other party materially breaches any of the covenants
and agreements under this Agreement, upon thirty (30) days written notice
to the other party.
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b)
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By
SPRI, if AMRI is substantially unable to perform assigned duties hereunder
whether due to sickness, disability or incapacity, or any other reason,
upon thirty (30) days written notice to
AMRI.
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c)
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By
AMRI, if SPRI fails to pay fees and/or fails to reimburse AMRI for
reimbursable expenses as provided in Section F.2. upon thirty (30) days
written notice to SPRI.
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d)
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[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] may terminate this
Agreement or any Project [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] upon
written notice to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] under the
[/*[CONFIDENTIAL TREATMENT
REQUESTED]*/]:
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5
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(i)
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if
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] desires to terminate the
Agreement or any Project [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] and
wind-down any Projects, [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] shall
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] the then current number of
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] until the total number of
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] have been [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]; or
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(ii)
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if
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] desires to terminate the
Agreement or any Project [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], then
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] shall [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] the
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] charges [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] under the [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]
as described [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] using the
[/*[CONFIDENTIAL TREATMENT
REQUESTED]*/].
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[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI – 02]
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4.
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If
any Research Project Appendix entered into prior to the end of the Term
shall have an expiration date after the last day of the Term, then
nothwithstanding the end of the Term set forth in this Section E, this
Agreement shall remain in full force and effect until the expiration of
such Research Project Appendix and references herein to “Term” shall refer
to the period ending with the expiration date of such Research Project
Appendix, but only with respect to such Research Project Appendix and the
Services described therein.
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F.
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Communications and
Payments:
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1.
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Communications: All
communications associated with this Agreement shall be by first class mail
or courier, addressed to the respective parties as
follows:
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To
AMRI:
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Chief
Financial Officer
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Albany
Molecular Research, Inc
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00
Xxxxxxxxx Xxxxxx
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Xxxxxx,
Xxx Xxxx 00000-0000
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With
a copy to:
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Director,
Contracts, Licensing & Legal Affairs
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Albany
Molecular Research, Inc
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00
Xxxxxxxxx Xxxxxx
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Xxxxxx,
Xxx Xxxx 00000-0000
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To
SPRI:
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Vice
President, Chemistry
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Schering-Plough
Research Institute
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0000
Xxxxxxxxx Xxxx Xxxx
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Xxxxxxxxxx,
Xxx
Xxxxxx 00000
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6
With
a copy to:
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Director,
Discovery Collaborations
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Schering-Plough
Research Institute
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0000
Xxxxxxxxx Xxxx Xxxx
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Xxxxxxxxxx,
XX 00000
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2.
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Payments: In
consideration of the Services that are performed by AMRI under this
Agreement, SPRI will pay AMRI at the following [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] for work conducted pursuant to agreed upon [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]:
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a)
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Fees: The
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] rate per FTE is outlined in the
table below. When the total number of FTEs employed under this
Agreement triggers [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] in the
applicable FTE rate below, then that [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] shall [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/].
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Number of
FTEs
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[/*[CONFIDENTIAL
TREATMENT
REQUESTED]*/]
Rate
Per FTE
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Estimated [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
Expenses per [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
per FTE
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||
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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||
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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||
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/]
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$[/*[CONFIDENTIAL
TREATMENT
REQUESTED]*/]
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Payment
to AMRI by SPRI shall not be later than [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]
of an appropriately documented and undisputed invoice. The above FTE
rate may be adjusted [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] by a percentage
that is [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] in the [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] for the [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] region
from the prior year, as reported by the [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/]. Such [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]
adjustments shall not exceed [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/].
7
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b)
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Reimbursed
Expenses: SPRI will reimburse AMRI for [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] reasonable and necessary expenses [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] while [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]
pursuant to this Agreement and which are in accordance with SPRI’s
Reimbursement Policy, a copy of which is attached hereto as Appendix 2. AMRI shall submit
signed requests with each invoice for reimbursement on AMRI’s letterhead
or other identifying stationery (“Expense Reports”), accompanied by a
reasonably detailed list of expenses. [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] reimbursable expenses shall not [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] an aggregate total of [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] multiplied by the [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]
working on SPRI projects without prior authorization from SPRI, such
authorization shall not be unreasonably delayed or
withheld. Reasonable and necessary expenses shall include:
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] used directly in the Projects;
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/], etc.); [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] used directly in the Projects; [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] used in the Projects (upon authorization by SPRI
to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]; and, [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] requested by SPRI. AMRI will not
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/], nor [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] in the normal course of performing
Services.
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[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI –
03]
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G.
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Assignment:
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Neither
party shall have the right to assign this Agreement or any of the rights
or obligations hereunder without the prior written consent of the other
party, except that either party may assign this Agreement to an affiliate
without such prior consent.
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H.
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Entire
Agreement:
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1.
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This
Agreement represents the entire agreement of the parties with respect to
the subject matter hereof and supersedes all prior understandings and
agreements with respect thereto.
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2.
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No
change or modification of the provisions of this Agreement shall be
effective unless it is in writing and signed by a duly authorized officer
of AMRI and SPRI.
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8
I.
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Project Ownership and
Retention of Records:
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1.
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Subject to SPRI satisfying its obligations under
C.3. and F.2., all [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] of
any kind and [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] supplied to AMRI
from SPRI or [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] the Services
performed hereunder shall be the sole and exclusive property of
SPRI. Any [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], whether
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] or not that may [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] above described or [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] shall be the sole and exclusive property of SPRI, and AMRI
agrees to assign or cause to be assigned all rights thereto to
SPRI. AMRI and its employees agree to cooperate with SPRI in
taking all steps which SPRI believes reasonably necessary or desirable to
secure its rights on this property at SPRI’s cost. In
consideration of the foregoing, SPRI agrees to grant to AMRI
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] to practice any [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] solely generated by AMRI that are specifically
directed to AMRI’s [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], to the extent
such technology has [/*[CONFIDENTIAL TREATMENT REQUESTED]*/]; provided,
however, that such use by AMRI under this [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] shall not [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] any
program or product [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/].
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[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI –
04]
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2.
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During
the term of this Agreement, AMRI shall maintain all written materials and
all other data obtained or generated by AMRI in the course of providing
the Services performed under this Agreement in a secure area reasonably
protected from fire, theft and destruction. At the expiration
or termination of this Agreement, all written materials and other data and
information obtained or generated by AMRI in the course of providing the
Services will be retained by AMRI in accordance with Section B.1.j or, at
SPRI’s option, be (a) delivered to SPRI or its designee in such form as is
then currently in the possession of AMRI, (b) retained by AMRI for SPRI
for a period of time mutually agreed upon by the parties, or (c) disposed
of, at the direction and written request of SPRI, unless such materials
are otherwise required to be stored or maintained by AMRI as a matter of
law or regulation.
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J.
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Safety and
Environmental:
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In
carrying out its responsibilities under this Agreement, AMRI agrees to
assure that the Services are conducted in compliance with any applicable
SPRI protocols and/or specifications of which AMRI is reasonably advised
in a timely manner and in compliance with all applicable laws, rules, and
regulations, including, but not limited to, the U.S. Food, Drug and
Cosmetic Act and the regulations promulgated pursuant
thereto. Also included is compliance with all relevant
environmental regulations in force at the U.S. Federal, State, and Local
levels.
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9
K.
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Miscellaneous:
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1.
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AMRI
represents and warrants that it will render the Services hereunder in
accordance with prevailing high professional standards and will make all
reasonable efforts to produce consistently high levels of accuracy and
expertise and to meet timetables set forth under this Agreement for
completion of Services. AMRI further represents and warrants
that personnel assigned to perform Services under this Agreement shall
have the skills necessary to efficiently perform such Services and shall
produce chemicals, data, and/or reports, as the case may be, in a form and
of a quality suitable to SPRI and that for each group of five (5) AMRI
employees providing Services hereunder, at least two (2) employees shall
have a doctorate degree in the chemistry
field.
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2.
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AMRI
will endeavor with all reasonable effort to conform to its obligations
identified herein. Although no delays or limits beyond AMRI’s reasonable control in
performing any Projects are expected, if such delays or limits are
encountered, AMRI will promptly notify SPRI accordingly and AMRI shall use
all reasonable efforts to eliminate or minimize such delays or
limits. SPRI agrees to accommodate any reasonable change in
timetables as a result of such delays that AMRI cannot reasonably
eliminate or minimize, provided the Projects have been proceeding to
SPRI’s satisfaction.
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3.
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AMRI
will further permit SPRI to audit AMRI’s relevant, non-financial records
during and after the term of this Agreement, but not more than once per
calendar year, solely to permit SPRI to confirm that the Services are or
have been performed in compliance with applicable laws and
regulations.
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4.
|
AMRI
is an independent company and nothing in this Agreement shall be construed
to create a partnership, joint venture, or employment relationship between
the parties.
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5.
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AMRI,
on behalf of itself and its employees, agents, subcontractors, and
affiliates agrees not to use the name of SPRI or any of its employees,
agents, affiliates, or subsidiaries, or reference any of their products,
in any publicity, advertising, or other publication without SPRI’s prior
written approval.
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6.
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If
any provision hereof shall be determined to be invalid or unenforceable,
such determination shall not affect the validity of the other provisions
of this Agreement.
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7.
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This
Agreement shall be governed in accordance with the laws of the State of
New York.
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8.
|
Waiver
by either party or the failure by either party to claim a breach of any
provision of this Agreement shall not be deemed to constitute a waiver or
estoppel with respect to any subsequent breach of any provision
hereof.
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10
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9.
|
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] agrees to assume the liability for injury or
damage caused by [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] provided by
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/], provided such [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] is not caused by [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/], intentional activity, or failure to meet required
specifications or breach of any applicable federal, state, or local
law. [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] to indemnify,
defend, and hold harmless [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] from
any and all liability arising out of such [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] assessed against it. [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/] agrees to assume the liability for [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] caused by its [/*[CONFIDENTIAL TREATMENT
REQUESTED]*/], provided such [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] is
not caused by [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], intentional
activity, or failure to meet required specifications or breach of any
applicable federal, state, or local law. [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] agrees to indemnify, defend and hold harmless
[/*[CONFIDENTIAL TREATMENT REQUESTED]*/] from any and all liability
arising out of said [/*[CONFIDENTIAL TREATMENT REQUESTED]*/], including
but not limited to [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] assessed
against it.
|
[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI – 05]
IN WITNESS WHEREOF, the
parties have caused this Agreement to be executed by their duly authorized
representatives.
Albany
Molecular Research, Inc.
|
SCHERING
CORPORATION,
acting
through its Schering-Plough
Research
Institute division
|
|||
By:
|
/s/
Xxxx X. Xxxxx
|
By:
|
Xxxxx
X. Xxxxxxx
|
|
an
authorized representative
|
||||
of
Schering-Plough Research Institute
|
||||
Name:
|
Xxxx
X. Xxxxx
|
Name:
|
Xxxxx
X. Xxxxxxx, Ph.D.
|
|
Title:
|
VP,
Business Development
|
Title:
|
President,
SPRI
|
|
Date:
|
January
10, 2006
|
Date:
|
January
13,
2006
|
11
APPENDIX
1
FORM OF
RESEARCH PROJECT APPENDIX
This
Research Project Appendix is entered into by Schering Corporation, acting
through its Schering-Plough Research Institute division (“SPRI”) and Albany
Molecular Research, Inc. (“AMRI”) as of the Effective Date of the Agreement
(defined below). This Research Project Appendix is entered into
pursuant to and is subject to the terms of that certain
Research/Manufacturing Agreement dated January 13, 2006 (the “Agreement”) by and
between SPRI and AMRI.
This
Research Project Appendix sets forth the Services to be performed by AMRI
(including deliverables to be provided to SPRI in connection therewith), the
timing for the Project, the cost and payment schedule, and any individuals
designated to have management responsibility for the Project or otherwise
required to perform the Services. NO TERM, CONDITION OR OTHER
PROVISION OF THIS RESEARCH PROJECT APPENDIX (INCLUDING ANY ATTACHMENTS) SHALL
SUPERSEDE ANY TERM, CONDITION OR OTHER PROVISION OF THE AGREEMENT, AND WITH
RESPECT TO ANY INCONSISTENCY, CONFLICT OR AMBIGUITY, THE AGREEMENT, INCLUDING
APPENDIX 2, SHALL CONTROL. ANY PROVISION OF THIS RESEARCH PROJECT
APPENDIX (INCLUDING ANY ATTACHMENTS) WHICH CONFLICTS WITH ANY TERM OF THE
AGREEMENT IS VOID AND OF NO FORCE OR EFFECT WHATSOEVER, NOTWITHSTANDING THAT
THIS RESEARCH PROJECT APPENDIX MAY BE EXECUTED AND DELIVERED AFTER THE EXECUTION
AND DELIVERY OF THE AGREEMENT. Subject to the foregoing, this
Research Project Appendix is incorporated into the Agreement and expressly made
a part thereof.
All
initially capitalized terms used in this Appendix but not defined in this
Appendix shall have the meanings given in the Agreement.
Purpose:
|
AMRI
will provide up [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] Full-Time
Equivalent (“FTE”) scientists (to the extent requested by SPRI) for
medicinal chemistry services and synthesis services of compounds as
described below or as may be amended from time to time in subsequent
writings signed by both parties. A detailed description of the
Project and Services is set forth in Attachment 1, which is incorporated
herein by reference.
|
[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI – 06]
Term:
|
Appendix
1 is in effect beginning on the Effective Date of the Agreement and
continues in effect until December 31, 2006 or earlier terminated by
either party pursuant to Article E of the Agreement.
|
Additional
FTE scientists or the use of other part-time support, such as computational
services or non-routine analytical services shall be subject to separate written
agreement.
12
AMRI
personnel resources:
AMRI
shall make available FTE scientists as follows:
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] FTEs [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] on the
Effective Date of the Agreement.
[/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] FTEs on or about February 1, 2006.
[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI – 07]
I.
|
AMRI
FTE Assignments and Deliverables
|
|
A.
|
AMRI
shall prepare compounds for biological screening and other compounds,
scaffolds, and reference compounds as SPRI directs AMRI during the term of
this Research Project Appendix.
|
|
B.
|
AMRI
shall provide Certificates of Analysis for all compounds, including at
least one proton NMR, mass spectrum, and other characterization as may be
required and mutually agreed to by the parties. AMRI shall conduct
analyses on the compounds pursuant to A) above utilizing appropriate
chromatographic and spectroscopic techniques.
|
|
C.
|
AMRI
shall prepare written reports on a periodic basis to SPRI detailing the
progress of the research hereunder.
|
II.
|
SPRI
Resources and Materials
|
SPRI
shall provide to AMRI compound formulae, samples, synthetic methodology,
spectral data, and literature references as SPRI deems appropriate and if
available. SPRI further reserves the right to supply AMRI with raw
materials and reagents.
III.
|
Invoicing
and Payment
|
AMRI
shall invoice SPRI [/*[CONFIDENTIAL TREATMENT REQUESTED]*/] for [/*[CONFIDENTIAL
TREATMENT REQUESTED]*/] devoted to this Project at the rate specified in Section
F.2.a of the Agreement, and SPRI shall pay each invoice as provided for pursuant
to Section F.2 of the Agreement.
[CONFIDENTIAL
TREATMENT REQUESTED BY AMRI – 08]
13
All terms
and conditions of the Agreement shall remain in full force and
effect.
NO WORK
SHALL BE PERFORMED HEREUNDER UNTIL BOTH PARTIES HAVE EXECUTED THIS RESEARCH
PROJECT APPENDIX. VERBAL AUTHORIZATION AND/OR INSTRUCTIONS TO
COMMENCE WORK (INCLUDING ANY SERVICES) SHALL BE OF NO EFFECT, AND ANY WORK OR
SERVICES PERFORMED BY AMRI PRIOR TO EXECUTION OF THIS RESEARCH PROJECT APPENDIX
BY BOTH PARTIES SHALL BE AT AMRI’S SOLE RISK AND EXPENSE.
14
In
Witness Whereof, the parties have duly executed and delivered to each other this
Appendix 1.
SCHERING
CORPORATION,
|
||||
acting
through its Schering-Plough
|
||||
Research
Institute division
|
||||
By:
|
/s/
Xxxx X. Xxxxx
|
By:
|
/s/
Xxxxx X. Xxxxxxx
|
|
an
authorized representative of
|
||||
Schering-Plough
Research Institute
|
||||
Name:
|
Xxxx
X. Xxxxx
|
Name:
|
Xxxxx
X. Xxxxxxx, Ph.D.
|
|
Title:
|
VP
Business Development
|
Title:
|
President,
SPRI
|
|
January
10, 2006
|
Date:
|
January
13,
2006
|
15
APPENDIX 2
REIMBURSEMENT POLICY
In accordance with SPRI’s standard policies and
procedures, the following are types of expenses for which SPRI will not
reimburse, unless expressly agreed to in a prior writing by the
parties:
-
|
Commuting expenses to and/or from your place of
business or residence (excluding transportation costs to and/or from the
airport for SPRI-requested
business)
|
-
|
Add-on costs with respect to outside services,
including but not limited to xxxx-up for the work product of outside
professionals, including but not limited to
freelancers
|
-
|
Meals (except during travel periods in connection
with the services rendered to SPRI). For this exception,
reasonableness shall be measured at US rates of $50 for dinner and $25
each for breakfast and lunch, tax and
tip included in all cases
|
-
|
Administrative and/or overhead percentages
|
-
|
Agency presentations for new
business
|
-
|
Business-class air travel. Business-class air travel
is only reimbursable if approved in writing in advance by the area Vice
President
|
The following types of expenses are not
reimbursable:
-
|
First-class air travel
|
-
|
Xxxx-up on any out-of-pocket
expenses
|
-
|
Travel
time
|
-
|
Gifts to SPRI’s
employees
|
-
|
Entertainment of SPRI’s
employees
|
This list
sets forth the major items for which SPRI will not reimburse you and is meant to
be merely illustrative and not exhaustive. All your expenses shall be reviewed
with respect to the reasonableness of such expenses.
16