Exhibit 10.21
MASTER
CLINICAL DEVELOPMENT
AGREEMENT
between
NEUROBIOLOGICAL TECHNOLOGIES,
INC.
Mahwah, NJ 07495
and
SCIREX CORPORATION
Horsham, PA 19044
MASTER CLINICAL DEVELOPMENT
AGREEMENT
THIS MASTER CLINICAL DEVELOPMENT AGREEMENT
(“Agreement”), made as of the date last signed below is
by and between Neurobiological Technologies, Inc., a company having
its principal place of business at Crossroads Corporate Center, One
International Boulevard, Suite 400, Mahwah, NJ 07495
(“NTI”), and SCIREX Corporation, a corporation of the
State of Delaware having its principal place of business at 755
Business Center Drive, Horsham, PA 19044
(“SCIREX”).
WITNESSETH:
WHEREAS, NTI is engaged in the development,
manufacture, distribution and sale of pharmaceutical products and
it currently considers from time to time the evaluation of new
drug(s) or biological product(s) (collectively, “Drug”
or “Drugs” as the context requires); and
WHEREAS, SCIREX is in the business of providing
services for the development of investigational new Drugs and
marketed Drugs; and
WHEREAS, NTI desires to contract with SCIREX
from time to time, and SCIREX desires to be contracted by NTI, for
the purposes of providing such services to assist NTI in the
execution of clinical development projects (“Project”
or “Projects” as the context requires) relating to
Drugs as outlined in the Project-specific exhibits to this
Agreement (“Exhibit” or “Exhibits” as the
context requires).
NOW, THEREFORE, the parties hereby agree as
follows:
1. OBLIGATIONS OF
SCIREX
1.1 SCIREX hereby agrees to conduct the Projects
with all due diligence in accordance with NTI’s instructions.
The details, specifications and obligations of each Project will be
included as an Exhibit to this Agreement. SCIREX will conduct the
Projects in accordance with agreed upon Protocols and as outlined
in the Exhibits.
1.2 No Project Exhibit shall be made or
incorporated as a part of this Agreement without first being
executed by the authorized representatives of the parties
hereto.
1.3 To the extent any terms set forth in a
Project Exhibit conflict with the terms of this Agreement, the
terms of this Agreement shall control unless otherwise expressly
set forth by the parties in the Project Exhibit.
1.4 Projects will be conducted in accordance
with all applicable federal, state and local laws, statutes,
ordinances and regulations, including without limitation the
Federal Food, Drug and Cosmetic Act, Public Health Service Act, and
Good Clinical Practices guidances as they may be amended from time
to time.
1.5 If SCIREX is required to execute or obtain
the execution of any agreements with a site to conduct a clinical
trial or study (“Site Agreements”), such Site
Agreements shall contain all provisions as specified by NTI in the
applicable Project Exhibit or as otherwise approved in advance by
NTI in writing, and shall include binding budgets approved in
advance by NTI.
1.6 SCIREX shall not subcontract or assign any
of its obligations unless otherwise expressly set forth by the
parties in the Project Exhibit.
1.7 SCIREX will immediately notify NTI of any
reasonable suspicion of fraud it has by any party.
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2. TRANSFER OF
RESPONSIBILITIES
2.1 For compliance under 21 C.F.R. 312.52, NTI
must identify all Investigational New Drug (IND) Exemption
responsibilities that will be transferred to SCIREX. Each Exhibit
will contain a description of transferred obligations. NTI agrees
that the same description should be included in form FDA-1571,
Section #13 relating to the specific Drugs under investigation.
SCIREX agrees to carry out diligently all transferred
obligations.
3. CLINICAL
SUPPLIES
3.1 Unless otherwise specified in an Exhibit,
NTI will supply the clinical investigators with the Drugs and other
clinical drug supplies as are agreed upon by SCIREX and NTI for the
timely completion of the Projects, and will direct the shipment, of
any such supplies to the location indicated by SCIREX, within a
reasonable time after receipt of notification from SCIREX of the
need for any such clinical supplies.
4. STATUS
REPORTING
4.1 SCIREX will provide status reports on the
Projects as agreed to in each specific Exhibit. The status reports
will include, but not be limited to, data regarding the number of
patients entering the Projects, as well as data regarding the
number of patients that either drop out of the Projects or complete
the Projects. Reports of monitoring visits will also be provided on
a timely basis as specified in the Exhibits.
5. RECORDS
5.1 SCIREX shall maintain all materials,
information, source documents, source code used to generate output,
correspondence, and data obtained or generated by SCIREX or its
employees, agents, consultants, or contractors, in the course of
providing services hereunder, including all electronic media,
computerized records and files (collectively “Records”)
in accordance with this Agreement, the Project Exhibit(s), Good
Clinical Practice, and all applicable laws and requirements and
will use its best efforts to ensure that they are maintained in a
safe and secure manner protected from fire, theft, disclosure and
destruction.
5.2 SCIREX shall cooperate with any internal
review or audit by NTI or NTI’s authorized representative and
make any and all Records available for examination and duplication,
during normal business hours and at mutually agreeable times.
SCIREX will cooperate with NTI in accommodating any unannounced
visits, investigations, or inspections by regulatory authorities
including without limitation FDA, and will provide documents,
information, and access properly requested. SCIREX will promptly
notify NTI of any regulatory inquiries, proposed regulatory
actions, investigations, site visits (whether announced or
unannounced), correspondence, or communications that relate to a
Project.
5.3 At any time NTI may request in writing that
all Records be (i) delivered to NTI to a location designated
in NTI’s written request in such form as is then currently in
the possess of SCIREX; (ii) retained by SCIREX for NTI in a
safe and secure manner as described in Paragraph 5.1 and for a
period to be defined by NTI’s written request at NTI’s
expense; or (iii) disposed of, at the direction and written request
of NTI, unless such materials are otherwise required to be stored
or maintained by SCIREX as a matter of law or regulation. In no
event shall SCIREX dispose of any Records without first giving NTI
sixty (60) days prior written notice of its intent to do
so.
5.4 SCIREX will permit NTI representatives to
examine or audit, with reasonable notice, the work performed under
this Agreement, the facilities, systems, and equipment at or with
which the services hereunder are performed, and the personnel,
procedures, programming, and records related to such
services.
5.5 SCIREX represents and warrants that all
computer systems and electronic records used by SCIREX comply with
all applicable laws and requirements, including without limitation
the Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule, and to its knowledge are free of any unintended
programming problems, viruses, locks, or access controls that will
impair NTI’s use of such records, recognizing that NTI must
have access from SCIREX to use such Records.
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6. CONFIDENTIAL
INFORMATION
6.1 All information received by SCIREX
concerning the implementation of the Projects is considered to be
confidential information to NTI (“NTI Confidential
Information”). NTI Confidential Information will be held in
confidence by SCIREX and not disclosed to third parties; provided
however, that NTI Confidential Information shall not include, and
the obligations of confidentiality and non-disclosure shall not
apply to, disclosed information that:
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A
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is or becomes
publicly available through no fault of SCIREX;
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B
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is disclosed to
SCIREX by a third party entitled to disclose such
information;
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C
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is already
known to SCIREX as shown by its prior written records;
or
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D
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is required by
law to be disclosed.
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6.2 SCIREX will only use the NTI Confidential
Information for the purpose of its obligations under this
Agreement. Upon the completion or earlier termination of this
Agreement, SCIREX will promptly return to NTI all written NTI
Confidential Information, as well as all written material which
incorporates any NTI Confidential Information, other than such
information that is required by government regulations to be
retained by it. Notwithstanding the foregoing, SCIREX shall have
the right to retain one copy of NTI Confidential Information for
the purposes of demonstrating compliance with Good Clinical
Practices, Standard Operating Procedures, NTI written instructions,
and all federal, state and local laws and regulations.
6.3 SCIREX will not disclose, without the prior
written consent of NTI, any NTI Confidential Information to any
third party other than employees who have a need to know such
information, hospital authorities, institutional review board
members, clinical investigators, and others who must be involved
with the Projects.
6.4 SCIREX will not use any NTI Confidential
Information for its own benefit or for the benefit of any third
party, and will not furnish to any third party any materials which
incorporate any confidential information except as otherwise
provided for herein. All obligations of confidentiality and
non-disclosure set forth in this Agreement will survive, without
limitation, the expiration or earlier termination, for any reason,
of this Agreement.
6.5 During the term of this Agreement and
thereafter (including following any termination), NTI, for itself
and its employees, agents and independent contractors, agrees to
retain in confidence and not disclose to any third parties any
SCIREX Confidential Information (defined below) without having
first obtained SCIREX written consent to
such disclosure. During the term of this Agreement, but not
thereafter (including following any termination), NTI may have
access or use SCIREX Confidential Information only in connection
with the Projects; provided, however, that NTI may not run or have
or have access to SCIREX computer programs or computer code without
SCIREX permission, although SCIREX will run its computer programs
as part of the services provided hereunder and as and when
requested by NTI during the term of this Agreement, “SCIREX
Confidential Information” shall include but not be limited to
confidential and proprietary know-how, statistical approaches,
computer programs, operating procedures, formulations, methods,
processes, specifications and all other intellectual property of
SCIREX that SCIREX considers confidential; provided, however, that
such information shall be to exceptions based on public knowledge,
prior or lawfully obtained NTI knowledge and requirements of law,
rules and regulations corresponding to the exceptions set forth in
6.1 A-D above.
7. ACCEPTANCE OF WORK
PRODUCT
7.1 NTI agrees to review all work products
submitted by SCIREX and to advise SCIREX promptly of any errors or
omissions of which NTI becomes aware in the course of its review or
thereafter. SCIREX shall, at its expense, correct all errors that
it discovers or which are brought to its attention by NTI within
ninety (90) days after submission of work product to NTI, and
will make corrections to all errors or omissions after ninety
(90) days for additional compensation at cost. Cost shall be
defined as SCIREX’s
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standard hourly rates reduced appropriately to
eliminate SCIREX’s corporate selling, general and
administrative expenses and profit. Cost shall also include
pass-through expenses.
8.
COMPENSATION
8.1 NTI shall pay to SCIREX the investigator
fees and other out-of-pocket costs and fees set forth in the
Exhibits. SCIREX shall complete the transferred obligations and the
Projects by the dates specified in the Exhibits except for delays
caused by NTI or others, events outside of SCIREX control, or
mutual agreement between SCIREX and NTI.
8.2 The payment schedule for each Project will
be contained in the appropriate Exhibit.
8.3 SCIREX will submit invoices to NTI according
to the schedule described in the Exhibits. All SCIREX invoices are
payable within thirty (30) days of receipt of an itemized
invoice and appropriate documentation reasonably acceptable to NTI
and in accordance with this Agreement and the Project Exhibit.
Payment may be withheld for only that portion of those invoice
items that NTI reasonably determines does not meet the requirements
of this Agreement or the Project Exhibit. NTI shall, within the
thirty (30) day period, notify SCIREX of any contested amounts
or questions regarding an invoice or invoice item. SCIREX agrees to
respond to requests by NTI to clarify questions on any invoice or
invoice item, and NTI agrees that it will use its best efforts to
resolve contested invoice items in a timely and reasonable fashion.
SCIREX acknowledges and agrees that NTI is not obligated to pay
such contested amounts otherwise due and payable within the thirty
(30) day period until such time as the contested issues are
resolved to the satisfaction of NTI, and that NTI will not be
subject to any penalty or finance charge for such withheld
payments, provided that NTI acts in good faith.
8.4 The total cost of the Projects, individual
budget components and time estimates are based on the specification
and assumptions contained in the Exhibits, and subject to
modification only as provided for in Section 9
hereof.
8.5 Travel, supplies, and other incidental
related expenses that are required in support of a Project and that
are consistent with the Project Exhibit and any applicable budgets,
shall be reimbursed by NTI provided that (i) all air travel
shall be at coach fare; and (ii) upon request by NTI, SCIREX
shall promptly provide documentation and receipts regarding any
such expenses.
8.6 SCIREX shall maintain complete and accurate
accounting records related to Projects hereunder in accordance with
Generally Accepted Accounting Principles. These records shall be
available for inspection, review and audit at reasonable times by
NTI, or its authorized representative, at NTI’s expense, for
three (3) years following the end of the calendar year in
which such costs are incurred.
9. CHANGE
ORDERS
9.1 In the event of a change in the scope of a
Project outside SCIREX’s control, the identifying party will
promptly notify the other party of such change. Outside
SCIREX’s control is defined for the purposes of this section
9 as situations limited to the following: (i) an amendment to
a Project Protocol requested by NTI; (ii) a deviation from the
Protocol required by generally accepted standards of clinical
research and medical practice relating to the safety of research
subjects; (iii) an unanticipated side effect of a Drug during the
course of a Project that significantly slows subsequent subject
enrollment; (iv) the occurrence of a Force Majeure; (v) a
significant change in the scope or nature of the services requested
of SCIREX; or (vi) a lack of reasonably timely execution of
the obligations of NTI. A change in one of the assumptions set
forth in a Project Exhibi