EXHIBIT 10.10
MASTER
CLINICAL DEVELOPMENT AGREEMENT
between
CORCEPT THERAPEUTICS INC.
Xxxxx Xxxx, XX 00000-0000
and
SCIREX CORPORATION
Xxxxxxx, XX 00000
MASTER CLINICAL DEVELOPMENT AGREEMENT
THIS AGREEMENT, made as of the date last signed below is by and between Corcept
Therapeutics Inc., a company incorporated in the State of Delaware, having its
principal place of business at 000 Xxxxxxxxxxx Xxxx, Xxxxx Xxxx, XX ("Corcept),
and Scirex Corporation ("Scirex) a corporation of the State of Delaware having
its principal place of business at 000 Xxxxxxxx Xxxxxx Xxxxx, Xxxxxxx, XX 00000.
WITNESSETH:
WHEREAS, Corcept is engaged in the development, manufacture, distribution and
sale of pharmaceutical products and it currently wishes to evaluate
Mifepristone; and
WHEREAS, Scirex is in the business of providing services for the development of
new drugs and marketed drugs; and
WHEREAS, Corcept desires to contract with Scirex, and Scirex desires to be
contracted by Corcept, for the purposes of providing such services to assist
Corcept in the execution of clinical development projects and studies, as set
forth in the attachments to this Agreement ("Exhibits").
NOW, THEREFORE, the parties hereby agree as follows:
1. DEFINITIONS
1.1 "Affiliates" means any corporation or other entity that directly, or
indirectly through one or more intermediaries, controls, is controlled by, or is
under common control with the designated Party but only for so long as such
relationship exists. For the purposes of this definition, "control" means i)
ownership of at least fifty percent (50%) of the shares of stock entitled to
vote for directors in the case of a corporation, or of at least fifty percent
(50%) of the interests in profits of a business entity other than a corporation;
or ii) the possession, directly or indirectly, of the power to direct or cause
the direction of the management and policies of an individual, corporation, or
other legal entity, whether through the ownership of voting securities, by
contract, or otherwise.
1.2 "Agreement" means this Master Clinical Development Agreement.
1.3 "Applicable Laws and Requirements" means all Federal, state and local laws,
regulations, policies, and requirements that govern or apply to conduct of the
Study and the Project and Services under this Agreement, including without
limitation, the Food Drug and Cosmetic Act, [and such foreign governmental
requirements as Corcept may inform Scirex are applicable],as they may be amended
from time to time.
1.4 "Project" means the work to be performed under a given assignment, including
the Study Protocol and various other attached materials, as they may be amended
in writing from time to time. The first such Project is the Scirex Proposal
entitled "A Proposal to Provide Clinical Research Services for A Phase III,
Multi-Center, Double-Blind, Placebo-Controlled Study of Safety and Efficacy of
Mifepristone in Patients with Major Depressive Disorder with Psychotic Features
(SCIREX Project 2169); A Phase III, Multi-Center, Open-Label Study of the Safety
and Efficacy of Misepristone in Patients with Major Depressive Disorder with
Psychotic Features" and dated 26 February 2001, (sometimes referred to as the
Proposal), as it may be amended in writing from time to time, along with the
corresponding Study Protocols, attached as Exhibit A.
1.5 "Project Exhibit" means the Exhibit describing the Project and containing
the Study Protocol(s) and the Proposal.
1.6 "Study" means a clinical trial of a Study Drug, as set forth in a Study
Protocol.
1.7 "Study Drug" means the drug being studied in the Protocol and in the
Clinical Trial, under the direction of Scirex.
1.8 "Study Protocol" means the documents describing the design and procedures
for the Study, set forth as a part of the Project Exhibit, as may be amended in
writing from time to time. The first such Study Protocols are entitled "A Phase
III, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety and
Efficacy of Mifepristone in Patients with Major Depressive Disorder with
Psychotic Features", and "A Phase III, Multi-Center, Open-Label Study of the
Safety and Efficacy of Mifepristone in Patients with Major Depressive Disorder
with Psychotic Features," attached as a part of Exhibit A, as they may be
amended in writing from time to time.
2. OBLIGATIONS OF SCIREX
2.1 Corcept may from time to time retain the services of Scirex to provide
clinical research services in connection with certain clinical research programs
Corcept is conducting (individually, a "Study") as set forth in this Agreement
and as will be more fully delineated in various project-specific descriptions
that will be attached hereto as Project Exhibits.
2.2 In the event that the parties reach agreement with respect to a particular
Study, a Project Exhibit for that specific Study shall, together with this
Agreement (but separate and apart from any other Project Exhibits), collectively
constitute the Agreement for that specific Study. 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. To the extent any terms
set forth in a Project Exhibit conflict with the terms set forth in this
Agreement, the terms of this Agreement shall control unless otherwise expressly
set forth by the parties in the Project Exhibit.
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2.3 Scirex will perform all services for Corcept in accordance with the relevant
Project Exhibit, including the Study Protocol, that will be provided by Corcept
as a part of the Project Exhibit or will be prepared by Scirex under Corcept's
direction and approved by Corcept. The Study Protocol will specify (without
limitation) the research project, design, purpose, information desired,
experimental and other procedures, estimated duration, budget, and other
relevant matters, and will become a part of this Agreement upon its approval by
the parties. If requested by Corcept, Scirex will assist in developing the Study
Protocol such that it is consistent with current and reasonably anticipated
Applicable Laws and Requirements. Scirex represents that it will provide all
reasonable, professional, expert efforts to so assist Corcept.
2.4 Scirex hereby agrees to perform, with all due diligence, its obligations as
described in this Agreement and each Project Exhibit (the "Services"). Such
Services may include strategic planning, expert consultation, clinical trial
services, statistical programming and analysis, data processing, data
management, regulatory, clerical, project management and such other research and
development services as Corcept may request and as may be set forth in the
Agreement and the Project Exhibits. In providing the Services and implementing
the Project Exhibits, Scirex shall fully comply with this Agreement; the Project
Exhibits; the Study Protocols; the written instructions of Corcept; standard
operating procedures approved in writing by Corcept; Good Clinical Practice;
relevant professional standards; and all Applicable Laws and Requirements.
2.5 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 Corcept in the
applicable Project Exhibit or as otherwise approved in advance by Corcept in
writing, and shall include binding budgets approved in advance by Corcept.
3. TRANSFER OF RESPONSIBILITIES
3.1 In order to achieve compliance under regulations at 21 CFR 312.52, Corcept
must identify all responsibilities that will be transferred to Scirex in each
Project Exhibit. Each Exhibit will contain a detailed description of transferred
obligations. Corcept agrees that the same description and extent of obligations
transferred should be included in form XXX-0000, Xxxxxxx #00 relating to the
specific Study Drug(s) under investigation. Scirex agrees to carry out
diligently all transferred obligations.
4. CLINICAL SUPPLIES
4.1 Unless otherwise specified in a Project Exhibit to this Agreement, Corcept
will supply the clinical investigators with Study Drugs and other clinical drug
supplies as are agreed upon by Scirex and Corcept 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
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supplies. If applicable pursuant to the Project Exhibit, Scirex shall
maintain an accurate inventory of such Study Drugs and, at the end of the Study,
or upon its earlier termination, shall promptly use its best efforts to cause
the Clinical Investigators to return all unused Study Drugs and other drug
supplies to Scirex, consistent with the inventory.
5. STATUS REPORTING
5.1 Scirex will provide status reports on the Projects as agreed to in each
specific Project Exhibit. The status reports will include, but not be limited
to: the number of patients entered, dropped, and completed in the Projects.
Reports of monitoring visits will also be provided on a timely basis as
specified in attached Project Exhibits.
6. PERSONNEL
6.1 The Services with respect to each Study shall be performed by Scirex under
the direction of the person identified as the project manager in the applicable
Project Exhibit or such other person identified by Scirex and acceptable to
Corcept ("Project Manager"). The services of the Project Manager and any other
Scirex personnel, as mutually agreed upon and named in a Project Exhibit, are
considered essential to the performance of each Study ("Key Personnel"). No
other person(s) may be substituted for any Key Personnel, Project Manager, or
Principal Investigator, except with Corcept's prior written approval, which
shall not be unreasonably withheld. In the event that any Key Personnel, Project
Manager, or Principal Investigators are substituted without the prior written
approval of Corcept, the Project or the Agreement may be terminated, in whole or
in part, by Corcept.
6.2 Scirex shall at all times provide, and and use its best efforts to cause its
subcontractors provide, a sufficient number of properly trained clinical
research personnel on a given Study to meet the demands of that Study. Scirex
represents that all persons assigned to a Project or otherwise performing work
under this Agreement are qualified, trained, and experienced in the performance
of their assigned tasks.
6.3 Scirex shall not subcontract or assign any Services involving administration
of Study Drug, or central laboratory services under a Project Exhibit without
the prior written consent of Corcept, which consent may be withheld with or
without reason. Scirex shall utilize the precise wording and provisions required
by Corcept for any such subcontract or assignment.
7. RECORDS
7.1 Scirex shall maintain all materials, information, source documents,
correspondence, and data obtained or generated by Scirex or its employees,
agents, consultants, or contractors, in the course of providing the Services
hereunder, including all electronic media, computerized records and files,
(collectively "Records") in accordance with this Agreement, the Project Exhibit,
Good Clinical Practice, all
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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. Scirex shall cooperate with any internal review or
audit by Corcept or Corcept'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 Corcept 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 Corcept of any regulatory inquiries, proposed regulatory actions,
investigations, site visits (whether announced or unannounced), correspondence,
or communications that relate to the Study, the Services, the Project Exhibit,
or this Agreement.
7.2 At any time Corcept may request in writing that all Records be (i) delivered
to Corcept to a location designated in Corcept's written request in such form as
is then currently in the possession of Scirex; (ii) retained by Scirex for
Corcept in a safe and secure manner as described in Paragraph 7.1 and for a
period to be defined by Corcept's written request; or (iii) disposed of, at the
direction and written request of Corcept, 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 Corcept
sixty (60) days prior written notice of its intent to do so.
7.3 Scirex will permit Corcept 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 are performed, and the
personnel, procedures, programming, and records related to such Services.
7.4 Scirex represents and warrants that all computer systems and electronic
records used by Scirex comply with all Applicable Laws and Requirements, and to
its knowledge are free of any unintended programming problems, viruses, locks,
or access controls that will impair Corcept's use of such records, recognizing
that Corcept must have access from Scirex to use such records in accordance with
the provisions of Paragraph 8.5.
7.5 Scirex shall make all reasonable efforts to assure cooperation and
compliance with the requirements of Paragraphs 7.1 through 7.4 by its employees,
agents, and subcontractors.
8. CONFIDENTIAL INFORMATION
8.1 All information received by Scirex from Corcept concerning the
implementation of the Projects is considered to be confidential information to
Corcept. This confidential information will be held in confidence by Scirex and
not disclosed to third parties; provided however, that 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) is or becomes publicly available through no fault of Scirex;
(b) is disclosed to Scirex by a third party entitled to disclose it;
(c) is already known to Scirex as shown by its prior written records; or
(d) is required by law to be disclosed.
8.2 Scirex will only use the confidential information furnished by Corcept for
the purpose of its obligations under this Agreement. Upon the completion or
earlier termination of this Agreement, Scirex will promptly return to Corcept
all written confidential information, as well as all written material that
incorporates any confidential information, other than such information that it
is required by government regulations to retain. Scirex shall have the right to
retain one confidential copy of all documents relating to the Projects.
8.3 Scirex will not disclose, without the prior written consent of Corcept, any
such confidential information to any third party other than employees ; hospital
authorities, institutional review board members, clinical investigators, and
others who must be involved in this Project program; provided that all such
parties have a need to know the information in order for this Agreement to be
performed. All confidential information will contain a statement from Corcept
indicating that the information is confidential and should not be disclosed to
unauthorized individuals.
8.4 Scirex will not use any such 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
herein above provided. 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.
8.5 During the term of this Agreement and thereafter (including following any
termination), Corcept, for itself and it employees, agents and independent
contractors, agrees to retain in confidence and not disclose to any third
parties any Scirex Confidential Information without having first obtained
Scirex' written consent to such disclosure. During the term of this Agreement,
but not thereafter (including following any termination), Corcept may have
access or use Scirex Confidential Information only in connection with the
Projects; provided, however, that Corcept 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 and provide printouts and raw data as part
of the Services provided hereunder and as and when requested by Corcept during
the term of this Agreement. Scirex will run computer programs and provide
printouts and raw data to Corcept after the term of this Agreement expires or is
terminated for any reason (i) if so requested by Corcept, and (ii) if Scirex and
Corcept have mutually agreed
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to terms for payment for such Services. If Scirex or a Scirex assignee or
successor is not available to run computer programs developed for the Project
due to bankruptcy or insolvency, then Scirex will make available such computer
programs to Corcept under the conditions of a confidential restricted use
license, the terms of which will be mutually agreed upon. If Scirex terminates
this Agreement without cause, and following such termination fails to reach
agreement with Corcept to either (i) run computer programs and provide printouts
and raw data, or (ii) make those programs available to Corcept for its use,
Corcept will not be required to pay Scirex for its Services to the extent such
Services are directly related to the development of those computer programs.
"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, provided that Scirex Confidential
Information shall be subject to exceptions based on public knowledge, prior or
lawfully obtained Corcept knowledge, and requirements of law, corresponding to
the exception set forth in Paragraph 8.1; and further provided that such
information is identified in writing as confidential at the time it is
disclosed.
8.6 Scirex shall require that its employees, agents, and shall use its best
efforts to cause its subcontractors comply with the requirements of Paragraphs
8.1 through 8.4 and shall, in any subcontract or assignment, require protections
regarding confidential information at least as rigorous as set forth in those
paragraphs.
9. ACCEPTANCE OF WORK PRODUCT
9.1 Corcept agrees to review all work products submitted by Scirex and to advise
Scirex promptly of any errors or omissions of which Corcept becomes aware in the
course of its review or thereafter. Scirex shall promptly, at its expense,
correct all errors or omissions that it discovers or which are brought to its
attention by Corcept within ninety (90) days after submission of work product to
Corcept, and will make corrections to all errors or omissions after ninety (90)
days for additional compensation at cost. Cost shall be defined as Scirex'
standard hourly rates reduced appropriately to eliminate Scirex' corporate SG&A
and profit. Cost shall also include pass-through expenses.
10. COMPENSATION
10.1 A payment schedule for the performance of the Services ("Payment Schedule")
and related expenses shall be included in each Project Exhibit attached to this
Agreement. Scirex shall use its best efforts to complete its obligations under
each Project Exhibit in the timeframe specified, recognizing that time is
important in the performance of this Agreement. Except as otherwise expressly
provided in the applicable Project Exhibit, Scirex shall submit to Corcept an
invoice describing the Services performed and, where applicable, expenses
incurred during a particular month on a monthly basis. Costs shall not exceed
those set forth in the Project Exhibit, except as mutually agreed to as
specified in Paragraph 11. Payment under this Agreement shall be made by Corcept
within thirty
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(30) days of receipt of an itemized invoice and appropriate documentation
reasonably acceptable to Corcept and in accordance with this Agreement and the
Project Exhibit. Payment may be withheld for only that portion of those invoice
items that Corcept reasonably determines does not meet the requirements of this
Paragraph. Corcept shall, within the thirty (30) day period, notify Scirex
respecting any contested amounts or questions regarding an invoice or invoice
item. Scirex agrees to respond to requests by Corcept to clarify questions on
any invoice or invoice item, and Corcept agrees that it will use its best
efforts to resolve contested invoice items in a timely and reasonable fashion.
Scirex acknowledges and agrees that Corcept 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
Corcept, and that Corcept will not be subject to any penalty or finance charge
for such withheld payments, provided that Corcept acts in good faith.
10.2 Payments will be made by check payable to the party designated and mutually
agreed upon herein, and sent to the appropriate persons designated in Paragraph
25.1 of this Agreement. For any payments to be made by Scirex to third parties
or subcontractors, as delineated in an appropriate Project Exhibit, Scirex shall
have the responsibility and obligation to make such payments, including proper
and timely disbursements of the funds received from Corcept for such purposes to
the appropriate parties.
10.3 Reasonable travel, supplies, and other incidental related expenses that are
required in support of the Study and that are consistent with the Project
Exhibit and any applicable budgets, shall be reimbursed by Corcept provided as
follows:
(a) All air travel shall be at coach fares; and
(b) Upon request by Corcept, Scirex shall promptly provide documentation
and receipts regarding any such expenses.
10.4 Taxes (and any penalties and interest thereon) imposed on any payment made
by Corcept to Scirex shall be the responsibility of Scirex.
10.5 Scirex shall maintain complete and accurate accounting records related to
its participation in the Study in accordance with Generally Accepted Accounting
Principles. These records shall be available for inspection, review and audit at
reasonable times by Corcept, or its authorized representative, at Corcept's
expense, for three (3) years following the end of the calendar year in which
such costs are incurred.
11. CHANGE ORDERS
11.1 In the event of a change in the scope of the project that is outside the
control of Scirex, the identifying party will promptly notify the other party
of such change ("Change
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Notice"). "Outside the control of Scirex" is defined for the purposes of this
section 11 as situations limited to the following:
(a) an amendment to the Study Protocol is requested by Corcept;
(b) a deviation from the Protocol is required by generally accepted
standards of clinical research and medical practice relating to the
safety of Research Subjects;
(c) an unanticipated side effect of the Study Drug during the course of the
Study significantly slows subsequent enrollment in the Study;
(d) the occurrence of a Force Majeure;
(e) a material failure on the part of Corcept to fulfill its
responsibilities in a timely manner; or,
(f) a material additional service, requested by Corcept, and not identified
in the Project Exhibit, which Scirex can establish was not
contemplated by the parties, and does not arise from either (i) the
requirement for Scirex to conduct the Study with due diligence and in
compliance with All Applicable Requirements; or from (ii) a Scirex
omission, oversight, mistake, or error in accurately predicting the
services and costs necessary to conduct the Study in compliance with
such requirements.
A change in one of the assumptions set forth in the Project Exhibits (including,
without limitation, those set forth in bold type) does not itself justify a
change order unless such change meets one of the above criteria. Within 20
working days of Scirex sending or receiving such Change Notice, Scirex shall
provide Corcept with its proposal of a modification to the timeline and the
costs arising from such change ("Change Order"), whether such change results in
an increase or decrease to the timeline or costs. Corcept shall have 15 working
days to review and respond to the Change Order. If the parties do not agree as
to whether a change outside the control of Scirex has taken place, or if Corcept
does not approve such Change Order and has not terminated the Project, both
parties will use their best efforts to agree in writing and on time and cost
estimates that are mutually acceptable.
11.2 Notwithstanding any other provision of this Agreement, Scirex shall not,
without the prior written approval of Corcept (a) exceed or alter the budgets or
cost estimates contained in the Project Exhibits (including, without limitation,
the enrollment costs), or authorize or approve any amendment or increase in the
budgets or cost estimates for the Site Agreements; (b) use any amounts
designated in the budget as intended for Site Agreements for any other purpose;
(c) exceed, in any Site Agreement, the maximum total per patient cost
established in the Project Exhibit. Pass-through expenses (including
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without limitation all Site Agreement costs and expenses) will be billed to
Corcept with no markup. SCIREX will use every reasonable effort to minimize
these pass-through expenses while meeting the Study requirements and the
requirements of this Agreement.
11.3 During the period when a Change Order is being prepared and reviewed,
Scirex shall continue to perform the Project and Study, if possible, but will
not be obligated to perform those services that have resulted from changes
outside of the control of Scirex until agreement has been reached on the Change
Order; provided, however, that, under certain emergency circumstances, including
situations involving patient safety or other time-sensitive matters, Scirex will
initiate work on a Change Order prior to its execution if Corcept provides
written authorization to perform such work.
12. EARLY TERMINATION
12.1 Study Drug administration and/or any patient participation in any Study or
Project Exhibit may be terminated, in whole or in part, by Corcept immediately
upon written notice to Scirex, if any of the following conditions occur:
(a) authorization and approval to perform the Study is withdrawn by the
governing regulatory body;
(b) animal, human and/or toxicological test results, in the opinion of
Corcept, support termination of the Study; or
(c) in consideration of patient safety and welfare.
12.2 This Agreement or any Project Exhibit or Study may be terminated by Corcept
at any time, with or without cause, upon thirty (30) days written notice to
Scirex. Scirex will make best reasonable efforts to mitigate and curtail
expenditures during such notice period.
12.3 Upon the effective date of termination, Scirex shall provide an accounting
of costs incurred and expenditures made by Scirex in relation to the Project
Exhibit; such accounting shall be subject to verification by Corcept. Within
thirty (30) days after receipt of adequate documentation and justification
therefore, Corcept shall make a payment to Scirex (and/or Scirex may retain from
monies previously paid by Corcept) for Services performed, including fees,
institutional costs, and other out-of-pocket costs, to the reasonable
satisfaction of Corcept as follows:
(a) actual reasonable, documented costs incurred by Scirex in performing
Services and in terminating the Project Exhibit until the effective
date of termination and for which Scirex has not yet been paid; and
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(b) reasonable non-cancelable obligations properly incurred by
Scirex prior to the effective date of termination that
cannot be mitigated through the reasonable best efforts of
Scirex.
Notwithstanding the preceding, Corcept may offset from such amounts any prior
overpayments or amounts otherwise owed by Scirex to Corcept, and any funds held
by Scirex which are unearned at the date of such termination shall be returned
to Corcept within thirty (30) days of termination.
12.4 Any funds held by Scirex which are unearned at the date of completion or
termination shall be returned to Corcept within thirty (30) days of completion
or termination of the Project Exhibit or this Agreement.
12.5 In the event of any early termination hereunder:
(a) Scirex shall furnish Corcept any work product completed
pursuant to the Project Exhibit. If Corcept plans to
continue the Study, Scirex shall assist in smoothly
transferring the conduct of the Study to Corcept or its
designee.
(b) Corcept and Scirex shall cooperate in a manner which
recognizes the interests and welfare of the patients and is
designed to be safe for the patients enrolled in the Study
in accordance with Good Clinical Practices and in compliance
with all Applicable Laws, regulations and rules.
(c) In addition to the costs, expenses and fees specified in
this Section 12, provided that (i) Corcept has not
terminated the Project(s) because of SCIREX' breach of a
material obligation under this Agreement, or (ii) the
Project has not been terminated in accordance with Paragraph
12.1 herein, Corcept shall pay to SCIREX the funds required
to cover expected labor costs for ninety (90) days following
the termination. Should team members transition to other
projects during this period, Corcept will not cover the
costs of those team members past the transition date(s).
SCIREX shall use its best efforts to transition team members
to other projects as quickly as possible. Prior to
transitioning to other projects, team members are fully
available to Corcept to work on any Corcept project under
Corcept direction at no additional cost, except for
reimbursement of out-of-pocket expenses.
13. INDEMNITY AND INSURANCE
13.1 Corcept will agree to indemnify the investigators upon request, and through
independent documentation, from and against any and all cost, loss, damage,
claim, or
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action (including reasonable attorney's fees) in accordance with its customary
terms and conditions.
13.2 Scirex Indemnity. Scirex shall indemnify, defend, and hold harmless Corcept
and its Affiliates and their successors and respective officers, directors,
employees, and agents from any loss, damage, liability, cost or expense
(including reasonable attorney's and expert's fees, costs, and disbursements)
(together a "Loss") arising from or related to any claim, demand, assessment,
action, suit, or proceeding ("Claim") arising, directly or indirectly from, or
occurring during the conduct of the Projects, to the extent caused, in whole or
part, by Scirex' non-performance of this Agreement, the Project Exhibit, and the
Study Protocol, all written instructions delivered by Corcept concerning
administration of the Study Protocol, and all Applicable Laws and Requirements,
the negligence, gross negligence, recklessness, intentional misconduct or
inaction of Scirex or its officers, directors, employees, or agents; provided:
(a) Scirex is notified within fifteen (15) working days of
Corcept's knowledge of any Loss arising from any Claim for
which indemnification and/or defense under this Agreement
might be sought; and
(b) Corcept its directors, officers, employees, and agents fully
cooperate with Scirex and its legal representative.
13.3 Corcept Indemnity. Corcept shall indemnify Scirex and its Affiliates and
their successors and respective officers, directors, employees, and agents from
any Loss arising from or related to a Claim (excepting those Losses or Claims
for which Scirex indemnification is provided under Paragraph 13.2) to the extent
that it arises from or relates to (i) personal injury to a participant in the
Study or personal injury to any employee or agent of Scirex directly or
indirectly caused by the Study Drug, or (ii) the Drug's harmful or otherwise
unsafe effect, or (iii) the negligence, gross negligence, recklessness,
intentional misconduct or inaction of Corcept in the performance of its
obligations under this Agreement, or a Project Exhibit, or any Study Protocol,
except for:
(a) Corcept is notified within fifteen (15) working days of
Scirex' knowledge of any Loss arising from any Claim for
which indemnification and/or defense under this Agreement
might be sought; and
(b) Scirex its directors, officers, employees, and agents fully
cooperate with Corcept and its legal representative. In
addition, Scirex will use its best efforts to obtain the
cooperation of the subcontractors.
13.4 Upon receipt of notice of any Claim that may give rise to a right of
indemnity from the other party hereto, the party seeking indemnification
(the "Indemnified Party") shall give prompt written notice thereof to the
other party, (the "Indemnifying Party") of such a Claim for indemnity. Promptly
after a Claim is made for which the Indemnified
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Party seeks indemnity, the Indemnified Party shall permit the Indemnifying
Party, at its own option and expense, to assume the complete defense of such
Claim.
13.5 The Indemnifying Party shall keep the Indemnified Party informed as to the
progress of its defense of any such Claim, and shall not compromise or otherwise
settle any such claim or lawsuit without the Indemnified Party's prior written
consent.
13.6 The obligations of the parties under this Section 13 shall survive the
termination of the Projects and this Agreement.
13.7 Scirex agrees that it will maintain and shall, upon written request,
provide evidence of same to Corcept, the following insurance or self-insurance
necessary to meet its liability obligations under this Agreement and any Project
Exhibit, and satisfactory to Corcept in amounts no less than that specified for
each type:
(a) general liability insurance (naming Corcept as an additional insured)
with combined limits of not less than $1,000,000 per occurrence and
$2,000,000 aggregate for bodily injury including death and property
damage; and
(b) professional liability coverage, including death and bodily injury
(naming Corcept as an additional insured) for the Scirex employees,
contractors and agents providing Services under this Agreement with
limits not less than $2,000,000 per occurrence and $4,000,000
aggregate; and
(c) Workers' Compensation insurance in the amount required by the law of
the state(s) in which Scirex's employees are located.
(d) automobile liability insurance in the amount of $1,000,000.
13.8 Corcept agrees that it will maintain and shall, upon written request,
provide evidence of same to Scirex, the following insurance or self-insurance
necessary to meet its liability obligations under this Agreement and any Project
Exhibit, and satisfactory to Scirex in amounts no less than that specified for
each type:
(a) product/completed operations coverage (including bodily injury and
property damage arising out of clinical testing arising out of
clinical testing of products manufactured or distributed by Corcept)
(naming Scirex as an additional insured), with combined limits of not
less than $5,000,000 per occurrence, and $5,000,000 aggregate; and
(b) Workers' Compensation insurance in the amount required by the law of
the state(s) in which Corcept's employees are located.
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13.9 Insurance required by Paragraph 13.7 and 13.8 shall be maintained during
the performance of this Agreement and, if on a "claims made" basis, for five
years thereafter. There shall be a thirty (30) day notice of cancellation with
respect to the insurance coverage required hereunder, and the other party shall
be promptly notified in the event of any cancellation, intention of insurer or
the party not to renew, or any material change in the insurance contract or
coverages afforded. Each party shall be solely responsible for the payment of
any deductible or self-insured retention under each of their respective
policies.
14. CONFLICTS AND FINANCIAL DISCLOSURES
14.1 Scirex represents and warrants that it is not a party to any agreement or
obligations that would prevent it from fulfilling its obligations under this
Agreement, or that might impair FDA's acceptance of the resulting data, or
Corcept's proprietary rights or interests in the Confidential Information, and
that no such obligations, impediments, or conflicts will be commenced, incurred,
or permitted without the prior written approval of Corcept. Scirex further
represents and warrants that all of its personnel performing work under this
Agreement will have all training, information, licenses, approvals, and
certifications necessary to safely, adequately, professionally, and lawfully
perform this Agreement and the Projects.
14.2 For any Project Exhibit that in any way relates to a Study that may be
submitted to FDA for review in a marketing application, and as applicable
pursuant to a Project Exhibit, Scirex is responsible for requiring that all
appropriate certifications and financial disclosure statements are completed by
affected entities or institutions, as provided in 21 C.F.R. Part 54, and as
described in this Paragraph 14.2. Scirex shall require, and use best efforts to
ensure, that any Institution or Investigator or other subcontractor performing
services under this Agreement each certify that they shall, in any form or
manner reasonably requested by Corcept, disclose and certify, and cause any
sub-Investigators for the Study to disclose and certify, all of the following
that they and their spouses, domestic partners and dependent children own or
possess directly, indirectly, or equitably (all collectively "Financial
Interests"):
(a) All compensation, payments (including other research grants,
consulting or director's fees, honoraria, speaking and
meeting travel fees, and reimbursement), and items or
services of value provided by or on behalf of Corcept
(excluding compensation received under this Agreement);
(b) All licenses, assignments, or other conveyances of rights or
interests in real, personal or intellectual property with
Corcept or relating to the Study Drug.
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(c) All forms of interest in the equity (including stock, options
and warrants) or debt of Corcept or of other entities having
a financial interest in the Study Drug; and
(d) All other financial interests, payments and other compensation
described in 21 C.F.R. Section 54.2(a)-(f).
Scirex shall also ensure that (i) during the conduct of the Study and for one
year after its completion, Institution and Investigator agree to execute and
update such forms, disclosures and certifications now or subsequently required
by Corcept or FDA related to the Financial Interests (ii) Institution warrants
that it has implemented a conflicts of interests disclosure and management
policy and program that complies with the requirements and regulations issued or
administered by applicable regulatory agencies and (iii) Investigator warrants
that he has and will continue to comply with such policies and programs.
In the event that any entity or individual declines to cooperate in providing
the information, disclosures, and certifications set forth above, Scirex shall
promptly notify Corcept.
15. NOTIFICATION OF DISCIPLINARY MEASURES
15.1 Scirex represents and warrants that it has not been, nor will it use in any
capacity any corporation, partnership, association or other entity or
individual, including an IRB and any contractors, to perform any manner of
service related to the Study, that has been: (i) subject to or threatened with
debarment, suspension, or disqualification under the provisions of the Federal
Food, Drug & Cosmetic Act, 21 U.S.C. 335a; or (ii) subject to any other suits,
complaints, restrictions, sanctions or other disciplinary measures by the FDA or
any other governmental agency, judicial, institutional or professional body
(including arbitrators and accreditation and licensing organizations) with
respect to the performance of scientific or clinical investigations, conflicts
of interest, or the provision of health care (including claims or suits
regarding medical malpractice); or (iii) as of the date of this Agreement,
subject to any pending or threatened claims, actions, complaints, disputes,
suits, proceedings or investigations that might result in such restrictions,
sanctions or other disciplinary measures. In the event that Scirex becomes aware
of any allegations or investigations regarding actual or threatened claims of
professional or research malpractice, misconduct, conflicts of interest, or
violation of law of any individual, corporation, partnership, association,
contractor, or other entity providing services that directly or indirectly
relate to performance of Studies, Scirex shall immediately inform Corcept.
Corcept shall have the right to terminate the Study or this Agreement
immediately upon receipt of any such notice. Scirex shall use reasonable
diligence to ascertain, on an ongoing basis, any of the foregoing disciplinary
measures relevant to this Agreement.
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16. LIMITATION ON LIABILITY
16.1 Exclusion of Damages. In no event shall either party be liable to the other
party, or its employees, officers, directors, agents, successors and assigns for
any special, exemplary, indirect, incidental, consequential or punitive damages
of any kind or nature whatsoever (including, without limitation, lost revenues,
profits, savings or business) or loss of records or data, whether in an action
based on contract, warranty, strict liability, tort (including, without
limitation, negligence) or otherwise, even if such party has been informed in
advance of the possibility of such damages or such damages could have been
reasonably foreseen by such party.
17. FORCE MAJEURE
17.1 No party shall be liable for a delay in performance or failure to perform
this Agreement to the extent such failure to perform is caused by any reason
beyond control, and by reason of any of the following: labor disturbances of any
kind, accidents, failure of any governmental approval, acts of God, energy or
conservation measures, failure of utilities, mechanical breakdown, material
shortages, fire, explosion, war, invasion, government acts, weather or civic
unrest, or disease; provided, however, that the party who is unable to perform
resumes performance as soon as possible following the end of the occurrence
causing delay or failure.
18. PROPERTY OWNERSHIP
18.1 All materials, documents, information and suggestions supplied to Scirex by
Corcept or prepared or developed by Scirex exclusively for this Agreement
(except for Scirex confidential and proprietary know-how, statistical
approaches, computer programs, operating procedures, formulations, methods,
processes, specifications and all other intellectual property as specified in
Paragraph 8.5) shall be the sole and exclusive property of Corcept, and Corcept
shall have the right to make whatever use it deems desirable of any such
materials, documents and information. Unless otherwise required by law or by the
terms of this Agreement, all such Corcept property which Scirex shall have in
its possession shall be maintained by Scirex for a period of not less than three
(3) years from the date or receipt thereof and shall be organized in such manner
that it will be ready for immediate reference. After three (3) years, Scirex may
dispose of such property in accordance with Corcept's instructions. If Corcept
fails to give said instructions, Scirex shall so notify Corcept; and if said
instructions are still not forthcoming within thirty (30) days of said
notification, then Scirex may destroy such property as it determines. In all
circumstances, Scirex may at its discretion, maintain a copy of such property
for customary business purposes.
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19. PUBLICATION
19.1 Scirex may not publish any articles or make any presentations relating to
this Agreement, the Services, or a Study or referring to data, information or
materials generated or developed as part of this Agreement, the Services, or a
Study or results therefrom or analyses thereof, in whole or in part, without the
prior written consent of Corcept.
20. USE OF NAME
20.1 The parties hereto shall not use or permit others to use the name of the
other party nor of any employee of the other party or refer to their
participation in any Study for any sales, publicity, promotional, press or media
purposes without the prior written consent of the other party. Scirex agrees not
to refer to its participation in the Studies for any sales, publicity,
promotional, press or media purposes without the prior written consent of
Corcept.
21. PATENT RIGHTS
21.1 Scirex will disclose promptly to Corcept or its nominee any and all
inventions, discoveries, and improvements conceived, reduced to practice, or
made by Scirex or its employees, or agents while providing services to Corcept
pursuant to the Agreement and relating to such services, and agrees promptly to
assign all its interest therein to Corcept or its nominee whenever requested to
do so by Corcept. Scirex will execute any and all applications, assignments, or
other instruments and give testimony which Corcept shall deem necessary to apply
for and obtain Letters of Patent of the United States or of any foreign country
or to otherwise protect Corcept's interests therein, and Corcept shall
compensate Scirex for the time devoted to said activities and reimburse it for
expenses incurred. These obligations shall continue beyond the termination of
this Agreement with respect to inventions, discoveries and improvements
conceived or made by Scirex while providing Services to Corcept pursuant to this
Agreement, and shall be binding upon Scirex' assignees and other legal
representatives.
22. MODIFICATIONS
22.1 No changes may be made in this Agreement except by written Agreement of
both parties. It is anticipated that this Master Clinical Development Agreement
will be modified from time-to-time by the mutually agreed to addition of Project
Exhibits and associated Change Orders.
23. ENTIRETY
23.1 This Agreement, together with attached Project Exhibits and modifications
that may be added to this Agreement from time to time, is the entire and
complete understanding between the parties in regard to the covered subject
matter.
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24. INDEPENDENT CONTRACTOR
24.1 Scirex' relationship with Corcept under this Agreement shall be that of an
independent contractor, and nothing in this Agreement or the arrangements for
which it is made shall constitute Scirex, or anyone furnished or used by Scirex
in the performance of the services contemplated by this Agreement, as an
employee, joint venturer, partner, or servant of Corcept. All matters of
compensation, benefits and other terms of employment for any employee, agent,
subcontractor or other personnel used by Scirex shall be solely a matter between
Scirex and such individuals or entity.
25. CONTACT PERSONS
25.1 All notices, correspondence, invoices and payments under this Agreement
shall be sent as follows:
If to Scirex: If to Corcept Therapeutics Inc.:
Scirex Corporation Corcept Therapeutics Inc.
Attn: Xxxxx Xxxxxx Xxxxxx Xxxxxxxx, M.D.
Associate Director, Contracts and Proposals Chief Executive Officer
000 Xxxxxxxx Xxxxxx Xxxxx 000 Xxxxxxxxxxx Xxxx
Xxxxxxx, XX 00000 Xxxxx Xxxx, XX 00000-0000
Phone: 215/000-0000, ext. 1055 Phone: (000) 000-0000
Fax: 215/000-0000 Fax: (000) 000-0000
26. NOTICES
26.1 Any notices which either party may be required or shall desire to give
hereunder shall be deemed to be duly given when delivered personally or mailed
by certified or registered mail, postage prepaid, to the party to whom notice is
to be given at the address first given above or such other address or addresses
of which such party shall have given written notice.
27. SEVERABILITY
27.1 If any provisions hereof shall be determined to be invalid or
unenforceable, the validity and effect of the other provisions of this Agreement
shall not be affected thereby.
28. GOVERNING LAW
28.1 This Agreement is a California contract. It shall be governed and construed
and interpreted in accordance with the laws of California, without reference to
principals of conflicts of law.
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29. WAIVER
29.1 The 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 or with respect to any other
provision thereof.
30. CAPTIONS
30.1 Any caption used in this Agreement is inserted for convenience and
reference only and is to be ignored in the construction and interpretation of
the provisions hereof.
31. SURVIVAL
31.1 The following provisions of this Agreement (in addition to those that
specifically so require) shall survive its term or earlier termination: 4.1, 7,
8, 12.3 - 12.5, 13, 14.2, 16.1, 19 - 21, and 28.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and
year written below.
Scirex Corporation Corcept Therapeutics Inc.
By: /s/ Xxxx XxXxxxx By: /s/ Xxxxxx Xxxxxxxx
Title: Executive Vice President Title: CEO
Date: 11 July 2001 Date: July 12, 2001
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