Exhibit 10.13
MASTER SERVICES AGREEMENT
THIS Master Services Agreement (the
“Agreement”) is effective as of the 28
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day of October, 2004, (the “Effective Date”), by and
between i3 Research, a division of Ingenix Pharmaceutical Services
(UK) Limited. (“Ingenix”), with offices at Sygnus
Court, 22-32 Market Street, Maidenhead, Berkshire, UK SL6 8AD, and
Corcept Therapeutics Incorporated (“Sponsor”), with
offices at 275 Middlefield Road, Suite A, Menlo Park, CA
94025.
WHEREAS, Sponsor is engaged in
research and development of pharmaceutical products; and
WHEREAS, Ingenix is engaged in
providing services to pharmaceutical manufacturers in support of
their clinical research and product development
activities;
WHEREAS, Sponsor wishes to retain
Ingenix, from time to time, to assist in certain product
development activities relating to certain of Sponsor’s
clinical studies (each of which shall be referred to as a
“Study”); and
WHEREAS, Sponsor agrees to compensate
Ingenix for its services.
NOW THEREFORE, in consideration of
the premises and the mutual promises and undertakings herein
contained, the parties agree as follows:
SECTION 1 — Services — General
1.1 Sponsor hereby retains Ingenix to provide the services (the
“Services”) that are described in written task orders
(“Task Orders”, a form of which is attached to this
Agreement as Exhibit A) which are executed by the parties from
time to time. The parties acknowledge and agree that their
respective Affiliates may execute Task Orders under this Agreement.
In that event, such Affiliate(s) shall be bound by all terms and
conditions of this Agreement and the applicable Task Order, and
entitled to all rights and protections afforded Sponsor or Ingenix
under this Agreement. While this Agreement creates certain
obligations between the parties, it does not create an obligation
on the part of Sponsor or any Sponsor Affiliate to engage Ingenix
to provide services, or an obligation on the part of Ingenix or any
Ingenix Affiliate to provide services; such obligations shall arise
only upon the execution of a Letter of Intent (a form of which is
attached hereto as Exhibit B), a Task Order, or a written
amendment to a Task Order (a “Change Order”, a form of
which is attached hereto as Exhibit C). The terms of this
Agreement shall be made a part of and incorporated by reference
into each Task Order and each Task Order is incorporated and made a
part of this Agreement. In the event of a conflict between the
terms of this Agreement and a Task Order, the terms of this
Agreement will govern, unless otherwise agreed in a Task
Order.
1.2 “Affiliate” means, when associated with a party to
this Agreement, any entity that controls, is controlled by or is
under common control with, that party. “Control” means
the possession, directly or indirectly, of at least 50% of the
share capital or voting rights or of the power to direct or cause
the direction of the management and policies of an entity, whether
through the ownership of voting securities, by contract or
otherwise.
1.3 Each Task Order shall constitute a unique agreement and shall
stand alone with respect to any other Task Order entered into under
this Agreement. To the extent required under Title 21 CFR Part
312.52 in the United States, and any equivalent laws of other
countries, the parties shall document separately in writing the
transfer by Sponsor to Ingenix of any of Sponsor’s
responsibilities. In the absence of such a separate document, the
description of Services provided in the relevant Task Order shall
be deemed the required written transfer of obligations from Sponsor
to i3 Research for that Study. Notwithstanding the foregoing,
Sponsor will retain the ultimate authority and control over
and
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responsibility for each Study. Sponsor shall retain and have
responsibility for all Study activities not specifically
transferred to Ingenix. The parties acknowledge and agree that
Sponsor shall at all times be deemed to be the
“sponsor” of each study pursuant to the terms of the U.
S. Federal Food, Drug and Cosmetic Act, as from time to time
amended, the regulations of the U.S. Food and Drug Administration
(“FDA”), as promulgated in the Title 21 of U.S. Code of
Federal Regulations, and any equivalent laws of other
countries.
1.4 The terms of a Task Order may be amended or modified by mutual
written agreement of Ingenix and Sponsor. If Sponsor wishes
(i) to change the timelines, deliverables or scope or scale of
the Services covered by a Task Order, (ii) to obtain
additional services not initially covered by a Task Order, or
(iii) to reduce or remove any of the Services covered by a
Task Order, Sponsor shall so advise Ingenix. If Ingenix believes a
change in the scope or scale of Services is necessary or advisable,
Ingenix shall so advise Sponsor. The parties will negotiate
diligently and in good faith the proposed revisions to the
timelines, deliverables, scope or scale of Services and the
professional fees and costs for performing changed or additional
services or for reducing or removing Services, and shall execute a
Change Order to the applicable Task Order. In the event Ingenix
provides additional services or expends resources, at
Sponsor’s written request and in strict accordance with
Sponsor’s requirements, in the absence of a Change Order,
Sponsor will compensate and/or reimburse Ingenix for all fees and
reasonable costs incurred.
1.5 The parties shall perform their obligations under this
Agreement and each Task Order in accordance with the terms of this
Agreement, the applicable Task Order, applicable provisions of the
Study protocol, agreed upon Standard Operating Procedures; the
current Guidelines for Good Clinical Practice (“GCP
Guidelines”); the Declaration of Helsinki of the 41st World
Medical Assembly, South Africa 1996 as amended; and applicable
local laws and regulations.
1.6 Neither party shall have any obligation of exclusivity of any
nature to the other, or any obligation to conduct, sponsor, or to
offer to conduct or sponsor, any particular services or study or
any number of studies, unless specified in a Task Order. Each party
shall be free to provide services to or conduct or sponsor clinical
or research studies involving other parties, so long as a
party’s agreement with any such third party does not prevent
it from performing its obligations under this Agreement or a Task
Order. Each party understands and agrees that the other party or
its Affiliates may be in a business similar to or offer products or
services the same as the other party (or one or more of its
Affiliates) and may already have developed, be in the process of
developing, or plan to develop products, services and information
similar to those owned or developed by the other. Nothing contained
herein shall be construed to prohibit a party from so doing as long
as it does so independently and without using Confidential
Information disclosed by the other.
1.7 During the term of this Agreement Ingenix shall maintain all
materials and all other data obtained or generated by Ingenix in
the course of providing the Services, including all computerized
records and files (“Work Product”), in a secure area
reasonably protected from fire, theft and destruction. At the
expiration or termination of this Agreement and each Task Order
Sponsor shall provide Ingenix with written instructions as to the
disposition of the Work Product obtained or generated by Ingenix in
the course of providing the applicable Services. Such written
instructions will provide that Ingenix (a) deliver the Work
Product, in the form in which Ingenix currently holds them, to a
designated Sponsor location or to such other entity or at such
other address as Sponsor may specify, (b) retain the Work
Product for the period of time specified in the Task Order, or
(c) dispose of the Work Product, except for those portions
which Ingenix is required by law or regulation to store or
maintain. After termination of this Agreement or the applicable
Task Order, storage, destruction, shipping and other services
relating to the final record disposition will be billed as Pass
— through Expenses (as defined below) to Sponsor.
Notwithstanding the foregoing, Ingenix may retain copies of any of
the Work Product as are reasonably necessary for regulatory or
insurance purposes, subject to its ongoing obligation to maintain
the confidentiality of such materials.
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SECTION 2 — Institution/Investigator —
Services
2.1 The parties acknowledge that Ingenix’ Services under a
Task Order may include identifying potential medical institutions
(“Institutions”) or clinical investigators
(“Investigators”) and/or negotiating, executing and/or
administering contracts with them governing their conduct of the
Study (“Study Agreements”). If, pursuant to a Task
Order, Sponsor delegates to Ingenix the responsibility for
negotiating and/or executing Study Agreements, the following
provisions will apply:
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(a)
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Sponsor may provide Ingenix with a
list of suggested Institutions and/or Investigators to be recruited
by Ingenix for a Study. Ingenix shall notify Sponsor in writing as
to any listed Institution or Investigator with which Ingenix does
not wish to contract.
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(b)
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Selection of all Institutions or
Investigators will be subject to approval by Sponsor, in writing,
prior to initiation of any Study-related activities involving that
Institution/Investigator or the start of any negotiations with such
Institution/Investigator.
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(c)
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Each Study Agreement shall be fully
consistent with this Agreement and the applicable Task Order. The
Study Agreement used with each Institution and Investigator will be
in substantially the form attached hereto as Exhibit D, and
subject to approval in advance by Sponsor. All changes to such form
agreement suggested by an Investigator will require Sponsor’s
prior review and approval.
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(d)
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Sponsor will provide Ingenix with a
current form of Power of Attorney, as required, for each country in
which the Study will be conducted.
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(e)
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If
an Institution/Investigator requests indemnification from Sponsor,
Sponsor will issue a letter of indemnification directly to the
Institution/Investigator. Sponsor acknowledges that Ingenix shall
have no indemnification obligation to any Institution/Investigator
relative to the Study drug or the applicable Study
protocol.
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(f)
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Ingenix will administer payments to
Institutions/Investigators from funds provided in advance by
Sponsor to Ingenix for that purpose. Ingenix will disburse payments
to Institutions/Investigators on behalf of Sponsor according to the
provisions of the Study Agreement and the applicable Task Order.
Ingenix will not be liable for payments not made on a timely basis
to any Institution/Investigator as a result of Sponsor’s
failure to provide, in advance, sufficient funds for such payments.
Ingenix will promptly return to Sponsor any funds received from
Sponsor for payments to Institutions/Investigators which are
remaining as unpaid or unpayable at the expiration or other earlier
termination of this Agreement or any Task Order.
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2.2 The parties acknowledge and agree that, for the purposes of
this Agreement or any Task Order, Institutions/Investigators shall
not be considered as employees, agents or subcontractors of Ingenix
or of Sponsor and that Investigators will be required to exercise
their own independent medical judgement. Ingenix’
responsibilities with respect to Institutions/Investigators shall
be limited to those specifically set forth in the applicable Task
Order.
SECTION 3 — Compensation and Expenses
3.1 As compensation for providing the Services, Sponsor shall pay
Ingenix professional fees in the amounts and upon the terms
specified in one or more attachments to the applicable Task Order.
Each Task Order will include as attachments a study budget
containing Ingenix’ estimated professional fees and
Pass-through Expenses (“the Budget”), a payment
schedule (the “Payment Schedule”) and a timeline
showing performance milestones (the “Timeline”). If the
assumptions under which the parties created the Budget, the Payment
Schedule or the Timeline prove to be inaccurate, in whole or in
part, or if matters reasonably beyond the control of the parties
detrimentally affect a Study, then the parties shall
review
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each of the Budget, the Payment Schedule and the Timeline and
incorporate reasonable revisions in a Change Order to the
applicable Task Order.
3.2 Sponsor will reimburse Ingenix for reasonable travel and other
reasonable out-of-pocket expenses incurred by Ingenix personnel
identified in the Budget or at the request of Sponsor
(“Pass-through Expenses”), unless Ingenix expressly
agrees in advance to waive such reimbursement. Pass-through
Expenses shall include the following:
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(a)
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Travel via commercial airlines
(using coach class or the equivalent), train or rental
car;
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(b)
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Local travel to places other than
Ingenix’ office by personal car at a rate to be agreed
between the parties for each country;
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(c)
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Actual and reasonable lodging and
meal expenses;
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(d)
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Actual and reasonable expenses for
telephone, mail, express courier, facsimile, storage and
photocopying services, and any other communication or technology
expenses incurred in the performance of the Services under this
Agreement; and
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(e)
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Payments to third party vendors,
consultants and independent contractors, including, upon the prior
written consent of Sponsor, payments to outside legal counsel
relating to review of Study Agreements in countries other than the
U.K.
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Ingenix shall submit a reasonably detailed invoice with copies of
receipts attached of such expenses to Sponsor on a monthly
basis.
3.3 Professional fees and estimated Pass-through Expenses, as
indicated in the applicable Budget, shall be exclusive of value
added tax (“VAT”), except where VAT is irrecoverable by
Ingenix.
3.4 All invoices and payments will be stated and made in Euros
unless otherwise provided for in the applicable Task Order. If
Ingenix performs Services whereby it incurs costs or expenses in a
currency different than Euros or another currency specified in a
Task Order, Ingenix shall have the option of invoicing Sponsor for
such costs and expenses in Euros after applying the applicable
exchange spot rate published in the Financial Times on the last
business day of the relevant invoice period to the initial
currency. Sponsor will pay each invoice, via check or wire transfer
of immediately available funds, within 30 days of receipt of
the invoice.
3.5 In the event Sponsor disputes one or more items in an invoice,
Sponsor will notify Ingenix in writing within fifteen
(15) business days of receipt of the invoice and such notice
shall contain a reasonably specific description of the item(s)
being disputed and the basis therefor. Ingenix will respond to
Sponsor within fifteen (15) business days of receipt of the
notification. This written communication pattern will continue
until Ingenix has provided Sponsor with sufficient justification
for the disputed item(s) or until the parties agree to a resolution
of the disputed amount. Sponsor shall pay the undisputed portion of
the invoice within thirty (30) days of receipt of the invoice
and shall use commercially reasonable best efforts to pay the
disputed amount within fifteen (15) days of resolution of the
dispute. In the event the parties are unable to reach a
satisfactory resolution within one hundred eighty (180) days
of the original invoice, either party can submit the dispute to
binding arbitration in accordance with Section 9.2 of this
Agreement.
SECTION 4 — Confidentiality
4.1 Each party acknowledges that in connection with the performance
of the Services, it may receive, learn or have access to
confidential, trade secret, or proprietary information concerning
the other party or third parties to whom the other party has an
obligation of confidentiality (“Confidential
Information”).
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4.2 Sponsor’s Confidential Information shall include, without
limitation, information regarding the Sponsor’s business;
drug products and proposed drug products; current or proposed
studies on Sponsor’s products; prior research and results of
studies on Sponsor’s drug products; and reports and decisions
resulting from clinical trials on Sponsor’s drug products.
Ingenix Confidential Information shall include, without limitation,
business information; information regarding Ingenix services and
documentation; Ingenix’ business methodologies and processes
and associated algorithms, tools, programs, software architecture,
including but not limited to source codes, and
technology.
4.3 Each party agrees that (a) it will use the other
party’s Confidential Information only as may be necessary in
connection with the Services; (b) it will treat such
information as confidential and proprietary; (c) without the
prior written consent of the other party it will not disclose such
information orally or in writing to any third party (except
however, to disclose such information to its respective agents or
representatives, IRB/Ethics Committee members, or the FDA or other
regulatory authorities, all of whom have a need to know such
information in connection with the purpose for which it is
disclosed to the party); (d) it will take all reasonable
precautions to protect the Confidential Information; and
(e) it will not otherwise appropriate such information to its
own use or to the use of any other person or entity. Without
limiting the foregoing, each party agrees to take at least such
precautions to protect the other party’s Confidential
Information as it takes to protect its own Confidential
Information. Upon termination of this Agreement, each party will
return to the other party or certify as destroyed all tangible
items containing any of the other party’s Confidential
Information that are held by that party or its employees, agents or
contractors. However, each party may retain archive copies of
information as required by applicable regulatory requirements. Each
party agrees to notify the other party if it becomes aware of any
unauthorized use or disclosure of the other party’s
Confidential Information.
4.4 If either party believes it is required by law or by a subpoena
or court order to disclose any of the other party’s
Confidential Information, it shall promptly notify the other party
prior to any disclosure and shall make all reasonable efforts to
allow the other party an opportunity to seek a protective order or
other judicial relief.
4.5 Nothing in this Agreement shall be construed to restrict
disclosure or use of information that (a) was in the
possession of or rightfully known by the recipient, without an
obligation to maintain its confidentiality, prior to receipt from
the other party; (b) is or becomes generally known to the
public without violation of this Agreement; (c) is obtained by
the recipient in good faith from a third party having the right to
disclose it without an obligation of confidentiality; (d) is
independently developed by the receiving party without reference to
the other party’s Confidential Information; or (e) is
required by law to be disclosed.
4.6 Each party agrees not to disclose or utilize individual patient
or medical claim information in any way that would violate any
physician-patient confidence or any state or federal laws or
regulations.
4.7 Except as required by law neither party shall disclose
Sponsor’s retention of Ingenix for professional services or
the terms of this Agreement or any Task Order, unless each party
has agre
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