1
Confidential Treatment Requested
by LXR Biotechnology, Inc.
located at 0000 Xxxxxx Xxx Xxxxx,
Xxxxxxxx, XX 00000.
CLINICAL SERVICES AGREEMENT
Innovex Project #5378
THIS AGREEMENT is made and entered into this 6th day of June, 1997, by and
between LXR Biotechnology, Inc., hereinafter referred to as "LXR" or "Client,"
and Innovex Inc., 00000 Xxxxxxxxx Xxxxxx, Xxxxxx, Xxxxxx 00000, hereinafter
referred to as "Innovex."
WHEREAS, LXR is a pharmaceutical company; and
WHEREAS, Innovex is in the business of providing contract pharmaceutical
services; and
WHEREAS, LXR proposes to retain Innovex for the specific purpose of performing
Clinical Services;
NOW, THEREFORE, IT IS AGREED AS FOLLOWS:
1. LXR hereby retains Innovex to provide Clinical Services as specified in
Schedule B - Services, to commence on or about June 6, 1997.
2. LXR agrees to pay Innovex fees and expenses as provided in Schedule A
Price.
3. The terms and conditions of Innovex's Standard Terms for Clinical
Services, and Schedule A and Schedule B, are incorporated herein and
shall apply to this Agreement.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date first above written.
INNOVEX INC. LXR BIOTECHNOLOGY, INC.
By: By:
--------------------------------- ----------------------------------
Xxxxx X. Xxxxxx
Vice President,
Finance & Support Services Title
--------------------------------
Date: ______________, 1997 Date: _______________, 1997
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STANDARD TERMS FOR CLINICAL SERVICES
1. INTERPRETATION
1.1 As used in these Standard Terms, unless the context requires
otherwise:
"Agreement" means any Clinical Services Agreement between Innovex
Inc., a Delaware corporation ("Innovex"), and a Client incorporating
these Standard Terms;
"Client" means the Client whose name and address are set out in the
Agreement;
"Client Information" means all technical and other information not
known to Innovex to be supplied by the Client to Innovex relating to
the provision of the Services;
"Client Materials" means all materials, including but not limited to,
documents and drugs supplied by the Client to Innovex for the
provision of the Services;
"Clinical Research Personnel" means any employee of Innovex involved
in the provision of the Services;
"GCP" means any applicable good clinical practice codes;
"Price" means the price specified in Schedule A for the Services;
"Product" means any drug forming part of the Client Materials;
"Proposal" means any proposal or quotation issued by Innovex;
"Adverse Drug Experience" means a significant or material hazard, side
effect, contraindication or precaution, in particular one which is
fatal, life-threatening or disabling or requires hospitalization or
prolongation of hospitalization or is a congenital anomaly, malignancy
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or overdose including, without limitation, any event required to be
reported under any relevant GCP;
"Services" means all or any part of the services that are the subject
of the Agreement or Proposal, details of which are set out in Schedule
B.
"Terms of Payment" means the terms of payment specified in Schedule A.
1.2 Unless the context requires otherwise, words and phrases defined in
any other part of the Agreement shall bear the same meaning in these
Standard Terms, references to the singular number include the plural
and vice versa, references to a gender include references to all other
genders, references to Schedules are references to schedules to the
Agreement and references to Sections are references to sections of
these Standard Terms.
2. APPLICABILITY OF STANDARD TERMS
These Standard Terms shall apply to every Proposal and Agreement and
(except as otherwise agreed by the parties) to any services additional to
the Services to be provided by Innovex for a Client. Innovex shall not be
bound by any term (other than a Special Term) which may be inconsistent
with these Standard Terms. No variation of or addition to these Standard
Terms or any other term of the Agreement shall be effective unless agreed
in writing by an authorized representative acting for and on behalf of
Innovex.
3. PROVISION OF THE SERVICES
3.1 Innovex shall carry out the Services as provided in Schedule B with
reasonable care and skill.
3.2 Innovex shall provide the Services in material conformance with all
local, state and federal laws and regulations applicable to clinical
investigations including, but not limited to, the Federal Food, Drug
and Cosmetic Act and the regulations of the United States Food and
Drug Administration.
3.3 The Client shall provide Innovex with full details and all necessary
Client Information and Client Materials which Innovex may require to
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provide the Services within the time periods agreed between Client and
Innovex and shall reimburse Innovex for any additional costs or
expenses that it may incur as a direct result of any delay in or
failure to provide the Client Information or Client Materials within
such time limits.
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3.4 Title to any and all equipment purchased by either party for use in
performing its obligations under the Agreement shall remain with such
party and shall be free of all claims, liens or encumbrances of the
other party.
4. PRICE AND TERMS OF PAYMENT
4.1 The Client shall pay the Price in accordance with the terms set forth
in Schedule A.
4.2 Unless otherwise indicated in writing by Innovex, all prices and
charges quoted by Innovex are net of any taxes (which shall be paid
by Client). Payment in full must be made within thirty (30) days of
the date of the invoice. Innovex Federal Employer Identification
Number is 00-0000000.
4.2.1 The preferred method of payment is by direct transfer to the
Innovex bank account. Wire transfer instructions are as
follows:
[**]
4.2.2 Payments by check should be mailed to Innovex's lock box as
follows:
Innovex Inc.
X.X. Xxx 00-0000
Xxxxxx Xxxx, XX 00000-0000
4.3 Prompt payment by the Client is essential. In the event of late
payment:
4.3.1 interest shall accrue on a daily basis at the lesser of two
percent (2%) above the Prime Rate as announced periodically
by Barclays Bank PLC (New York branch) or the maximum rate
permitted by law, on any amount overdue from the date payment
became due until payment is made in full; and
** Confidential Treatment Requested
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4.3.2 Innovex shall, at its sole discretion, and without prejudice
to any other of its accrued rights, be entitled to suspend
the provision of the Services, or to treat the Agreement as
repudiated by giving notice in writing to the Client.
5. LIABILITY
5.1 Client shall indemnify, defend and hold harmless Innovex, its
affiliates and its and their respective directors, officers,
employees and agents (each, an "Innovex Indemnified Party") from and
against any and all losses, claims, actions, damages, liabilities,
costs and expenses, (including reasonable attorneys' fees and court
costs) (collectively, "Losses"), relating to or arising from or in
connection with this Agreement or the Services contemplated herein
(including, without limitation, any Losses arising from or in
connection with any Project, study, test, product or potential
product to which this Agreement relates) or any litigation,
investigation or other proceeding relating to any of the foregoing,
except to the extent such Losses are determined to have resulted
solely from the negligence or intentional misconduct of the Innovex
Indemnified Party seeking indemnity hereunder.
5.2 Innovex shall indemnify, defend and hold harmless Client, its
affiliates and its and their respective directors, officers,
employees and agents from and against any and all losses, claims,
actions, damages, liabilities, costs and expenses, (including
reasonable attorneys" fees and court costs) (collectively, "Client
Losses"), to the extent such Client Losses are determined to have
resulted solely from the negligence or intentional misconduct of
Innovex.
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5.3. The party seeking indemnification hereunder (the "Indemnified Party")
shall: (a) give the party obligated to indemnify (the "Indemnifying
Party") prompt notice of any such claim or law suit (including a copy
thereof) served upon Indemnified Party; and (b) Indemnified Party and
its employees shall fully cooperate with Indemnifying Party and its
legal representatives in the investigation of any matter the subject
of indemnification; and (c) Indemnified Party shall not unreasonably
withhold its approval of the settlement of any such claim, liability,
or action by Indemnifying Party covered by this Indemnification
provision; provided, however, that Indemnified Party's failure to
comply with its obligations pursuant to Section 12 shall not
constitute a breach of this Agreement nor relieve Indemnifying Party
of its indemnification obligations, except to the extent, if any, that
Indemnifying Party's defense of the affected claim, action or
proceeding actually was materially impaired hereby.
5.4 Neither Innovex, nor its affiliates, nor any of its or their
respective directors, officers, employees or agents shall have any
liability for any special, incidental, or consequential damages,
including, but not limited to the loss of opportunity, loss of the
use of any data or information supplied hereunder, or loss of revenue
or profit, in connection with or arising out of this Agreement, the
Services performed by Innovex hereunder or the existence, furnishing,
functioning, or Client's use of any information, documentation or
Services provided pursuant to this Agreement, even if Innovex shall
have been advised of the possibility of such damages. In addition, in
no event shall the collective, aggregate liability of Innovex and its
affiliates and its and their respective directors, officers,
employees and agents under this Agreement exceed the amount of
compensation actually received by Innovex from Client for the
assignment or task from which such liability arose.
5.5 The Client and Innovex shall each at its own expense obtain and
maintain insurance of a type and amount adequate to cover any and all
costs, claims, damages, demands, losses, liabilities and expenses, in
respect of which it is obliged to indemnify the other under this
Agreement and shall not do or omit to do any act, matter or thing
that could prejudice or render voidable such insurance. Either party
shall, promptly upon request by the other, provide such evidence of
the insurance as may reasonably be required.
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5.6 Nothing contained in these Standard Terms shall purport to exclude or
restrict any liability for death or personal injury resulting
directly from gross negligence or willful misconduct by Innovex in
carrying out the Services.
5.7 The obligations under this Section 5 shall survive the termination of
the Agreement for whatever reason.
6. RELATIONSHIP BETWEEN THE PARTIES
6.1 The Clinical Research Personnel shall be and remain employees of
Innovex subject to Clause 6.5 below and shall represent themselves to
third parties as Innovex employees under contract to work for the
Client.
6.2 Each party to the Agreement shall act as an independent contractor
and no relationship of employer or employee, joint venturer or
partner shall arise or be created by or under the Agreement as
between Innovex or the Clinical Research Personnel and the Client or
the Client's employees. Accordingly, neither party shall enter into a
contract or agreement with a third party that purports to obligate or
bind the other party.
6.3 Where the Services are to be provided by Clinical Research Personnel
at the Client's premises or at premises under the Client's control,
the Client shall be responsible and shall hold harmless Innovex for
the Clinical Research Personnel's safety and security while on those
premises; provided, however, that Innovex shall use its reasonable
efforts to ensure that the Clinical Research Personnel comply with
all reasonable directions given by the Client as to general safety
and security requirements for such premises.
6.4 The cost of recruiting and training any replacement Clinical Research
Personnel will be borne by Innovex, except as provided in this Clause
6.4. Should the performance of Clinical Research Personnel be
mutually agreed as acceptable by the parties but for other reasons
the Client requests that Innovex replace any Clinical Research
Personnel, then the Client shall pay the cost of recruiting and
training any
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replacement. Should the Client consider in its reasonable opinion
that any of such Clinical Research Personnel requires replacement
because of his or her unsatisfactory performance, Innovex shall
recruit and train any replacement at its own expense.
6.5 If any of the Clinical Research Personnel providing Services at the
Client's premises ceases to be employed by Innovex and is employed by
the Client during the term of the Agreement or within a six(6)-month
period after its termination, then to compensate Innovex for any
losses it incurs as a result thereof including, without limitation,
the cost of recruiting and training a replacement employee, a sum
equal to twenty percent (20%) of such employee's annual salary when
such employee was last employed by Innovex shall be payable by the
Client to Innovex upon commencement of such employment with the
Client.
7. CONFIDENTIALITY AND INTELLECTUAL PROPERTY
7.1 It is understood that during the course of this Agreement, Innovex
and its employees may receive data and information which is
confidential and proprietary to Client. All such data and information
(hereinafter "Client Confidential Information") written or verbal,
tangible or intangible, made available, disclosed, or otherwise made
known to Innovex and its employees as a result of services under this
Agreement shall be considered confidential and shall be considered
the sole property of Client. All information regarding Innovex's
operations, including but not limited to Innovex's Property,
disclosed by Innovex to Client in connection with this Agreement is
proprietary, confidential information belonging to Innovex (the
"Innovex Confidential Information", and together with the Client
Confidential Information, the "Confidential Information"). The
Confidential Information shall be (a) marked as confidential, (b)
otherwise represented by the disclosing party as confidential either
before or within a reasonable time after its disclosure, or (c)
otherwise represent information of the type afforded confidential
treatment. The Confidential Information shall be used by the
receiving party and its employees only for purposes of performing the
receiving party's obligations hereunder. Each party agrees that it
will not reveal, publish, or otherwise disclose the Confidential
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Information of the other party to any third party without the prior
written consent of the disclosing party, provided that the foregoing
obligations shall not apply to Confidential Information which:
(a) is or becomes generally available to the public other than as a
result of a disclosure by the receiving party;
(b) becomes available to the receiving party on a non-confidential
basis from a source which is not prohibited from disclosing such
information by a legal, contractual or fiduciary obligation to
the disclosing party;
(c) the receiving party develops independently of any disclosure by
the disclosing party;
(d) was in the receiving party's possession or known to the receiving
party prior to its receipt from the disclosing party; or
(e) is required by law to be disclosed.
This obligation of confidentiality and non-disclosure shall remain in
effect for a period of five years after the termination of this
Agreement.
7.2 All data and information necessary for Innovex to conduct project
assignments will be forwarded by Client to Innovex. All data and
information generated or derived by Innovex as the result of services
performed by Innovex under this Agreement shall be and remain the
exclusive property of Client. Any inventions that may evolve from the
data and information described above or as the result of services
performed by Innovex under this Agreement shall belong to Client and
Innovex agrees to assign its rights in all such inventions and/or
related patents to Client. Notwithstanding the foregoing, Client
acknowledges that Innovex possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties
and other assets, including, but not limited to analytical methods,
procedures and techniques, computer technical expertise and software,
which have been independently developed by Innovex (collectively
"Innovex's Property"). Client and Innovex agree that any Innovex
Property or improvements thereto which are used, improved, modified
or developed by Innovex under or during the term of this Agreement
are the sole and exclusive property of Innovex.
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7.3 It is expressly agreed that neither party transfers to the other
party by operation of the Agreement any patent right, copyright or
other proprietary right either party owns, except as specifically set
forth herein.
7.4 The obligations of Innovex and the Client under this Section 7 shall
survive the termination of the Agreement for whatever reason.
8. TERM AND TERMINATION
8.1. If it becomes apparent to Innovex or the Client at any stage in the
provision of the Services that it will not be possible to complete the
Services for technical reasons, or because of the unavailability of
suitable patients or investigators, a thirty-day (30-day) period shall
be allowed for discussion to resolve such problems. If such problems
are not resolved within such period, Innovex and the Client shall each
thereafter have the right to terminate the Agreement by notice in
writing. In the event of such termination by the Client, the Client
shall pay to Innovex a termination fee calculated by Innovex to
include all profit, costs and expenses incurred by Innovex to the date
of termination and including, without limitation, the costs of
terminating any commitments entered into under the Agreement, such
termination fee not to exceed the Price.
8.2 The term of the Agreement shall, subject to Sections 8.3 and 8.4
below, be approximately twenty-four (24) months, beginning on or
about June 6, 1997, and ending June 1, 1999, unless otherwise agreed
by the parties in writing at least sixty (60) days prior to the end
of the original term of this Agreement.
8.3 The Agreement may be terminated by either party upon written notice
if any of the following events occur:
8.3.1 the authorization and approval to provide the Services in the
United States is withdrawn by the U.S. Food and Drug
Administration;
8.3.2 animal, human or toxicological test results, in the
reasonable opinion of either party, support termination of
the Agreement;
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8.3.3 the emergence of any adverse drug experience or side effect
with any Client Material used in the performance of the
Services is of such magnitude or incidence in the reasonable
opinion of either party to support termination of the
Agreement.
8.4 Termination of the Agreement for whatever reason shall not affect the
accrued rights of either Innovex or the Client arising under or out
of the Agreement and all provisions which are express to or by
implication survive the Agreement shall remain in full force and
effect.
9. IMPROPER ACTIVITIES
If either party shall be of the reasonable opinion that the Clinical
Research Personnel are being used for purposes or are involved in any
activity which is illegal or which xxxxx the other party's standing or
professional reputation, then that party shall be entitled to give written
notice to the other specifying the purpose or activity giving rise to the
complaint and requiring that the other cease such activity within fourteen
(14) days, in default of which the Agreement may be terminated immediately
by the party giving notice.
10. ADVERSE DRUG EXPERIENCE
If Innovex and/or the Clinical Research Personnel become aware of any
adverse drug experience reports involving use of any Client product they
shall immediately inform the Client in accordance with Innovex or the
Client's standard operating procedures, as appropriate, and shall comply
with any legal or regulatory reporting requirements with respect to such
matters. When Client communicates information concerning adverse drug
experience reports to its own employees, investigators or in compliance
with any legal or regulatory requirements, such information shall be
communicated to Innovex and the Clinical Research Personnel in a manner
consistent with Client standard operating procedures.
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11. FORCE MAJEURE
The performance by either party of any covenant or obligation on its part
to be performed hereunder shall be excused by floods, strikes or other
labor disturbances, riots, fires, accidents, wars, embargoes, delays of
carriers, inability to obtain materials, failure of power or natural
sources of supply, acts, injunctions or restraints of government, or any
act of God or other force majeure preventing such performance whether
similar or dissimilar to the foregoing that is beyond the reasonable
control of the party bound by such covenant or obligation, provided,
however that the party affected shall use all reasonable endeavors to
eliminate or cure or overcome any of such causes and to resume performance
of its covenants with all possible speed.
12. RECORD KEEPING AND ACCESS
12.1 Client authorized representatives, and regulatory authorities to the
extent required by law, may, during regular business hours, arrange
in advance with Innovex to examine and inspect Innovex facilities
required for performance of the Services, and inspect and copy all
data and work products relating to the Services.
12.2 Innovex representatives from Innovex Quality and Innovation group
may, during regular business hours, arrange in advance with Client to
examine and audit the performance of Services by Innovex employees
and Clinical Research Personnel.
12.3 Within thirty (30) days of the expiration or termination of the
Agreement, Innovex shall return to the Client or as the Client
directs (at the Client's expense) all Client Materials other than
those which Innovex has a legal or regulatory obligation to retain.
13. TRANSFER OF OBLIGATIONS
All obligations of Client which have been transferred to Innovex, pursuant
to 21 CFR 312.52, are identified by attachment to this Agreement or in the
Protocol, and shall be included in Form FDA 1571. Innovex agrees to
diligently carry out all transferred obligations.
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14. NO DEBARRED PERSONS
Innovex represents, warrants and covenants that it is not using, and will
not use, in any capacity, in connection with any of the Services performed
hereunder, the services of any person debarred under subsections 306(A) or
306(B) of the Generic Drug Enforcement Act of 1992. Innovex agrees to
immediately disclose in writing to Client if any employee is debarred or if
any action, suit, claim, investigation or legal or administrative
proceeding is pending or, to the best of Innovex knowledge, threatened,
relating to the debarment of any person performing services hereunder.
15. RELATIONSHIP WITH INVESTIGATORS
If this Agreement obligates Innovex to contract with investigators or
investigative sites (collectively, "Investigators") or facilitate Client's
contracting with Investigators (or other independent contractors such as
central laboratories), then any such contract shall be on a form mutually
acceptable to Innovex and Client, which contract may include, without
limitation, provisions addressing the specific duties and standards of the
parties, confidentiality, indemnification, ownership of property and patent
rights, and insurance coverage. Client shall be responsible to promptly
review, comment on and/or approve such form contracts. Client acknowledges
that (a) an Investigator engaged for a particular Project shall be solely
responsible for his or her (or its) own independent medical judgment and
his or her (or its) acts and omissions in performing the clinical
investigation and related services, and (b) Innovex shall have no
responsibility whatsoever for the acts and omissions of any such
Investigator; rather, Innovex's sole responsibility with respect to any
such Investigator shall be those responsibilities specifically set forth in
this Agreement.
16. RELATIONSHIP WITH AFFILIATES
16.1 Client agrees that Innovex may utilize the Services of its corporate
affiliates to fulfill Innovex's obligations under this Agreement. Any
affiliate so utilized shall be (i) subject to all of the terms and
conditions applicable to Innovex under this Agreement, including, but
not limited
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to, provisions establishing the standards for performance, and (ii)
entitled to all rights and protections afforded Innovex under this
Agreement, including, but not limited to, the indemnity and
limitation of liability protections set forth herein.
16.2 When used in this Agreement, the term "affiliate" shall mean all
entities controlling, controlled by or under common control with
Client or Innovex, as the case may be. When used herein, the term
"control" shall mean the ability to vote fifty percent (50%) or more
of the voting securities of any entity.
17. CHOICE OF LAW, JURISDICTION, ENFORCEABILITY
17.1 This Agreement shall be governed by and construed in accordance with
the laws of the State of Kansas applicable to agreements made and to
be performed entirely within such State, including all matters of
enforcement, validity and performance.
17.2 No failure or delay on the part of Innovex or the Client to exercise
or enforce any rights conferred on it by the Agreement shall be
construed or operate as a waiver thereof, nor shall any single or
partial exercise of any right, power or privilege or further exercise
thereof operate so as to bar the exercise or enforcement thereof at
any time.
17.3 The illegality or invalidity of any provision (or any part thereof)
of the Agreement or these Standard Terms, shall not affect the
legality, validity or enforceability of the remainder of its
provisions or the other parts of such provisions as the case may be
which provisions shall remain in full force and effect.
18. MISCELLANEOUS
18.1 Neither Innovex nor the Client shall assign the Agreement without the
prior written consent of the other.
18.2 The text of any press release or other communication to be published
by or in the media concerning the content of the Agreement or the
involvement of Innovex and the Client shall require the written
approval
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of Innovex and the Client. Any such communication on the subject
matter of the Agreement shall require the prior written approval of
the Client.
18.3 The Client may use, refer to and disseminate reprints of scientific,
medical and other published articles which disclose the name of
Innovex consistent with U.S. copyright laws, provided such use does
not constitute an endorsement of any commercial product or service by
Innovex. Except as otherwise required by law, Innovex shall not
disclose publicly or utilize in any advertising or promotional
materials the existence of the Agreement or Innovex's association
with the Client or the use of the Client's name or the name of any of
the Client's divisions, products or investigations without the prior
written permission of the Client.
18.4 The Agreement and the Standard Terms for Clinical Services constitute
the entire understanding of the Client and Innovex. No changes,
amendments or alterations shall be effective unless in writing and
signed by the Parties. Any notice required to be given under this
Agreement shall be in writing and delivered by facsimile with a copy
thereof delivered by certified mail, postage prepaid, addressed to
the parties as follows (or as otherwise notified in writing in
accordance with this section):
If to the Client:
LXR Biotechnology, Inc.
Attn: Xx. Xxxxxxx X. Xxxxxxxx
Director of Regulatory Affairs
0000 Xxxxxx Xxx Xxxxx
Xxxxxxxx, XX 00000
Phone: (000) 000-0000
Fax: (000) 000-0000
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If to Innovex:
Innovex Inc.
Attn: Xxxxx Xxxxx
President and General Manager
00 Xxxxxxxxx Xxxxxxxxx
Xxxxxxxxxx, XX 00000
Phone: 000-000-0000
Fax: 000-000-0000
With a copy in the case of dispute or legal matters to:
L. Xxxxxxx Xxxxxx
General Counsel
00000 Xxxxxxxxx Xxx.
Xxxxxx, XX 00000
Phone: 000-000-0000
Fax: 000-000-0000
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SCHEDULE A - PRICE
1. CLINICAL POSITION TITLES AND DAILY RATE. Attached, Schedule A-1.
2. PROJECT COSTS. Attached, Schedule A-2.
3. FEES. Within ten (10) days of the execution of this Agreement Client shall
pay Innovex an initial deposit which is the equivalent of fees for two (2)
months, plus estimated travel expenses. Thereafter, Innovex agrees to invoice
the Client at the end of each month in arrears for all Services provided to the
Client by Innovex hereunder. The initial deposit will be offset against charges
to Client for the final two months of the Agreement. Upon expiration or
termination of the Agreement the parties will reconcile total payments received
against total days worked. Any credit or refund due will be paid by Innovex
within 30 days. Any charge due by Client will be invoiced by Innovex for payment
within 30 days.
Invoices shall reflect the name(s) of Personnel for which the client is
being billed, the number of days worked during the invoice period, the total due
for each individual Personnel for the invoice period and a grand total of all
fees for the invoice period. Upon request, supporting documentation will be made
available to the Client.
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SCHEDULE A-1
CLINICAL POSITION TITLES AND DAILY RATES
[**]
Note: Daily rate is shown in U.S. Dollars. Position titles are shown in
descending order their daily rates.
** Confidential Treatment Requested
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SCHEDULE A-2
PROJECT COSTS: CARDIAC TRANSPLANTATION
[**]
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SCHEDULE A-2
PROJECT COSTS: CARDIAC TRANSPLANTATION
[**]
** Confidential Treatment Requested
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SCHEDULE A-2
PROJECT COSTS: CARDIAC TRANSPLANTATION
[**]
TOTAL PROJECT COSTS 565,274
** Confidential Treatment Requested
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SCHEDULE B - SERVICES
A copy of the description of specific services to be performed is attached,
dated April 28, 1997.
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Xx. Xxxxxxx X. Xxxxxxxx April 28, 1997
Director of Regulatory Affairs
LXR Biotechnology, Inc.
0000 Xxxxxx Xxx Xxxxx
Xxxxxxxx, XX 00000
Dear Xxxxxxx,
Per Your recent discussions with Xx. Xxxxxxx Xxxxxx in reference to the LXR
Biotechnology Heart Transplant study, LXR Biotechnology's intends to enter into
agreement with Innovex Inc. for the services listed below.
Innovex will provide the following Clinical Research Services: project
management, clinical monitoring, site management, medical monitoring, regulatory
affairs, data management, statistical analyses, report writing and quality
assurance.
STUDY OUTLINE (DRAFT)
---------------------
Study: [**], Innovex # 5378
Indication: Heart Transplant
Number of Sites: [**]
Countries: U.S./Europe
Start Date: [**]
Enrolled Patients: 120
Accrual Rate: [**]
Accrual Period: [**]
Treatment and Follow-up: [**]
% Population with
potential SAEs: [**]
CRF pages/patient: [**]
Total CRF Volume: [**]
Contract End Date: June 1, 1999
**Confidential Treatment Requested
25
THE BRIEF
LXR Biotechnology has asked Innovex to submit a Proposal for Services to provide
project management, clinical monitoring, site management, medical monitoring,
regulatory affairs, data management, statistical analyses, report writing and
quality assurance for the LXR Heart Transplant Study, [**]. The total cost
associated with this project is [**]. A detailed cost estimate is attached
following the description of services.
SERVICES
PROJECT MANAGEMENT will provide total project planning for the execution of
study related activities and coordination of the project team to achieve project
goals and objectives. Specifically, PROJECT MANAGEMENT will:
- participate in the project planning activities including writing and review
of the protocol, CRF design and review, as well as clinical laboratory and
drug shipments
- set-up and maintain project timelines through the use of interactive,
relational Xxxxx charts
- implement the utilization of InnTrax (the Innovex project tracking system)
- set-up and maintain secure project central files
- monitor and report on budgetary parameters related to scope of work
deliverables and changes
- administer investigator grant payments
- facilitate and document project team meetings
- act as the liaison on all project information between LXR Biotechnology and
Innovex functional departments
- prepare and distribute monthly activity/progress reports
INVESTIGATOR ADMINISTRATION includes all tasks associated with investigator
contacts, recruitment, selection and training and the preparation of study
materials and documents. Specifically, this entails:
- review and printing of CRFs
- preparation of site materials including conventions, annotations, site
manual and study aids
- making initial contact with sites and send the pre-study documents
(including protocol, consent form and letters of confidentiality) necessary
to determine the Investigator's interest and ability to participate
- performing pre-study site visits to inspect each site prior to study
initiation
- distributing and collecting study documents in preparation for initiation
- conducting investigator contract and budget negotiations
- collecting and reviewing site regulatory documents and IRB approvals
**Confidential Treatment Requested
26
INVESTIGATOR ADMINISTRATION cont'd
- preparing investigator site binders
- performing initiation visits to instruct the investigator and study
coordinator in the technical aspects of the study
- providing project specific and therapeutic area training for CRAs and other
team members
CLINICAL MONITORING will monitor the investigative sites and the data during
the course of the study and upon close out according to LXR Biotechnology and
Innovex SOP's and local, state and federal regulations and GCPS. This
monitoring will include:
- site visits during the course of the study where activities include:
source document verification
collection of completed CRF's
listings of corrected discrepancies
patient accrual status
protocol compliance or deviations
drug accountability
regulatory document status
patient safety issues
- site management utilizing InnTrax and writing site summaries
- in-house CRF logging, reviewing and query resolution
- closeout visits to remove all appropriate study documentation, CRF's drug
supplies, etc. from each site with review of the investigator binder for
completeness and regulatory compliance
MEDICAL MONITORING is responsible for the medical management of the study,
review of all reported adverse events and reporting of all serious adverse
events to LXR Biotechnology according to federal regulations and assist with the
preparation of clinical reports. Specifically, MEDICAL MONITORING will:
- answer questions and address issues from LXR Biotechnology, the clinical
sites and the Innovex project team regarding patient eligibility,
indication-specific information and study drug administration
- review appropriate CRF pages and data listings for eligibility and safety
- track adverse events according to SOP's agreed upon
- report serious adverse events according to regulatory guidelines
27
DATA MANAGEMENT will produce a clean, authorized and validated database for the
study. Specifically, DATA MANAGEMENT will:
- design a database plan including data entry conventions, annotated CRF'S,
QC guidelines, standard edit checks and validation plan
- program a database, edit checks and data entry screens according to LXR
Biotechnology's specifications
- provide database verification, documentation and administration
- perform double-key data entry and reconciliation of the dual entries
- utilize standard computerized edit checks including invalid or out of range
values, logic checks and missing data
- generate, review, investigate and resolve data discrepancies
- utilize InnTrax to track CRF's and queries
- maintain the integrity of the database
STATISTICS will support development of a statistically sound protocol and CRF
and plan and execute the statistical analysis of the data generated from the
study. Specifically, STATISTICS will:
- review the protocol and CRFs for clarity and consistency of study concepts
and procedures
- perform a sample size assessment and create a statistical methods section
in the protocol
- prepare specifications and template versions of all tables, listings and
graphs to be included in the final statistical report
- generate all tables, listings and graphs according to specifications
- perform statistical analysis of protocol-specified efficacy and/or safety
parameters
- generate a statistical report summarizing all rules and definitions,
describing results of statistical analyses and including a more technical
statistical appendix
- archive all relevant data, programs and documents with copies delivered to
client
MEDICAL WRITING will prepare and deliver a draft and final clinical/statistical
integrated report in an agreed format. Specifically, MEDICAL WRITING will:
- prepare a draft report explaining the study plan, variables measured,
method of analysis and results of the study
- include summary tables and listings produced by the analyses
- produce a final report for the study, incorporating comments from the
project team and LXR Biotechnology
- send a written and electronically-formatted copy of the final integrated
report to LXR Biotechnology
28
QUALITY ASSURANCE will provide documentation to LXR Biotechnology and Innovex
management that the study is being carried out in accordance with the protocol,
SOPs and local, state and federal regulations and GCPs.
