Exhibit 10.1
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Master Services Agreement
This AGREEMENT (this “Agreement”) is made and entered into as of the date of
last signature below (“Effective Date”), by and between Amarex Clinical
Research, LLC, a for-profit Maryland limited liability company with its
principal place of business at 20201 Century Boulevard, Suite 450, Germantown,
MD 20874 (“Amarex”), and Innovate Biopharmaceuticals, Inc. (“Innovate”), a
Delaware corporation with its principal place of business at 8480 Honeycutt
Road, Suite 120, Raleigh, NC, 27615.

WITNESSETH
WHEREAS, Innovate is engaged in research and development projects (each, a
“Project”) involving pharmaceutical products; and
WHEREAS, Amarex, a contract research organization, is engaged in the business of
providing clinical trial management services and consulting; and
WHEREAS, Amarex desires to assist Innovate in certain product development
activities set forth herein and Innovate desires to retain Amarex upon the terms
and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises and
undertakings herein contained, the parties hereto agree as follows:
SECTION 1: SERVICES
1.01
During the Term, Amarex agrees to provide services as described in project
orders (as amended by any subsequent Amendments (defined below), each a “Project
Work Order”) which will be requested of Amarex by Innovate, the form of which is
set forth as Exhibit 1. Such services shall be performed in accordance with
applicable laws and regulations and the terms and conditions of this Agreement.
Amarex agrees to grant Innovate access to Amarex’s electronic data capture
system.

1.02
After receipt of a Project Work Order request, Amarex shall provide Innovate
with a Project Work Order describing the services to be performed and a fee for
performing the services. The Project Work Order will be negotiated and mutually
agreed to and approved in writing before any work is performed by Amarex and,
once executed, will be incorporated by reference into this Agreement.

1.03
Innovate or Amarex may request changes in any Project Work Order (a “Change
Proposal”) by providing written notification of such changes to the other party,
whereupon Innovate and Amarex shall review such request and negotiate in good
faith the changes to be implemented. If the parties reach agreement regarding
the Change Proposal, Amarex shall submit to Innovate a Project Work Order
Amendment (“Amendment”) which will detail all changes and associated cost
estimates, and any other proposed revision to the services under the relevant
Project Work Order. If the parties execute and deliver such Amendment, it will
then be incorporated as part of this Agreement. In the event of a conflict
between the terms

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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of this Agreement and any Project Work Order, the terms of this Agreement shall
govern unless such Project Work Order expressly states and identifies which
specific contrary terms shall supersede the terms and conditions of this
Agreement. All terminology in this Agreement that has not been specifically
defined shall be interpreted according to standard practices in the field of
pharmaceutical clinical research.

SECTION 2: TERM
2.01
This Agreement shall be effective from the Effective Date and shall thereafter
remain in full force and effect for a period of three (3) years, unless earlier
terminated as provided herein (“Initial Term”). Thereafter, this Agreement may
be renewed upon Innovate’s written request for up to two (2) additional one (1)
year terms (“each a Renewal Term,” and together with the Initial Term, the
“Term”).

SECTION 3: COMPENSATION AND PAYMENT
3.01
As compensation for Amarex’s services hereunder, Innovate shall pay Amarex the
undisputed amounts of each invoice prepared by Amarex relevant to services
performed under each Project Work Order or any portion thereof. All payments by
Innovate for undisputed amounts shall be made within [***] days of the date of
Innovate’s receipt of a written invoice from Amarex. Innovate shall notify
Amarex of any disputed amounts within [***] days of Innovate’s receipt of the
disputed invoice. The parties shall negotiate in good faith to resolve any
disputed amounts in accordance with Section 13.04. Unless otherwise expressly
provided herein, each party shall be responsible for its own expenses relating
to its performance of this Agreement and shall not incur expenses for the other
party’s account unless expressly authorized in writing to do so by the other
party. Further, Innovate will reimburse Amarex for all pre-approved, reasonable
out-of-pocket expenses (without markup) incurred by Amarex in connection with
the services; provided, however, that any travel and lodging (if requested by
Innovate) expenses must be consistent with Amarex’s company travel policy and
any all out-of-pocket expenses that individually or cumulatively exceed [***]
Dollars ($[***]) must be approved by Innovate in advance; such pre-approval may
be accomplished via e-mail communication. For clarity, reasonable out-of-pocket
expenses described or set forth in, and not in excess of, a Project Work Order
budget are deemed pre-approved by Innovate. Upon Innovate’s request, Amarex
shall provide reasonable documentation to substantiate any out-of-pocket
expense. All such out-of-pocket expenses shall be included on the appropriate
invoice described in this Section 3.01.

3.02
All invoices and/or other requests for payment shall be billable and payable in
U.S. Dollars unless otherwise agreed upon in writing by both parties.

3.03
All invoices and/or other requests for payment shall be itemized with a
reasonable degree of specificity to ensure accuracy in accounting for services
and/or goods provided and billed for. All invoices and/or other requests for
payment shall be sent to:

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Innovate Biopharmaceuticals, Inc.
c/o Accounts Payable
8480 Honeycutt Rd, Suite 120
Raleigh, NC 27615
Email invoice to: ap@innovatebiopharma.com AND innovatebio@bill.com
Innovate shall not be responsible for any invoices and/or other requests for
payment sent to any address or department other than that provided immediately
above.
3.04
Payments to Amarex will be made out to Amarex Clinical Research, LLC (Tax ID:
[***]).

3.05
A [***]% annual interest rate will be charged to any and all undisputed amounts
that remain unpaid past their applicable due dates.

3.06
During the Term and for a period of [***] months after its expiration or
termination, upon fourteen (14) days’ prior written notice, at its expense once
annually and at reasonable times during normal business hours, Innovate shall
have the right to audit and examine all records which are necessary to verify
performance by Amarex of the services in accordance with any Project Work Order.
Innovate will not be entitled to audit (i) data or information of other
customers or clients of Amarex; (ii) any cost information unless such is the
basis of an out-of-pocket expense; (iii) Amarex’s quality assurance reviews and
contract management reports; or (iv) any other confidential Information of
Amarex that is not directly relevant for the authorized purposes of the audit.
Any notice shall contain detailed information regarding the records and time
periods being audited. The auditors and other representatives of Innovate will
execute and deliver such confidentiality and non-disclosure agreements and
comply with such reasonable security and confidentiality requirements as Amarex
may require in connection with such audits. If errors or deficiencies are
identified as a result of an audit, Amarex shall take prompt action to correct
any such error or deficiency mutually agreed upon by the parties in accordance
with the dispute mechanism set forth herein, including refunding any
overpayments by Innovate to Amarex within thirty (30) days of being notified of
such overpayment.

SECTION 4: CONFIDENTIALITY
4.01
With respect to any and all information indicated in writing or reasonably
understood from the context as being of a confidential nature, including but not
limited to, protocols, data forms, and study results acquired by Amarex from
Innovate as a result of this Agreement or from performance of the services to be
rendered hereunder, Amarex agrees that it will not use said information other
than for the purposes of this Agreement, and it will not disclose any of said
information to any third party; provided, however, that Amarex may disclose such
information (i) on a need-to-know basis to its agents, employees and consultants
who are under a written obligation to maintain the confidentiality of said
information, (ii) in

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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response to a written request or order from a regulatory agency with competent
jurisdiction in which case Amarex shall provide Innovate with a copy of such
request in advance of such disclosure, or (iii) which Amarex is required by law
to release, so long as Innovate has had an opportunity to challenge such
release, to the extent reasonably practicable. Except for personally
identifiable information, the foregoing obligation shall not apply to
information:
1)
which can be shown by written documentation to have been known to Amarex prior
to its receipt from Innovate;

2)
which is or lawfully becomes generally available to the public through no fault
of Amarex;

3)
which is lawfully acquired from third parties who have a right to disclose such
information; or

4)
which by mutual agreement is released from a confidential status.

4.02
Innovate will treat Amarex confidential information, including but not limited
to, business information, pricing, proprietary software and programs, in
accordance with the same terms as Amarex’s treatment of Innovate information, as
detailed in Section 4.01 above.

4.03
The terms of this Section 4, Section 6, Section 9, and the parties’ obligations
hereunder, shall survive for three (3) years after termination or expiration of
this Agreement and the completion of all Project Work Orders duly made a part
hereof. Further, the provisions of this Agreement that would by their nature
survive the expiration or termination of this Agreement, shall survive any
expiration or termination of this Agreement for three (3) years.

SECTION 5: TERMINATION/RENEGOTIATION
5.01
This Agreement or any Project Work Order may be terminated by Innovate at any
time by giving a 30-day prior written notice to Amarex. During the 30-day period
between the notice of termination and the effectiveness of such termination,
Amarex shall use all reasonable efforts to terminate its work under any Project
Work Order being terminated as early as practicable and to reduce or eliminate
further costs, and to cancel, if permitted under the terms of applicable
agreements, any third party obligations. Within thirty (30) days after the
completion of wind-up of the applicable Project Work Order (which wind-up
includes receipt by Innovate of any statistical analyses and other deliverables
prepared by Amarex, if any, prior to the date of termination), Amarex shall
provide Innovate with a written itemized statement of all services already
performed by Amarex under the Project Work Order being terminated. In the event
of termination of a Project Work Order pursuant to this Section 5.01, Amarex
shall be entitled to a payment based on the pro rate amount of services provided
by it under such Project Work Order through the later date of termination or
winding up period plus pass-through related costs incurred through such date. If
the amount already paid by Innovate to Amarex exceeds such pro rate amount,
Amarex shall refund such excess to Innovate and if such pro rate amount is
greater than the amounts already paid by Innovate

    
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to Amarex, then Innovate shall pay the balance due to Amarex upon Amarex’s
invoice therefor.
5.02
This Agreement may also be terminated by either party (a) upon material default
in performance of the other party, provided that any defaulting party shall be
given not less than thirty (30) days’ prior written notice of default and the
opportunity to cure the default during such period or (b) immediately upon the
other party becoming insolvent or bankrupt or making an assignment for the
benefit of its creditors, upon appointment of a trustee or receiver for the
other party of all or substantially all of its property, or upon the filing of a
involuntary petition (unless the case is dismissed by midnight at the end of the
sixtieth (60th) day after commencement) or voluntary petition by or against the
other party under any bankruptcy or insolvency law, the reorganization or
rearrangement provisions of the United States Bankruptcy Code, or any similar
law. If this Agreement is terminated pursuant to this Section 5.02, Amarex shall
retain such sums as may have been paid to it by Innovate under the terms of this
Agreement to compensate Amarex for services already performed. If the amount
previously paid by Innovate exceeds the sum earned by Amarex for services
already performed in accordance with the Project Work Order, the excess shall be
refunded to Innovate. Innovate shall pay Amarex any additional undisputed
amounts owed but not yet paid for services already performed.

5.03
If payments for undisputed amounts in any invoice are not received within [***]
days of receipt of the applicable invoice, and after fifteen (15) days’ written
notice to Innovate, Amarex shall have the right to cease all work and to
terminate this Agreement and the applicable Project Work Order if the past due
balance is in excess of $[***]. Should any part of the invoice be in dispute,
Innovate shall pay the remainder of the undisputed amount according to the terms
and conditions described herein while said dispute is being resolved, and the
parties will work in good faith to resolve the disputed portion of the invoice
within a forty-five (45) day period beginning from the time that Amarex received
notification of the disputed portion of the invoice. In addition, Innovate shall
provide Amarex with written notice setting forth (in detail) the basis of the
dispute and the parties agree to use best efforts to resolve such dispute in an
expeditious manner.

5.04
Any payments due under this Section 5 shall be made within [***] days after
termination.

SECTION 6: INDEMNIFICATION
6.01
Innovate agrees to indemnify, defend and hold harmless Amarex and its officers,
directors, employees, agents, advisors, representatives, successors and
permitted assigns from and against any loss, damage, cost and expense
(including, without limitation, reasonable attorneys’ fees and expenses)
incurred in connection with any third-party claims, proceedings or
investigations to the extent arising out of or in connection with actual or
alleged gross negligence or willful misconduct of Innovate or its employees.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
    
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6.02
Amarex agrees to indemnify, defend and hold harmless Innovate and its respective
officers, directors, employees, agents, advisors, representatives, successors
and permitted assigns from and against any loss, damage, cost and expense
(including, without limitation, reasonable attorneys’ fees and expenses)
incurred in connection with any third-party claims, proceedings or
investigations to the extent arising out of or in connection with actual or
alleged gross negligence, willful misconduct of Amarex or its employees or
permitted contractors.

6.03
Each party shall indemnify, defend, protect and hold harmless the other party
and its respective officers, directors, employees, agents, advisors,
representatives, successors and permitted assigns from and against any loss,
damage, cost and expense (including, without limitation, reasonable attorneys’
fees and expenses) incurred in connection with any third-party claims,
proceedings or investigations to the extent arising out of or in connection
with: (i) any breach by such first party or its agents, employees or contractors
of any covenant, representation, warranty or other obligation contained in this
Agreement; or (ii) any injury to any person, including death, illness or bodily
injury, or damage to real or tangible personal property, based on the
negligence, gross negligence, willful misconduct of such first party or its
employees or permitted contractors.

6.04
Any party seeking indemnification pursuant to this Section 6 (the “Indemnitee”)
shall give notice within a reasonable amount of time to the party from whom
indemnification is sought (the “Indemnitor”) of any claim, proceeding or
investigation. The Indemnitee shall cooperate in the defense of such claim,
proceeding or investigation, subject to reimbursement by the Indemnitor for all
reasonable out-of-pocket expenses. The Indemnitor shall, at its option, assume
control of the defense of any such claim, proceeding or investigation. The
indemnities set forth in Sections 6.01 and 6.02 shall include amounts paid in
settlement, provided, however, that no such settlement shall be entered into
without the Indemnitor’s consent, which consent shall not be unreasonably
withheld. In no event shall the Indemnitor compromise or settle any claim,
proceeding or investigation in a manner that admits fault or negligence on the
part of the Indemnitee, or does not fully release the Indemnitee from all claims
and all future claims arising out of the subject, or that would otherwise
adversely affect any rights of the Indemnitee, without the prior written consent
of the Indemnitee. The Indemnitee shall have the right to retain separate legal
counsel at its own expense to participate in the defense of any such claim,
proceeding or investigation.

SECTION 7: PUBLICITY
7.01
Neither party shall disclose the existence of this Agreement, except as required
by law, or as required to fulfill regulatory obligations as the sponsor of an
IND, NDA, BLA, 510K, IDE, or PMA, nor use or publish the other party’s name in
promotion, advertising or for any other purpose, without prior written approval
of the other party. This Agreement does not entitle either party to the use of
the trademarks, copyrights or other intellectual property of the other party.

    
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SECTION 8: RELATIONSHIP OF PARTIES
8.01
Amarex shall perform services under this Agreement only as an independent
contractor and nothing contained herein shall be construed to be inconsistent
with that relationship or status. Amarex and its consultants and subcontractors
shall not be considered employees or agents of Innovate. This Agreement shall
not constitute, create or in any way be interpreted as a joint venture,
partnership or business organization of any kind.

8.02
Neither party shall, during the term of this Agreement, and for a period of
twelve (12) months following expiration or termination thereof, without the
prior written consent of the other party, for itself or on behalf of or through
any third party, directly or indirectly, solicit to employ or engage as an
independent contractor, any employee or consultant of the other party who was in
any way involved in rendering or receiving services under this Agreement or any
Project Work Order.  Notwithstanding the above, the following shall not be
prohibited: (a) any solicitation if, at the time of such solicitation, the
individual is no longer employed by the other party as an employee or
independent contractor for reasons not associated with pursuing a future
business or employment relationship with the soliciting party; (b) solicitations
initiated through general print advertisements and other general circulation
materials, including web-based postings, not directly targeted at such
individuals; and (c) solicitations of such individuals who have first contacted
either party on their own initiative, directly or through third party
recruiters, regarding employment or engagement as an independent contractor.

SECTION 9: OWNERSHIP
9.01
All information, materials, documents and raw data supplied to Amarex or
developed by Amarex as a result of performing the services hereunder are owned
by Innovate. All such information shall be disclosed to Innovate. Innovate shall
have the right to make any use of such information. Following completion of the
services outlined in a Project Work Order, Amarex will ensure return to Innovate
of client data or other materials furnished to Amarex, at Innovate’s cost. All
Intellectual Property Rights subsisting in or relating to any calculations,
data, methods, specifications, papers, documents, and any other items, material
or information generated in any form or media in the performance of the services
by Amarex under this Agreement are vested in and are the sole and exclusive
property of Innovate, except that Amarex shall have the rights to any innovative
methodology developed which has generic applications and is not specific to any
particular Innovate Project. Accordingly, without additional consideration,
Amarex hereby assigns to Innovate its entire right, title and interest in and to
such Intellectual Property Rights and other work product that Innovate is to own
under this Section 9.01, waives all moral rights thereto, and shall cause its
employees, agents, contractors, subsidiaries and their respective employees,
agents and contractors to do the same. “Intellectual Property Rights” means,
without limitation, and

    
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whether or not patentable, all ideas, discoveries, inventions, improvements,
patents, patent applications and issued patents, designs, design applications
and design registrations, trademarks, trade mark applications, trade mark
registrations, trade names (whether registered or unregistered), copyright,
copyright applications and registrations, processes, data, studies, physician
and pharmacist’s lists, trade secrets and proprietary information related to the
services (or their research, development, manufacture, use or
commercialization), including any enforcement rights.

SECTION 10: COMMUNICATIONS & PAYMENTS
10.01
Communications regarding routine operational matters may be carried out using
e-mail. All other administrative communications provided for in this Agreement
shall be sent via first class mail (subject to Section 10.02 below), postage
prepaid, addressed to the respective parties as follows:

To Amarex:                        To Innovate:

Kazem Kazempour                    June Almenoff MD, PhD
President and CEO
Chief Operating Officer and Chief Medical Officer

Amarex Clinical Research, LLC            Innovate Biopharmaceuticals, Inc.
20201 Century Boulevard, Suite 450            8480 Honeycutt Road, Suite 120
Germantown, MD 20874                Raleigh, NC 27615
jalmenoff@innovatebiopharma.com
10.02
Other than routine correspondence described in Section 10.01, any communication
required under this Agreement shall be sent by certified mail and addressed to
the respective parties at the addresses set forth in Section 10.01 above. All
legal notices shall be in writing and sent by certified mail, return receipt
requested, to such addresses, to the attention of the relevant contact person
specified above. Such notices shall be effective upon mailing.

SECTION 11: ASSIGNMENT
11.01
Neither party shall have the right to assign (including by operation of law)
this Agreement or any of the rights or obligations hereunder without the prior
written consent of the other party, except that either party may assign without
such consent this Agreement or any of its rights or obligations hereunder to any
of affiliated companies or subsidiaries or to a successor to substantially all
of the business of such party to which this Agreement relates, whether in a
merger, sale of stock, sale of assets or other transaction. Any assignment or
attempted assignment by either party in violation of the terms of this Section
11.01 shall be null and void and of no legal effect.

    
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SECTION 12: STANDARDS; REPRESENTATIONS
12.01
Amarex provides services to its customers on a contractual fee-for-service
basis. Amarex represents and provides its sole warranty that it will perform the
services in a timely, workmanlike manner by qualified (and, where appropriate,
licensed) personnel with due care and diligence in accordance with generally
prevailing industry standards, Innovate instructions (provided that Amarex will
not have any liability for following Innovate instructions that run counter to
industry standards, applicable regulations, or Amarex SOPs), and applicable
government regulations, laws and rules, as well as the objectives of this
Agreement. Amarex represents that all staff assigned to provide the contracted
services will undergo standard and ongoing training such that Amarex’s staff
will have the facilities, equipment and requisite training, expertise,
qualification, experience and skill to render the services in the manner
required by this paragraph above.

Each party represents that (i) the execution, delivery and performance of this
Agreement has been duly authorized and does not and will not conflict with any
existing obligation or contract of such party, (ii) during the Term hereof, such
party will not enter into any contract or assume any obligation that conflicts
with this Agreement, and (iii) performance of its obligations hereunder will not
infringe or violate the Intellectual Property Rights of any third party.
Amarex represents that its services are setup and tested in compliance to 21
Code of Federal Regulations (CFR), Part 11 and FDA’s 1999 and 2004 Guidance for
Computerized Systems Used in Clinical Trials (CSUCT).
Amarex represents that: (i) its computer server room is climate controlled with
anti-static flooring and secured by access key fobs (with a keypad and
combination door lock as backup); (ii) access to the room is limited to Amarex’s
IT staff; (iii) its equipment includes high-density filing systems located in a
fire-protected document storage room that is secured by a keypad combination
door, and all original study-related documents and hard copy Case Report Forms
will be stored in this storage room; (iv) it shall employ a secure, wide-area
network with redundant Internet access that is client/server based and is driven
by the Microsoft Windows Server System running on Dell PowerEdge and HP Proliant
series servers, which include high availability and redundancy (RAID 1 and 5
hard disk subsystems, gigabit network adaptor teaming, and primary and secondary
power supplies); (v) all servers and network equipment are connected to UPS
(Uninterruptible Power Supplies) in the event of brown or black outs; (vi) it
shall perform daily backups on all of servers and databases to a hardware data
recovery appliance; (vii) these backups are stored in a secure offsite facility;
(viii) monthly full backups are performed and sent offsite to a secure storage
facility where they are held for a minimum of 10 years; (ix) backups are
periodically tested to ensure that they are working correctly; (x) data
integrity is maintained using frequently updated virus checks; (xi) it has and
shall maintain a detailed disaster recovery plan which

    

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includes a cold place to reestablish the company data/operational information
within 24 hours, and as part of this plan, data is backed up, and stored in an
offsite secure storage facility; (xii) in the event of a disaster, Amarex shall
either retrieve the backups from the offsite storage facility or receive a
replacement data recovery appliance to load the applications and data on new
computers. Amarex further represents that it shall provide the services in
accordance with its SOPs.
In the event Amarex reasonably anticipates that it cannot meet its obligations
under this Agreement, it shall inform Innovate in writing, and the parties shall
negotiate in good faith to reach a mutually agreeable solution to address such
deficiencies. The remedies for verifiable breach of any warranty set forth in
this Agreement shall be for Amarex to promptly re-perform the services at no
charge to Innovate or to return the fees paid in connection with such services.
Amarex shall have a reasonable opportunity to cure any breach of the warranty
through re-performance, unless Amarex waives this right in writing. Except as
expressly set forth herein, under no circumstances shall either party be liable
to the other party or any third party claiming by or through such party as a
result of a party’s failure to perform its obligations hereunder for any
consequential, indirect, special, or other damages, and the warranty set forth
above is in lieu of any and all other warranties relating to the services to be
performed, express or implied, including, without limitation, any implied
warranties of merchantability or fitness for a particular purpose, or for
non-infringement of intellectual property rights. Except for: (1) the
indemnification obligations set forth herein; (2) claims related to a party’s
breach of its confidentiality obligations; and (3) gross negligence or willful
misconduct, in no event shall either party be responsible or liable for an
aggregate damage total in excess of [***].
Innovate shall provide Amarex with all materials set forth in a Project Work
Order and, upon Amarex’s reasonable request, will reasonably cooperate and
assist Amarex in connection with Amarex’s performing the services pursuant to
the Project Work Order.
Innovate shall be responsible for reporting of serious adverse events (“SAEs”)
to any regulatory authorities as appropriate.
12.02
Amarex represents that: (i) it will handle all information containing personal
data in accordance with all applicable laws governing patient privacy; (ii) all
individuals and subcontractors performing services hereunder are and shall be
subject to binding written obligations to assign all of their right, title and
interest in and to any Inventions and related intellectual property rights
(including enforcement rights) to Amarex or Innovate and to abide by the
obligations of confidentiality set forth (and in the absence of such binding
written obligations by and between Amarex and one (1) or more individuals and/or
subcontractors that Amarex intends will perform services hereunder, Amarex shall
notify Innovate and take all commercially reasonable actions requested by
Innovate to achieve the foregoing); and (iii) it is not a debarred or
disqualified person or entity under the authority of the Generic Drug
Enforcement Act of 1992, as amended, or any other law or regulation

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
    
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relating to the conduct of human research, and has not used and will take
reasonable measures to avoid the use of services of any such debarred or
disqualified person or entity in any capacity or connection with any of the
services performed pursuant to this Agreement. This certification applies in
respect of Amarex’s colleagues, associates, agents and employees as well as
third parties with which Amarex may subcontract. Amarex shall notify Innovate
promptly in the event it or any such person or entity becomes subject to
debarment or disqualification proceedings.
12.03
Innovate shall be entitled, with a minimum prior notice of [***] business days
and during the term of the related Project Work Order, to inspect the conduct of
services and to validate compliance with the requirements of this Agreement and
applicable laws by Amarex relating to a Project Work Order under this Agreement.
Innovate will not be responsible for payment to Amarex for time spent on audits
that are no more frequent than once per year, and last no more than [***] per
audit. Innovate may perform additional audits where an audit by a regulatory
authority has revealed a deficiency that affects a project with Innovate.
Furthermore, Amarex agrees to respond to all audit findings from Innovate within
forty-five (45) days of receipt of the audit report and respond to any
subsequent follow-up discussions as deemed necessary by Innovate including
possible discussions with regulatory authorities. In the case of a disagreement,
Amarex and Innovate will attempt to resolve the dispute in good faith within
fifteen (15) days. In the event that the parties cannot come to an agreement
then without limiting any other remedies Innovate may have under this Agreement
or otherwise, Innovate may terminate this Agreement or any Project Work Order
for convenience in accordance with Section 5. Except with respect to audit
findings that are the subject of a bona fide dispute, Amarex will at its expense
promptly come into compliance with the requirements of this Agreement as a
result of any audit findings that apply to the integrity and proper conduct of
the services under a Project Work Order.

SECTION 13: MISCELLANEOUS
13.01
This Agreement constitutes the entire agreement between the parties on the
subject matter to be described and defined in future Project Work Orders and
supersedes all prior contracts, agreements and understandings relating to the
same subject between the parties. The parties intend this Agreement to be a
complete statement of the terms of their agreement and no change or modification
of any of the provisions of this Agreement shall be effective unless it is in
writing and signed by a duly authorized officer of Amarex and Innovate. The
parties agree that no “click-through,” “shrink-wrap,” “browse-wrap” or similar
terms that have not been specifically negotiated by the parties, whether before,
on, or after the date of this Agreement, will be effective to add to or modify
the terms of this Agreement, regardless of any party's and/or its
representative’s “acceptance” of those terms by electronic means.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
    
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13.02
This Agreement may be signed in any number of counterparts, which, when taken
together, will constitute one and the same Agreement. Delivery of an executed
counterpart by facsimile or by email transmission in portable document format,
or similar format, is as effective as executing and delivering this Agreement in
the presence of the other party to this Agreement.

13.03
This Agreement shall be governed by the laws of the State of Delaware, U.S.A.

13.04
In the event of a dispute between the parties regarding this Agreement, the
parties shall first attempt to resolve their dispute within fifteen (15) days’
after such dispute is raised through amicable discussion between designated
executives of each party with requisite authority to resolve such dispute(s). If
at the end of such fifteen (15) day period the dispute remains unresolved, the
parties may seek relief for such dispute using any appropriate judicial
mechanism which may be available, subject to Section 13.03 (governing law). The
provisions of this Section 13.04 will not restrict in any way the parties’
rights to seek preliminary injunctive or other equitable relief from any court
having jurisdiction.

13.05
No party shall be deemed in breach of its obligations, for failure or delay in
fulfilling or performing any term of this Agreement or any Project Work Order if
such failure or delay results from an act or event that is beyond the reasonable
control of and not the fault of the nonperforming party, and if the
nonperforming party has been unable to avoid or overcome the act or event by the
exercise of customary due diligence.

13.06
The invalidity or unenforceability of any term or provision of this Agreement
shall not affect the validity or enforceability of any other term or provision
of this Agreement.

13.07
Termination of this Agreement shall be without prejudice to any rights that
shall have accrued to the benefit of either party prior to such termination, and
shall not relieve either party of any obligations that have accrued to the other
party prior to such termination or that survive such termination. In addition,
upon expiration or termination of this Agreement, each party promptly will
return or destroy all Confidential Information of the other party hereunder
(except that each party may retain one (1) copy of the Confidential Information
of the other party received hereunder, solely for record purposes).

13.08
Amarex will maintain or cause to be maintained, with financially sound and
reputable insurers, such insurance coverages with respect to liabilities, losses
or damage in respect of the assets, properties and businesses of Amarex as may
customarily be carried or maintained under similar circumstances by companies of
established reputation engaged in similar businesses, in each case in such
amounts (giving effect to self-insurance), with such deductibles, covering such
risks and otherwise on such terms and conditions as shall be customary for
companies similarly situated in the industry.

[signature page follows]

    
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[Signature Page to Master Services Agreement]
The parties have executed this Agreement on the date of the last signature
below.
ACKNOWLEDGED, ACCEPTED, AND AGREED TO:
For and on behalf of Innovate Biopharmaceuticals, Inc.:
For and on behalf of Amarex Clinical Research, LLC:
Print Name:
Jay Madan
Print Name:
Kazem Kazempour
Signature:
/s/ Jay Madan
Signature:
/s/ Kazem Kazempour
Title:
President
Title:
President and CEO (Member)
Date:
Aug. 17, 2018
Date:
20 Aug 18
 

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Exhibit 1
Project Work Order

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Response to Innovate Biopharmaceuticals’
Request for Proposal for Data Management and Statistical Support

August 3, 2018

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Important Information
This document is provided to Innovate Biopharmaceuticals, Inc. (Innovate) solely
for the purpose of its evaluation. The information contained herein is not
intended to be used by Innovate for any other purpose and Innovate agrees not to
voluntarily disclose any of the information contained herein to any third party
without the prior written consent of Amarex Clinical Research, LLC (Amarex).
This document and the proposal contained herein are subject to negotiation and
execution of a mutually-acceptable definitive agreement between Amarex and
Innovate as well as the requisite corporate approval of both parties.
Accordingly, this document shall not create any legal rights or obligations on
the part of either party except for the confidentiality obligation noted above.
Proposal Expiration Date: August 24, 2018

Prepared for:
Innovate Biopharmaceuticals, Inc.
8480 Honeycutt Road, Suite 120
Raleigh, NC, 27615

Prepared by:
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone: (301) 528-7000
Fax: (301) 528-2300

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Table of Contents
Our Understanding of Innovate’s Needs
4

Our Solution to Innovate’s Needs
4

An Experienced CRO
4

Data Management
4

Biostatistics
5

Safety Tracking, Monitoring, and Reporting
5

Previous Multi-CRO Integration
5

Strong Sponsor-Oriented CRO
5

Summary
5

Key Study Assumptions
6

Study Parameters
6

Study Roles and Responsibilities
8

Project Management
11

Prospective Issues Resolution
11

Project Management Tools for Success
11

Project Plan
11

Communication
12

Coordination of Amarex’s Internal Project Team
12

Teleconferences with Innovate
12

Product Management
13

Meetings and Training
13

Kick Off Meeting with Innovate
13

Project Meeting With Sponsor
13

Data Management
14

Data Management Team
14

Data Management Plan Preparation
14

EDC
15

Data Cleaning and Query Resolution
17

Database Design, Programming, and Testing
18

Database Programming and Database Validation
18

Edit Check Programming and Validation of Programming
18

Database Production
18

Test Transfers of Electronic Data
18

External Electronic Data Transfers
18

Data Cleaning and Query Resolution
18

Database Lock
19

Final Database Quality Control
20

Information Technology
20

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Database Backup Procedures
20

Disaster Recovery
20

Biostatistics
22

Template Design for Tables, Listings, and Graphs
22

Programming and Validation of All Analyses
22

Perform Final Statistical Analysis
22

Randomization/Stratification
23

Safety
27

Serious Adverse Event Start Up and Tracking System Set Up
27

SAE Receipt, Processing, Evaluation, and Reporting
27

Medical Coding (AEs and Concomitant Medications)
28

Data Safety & Monitoring Board (DSMB)
28

DSMB Formation
28

DSMB Meeting Organization
28

Program Tables and Listings for DSMB
29

Proposed Amarex Direct Services Budget
30

Optional Services
32

Estimated Pass-Through Costs
32

Payment Schedule and Terms
33

Payment Schedule for Services
33

Payment Schedule for Pass-Through Expenses
33

Payment Terms
33

Agreement in Principle
35

    

v

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Our Understanding of Innovate’s Needs
Based on the Request for Proposal and our discussions with Innovate, Amarex
understands that the general requirements for this trial are as follows:
•
An experienced CRO

•
Data management

•
Biostatistics

•
Safety tracking, monitoring, and reporting

•
Previous multi-CRO integration

•
Strong sponsor-oriented focus from CRO

Our Solution to Innovate’s Needs

--------------------------------------------------------------------------------

An Experienced CRO
Amarex’s experience in global clinical research studies enables rapid study
start up, expedited regulatory approval, and efficient trial conduct.
Amarex has over 19 years of experience which includes managing all aspects of
clinical development, all trial phases, and a wide range of therapeutic areas.
We have extensive experience in the conduct of gastrointestinal (GI) trials –
this experience results in rapid study start up, expedited regulatory approval,
accurate protocol execution, and efficient trial conduct.

Data Management
Amarex can perform this study with either electronic CRFs (EDC) or paper CRFs.
Using either paper or EDC, we employ true parallel processing that provides
views of accumulating data throughout the trial helping you to make better
decisions.
Amarex has significant experience offering data management services with either
paper-based or EDC solutions. Amarex’s preference is to use EDC options for data
management. This allows for much better insight into data collection and faster
data lock at the end of the study. We can use either a client preferred system
or our own in-house system. We are able to integrate our clinical trial
management system (CTMS) system with either approach. Additionally, our Parallel
Processing approach enables us to accelerate study start up and shorten the
period of post-data lock at study closeout. Data integrity is maintained through
the use of in-house, access-control servers, regular data back-ups with off-site
storage, and extensive electronic checks. At study completion, Innovate will
receive a complete set of electronic images of those same CRFs.

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Biostatistics
We offer excellence in SAP writing through final analysis reporting.
Amarex provides full, in-house biostatistical support with a staff of
biostatisticians who have extensive experience with ICH E9 (Statistical
Principles for Clinical Trials) guidelines as well as analysis and reporting of
clinical trial data. Amarex’s biostatisticians will, design all required tables,
listings, and graphs, and provide final output of all clinical trial data and
final analyses. They also provide insight into the need for expanded analyses in
order to clarify a trial’s outcome with respect to all endpoints evaluated. All
analyses are performed with SAS.

Safety Tracking, Monitoring, and Reporting
Amarex can provide full safety reporting services for the Innovate project.
Amarex can provide safety reporting services for the Innovate project. The
Safety Associates would set up and periodically reconcile the safety tracking
system; receive, process, evaluate and prepare the narrative for all SAEs;
prepare CIOMS reports; and then distribute the reports to the study sites, and
regulatory personnel.

Previous Multi-CRO Integration
We have extensive experience working alongside other CROs and understand the
challenges of multi-CRO integration.
Amarex has previously worked on clinical trials requiring the integration of
work from several CROs by providing project management, data management, site
management, monitoring, and safety services. We have extensive experience
working alongside other CROs and understand the challenges that sometimes arise
with multi-CRO integration.

Strong Sponsor-Oriented CRO
Customer satisfaction is very important to us, and we work hard to make sure our
staff is prepared to meet your needs through constant communication and
tracking.
Amarex is a Sponsor-oriented CRO, and as such our project teams are responsive
to your requests. In addition to regular status reporting, Amarex has developed
many innovative ways to communicate with Sponsors, including providing access to
the most up-to-date study information through WebViewSM. Innovate’s satisfaction
is critical to the Amarex team, and our service delivery is based on this
concept.

Finally, Innovate will have direct access to Amarex’s CEO for impromptu
assistance, as needed.

Summary

--------------------------------------------------------------------------------

Amarex has the experience to help Innovate meet its goals.
Amarex offers Innovate performance, reliability, demonstrated therapeutic
experience, and responsive customer service that lead to high-quality results.
Amarex has the resources and the right approach to deliver the results that will
make this project a success.

v

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Key Study Assumptions

The protocol will be conducted at approximately [***] investigational sites
across the globe that will be selected and managed by another CRO. Amarex’s work
on this study would be limited to data management (using Amarex’s EDC platform),
statistics, and safety services. All Amarex work will be in English. If local
regulations require hard copy translations for selected countries, that will be
managed by the clinical CRO. It is assumed that Amarex will receive data from up
to [***] outside sources: [***]. [***] will interface with sites for all medical
and safety discussions. Amarex will work through [***] for any safety-related
data requests. [***] will take the lead in preparing the Pharmacy Manual, and
Amarex will support the preparation with information on the WebView system, kit
numbers, etc.

Study Parameters

--------------------------------------------------------------------------------

Following is a list of study parameters Amarex has used in order to prepare this
proposal response:
Table 1. Study Parameters Used to Prepare This Proposal
STUDY PARAMETERS
 
Number of sites
[***] 
Number of countries participating in study
[***]
Number of subjects screened
[***]
Number of subjects randomized/enrolled
[***]
Number of subjects completed
[***]
MEDICAL MONITORING
 
Estimated number of SAEs
[***]
Estimated number of reportable events
[***]
DATA MANAGEMENT
 
Estimated Number of Adverse Events and Concomitant Medications to code
[***] 
Number of unique pages in eCRF book
[***]
Number of central labs and outside data vendors
[***]
Number interim database locks
[***]
BIOSTATISTICS
 
Number of stat. tables for interim analysis (uniques/replicate)
[***]

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Number of stat. listings for interim analysis (uniques/replicate)
[***]
Number of stat. tables for final analysis (uniques/replicates)
[***]
 
 
Number of listings for final analysis (uniques/replicates)
[***]
Number of graphs for final analysis (uniques/replicates)
[***] 
CLINICAL STUDY REPORT WRITING
 
Write interim clinical trial report
[***]   
Write final clinical trial report
[***]  
PROJECT MANAGEMENT
 
Number of months for project setup
[***] 
Number of months for enrollment
[***]
Number of months for follow-up (treatment period)
[***]
Number of months of active study phase for monitoring
[***]
Number of months for close out
[***]
Number of months of project management (including set up and close out)
[***]

v

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Study Roles and Responsibilities
Clearly-defined roles and responsibilities are essential to project success, and
Amarex will work closely with Innovate to make sure all project tasks are
covered. It is our current understanding that the tasks associated with this
trial are assigned as shown in Table 2, below.
Table 2. Study Tasks and Responsibilities
Service
Not Required
Amarex
Innovate or Other
PROTOCOL AND INFORMED CONSENT DEVELOPMENT  X
PROJECT MANAGEMENT
 
 
 
Meetings, Training, and Study Start Up
 
 
 
Prepare for and participate in Kick-off Meeting (Telecon) & Study Start-Up
 
X
X
Plan or Assist with Planning of Investigator's Meeting
X
 
 
Prepare for and Attend Investigator's Meeting
X
 
 
Attend Project Meetings at Sponsor Office (if requested)
 
X
X
Communication and Tracking
 
 
 
Coordinate Amarex's Internal Project Team
 
X
 
Communicate with Sponsor
(includes standard teleconferences with activities reports, emails, faxes)
 
X
X
Collaborate with vendors associated with study:
•    central laboratory ([***]);
•    clinical monitoring ([***]);
•    ePRO ([***]);
•    drug depot ([***].
 
X
X
Tracking Systems Setup
 
X
 
REGULATORY SERVICES
 
 
X
PRODUCT MANAGEMENT
 
 
 
Set up of WebView product supply tracking and email alert system. Track drug
shipments to sites, drug supply depots, auto-email requests for resupply based
on randomization. Require acknowledgement email from drug depot.
 
X
 
Maintenance for WebView Resupply and Tracking
 
X
 
Develop Pharmacy Manual (includes up to 1 round of edits)
 
X
X
DATA MANAGEMENT SERVICES
 
 
 
Data Management
 
 
 
Develop Data Management Plan
 
X
 
Standard Data Cleaning (Run edit checks; generate, process, and track data
queries)
 
X
 
Data Operations
 
 
 
Develop Edit Specifications
 
X
 

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Program Edit Checks
 
X
 
Set Up SAS Data Transfer from [***]
 
X
 
Receive, Load, and Reconcile Clean SAS Data from [***]
 
X
 
Set Up Transfer of Final SAS Data to Sponsor
(in Amarex's format)
 
X
 
Set Up of Coding System to Code AEs and Medications
 
X
 
Code Adverse Events and Medications
(Using MedDRA and WHO Drug ATC Level)
 
X
 
Perform Data Transfer to Sponsor
(Including export of final SAS Analysis Datasets)
 
X
 
EDC
 
 
 
Development of CRF Screen Shots
 
X
X
EDC Programming
 
X
 
EDC Maintenance
 
X
 
Conduct Electronic Data Capture Site Training by WebEx
 
X
 
Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits)
 
X
 
Conduct QC of EDC Database
 
X
 
Provide Electronic Data Capture Help Desk
 
X
 
CLINICAL SITE SERVICES
 
 
X
SAFETY
 
 
 
SAE Start Up
 
X
 
Prepare and Implement Safety Management Plan (includes draft Safety Exchange
Agreement and information on safety table/listing output frequency)
 
X
 
Set Up EDC SAE Reporting Module
 
X
 
Receive, Process, Evaluate, Prepare Narrative, and Report SAEs (CIOMS)
 
X
 
Prepare and Distribute SUSAR Letters to Sites
 
X
 
Follow up with Sites to Collect Additional SAE Information
 
 
X
Submit Expedited Safety Reports to Regulatory Authorities
 
 
X
Prepare Standard Aggregate Safety Tables and Listings for Quarterly Review by
Sponsor, and for Inclusion in the Annual Report/DSUR
 
X
 
Prepare and Submit Full Annual Report/DSUR to Regulatory Authorities
 
 
X
Append Historical SAEs to Safety System
 
X
 
Prepare Subject Narratives for CSR
 
X
 
DATA SAFETY MONITORING BOARD (DSMB) for Interim Analysis – for sample size
re-assessment
 
 
 
Establish and Manage 3-Member DSMB
 
X
 
Develop DSMB Charter (includes up to 1 round of edits)
 
X
 

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Organize, Conduct and Participate in DSMB Meetings
 
X
 
ENROLLMENT, RANDOMIZATION AND STRATIFICATION
 
 
 
Develop WebView Enrollment/Randomization/Stratification Module [***]
 
X
 
Generate WebView Randomization/Stratification Code and Plan
 
X
 
Conduct WebView Enrollment/Randomization/Stratification Maintenance (including
ongoing cross-checking randomization/ stratification on a monthly basis)
 
X
 
BIOSTATISTICS
 
 
 
Prepare Statistical Analysis Plan (1 draft and 1 final, mock templates for TLGs,
and data set conventions)
 
NA
 
Program Tables, Listings and Graphs for Interim Analysis
 
X
X
Program Tables, Listings and Graphs for Final Analysis
 
X
X
Conduct QC Audit of Stats
 
X
 
Production and Review of Tables, Listings, and Graphs for Interim Analysis
 
X
 
Production and Review of Tables, Listings, and Graphs for Final Analysis
 
X
 
Prepare Statistical Report (includes up to 1 round of edits)
 
X
 
Convert Data to CDISC
 
X
 

v

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Project Management
Effective project management is the cornerstone of any trial; and Amarex’s well
established processes and SOPs will make sure your study is completed on time,
within budget, and with the quality data you expect.
Besides defensible study design, reliable data, and correct analyses methods,
user friendly SOPs are an additional component necessary for successful clinical
product development. We have developed a set of FDA/ICH-based clinical, data
management, biostatistics, safety compliance and coding, regulatory, and medical
writing SOPs that help to protect the quality and integrity of all clinical
trial data that is managed, monitored, analyzed, and reported by Amarex. These
SOPs provide for a systematic, standard, and documented monitoring, management,
analyses, and presentation of the clinical trial data.

Prospective Issues Resolution
The ability to initiate solutions to study-related issues before they become
problems maintains timelines, increases efficiency, and helps to eliminate
clinical trial problems.
Our thorough preparatory work, including written plans for the major components
of a project, combined with Parallel Processing, enables a process we call
“Prospective Issues Resolution” – the anticipation and identification of
potential trial conduct and analysis issues, along with the presentation of
several potential resolutions to the Sponsor. The ability to initiate solutions
to study-related challenges before they become problems maintains timelines,
increases efficiency, and helps to eliminate problems routinely faced during the
conduct of a clinical trial.

Project Management Tools for Success

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The following tools will be used to ensure effective study conduct:

Project Plan
A Project Plan will be jointly developed to ensure project success.
Shortly after the project has been awarded, Innovate and Amarex’s project team
will meet to discuss and finalize a detailed Project Plan. This plan may
include, but will not be limited to, the following:

•
Description of individual roles and responsibilities

•
Timeline schedule and monitoring of key milestones

•
Organizational design plan with strategies and resources required to achieve
milestones

•
General policy guide for decision making and individual actions

•
Communication plan for the Amarex’s project team, Innovate, and Investigators

•
A project reporting plan

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Communication

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Effective and efficient communication between Amarex and Innovate will ensure
smooth study conduct.
Amarex believes that effective project communication with Innovate is the single
most important factor in ensuring that a cohesive partnership exists. We make
every effort to ensure that the lines of communication are open and encourage
candid feedback from all participants.
To facilitate optimal communication throughout the study, the following
activities will take place:

Coordination of Amarex’s Internal Project Team
The Amarex project team will meet regularly to review project status.
Coordination of Amarex’s internal project team comprises all activities required
to facilitate smooth and efficient conduct of the study. The Amarex project team
will meet regularly to review all aspects of the project including timeline
adherence and status of project deliverables.

Teleconferences with Innovate
The Project Manager will lead teleconferences to review project status, discuss
milestones, and identify and resolve study issues.
Amarex’s Project Manager will schedule, coordinate, and conduct teleconferences
with Innovate and other study vendors on a regular basis throughout the study.
The purpose of the teleconferences will be to review the status of the project,
discuss key upcoming milestones, identify project issues, and develop an action
plan for issue resolution. We want to be sure that you are fully aware of your
study’s status in a timely manner.
While a core team of individuals will participate on each call, other
subject-matter experts may also be included in order to facilitate expedient
issue identification and resolution.
The Project Manager will prepare and distribute an agenda for each
teleconference to facilitate efficient use of call time. While a core team of
individuals will participate on each call, other subject-matter experts may also
be included in order to facilitate expedient issue identification and
resolution. After each teleconference, action items and resolutions will be
issued. The action items discussed during the teleconferences will always be a
part of the agenda for the following teleconference.

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Product Management

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WebViewSM product resupply provides effective, timely, and efficient
distribution over the course of your study – ensuring that sites have product
when they need it.
Amarex will use WebViewSM as an inventory system to keep track of product supply
for each site. With the WebViewSM resupply system, every time a subject is
randomized, an accounting of that site’s supplies is evaluated. If the site’s
supplies are below a predefined limit, emails will be sent to pre-selected
individuals and a request for more product to the site will be initiated and
sent to the distribution depot. Follow up emails to the site will be sent until
resupply receipt has been confirmed.

This system provides effective, timely, and efficient distribution over the
course of your study – ensuring that sites have product when they need it, yet
aren’t required to warehouse large quantities of supplies that may not be used.

Meetings and Training

--------------------------------------------------------------------------------

Kick Off Meeting with Innovate
A well-organized project kickoff meeting will set the stage for the project.
Early agreement on all aspects of study conduct will guarantee smooth execution.
At the beginning of the project, the Project Manager, Clinical Data Manager,
Medical Monitor (if used), and Biostatistician will meet with Innovate and other
applicable vendors to review the timelines, activities, tracking outputs, and
expectations for the study. Amarex will assist in preparing a meeting agenda to
facilitate the discussion of all tasks associated with the conduct of the study
and prepare meeting minutes to summarize discussions and agreements reached at
the meeting. This kickoff meeting will require about 4 hours and is included in
the budget as a one-time event that will occur via teleconference.

Project Meeting With Sponsor
 
Amarex will send a data manager and statistician to meet in person with the
Innovate team in North Carolina on a periodic basis. The initial meeting will be
to provide training on the EDC system, and later on to discuss data lock and
final analysis. These are anticipated to be 8 hour meetings.

v

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Data Management

Data Management Team

--------------------------------------------------------------------------------

Amarex will provide an experienced and thoroughly trained data management team
for your project.
At the beginning of the project, Amarex will assemble an experienced data
management team consisting of a Clinical Data Manager, Clinical Data
Coordinator, SAS Programmer, Database Programmer, and Biostatistician.

Following are the tasks that a Clinical Data Manager typically performs:
•
Coordinate and attend all data management team meetings

•
Ensure on time and accurate completion of all data management activities

•
Determine the data management services required for your project and prepare
timelines that will be reviewed and mutually agreed upon by Amarex and Innovate.

•
Maintain frequent communications with the Amarex Project Manager, Innovate and
other study vendor representatives to report on the status of data management
activities.

Amarex has comprehensive data and computer systems that are 21CFR Part 11
Compliant.
The Amarex Data System allows us to process data (either electronically or on
paper), conduct data editing checks, generate data queries, tabulate, and
document data with extreme efficiency. The Amarex Data System offers an audit
trail of WHO made each data change, WHEN the change was made, and WHAT was
changed. All Amarex computer systems are Part 11 Compliant.

Amarex utilizes industry-standard relational databases. SQL Server is our
preferred platform for clinical databases. We use SAS for edit checks, analyses,
graphs, listings, and summary tables output.

Data Management Plan Preparation

--------------------------------------------------------------------------------

A comprehensive Data Management Plan will be drafted for this study. This plan
details the project-specific data management procedures to be followed
including: data entry instructions, coding conventions, specifications for data
review and data editing (data validation specifications) for eCRF data, and
externally transmitted data (e.g. central laboratory data).

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EDC

--------------------------------------------------------------------------------

Using EDC, we employ true parallel processing that provides views of
accumulating data throughout the trial helping you to make better decisions.
Amarex provides the latest in EDC technology for trial data management.
Reliability
The EDC platform is a Microsoft product, and at Amarex clinical researchers (not
IT programmers) provide complete support for your EDC system.
Ease of Use - Minimal Training
The EDC platform has an intuitive web based interface, modeled on the most
commonly used internet programs, which makes Amarex’s EDC software solution as
easy as can be for site staff to quickly master secure trial data entry.

Amarex’s EDC provides an intuitive navigation interface with a hierarchical
study tree that gives you the ability to drill down from study, to site, to
patient, to visit, to eCRF page. Clicking on different levels of the tree
provides summaries and details about each study component.

Flexible task-based workflow in the Administrator’s module provides trial
managers with screens to easily define and manage study sites, users, user
roles, imports and exports.

Amarex’s EDC provides a robust interface for easily managing the permissions for
each user role within the trial. Easily configurable, out-of-the-box task lists
for study coordinators, investigators and monitors provide pre-defined lists for
each role within the clinical trial process for identifying incomplete CRFs,
completed CRFs awaiting signatures, signed CRFs awaiting monitoring, CRFs with
action queries, and CRFs with open queries.
 
Data Capture and Monitoring
Sophisticated trial management features include dynamic visit schedule
allocation based upon subject status e.g., Screened, Enrolled, Randomized,
etc.). It’s easy to add unplanned eCRFs and Visits by site users.
Functionalities such as radio buttons, check boxes, dropdown lists and calendar
controls minimize data entry time, and the Date and Time fields even support the
use of “Today” and “Now” buttons for data entry efficiency.

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Amarex’s EDC can allow data calculations to be performed immediately, while data
is entered into the fields required for calculation, even before the data is
saved. This immediate feedback helps to prevent data entry and transcription
errors prior to saving. Amarex’s EDC will also automatically trigger dual data
validation at the time of entry and at the time of posting to the server.

Regardless of whether edit checks involve a single field, multiple fields,
multiple forms, or visits, validation messages can be triggered and alert the
user immediately upon its detection. There’s no need to save the form first or
to run any batch job to detect even the most complex validation checks.

The built-in messaging and notification subsystem easily triggers internal and
external (via any email address) notifications of over 30 key study-related
activities such as Enrollment of a Subject, Dropped Subjects, Completion of an
AE Form, Opening or Responding to a Query, or Data Export Available.

The data review and signatures feature in Amarex’s EDC includes an out of the
box task list for eCRFs awaiting signatures. The system supports a signature
password that is different than the login password, and signatures are supported
at different levels (single form or group of forms). Permissions for signing
eCRFs can be set at the CRF category level. Examples of common configurations
include; Signing of any eCRFs restricted to Investigator only and signing of any
eCRFs shared between Investigator and Coordinator roles.

Data Monitoring & Cleaning in the platform is fast and efficient. The system
supports read-only access for CRAs and Monitors with the ability to monitor and
query data. Using the out of the box Task List for Monitoring and Query
Management, Data Managers and CRAs can open, respond to, and close a query.

Amarex will work with [***] to prepare specific reports to support [***] in
risk-based monitoring. The types of data assessed could be missing data, primary
endpoint data, ePRO data, etc. These reports will be programmed and then
produced on a monthly basis.

The system provides the ability to easily perform monitoring (source document
verification) at the field, page, visit, patient, site, and the study level.
Monitors can lock and unlock data from the page level up to the study level and
perform monitoring activities across multiple studies and sites through a single
sign-on.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Reports Package
Amarex’s EDC contains a robust Standard Reporting Module. A sample of the
extensive list of easy to access reports includes: Summary Reports, Project
Status Reports, Subject Enrollment Reports, Subject Status Reports, eCRF Status
Reports, Open Query Reports, Comments and Queries by eCRF, Security Permissions
by Role, Visit Reports, Data Group Specifications and Code List Reports. The
system also renders custom standard reports that include AE Reports, Concomitant
Medication Reports, Drug Inventory Reports, SAE Reports and MedWatch Forms.
 
Programming Process
Amarex starts the programming process by preparing mock eCRF screen shots for
review by the Sponsor. Once the basic screen shots are approved, Amarex begins
the process of programming the EDC platform to support the eCRF. The first round
of User Acceptance Testing (UAT) includes review of the programmed eCRF.
Following UAT 1, edits are programmed and reviewed in UAT 2. After modifications
from UAT 2 are made, a final UAT 3 is conducted to fine tune the system. After
UAT 3 the EDC system is ready for production and to go live for use in the
trial.
 
EDC Data Output
Exports are available on demand as SAS Transport Files, CSVs, Tab Delimited and
XML. In addition, the latest version of the platform has an SDTM custom output
module that allows the study design to create SDTM compliant outputs at the
beginning of the study so that getting SDTM during the course of a study is just
a push of a button. Other custom outputs are available.
Beyond data exports, a set of standard reports is available and a wizard-driven
Ad Hoc reporting tool. Setting up custom reports - even for non-technical users
- is a very straightforward process.

Database Cleaning and Query Resolution

--------------------------------------------------------------------------------

Amarex performs data validation checks (edit-check runs) on a periodic basis as
scheduled in the Data Management Plan for any edits programmed outside the EDC
platform. However, when using EDC, it is assumed that the bulk of the edits will
be embedded in the EDC platform. All edit checks that are built into the EDC
platform (univariate, multi-variate, cross-form, etc.) all fire immediately once
the particular data has been entered (i.e. once the user leaves the input
field). Batch edit checks are available, but are used in only rare cases (such
as refiring all edits before final lock).

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Database Design, Programming, and Testing

--------------------------------------------------------------------------------

Database Programming and Database Validation
Amarex’s computer system is validated and Part 11 compliant. The clinical
database will be built in accordance with Amarex SOPs using a validated
relational database. All database building, validation, and testing
documentation are available for review.

Edit Check Programming and Validation of Programming
Data validation checks will be programmed in SAS under the direction of the
Database Programmer for this project. All programmed edit specifications will be
tested and validated.

Database Production

--------------------------------------------------------------------------------

Test Transfers of Electronic Data
Amarex will establish procedures and timelines for data transfer from all
Central Labs to ensure accurate collection.
Before study start, it will be important for Amarex to discuss formats of any
electronic data to be transmitted by vendors (e.g., central lab data) and to
have at least one test transfer of “dummy” data of each type. This will allow us
to validate the electronic transmission process and ensure data integrity for
subsequent analyses.

External Electronic Data Transfers
External electronic data, as applicable to the project, will be transferred to
Amarex on a periodic basis and archived according to specifications in the
Sponsor-approved Data Management Plan.
For each transmission of data, checks of subject ID and relevant demographic
fields will be conducted versus monitored CRFs to ensure proper identification
and verification of each data point.
Data Cleaning and Query Resolution

--------------------------------------------------------------------------------

Amarex will perform data validation checks (edit-check runs) on a periodic basis
as scheduled in the Data Management Plan. Amarex will program and run edit
checks external to the EDC that are typically not available through EDC vendor
systems. Data queries will be generated from discrepancies detected during each
edit-

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check run of the monitored CRF. All queries will be automatically logged and
individually tracked until query resolution. All changes to submitted CRFs will
require Investigator sign off. Finalized Data Clarification Forms (DCF) will be
filed with and considered part of the CRF, providing a paper trail of changes to
the originally-submitted CRF.
In the event that a CRA notes a data discrepancy on a previously submitted CRF
while at the study site, an electronic “Monitor’s Query Form” will be used to
correct the data point and will be signed by the Investigator.
As part of the Data Management Plan, data conventions will be established to
correct self-evident errors in the CRFs, thereby avoiding needless querying of
the site for these small changes. Prior to final data lock, a list of
self-evident changes for each subject will be provided to the Investigator for
concurrence and sign-off.

Database Lock

--------------------------------------------------------------------------------

Steps to database lock in preparation for interim and/or final analyses include:
•
Check that all eCRFs have been completed, monitored and signed.

•
Conduct final programmed edit checks for data logic and consistency. All
remaining queries resolved.

•
Conduct final manual edit checks for logic and consistency. All remaining
queries resolved.

•
Final verification and client approval of all AE coding.

•
Final verification and client approval of all medication coding.

•
Final SAE reconciliation between the clinical and safety database.

•
Final database QC.

•
Final update of draft data listings provided to client for review and approval.

After Sponsor approval to lock, database lock is accomplished by removing
write-access to the data.

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Final Database Quality Control

--------------------------------------------------------------------------------

Amarex will conduct an audit of the analysis data versus eCRF and resolved data
queries in order to ensure that all analyzed data accurately portray the
site-submitted, Investigator-approved subject data.

Information Technology

--------------------------------------------------------------------------------

All Amarex systems are in compliance with 21CFR 11 and preserve integrity of
electronic records.
All systems are setup and tested in compliance to 21 Code of Federal Regulations
(CFR), Section 11 and FDA’s 1999 and 2004 Guidance for Computerized Systems Used
in Clinical Trials (CSUCT). Amarex’s computer server room is climate controlled
with anti-static flooring and secured with a keypad and combination door lock.
Access to the room is limited to Amarex’s IT staff. Equipment includes
high-density filing systems located in a fire-protected document storage room
that is secured by a keypad combination door. All original study-related
documents and Case Report Forms will be stored here.

Amarex employs a secure, wide-area network with direct Internet access. Amarex’s
network is client/server based and is driven by the Microsoft Windows Server
System running on Dell PowerEdge series servers. High availability and
redundancy features include RAID 1 and 5 hard disk subsystems, gigabit network
adaptor teaming, and primary and secondary power supplies. All servers and
network equipments are connected to UPS (Uninterruptible Power Supplies) in the
event of brown or black outs.

Database Backup Procedures
Amarex performs daily backups on all of our servers and databases. These backups
are stored in a secure offsite facility. Additionally, monthly full backups are
performed and sent offsite to a secure storage facility where they are held
indefinitely. All backups are periodically tested to ensure that they are
working correctly. In addition, data integrity is maintained using frequently
updated virus checks.

Disaster Recovery
Amarex has a detailed disaster recovery plan which includes a cold place to
reestablish the company data/operational information

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within 24 hours. As part of this plan, data is backed up, put on tape, and
stored in an offsite secure storage facility. In the event of a disaster, Amarex
would retrieve the tapes from the offsite storage facility and load the
applications and data on new computers.

v

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Biostatistics

Template Design for
Tables, Listings, and Graphs

--------------------------------------------------------------------------------

Production of validated graphs render a reader-friendly report, resulting in
“understandability” and fewer FDA questions during review.
As soon as the SAP is approved, Amarex will begin designing the templates for
data summary tables, data listings, and graphs to be used in interim analyses,
the final report and/or for safety monitoring committees. All data summary
tables, data listings, and graphs will be programmed in SAS and validated by a
second statistician/programmer before finalization.

•
Interim Analysis – Amarex estimates that the following will be prepared for the
interim analysis:

•
[***] unique and [***] replicate tables

•
[***] unique and [***] replicate listings

•
Analysis Datasets – Amarex will create SAS datasets using SAS programs, and the
data conversion process will be validated. These SAS validated datasets will be
sent to Innovate after the study is completed.

•
Final Analysis – Amarex estimates that the following will be prepared for the
final analysis:

•
[***] unique and [***] replicate tables

•
[***] unique and [***] replicate listings

•
[***] unique and [***] replicate graphs

There will be a quality assurance review of all data displays prior to transfer
to Innovate.

Programming and Validation of All Analyses

--------------------------------------------------------------------------------

Full programming and validation will be performed using on-going study data
during the active life of the trial. All quality control documentation will be
provided to Innovate upon request.

Perform Final Statistical Analysis
Once the database has been locked, the final statistical analysis will be
completed for inclusion in the CSR.
Following database lock for the interim and final analyses, tables and listings,
including all statistical analyses, will be generated. Statistical conclusions
and the statistical sections for the Clinical Study Report will be provided to
the Medical Writer for inclusion in the Clinical Study Reports.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Randomization/Stratification

--------------------------------------------------------------------------------

Amarex’s WebViewSM provides superior enrollment/ randomization usability over
conventional IVRS systems.
In order to facilitate enrollment, we suggest that the use of WebViewSM for
online randomization/stratification. The use of the WebViewSM central
randomization system provides many advantages over telephone-based Interactive
Voice Recognition Systems (IVRS) or envelope/fax-based systems. These advantages
include:

•
A computerized enrollment/randomization/stratification procedure that is fully
validated and 21 CFR, Part 11 compliant.

•
24-hour, rapid, and secure access to enrollment/ randomization/stratification
data.

•
User-friendly screens for entry of enrollment and/or
randomization/stratification data. Entry of these data is much like ordering
products on-line through the Web, which negates the need for tedious, often
frustrating, and time-consuming verbal confirmation and verification prompts
that are standard to telephone-based randomization systems.

•
Ability to instantly review (revise if needed) and print the
enrollment/randomization/stratification confirmation.

•
Availability of real-time notification and real-time access to site-specific
subject accrual numbers, as well as preliminary demographics of the subject
population (or any other subject- or site-specific data desired by Innovate)
through WebViewSM Status Reports.

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Figure 1 provides an example screen into which site personnel enter subject data
for randomization into an open-label trial.
Figure 1. Example WebViewSM Randomization Entry Screen
amarexfigure1a01.jpg [amarexfigure1a01.jpg]

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Figure 2 provides an example randomization confirmation screen.
Figure 2. Example Randomization Authorization Screen (Open Label)

amarexfigure2a01.jpg [amarexfigure2a01.jpg]

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Figure 3 provides an example e-mail that is sent simultaneously to
Innovate-specified recipients, with information regarding
enrollment/randomization.
Figure 3. Example WebViewSM Randomization Notification
ctrredactedversionama_image7.gif [ctrredactedversionama_image7.gif]
Please note that all of these screens and the e-mail notification are fully
customizable for the Sponsor.

v

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Safety

Serious Adverse Event Start Up and Tracking System Set Up
Amarex will set up a tracking system and adhere to standard policies and
procedures to handle SAEs.
Amarex will begin the pharmacovigilance for each study by reviewing current SOPs
in order to ensure compliance to current regulatory standards and protocol
requirements. Amarex will set up a secure Serious Adverse Event (SAE) tracking
system for this study in OpenClinica. [***] will be the main contact for site
discussions on all SAEs. All SAEs will be followed to resolution or
stabilization. A Safety Management plan will be prepared that will have two main
objectives: 1) provide information on SAE Reporting, and 2) describe the
frequency and types of safety table and listing outputs that will be provided.
Safety tables and listings for aggregate safety will be prepared on a quarterly
basis for review by Amarex, Innovate, and [***]. Amarex will also run a set for
inclusion in the annual report/DSUR.

SAE Receipt, Processing,
Evaluation, and Reporting

--------------------------------------------------------------------------------

SAEs and non-serious adverse events are reported immediately to Amarex.
Amarex will design a SAE reporting form and prepare a protocol-specific SAE
Reporting Plan (part of the Safety Management Plan). Each Principal Investigator
and his/her staff will be instructed to immediately report any SAEs or any
non-serious adverse event that requires withdrawal from the study through
OpenClinica. Sites will report all SAEs with supportive documents according to
the SAE plan. Sites will be provided with an [***] toll-free telephone number
for access to the Medical Monitor. Amarex will work through [***] and EDC
queries to collect relevant necessary safety information not already provided by
the site in the initial reporting, and will setup a safety exchange agreement
with [***] for this purpose. [***] will be responsible for interfacing with the
sites.
The Safety Monitor will ensure that each event is recorded properly and
reported.
We will review each SAE and forward its findings to Innovate to determine the
appropriate interval of reporting. Amarex will notify Innovate of all SAEs
within 1 day of receiving an initial report from a study site.

Amarex will receive the Investigator’s initial report of the SAE, and then all
follow-up information will come through [***]. Each event will be assigned a
unique number and will be stored in a separate folder. The Amarex lead Safety
Monitor will review each event and prepare a narrative for all SAEs. The event
will be closed when all source documents have been received, reviewed,
evaluated, and final narrative approved.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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CIOMS reports will be prepared by the Amarex Safety Department for all expedited
events, and forwarded to Innovate within one working day for triage of reporting
status. SAE queries will be issued through the EDC or forwarded to the [***] CRA
for resolution with site personnel. SUSAR letters will be prepared by Amarex for
expedited events, and sent to the sites.

Medical Coding
(AEs and Concomitant Medications)
Amarex will use MedDRA and WHO Drug coding dictionaries unless otherwise
directed by Innovate.
Amarex generally codes adverse events using the MedDRA version specified by the
Sponsor (other adverse event coding dictionaries are also available). Coding
will be performed to all MedDRA levels. Auto-encoding will be reviewed by the
Amarex Medical Monitor for consistency according to the Data Management Plan,
and coding reports will be forwarded to Innovate for approval. Coding for
concomitant medications is usually done according to WHO Drug ATC levels.
However, Amarex can code concomitant medications using a client-specified
dictionary and auto-encoder. Processing and review of medication coding follows
the same procedure as for AE coding review. Innovate is responsible for their
licensing obligations with MedDRA and WHO Drug.

Data Safety & Monitoring Board (DSMB)

--------------------------------------------------------------------------------

DSMB Formation
Amarex will organize and assemble the DSMB for the Innovate study.
Amarex will organize and assemble the DSMB for the Innovate study and will be
responsible for the drafting and development of the written DSMB Charter (which
will provide guidance to the DSMB), meeting organization, written data report to
the DSMB, meeting agenda, and meeting minutes. The DSMB chairman of the
committee, prior to the first meeting, will approve the DSMB Charter. Amarex
will work with Innovate to identify three voting members to participate in the
meetings. One will be the chair, one will be a medical person, and the third
will be a blinded statistician.

DSMB Meeting Organization
Amarex will organize all DSMB meetings. The DSMB will meet via teleconference
and will include the following activities:
•
The committee will review all safety information (in blinded fashion, if
appropriate to the study, and unblinded only as deemed necessary by the DSMB
chairman).

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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•
Amarex will record minutes of the meeting and prepare appropriate follow up
documentation, according to the approved DSMB Charter.

•
Amarex will assist the DSMB chairman in the distribution of committee
recommendations, according to the approved Charter.

The first meeting of the DSMB will be to review the Charter and planned analyses
for the next meeting where the actual data will be reviewed.

Program Tables and Listings for DSMB
Amarex will program all tables and listings per the SAP for the interim
analysis. Amarex has assumed that [***] unique tables and [***] replicate
tables, and [***] unique listings and [***] replicate listings will be required
based on the current SAP. Amarex will prepare a statistical report from these
analyses, which will be shared with the DSMB members. The Amarex un-blinded
Biostatistician will prepare and distribute all data for the DSMB.

v

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

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Proposed Amarex Direct Services Budget
(US Dollars)
AMAREX DIRECT SERVICES FEES
 
 
 
 
 
Bid ID
Service
Unit Description
 Unit Cost $
No.
Units
 Total
Cost $
 Category
Total $
B
PROJECT MANAGEMENT
 
 
 
 
 
 
Meetings, Training, and Study Start Up
 
 
 
 
 
10
Prepare for and Participate in Kick-off Meeting (Telecon) & Study Start-Up
per protocol
[***]
[***]
[***]
 
 
Communication and Tracking
 
 
 
 
 
16
Coordinate Amarex's Internal Project Team
per month
[***]
[***]
[***]
 
17
Communicate with Sponsor
(includes standard teleconferences with activities reports, emails, faxes)
per month
[***]
[***]
[***]
 
19
Tracking Systems Setup
fixed fee
[***]
[***]
[***]
[***]
D
PRODUCT MANAGEMENT
 
 
 
 
 
50
Set up of WebView product supply tracking and email alert system. Track drug
shipments to sites, supply depots, auto-email requests for resupply based on
randomization. Require acknowledgement email from supply depot.
per project
[***]
[***]
[***]
 
51
Maintenance for WebView Product Resupply and Tracking
per month
[***]
[***]
[***]
[***]
E
DATA MANAGEMENT SERVICES
 
 
 
 
 
 
Data Management
 
 
 
 
 
56
Develop Data Management Plan
per project
[***]
[***]
[***]
 
64
Standard Data Cleaning (Run edit checks; generate, process, and track data
queries)
per query
[***]
[***]
[***]
 
 
Data Operations
 
 
 
 
 
76
Develop Edit Specifications
per project
[***]
[***]
[***]
 
77
Program Edit Checks
per edit check
[***]
[***]
[***]
 
79
Set Up SAS Data Transfer [***]
fixed cost/per lab-vendor
[***]
[***]
[***]
 
80
Receive, Load, and Reconcile Clean SAS Data [***]
per transfer/per lab-vendor
[***]
[***]
[***]
 
81
Set Up Transfer of Final SAS Data to Sponsor
(in Amarex's format)
per dataset
[***]
[***]
[***]
 
82
Perform Data Transfer to Sponsor
(Including export of final SAS Analysis Datasets)
per transfer
[***]
[***]
[***]
 
139
Set Up of Coding System to Code AEs and Medications and Prepare Medical Coding
Plan
fixed cost
[***]
[***]
[***]
 
140
Code Adverse Events and Medications
(Using MedDRA and WHO Drug ATC Level)
per term
[***]
[***]
[***]
 
 
EDC Support
 
 
 
 
 
85
Conduct Electronic Data Capture Site Training by WebEx
per training
[***]
[***]
[***]
 
86
Prepare EDC Manual and Completion Instructions (includes up to 1 round of edits)
per manual
[***]
[***]
[***]
 
87
Prepare User Acceptance Testing (UAT) Management Plan
per document
[***]
[***]
[***]
 
88
Conduct QC of EDC Database
per subject enrolled
[***]
[***]
[***]
 
89
Provide Electronic Data Capture Help Desk
per month
[***]
[***]
[***]
[***]
 
EDC PROGRAMMING
 
 
 
 
 
91
Development of CRF Screen Shots
per unique page
[***]
[***]
[***]
 
92
EDC Programming (Initiation)
per study
[***]
[***]
[***]
 
93
EDC Programming (UAT 1)
per study
[***]
[***]
[***]
 
94
EDC Programming (System Activation)
per study
[***]
[***]
[***]
 
95
EDC Maintenance
per month
[***]
[***]
[***]
[***]
G
SAFETY
 
 
 
 
 
126
SAE Start Up
fixed fee
[***]
[***]
[***]
 
127
Prepare and Implement Safety Management Plan [***]
per plan
[***]
[***]
[***]
 
128
Set Up EDC SAE Reporting Module
per project
[***]
[***]
[***]
 
129
Quarterly and Annual Aggregate Safety Tables and Listings
per project
[***]
[***]
[***]
 
130
Receive, Process, Evaluate, Prepare Narrative, and Report SAEs (CIOMS)
per event
[***]
[***]
[***]
 
134
Prepare and Distribute SUSAR Letters to Sites
per reportable event
[***]
[***]
[***]
 
135
Append Historical SAEs to Safety System
per SAE
[***]
[***]
[***]
 
189
Prepare Subject Narratives for CSR
per narrative
[***]
[***]
[***]
[***]

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
Amarex Clinical Research, LLC Confidential and Proprietary Information    Page
30

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amarexlogoa01.jpg [amarexlogoa01.jpg]

AMAREX DIRECT SERVICES FEES
 
 
 
 
 
Bid ID
Service
Unit Description
 Unit Cost $
No.
Units
 Total
Cost $
 Category
Total $
H
DATA SAFETY MONITORING BOARD (DSMB)
 
 
 
 
 
142
Establish and Manage 3-Member DSMB
fixed cost
[***]
[***]
[***]

 
143
Develop DSMB Charter (includes up to 1 round of edits)
per project
[***]
[***]
[***]

 
144
Organize, Conduct and Participate in DSMB Meetings
per meeting
[***]
[***]
[***]

[***]
I
RANDOMIZATION AND ENROLLMENT
 
 
 
 
 
155
Develop WebView Enrollment/Randomization/Stratification Module [***]
per project
[***]
[***]
[***]

 
156
Generate WebView Randomization/Stratification Code and Plan
per project
[***]
[***]
[***]

 
157
Conduct WebView Enrollment/Randomization/Stratification Maintenance (including
ongoing cross-checking randomization/ stratification on a monthly basis)
per month
[***]
[***]
[***]

[***]
J
BIOSTATISTICS
 
 
 
 
 
162
Program Tables [***]
per unique table
[***]
[***]
[***]

 
163
Program Tables [***]
per replicate table
[***]
[***]
[***]

 
164
Program Listings [***]
per unique listing
[***]
[***]
[***]

 
165
Program Listings [***]
per replicate listing
[***]
[***]
[***]

 
168
Program Tables for Final Analysis (unique tables)
per unique table
[***]
[***]
[***]

 
169
Program Tables for Final Analysis (replicate tables)
per replicate table
[***]
[***]
[***]

 
170
Program Listings for Final Analysis (unique listings)
per unique listing
[***]
[***]
[***]

 
171
Program Listings for Final Analysis (replicate listings)
per replicate listing
[***]
[***]
[***]

 
172
Program Graphs for Final Analysis (unique graph)
per unique graph
[***]
[***]
[***]

 
173
Program Graphs for Final Analysis (replicate graph)
per replicate graph
[***]
[***]
[***]

 
174
Conduct QC Audit of Stats
per lock
[***]
[***]
[***]

 
175
Production and Review of Tables, Listings, and Graphs [***](per unique display)
per unique display
[***]
[***]
[***]

 
176
Production and Review of Tables, Listings, and Graphs [***] (per replicate
display)
per replicate display
[***]
[***]
[***]

 
177
Production and Review of Tables, Listings, and Graphs for Final Analysis (per
unique display)
per unique display
[***]
[***]
[***]

 
178
Production and Review of Tables, Listings, and Graphs for Final Analysis (per
replicate display)
per replicate display
[***]
[***]
[***]

 
179
Prepare Statistical Report (includes up to 1 round of edits and Report for DSMB)
First report for DSMB, Second for Final CSR
per report
[***]
[***]
[***]

 
 
Other
 
 
 
 
 
181
Convert Trial Data to CDISC (ADaM or SDTM)
per type
[***]
[***]
[***]

 
182
QA CDISC Data Conversion
per type
[***]
[***]
[***]

 
184
Prepare Program for Risk-Based Monitoring
per data type
[***]
[***]
[***]

 
185
Run Risk-Based Programs
per program per month
[***]
[***]
[***]

[***]
 
 
 
 
 
 
 
 
TOTAL OF ACTIVITY-BASED COSTING
 
 
 
[***]

 
 
 
 
 
 
 
 
 
EXECUTIVE DISCOUNT ( [***]%)
 
 
 
[***]

 
 
 
 
 
 
 
 
 
TOTAL WITH DISCOUNT
 
 
 
$
1,067,819.48

 

The unit costs provided in the budget are discounted according to certain
economies of scale. A reduction of tasks or units could result in higher unit
costs for remaining tasks or units. Additional units in excess of those planned
above will be billed at the same unit rate as shown above.
Amarex budgets services by ‘tasks’ as opposed to by hours. Each task has a fixed
unit price associated with it and an estimated number of units proposed for the
project. Please examine the estimated number of units for each task carefully to
make sure they agree with your expectation. Amarex reserves the right to
increase its rates on an annual basis. This increase will not exceed [***]% per
year.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
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31

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Optional Services
OPTIONAL SERVICES
 
 
 
 
 
Bid ID
Service
Unit Description
Unit
Cost $
No.
Units
 Total
Cost $
 Category
Total $
13
Attend Project Meetings at Sponsor Office Upon Request
(includes travel time)
per person / per day
[***]
[***]
[***]
[***]

Optional services will be performed upon request. The [***]% discount will also
apply to Optional Services if they are requested.

Estimated Pass-Through Costs
(US Dollars)
ESTIMATED PASS THROUGH COSTS
 
 
 
 
 
Bid ID
Service
Unit Description
Unit
Cost $
No.
Units
 Total
Cost $
 Category
Total $
A
TRAVEL AND MEETINGS
 
 
 
 
 
 
Meetings-Amarex's Personnel
 
 
 
 
 
6
Travel Expenses for Meetings at Sponsor Office, if requested by Sponsor
per person
[***]
[***]
[***]
[***]
F
PRINTING & ASSEMBLY OF STUDY MATERIALS
 
 
 
 
 
36
Miscellaneous Printing/Copying
per month
[***]
[***]
[***]
[***]
G
SHIPPING COSTS (CRFs, Study Binders, etc.)
 
 
 
 
 
39
Overnight delivery (UPS/FedEx)
per month
[***]
[***]
[***]
[***]
I
MISCELLANEOUS
 
 
 
 
 
48
DSMB Honorarium
per person per meeting
[***]
[***]
[***]
 
51
Ad Hoc Electronic Data Transfers Over 12MB, if requested by Sponsor
per transfer
[***]
[***]
[***]
 
52
WebEx Host Line Fee, if requested by Sponsor
per usage
[***]
[***]
[***]
[***]
 
 
 
 
 
 
 
 
TOTAL OF ESTIMATED PASS THROUGHS
 
 
 
[***]
 

Budget notes: Items 6, 51, 52, will only be used if requested by Innovate.

Pass-through expenses, such as: approved travel, document shipping and printing,
and other project related out-of-pocket expenses incurred by Amarex in the
conduct of the study will be invoiced to Innovate at the actual cost plus [***]%
to cover administrative services required to process the expenses. These
expenses will be supported by acceptable documentation or actual receipts.

v

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
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32

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amarexlogoa01.jpg [amarexlogoa01.jpg]

Payment Schedule and Terms

Payment Schedule for Services

--------------------------------------------------------------------------------

The payment terms and obligations for the services outlined in this proposal are
as follows:

Payment Description
Percentage Due
Amount
Execution of Project Work Order
[***]%
$[***]
Monthly Unit-Based Billing
Balance Due
$[***]
TOTAL
 
$1,067,819.48

The Execution payment will be credited back to Innovate as a credit to monthly
invoices in [***] installments. The first credit of $[***] will be applied when
the total amount billed for services reaches $[***]. The second credit of $[***]
will be applied when the total amount billed for services reaches $[***]. The
third credit of $[***] will be applied when the total amount billed for services
reaches $[***].

Payment Schedule for Pass-Through Expenses

--------------------------------------------------------------------------------

Pass-through expenses such as approved travel, document shipping and printing,
and other reasonable expenses will be invoiced to Innovate at cost plus [***]%.
These expenses will be supported by acceptable documentation or actual receipts
and will be invoiced on a monthly basis.

Payment Terms

--------------------------------------------------------------------------------

•
Payments are due 30 days after delivery of an invoice.

•
Late payment fee: 1% per month interest on all past due, unpaid balances.

•
Payments will be made out to: Amarex Clinical Research, LLC

•
Tax ID: [***]

•
Payments will be sent to:

Kazem Kazempour, President and CEO (Member)
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone (301) 528-7000
Or

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
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33

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•
Payments will be wire transferred to the Amarex Clinical Research, LLC bank
account at:

[***]
Type of Acct:  Checking
Acct. No.: [***]    
Wire Routing No.:  [***]
SWIFT Code: [***]
Bank Address:
[***]
[***]
Phone: [***]

v

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
Amarex Clinical Research, LLC Confidential and Proprietary Information    Page
34

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Agreement in Principle
SIR/MADAM:
This Letter sets forth our mutual understanding and Agreement in Principle
pursuant to which Innovate Biopharmaceuticals, Inc. (hereunder referred to as
“Company“) authorizes Amarex Clinical Research, LLC, a for-profit Maryland
limited liability company (hereunder referred to as “Amarex”) to commence
certain works (herein referred to as “Services”) for the Celiac Trial (the
“Project”) as outlined in this Proposal dated August 3, 2018 (the “Effective
Date”) and based on terms, items and budget presented herein below, prior to the
signing of a definitive agreement that is currently being negotiated between the
parties.

The signatures below indicate the existence of this Agreement in Principle
between the parties whereby Amarex will perform the Services until a definitive
agreement is reached and signed between the parties. This Agreement in Principle
is not a substitute for the definitive agreement and will expire upon signing of
said definitive agreement. The definitive agreements with respect to the
Services contemplated hereby will contain mutually agreeable provisions,
representations, warranties, and any other appropriate and customary terms and
conditions.
The purpose of this Agreement in Principle is to authorize commencement of work
on the Project with the understanding that the definitive agreement shall be
executed in the future. Upon acceptance of the Agreement in Principle by Amarex
and Company, the Company shall remit to Amarex the sum of U.S. $[***] ([***]% of
the projected contract budget) to be used for commencement of work on the
Project. However, if the Project is terminated before a definitive agreement is
executed by the parties, then the said sum paid on acceptance of this Agreement
in Principle, minus all verifiable and documented expenses incurred by Amarex
prior to such termination, shall be refunded to Company.
Company shall have the right to terminate this Agreement in Principle, with or
without cause, upon written notice to Amarex. In the event that Company decides
to terminate Services under this Agreement in Principle, Amarex shall not
undertake any further work, except as agreed to by Amarex and Company, or incur
any additional expenses, or enter into further commitments with third parties in
regard to this Agreement in Principle after receiving notice of termination from
Company. Upon submission of reasonable documentation to Company, Amarex shall be
entitled to receive payment for all work actually performed, for all verifiable
out-of-pocket expenses incurred, and for non-cancellable commitments actually
entered into with regard to this Agreement in Principle. If the amount that
Company has previously paid to Amarex exceeds the amount that Amarex is actually
owed, Amarex shall reimburse the balance to Company within 60 days of receipt of
the notice of termination. Nothing in this paragraph shall affect Company’s
rights in the event of failure by Amarex to perform its obligations under this
Agreement in Principle.

This Letter shall be governed by, and construed in accordance with, the laws of
the State of Maryland.

[***] Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.

Amarex's Response to Innovate's Request for Proposal    8/3/18
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35

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If the terms of the foregoing meet with your approval, please indicate your
acceptance by signing two copies of this Agreement in Principle and returning
both to the undersigned for counter-signature.

Peter Frantz, MS, MBA
Vice President, Business Operations
Amarex Clinical Research, LLC
20201 Century Boulevard, Suite 450
Germantown, MD 20874
Phone (301) 528-7000

ACKNOWLEDGED, ACCEPTED, AND AGREED TO:
For and on behalf of Innovate Biopharmaceuticals, Inc.:
For and on behalf of Amarex Clinical Research, LLC:
Print Name:
Christopher Prior
Print Name:
Kazem Kazempour
Signature:
/s/ Christopher Prior
Signature:
/s/ Kazem Kazempour
Title:
Chief Executive Officer
Title:
President and CEO (Member)
Date:
August 15, 2018
Date:
20 Aug 18

Amarex's Response to Innovate's Request for Proposal    8/3/18
Amarex Clinical Research, LLC Confidential and Proprietary Information    Page
36