Master Clinical Study Agreement

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

MASTER CLINICAL STUDY AGREEMENT

This Master Clinical Study Agreement (“Agreement”), effective as of the date of full execution hereof

(“Effective Date”) sets forth the terms and conditions by and between AbbVie Inc. (“AbbVie”) and The

University of Texas Health Science Center at Houston; The University of Texas Health Science Center at

San Antonio, The University of Texas Health Science Center at Tyler; The University of Texas Medical

Branch at Galveston; The University of Texas Southwestern Medical Center; The University of Texas Rio

Grande Valley, and The University of Texas at Austin (“Institution” or collectively, “Institutions”), each a

member institution of The University of Texas System (“System”). In consideration of the mutual promises

set forth herein, the parties hereto agree as follows:

1. Scope of Agreement.

(a) For purposes of the Agreement,“Affiliate” means an entity that, directly or indirectly, through one

or more intermediaries, controls, is controlled by, or is under common control with the party being

referenced, excluding, with respect to AbbVie, Pharmacyclics LLC. For purposes of this definition,

“control” means the possession, direct or indirect, of the power to cause the direction of the

management and policies of the applicable entity, whether through ownership of fifty percent

(50%) or more of the voting securities of such entity, by contract or otherwise, The parties agree

that AbbVie’s Affiliates are hereby authorized to issue and execute Statements of Work pursuant

to the terms of this Agreement in their own name, and shall accrue and be bound by the same

rights and obligations AbbVie would under such an executed Statement of Work.

(b) This Agreement allows the parties to specify distinct clinical studies to be performed by Institution

through the issuance of multiple individual written agreements between AbbVie or an AbbVie

Affiliate (an “AbbVie Party”) and Institution related to the specific clinical study, forms of which are

attached hereto and incorporated herein as Exhibit A-1 (Standard Statement of Work Template),

and Exhibit A-2 (ABT- 199 Statement of Work Template) (each a “Statement of Work”). This

Agreement covers the provision of certain AbbVie-sponsored or AbbVie Affiliate-sponsored

clinical studies (each, the “Study”) in relation to certain AbbVie Party products identified in the

Statement of Work (each, the “Study Product”). The AbbVie Party executing a Statement of Work

shall be considered the “Sponsor,” as that term is defined in 21 C.F.R. § 312.3(b), for the Study

relating to such Statement of Work. AbbVie shall, in its sole discretion, determine when and

whether to offer a Study under this Agreement to Institution including, without limitation, the

decision whether or not to enter into a specific Statement of Work.

2. Statement of Work. The specific details and tasks of each Study shall be specified in writing in the

Statement of Work. The Statement of Work shall be executed by an authorized representative of

Institution and the applicable AbbVie Party and shall be acknowledged by the relevant qualified lead

Institution employee responsible for the conduct of the Study at Institution (each a “Principal

Investigator”). Each Statement of Work shall include, without limitation, identification of the Study

Product, identification of the Principal Investigator, the title of the Study protocol, which may be

amended from time to time (the “Protocol”), the detailed Study budget and payment schedule (the

“Budget”); and term of Statement of Work (the “Study Term”). The Protocol shall be provided

separately for each individual Study and shall be referred to and incorporated by reference into the

Statement of Work. The Statement of Work shall be subject to all of the terms and conditions of this

Agreement, in addition to the specific details set forth in the Statement of Work.

3. Conduct of Study.

(a) Institution shall conduct and shall require Principal Investigator, subinvestigator(s), and

Institution’s other employees, subcontractors and agents performing work in connection with the

Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this

Agreement and the relevant Statement of Work; (ii) the IRB-approved Protocol; (iii) all reasonable

written instruction provided by AbbVie; (iv) Institution’s ethical standards and/or policies; and (v)

all applicable federal, state and local laws and regulations and guidelines (collectively, “Law(s)”),

including without limitation (and each to the extent applicable to a Study), anti-bribery and anti-

corruption laws, International Conference on Harmonisation of Technical Requirements for

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice as adopted by the

FDA (“ICH-GCP”), regulations of the United States Food and Drug Administration (the “FDA”), the

Patient Protection and Affordable Care Act of 2010, the Medicare/Medicaid Anti-kickback statute,

the Social Security Act of 1935, the Controlled Substances Act, data protection and privacy laws,

the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information

Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and the Federal Food,

Drug and Cosmetic Act of 1938, as each may be amended, from time to time. In furtherance of

the foregoing obligations, Institution shall ensure that an Institution Review Board (“IRB”)

established and constituted in accordance with applicable Laws approves and oversees the

conduct of the Study prior to the commencement of the Study. Institution will comply with the

instructions of the IRB respecting the conduct of the Study, and will notify AbbVie to the extent

any such instructions vary from the Protocol.

(b) Prior to each Study subject’s participation in the Study, Institution shall obtain a signed informed

consent and/or authorization document (collectively, “ICF”), as reviewed by AbbVie and approved

by the IRB. If Institution or Principal Investigator proposes to publish any Study subject

recruitment advertisements, such advertisements require AbbVie’s prior review in advance of

submission to the applicable IRB. Institution and Principal Investigator shall report all serious

adverse events or other safety concerns arising from the conduct of the Study that Principal

Investigator becomes aware of as further specified in the Protocol and in accordance with

applicable Laws.

an employee of Institution. Institution agrees that no other investigator may be substituted for the

Principal Investigator without the prior written consent of AbbVie. If the Principal Investigator is no

longer employed by Institution or becomes unwilling or unable to perform the duties required by

this Agreement and relevant Statement of Work, Institution shall promptly notify AbbVie and

reasonably cooperate with AbbVie to promptly find a mutually acceptable replacement Principal

Investigator. If the parties cannot agree to a replacement Principal Investigator, either party may

immediately terminate the relevant Statement of Work upon written notice to the other party.

(d) Institution shall ensure that Principal Investigator and subinvestigator(s): (i) complete and return

to AbbVie the FDA Form 1572 provided by AbbVie to ensure compliance with 21 C.F.R. Part

312.53 prior to the initiation of the Study and promptly notify AbbVie of any change in its accuracy

during the Study Term of the applicable Statement of Work; and (ii) complete and return to

AbbVie the Financial Disclosure Certification provided by AbbVie to ensure compliance with

21C.F.R. Part 54 prior to the initiation of the Study and promptly notify AbbVie of any change in

the accuracy of the Financial Disclosure Certification during the Study Term of the applicable

Statement of Work and for one (1) year following completion of the Study. Institution understands

and agrees that Principal Investigator and subinvestigator(s), and their immediate families, may

not, in violation of any applicable Law, have a direct ownership interest (including, without

limitation, intellectual property rights or royalty rights) in the Study Product and may not be

compensated with AbbVie securities in exchange for being a Principal Investigator or

subinvestigator(s) in the Study.

(e) Institution shall require Principal Investigator to comply with all applicable disclosure Laws relating

to his/her relationship with AbbVie including, without limitation, full disclosure of the existence and

nature of this relationship that (i) may be externally imposed on Principal Investigator based on

his/her affiliation with any formulary, pharmacy and therapeutics (P&T) committee, or committee

associated with the development of treatment protocols or standards (including clinical

guidelines); or (ii) are required by any health care institution, medical committee or other medical

or scientific organization with which Principal Investigator is affiliated. Institution shall require

Principal Investigator to abide by such committee’s or medical or scientific organization’s

procedures, which may include recusing himself/herself from decisions relating to any Study

Product for which Principal Investigator is conducting the Study under the relevant Statement of

Work. This disclosure requirement shall extend for one (1) year beyond the termination or

expiration of the relevant Statement of Work.

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

(f) Institution and Institution Personnel shall not bill or seek reimbursement from any third party for

any Study Materials (as defined below) or other items or services that are paid for or provided

without charge by or on behalf of AbbVie under this Agreement. Institution shall follow all

applicable Law requiring disclosure that such Study Materials and/or other items, or services

were paid for or provided without charge by or on behalf of AbbVie under this Agreement.

4. Sponsor Obligations.

(a) AbbVie shall comply with applicable Laws in the performance of its activities relating to the Study

and shall obtain all approvals required in connection with such activities.

(b) AbbVie shall be responsible for data and safety monitoring as specified in the Protocol. During

the performance of the Study at Institution and for two (2) years thereafter, AbbVie agrees to

report promptly to the Institution any information (including without limitation any aspect of the

Protocol, information discovered during site monitoring visits, or the Study Records/results) that

AbbVie reasonably expects to affect, as applicable, (i) the well-being, medical care, health or

safety of past or current Study subjects, (ii) Study subjects’ willingness to continue participation in

the Study, (iii) the conduct of the Study, or (iv) the IRB’s approval to continue the Study.

Notwithstanding anything to the contrary in this Agreement, Institution and Principal Investigator

are free to communicate such information to each Study subject and the IRB.

requirements described in Section 801 of the Food and Drug Administration Amendment Act.

5. Study Materials; Licenses; Equipment.

(a) AbbVie will provide sufficient quantities of Study Product, investigator brochures, and if

applicable, access to an electronic data capture system for completing Case Report Forms

(“CRFs”), any other compounds, materials, and access to or copies of certain patient reported

outcomes (electronic or paper) surveys, questionnaires, and/or scales (collectively, “PROs”) that

the Protocol specifies or that AbbVie deems necessary to conduct the Study at no cost to

Institution (together, the “Study Materials”). All Study Materials and other information provided by

AbbVie in connection with this Agreement and Statement of Work are and shall remain the sole

property of AbbVie. AbbVie represents that the Study Product will have been manufactured in

accordance with current Good Manufacturing Practices.

(b) Institution shall maintain adequate records to account for the Study Materials including, without

limitation and if applicable, dates, quantity, and use by Study subjects. Institution or Principal

Investigator shall, if applicable, inspect the Study Materials upon receipt and notify AbbVie upon

becoming aware that any Study Materials are damaged or that the supply of Study Materials is

inadequate.

brochure, or material data safety sheet, as applicable, of the applicable Study Materials, and in

accordance with applicable Law, and AbbVie’s reasonable written instructions, (ii) not be used

past their respective labeled expiration dates, if any.

(d) Neither Institution, Principal Investigator, nor any other Institution Personnel shall (i) publish any

part of the PROs in any manuscript, poster, oral presentations, or otherwise, except to the extent

information contained in the PROs constitutes Study data or results, in which case such

information may be published in accordance with Section 12 (Publications and Presentations)

below; (ii) remove or alter any notice contained in the PROs; or (iii) modify, transfer, distribute, or

release the PROs to any third party, except in connection with performing the Study, in

accordance with the Protocol or except as set forth in this Agreement.

(e) Upon conclusion of the Study, termination of this Agreement or a Statement of Work, or at

AbbVie’s request, any remaining or expired Study Materials, as applicable, shall be returned to

AbbVie at AbbVie’s reasonable expense in accordance with the Protocol and AbbVie’s

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

reasonable written instructions and in compliance with applicable Law governing the shipment of

such Study Materials. If the parties agree that the return of such Study Materials is not practicable

or is prohibited under applicable Laws, any remaining or expired Study Materials, as applicable,

will be destroyed in full compliance with applicable Laws. Upon any such destruction, Institution

will promptly provide AbbVie with a certificate of destruction or similar document verifying the final

disposition of the Study Materials.

(f) If necessary for purposes of conducting the Study, AbbVie may provide Institution with certain

equipment. Any equipment provided by AbbVie hereunder is described in Exhibit B of the

Statement of Work (Equipment to be provided by AbbVie) (“Equipment”). For any Equipment

provided by AbbVie, Institution shall (i) promptly inspect the Equipment following receipt and

notify AbbVie upon becoming aware that any Equipment is damaged or malfunctioning; (ii) use

the Equipment in accordance with the user manual and/or other reasonable instructions provided

with the Equipment; (iii) maintain the Equipment in a secure manner designed to protect such

Equipment from unauthorized use, theft, or damage and exercise the same degree of care with

respect to the Equipment that Institution exercises with respect to its own equipment of similar

type and value. If, due to the gross negligence of Institution or any Institution Personnel, any of

the Equipment is lost, stolen, or damaged, then Institution shall pay the reasonable cost of

replacement or repair, as applicable, which shall not exceed the estimated value of such

Equipment set forth in Exhibit B of the Statement of Work. At AbbVie’s direction and expense,

the Equipment shall be returned to a location specified by AbbVie at the end of the Study or

earlier termination of the Statement of Work.

(g) In the event the Protocol requires Institution to provide Equipment to Study subjects for their use

during the Study, Institution shall instruct the Study subjects as to the proper use of the

Equipment. If any of the Equipment is lost, stolen, or damaged by a Study subject or while under

the control of a Study subject, then AbbVie shall pay the reasonable cost of replacement or

repair, as applicable.

(h) Institution shall use the Study Materials and the Equipment solely for the conduct of the Study

and not for any other study nor for any other use.

6. Monitoring of Study; Records; Reporting.

(a) Upon the reasonable request of AbbVie, Institution shall submit oral or written reports on the

progress of the Study at reasonable intervals during the Study Term. Within ninety (90) days

following completion or termination of a Study at Institution, Institution shall furnish AbbVie with (i)

a final report on the Study, which may be the final IRB Study report prepared by the Principal

Investigator for the IRB; and (ii) all data, records CRFs, reports, and other information generated

(excluding source documents, medical records, and Institution Records) in the conduct of the

Study (collectively, “Records”), which shall be the exclusive property of AbbVie. Notwithstanding

the foregoing, source documents, medical records, laboratory notebooks, Protected Health

Information (as such term is defined by HIPAA), Institution’s business records, regulatory and

compliance documents, research notebooks, or any other information that is required by Law or

regulation to be retained by Institution, (collectively referred to as “Institution Records”) shall be

considered the exclusive property of Institution. Institution agrees that, subject to Section 9

(Subject Confidentiality; Data Protection) of this Agreement, AbbVie shall have the right to use

the information described in such source documents and medical records (i) to the extent

permitted by the IRB approved ICF signed by the Study subject (“Subject ICF”), (ii) in accordance

with any reasonable instructions from Institution’s IRB that are consistent with the Protocol and

such Subject ICF, and (iii) only in accordance with applicable Law. Notwithstanding the foregoing

and subject to Section 8 (Confidentiality), Institution retains the right to use any Records for its

internal and non-commercial research, teaching, patient care purposes and for publication

purposes in accordance with Section 12 (Publications and Presentations).

(b) During normal business hours, Institution shall permit AbbVie and AbbVie’s designees access to

any facilities at which the Study is conducted to monitor the conduct of the Study and to audit the

Records, source documents generated in the conduct of the Study, and other Study data

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

(collectively, “Study Documents”) to verify compliance with this Agreement, provided that

Institution may redact such Study Documents as legally required to protect subject confidentiality.

Except in cases where AbbVie requires immediate access to Study site in connection with audits

and responses to requests made by regulatory authorities (in which case Institution shall permit

access upon reasonable advance notice), monitoring visits shall be scheduled at mutually

agreeable times.

cured or is incapable of timely cure, AbbVie may immediately terminate any Statement of Work.

AbbVie’s rights in this Section shall be subject to Institution’s reasonable measures for purposes

of confidentiality, safety, and security, and will be further subject to AbbVie’s compliance with

Institution’s premises rules that are generally applicable to all persons at Institution’s facilities;

provided, however, that all such policies and procedures are reasonable, and consistent with

applicable Laws and regulations. Should AbbVie utilize one or more third party(s) in exercising its

rights in this paragraph, AbbVie certifies that such party(s) shall be subject to an obligation of

confidentiality consistent with the obligations of confidentiality required of AbbVie hereunder and

such third party(s) shall be subject to any and all conditions upon AbbVie’s rights that are set forth

in this Section 6.

(d) Institution shall, to the extent permitted by applicable Laws, promptly (i) notify AbbVie upon

receiving any requests to inspect and have access to Study Documents by any regulatory

authority having jurisdiction over the Study, and (ii) provide AbbVie with a copy of any relevant

documents received from such regulatory authority that relate to the Study. In the event a

regulatory citation or notice (including, without limitation, a FDA Form 483 or FDA warning letter)

is issued relating to the Study, Institution agrees, to the extent permitted by applicable Laws, to

furnish to AbbVie within thirty (30) days of receipt of such regulatory citation or notice (A)

notification of such citation or notice, and (B) a summary of such citation or notice. AbbVie shall

hold all such documents, citations, notice, and correspondence in confidence.

(e) Institution shall retain the Study Documents in accordance with applicable Laws (the “Retention

Period”). If AbbVie requests that Institution retain the Study Documents beyond the Retention

Period, the parties shall cooperate in good faith in an effort to mutually agree upon the costs to be

paid by AbbVie and the duration for such extended Retention Period.

(f) If AbbVie obtains, learns of, comes in contact with, or otherwise has access to any protected

health information, as defined in HIPAA (“PHI”), AbbVie shall, and shall ensure that AbbVie

representatives or designees will keep such information confidential, and will collect, use, store,

access PHI only in accordance with applicable Laws and to the extent permitted by the applicable

IRB approved ICFs and any reasonable instructions from Institution’s IRB.

7. Compensation.

(a) In support of the conduct of each Study, AbbVie shall pay Institution in accordance with the

Budget. Institution understands and agrees that none of Principal Investigator or

subinvestigator(s) will receive any funds from AbbVie in connection with the performance of the

Study other than the funds paid to Institution in accordance with the Budget. The parties agree

that the amount for payments set forth in the Budget represents the fair market value for the

services to be rendered and has not been determined in any manner that takes into account the

volume or value of any referrals or business otherwise generated between Institution and AbbVie.

Institution agrees that the overhead charged to AbbVie under a Statement of Work shall not

exceed Institution’s overhead rate applicable to that Statement of Work that is in effect as of the

effective date of such Statement of Work.

(b) In the event that the Agreement or Statement of Work is terminated, AbbVie shall pay Institution

for work performed, expenses incurred and non-cancelable obligations made up to the effective

date of termination. AbbVie shall not be obligated to reimburse Institution for expenses that are

invoiced to AbbVie more than two hundred forty (240) days after the termination date of the

relevant Statement of Work.

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

or inaccurate; or (ii) work performed in violation of the Protocol (provided, however, that actions

(including deviations from the Protocol) taken by Institution or Institution Personnel that are based

on generally accepted standards of clinical research and medical practice, necessary to treat a

condition that poses an immediate risk to the safety, life or well-being of a Study subject shall not,

in and of themselves, constitute a violation of the Protocol or this Agreement). If AbbVie has

previously paid for such work, the payment shall be deducted from the final payment due under

the Statement of Work (the “Final Payment”).

(d) In the event of any payment dispute under a Statement of Work, (i) AbbVie shall pay undisputed

amounts upon receipt of an invoice therefor, and (ii) the parties shall cooperate in good faith to

resolve such dispute in a timely manner. Following resolution of such dispute, Institution shall re-

invoice AbbVie and AbbVie shall pay for the amounts the parties mutually agree are due. In no

event may Institution or Institution Personnel withhold Study data or Records that are otherwise

required to be submitted to AbbVie hereunder, pending resolution of a payment dispute.

(e) AbbVie will make the Final Payment due under a Statement of Work and send a financial

reconciliation to Institution after completion of the performance of all work contemplated

thereunder and the delivery to AbbVie of all CRFs and all other items described in Section 6(a). If

AbbVie has paid Institution less than Institution is entitled at the time of financial reconciliation,

AbbVie shall pay the remaining amount due as part of the Final Payment. Any overpayment due

AbbVie at the time of final reconciliation, shall be made payable to AbbVie Inc. within ninety (90)

days of discovery of such overpayment along with an explanation of such overpayment, to the

AbbVie Study Contact (as defined below) set forth in the Statement of Work.

(f) Upon written notice to Institution, AbbVie may delegate certain payment obligations under a

Statement of Work to a contract research organization (“CRO”). In such event, Institution agrees

that as to any payments delegated by AbbVie to such CRO, Institution shall first seek redress

from the CRO for compensation. If after seeking redress from the CRO for such payments

Institution is not paid the amounts due under this Section 7, then AbbVie shall pay undisputed

amounts. Additionally, for any Study in which AbbVie has delegated certain Study obligations to a

CRO, AbbVie shall endeavor to require that its CROs either (a) use this Agreement or (b)

conform its clinical study template to the substantive provisions from this Agreement.

8. Confidentiality.

(a) The parties may wish, from time to time, in connection with work contemplated under this

Agreement and a Study, to disclose confidential information to each other. During the Term of this

Agreement, including any extensions thereof, and for a period of seven (7) years after expiration

or termination of this Agreement, (i) Institution and Institution Personnel (collectively “Receiving

Party”) shall not disclose to any third party or use AbbVie Confidential Information (as defined

below) for any purpose other than that indicated in this Agreement without AbbVie’s prior written

consent and (ii) AbbVie shall not use or disclose Institution’s Confidential Information (as defined

below) without Institution’s prior written consent unless permitted hereunder. Notwithstanding the

foregoing, Confidential Information identified as a trade secret will not be disclosed by AbbVie to

Institution unless AbbVie first notifies Institution in writing that AbbVie wishes to disclose a trade

secret and the nature of the trade secret, and Institution has then specifically agreed in writing in

advance to receive such trade secret. In such event, Institution’s obligations of confidentiality and

non-use with respect to such disclosed trade secret shall survive for the period required by law.

(b) “AbbVie Confidential Information” shall include any information provided to Receiving Party by or

on behalf of AbbVie, including but not limited to the Protocol, Investigator Brochures, Study

Materials, and Records. “Institution Confidential Information” shall include the information and

materials provided to AbbVie by or on behalf of Institution, including any information concerning

Institution and its business related to the Study. AbbVie Confidential Information and Institution

Confidential Information shall be referred to herein collectively as “Confidential Information”.

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

(i) is known to the Receiving Party prior to receipt thereof under this Agreement, as evidenced

by its written records;

(ii) is disclosed to the Receiving Party after acceptance of this Agreement by a third party who,

to the knowledge of Receiving Party, has a right to make such disclosure in a nonconfidential

manner;

(iii) is or becomes part of the public domain through no fault of the Receiving Party; or

(iv) is independently developed by the Receiving Party without use of, or reference to AbbVie

Confidential Information.

(d) Institution Confidential Information shall not include information or any portion thereof which:

(i) is known to AbbVie prior to receipt thereof under this Agreement, as evidenced by its written

records;

(ii) is disclosed to AbbVie after acceptance of this Agreement by a third party who, to the

knowledge of AbbVie, has a right to make such disclosure in a non-confidential manner;

(iii) is or becomes part of the public domain through no fault of AbbVie; or

(iv) is independently developed by or for AbbVie without use of or reference to the Institution

Confidential Information, as evidenced by its written records.

(e) Notwithstanding the foregoing, Institution may disclose AbbVie Confidential Information to the

extent it is required to be disclosed (i) in order to obtain informed consent from subjects who may

wish to enroll in the Study, provided, however, that the AbbVie Confidential Information will be

disclosed only to the extent necessary and will not be provided in answer to unsolicited inquiries

by telephone or to individuals who are not eligible Study candidates; (ii) to a Study subject for the

safety or well-being of the Study subject; or (iii) is communicated to Institution’s scientific and/or

institutional review committees provided, however, that such persons are obligated to maintain

the confidentiality of such information consistent with the terms of this Agreement.

(f) Nothing in this Agreement will be construed to restrict either party from disclosing Confidential

Information as required by Law or court order or other governmental order or request, provided in

each case such party shall, to the extent practicable, give the other party written notice as soon

as reasonably possible in order to allow the affected party to take whatever action it deems

necessary to protect its Confidential Information. In the event that no protective order or other

remedy is obtained, or either party waives compliance with the terms of this Section 8, a

disclosing party shall furnish only that portion of the Confidential Information which it is legally

required to disclose. In addition, each party will permit the affected party to attempt to limit such

disclosure by appropriate legal means.

(g) Neither party will disclose to the other party any information which is confidential or proprietary to

a third party unless such party has first obtained the prior written approval of both such third party

and the other party.

(h) Within forty-five (45) days following completion or termination of the applicable Statement of

Work, each party will return or destroy all tangible materials that contain the other party’s

Confidential Information, provided, however, that each party will be permitted to retain one (1)

archival copy of the other’s party’s Confidential Information solely as required for regulatory, legal,

or insurance purposes or as permitted by this Agreement.

9. Subject Confidentiality; Data Protection. Institution shall comply with all applicable Laws regarding

Study subject confidentiality and data protection, including without limitation, HIPAA, HITECH, and

applicable state privacy Laws, in the collection, use, storage and disclosure of PHI. Institution does

not intend to provide any PHI to AbbVie, provided, however, that to the extent any Records, Study

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

Documents, results or data of the Study or information provided to AbbVie or accessed by AbbVie

may include any PHI, AbbVie shall and shall ensure that AbbVie’s representatives shall hold such

information in confidence, and collect, use, store, access and disclose such PHI only in accordance

with applicable Law and to the extent permitted by the applicable Subject ICF and in accordance with

any reasonable instructions from Institution’s IRB that are consistent with the Protocol and such

Subject ICF.

10. Publicity.

(a) Except as required by Law or regulation or as permitted hereunder, including, but not limited to

requirements set forth in Section 12 (Publications and Presentations), neither party shall disclose

the terms of this Agreement or make any public announcements regarding the existence of this

Agreement without the other party’s written consent.

(b) Neither party shall use the trademark, servicemark, or logo of the other party or the other party’s

affiliates in any publicity, advertising, or other information intended to be disseminated to any third

person or to the general public without the other party’s prior written consent. Neither party shall

use the name of the other party or the other party’s affiliates in any publicity, advertising, or other

information intended to be used for commercial or promotional purposes without the other party’s

prior written consent. Notwithstanding the foregoing, Institution and Principal Investigator may

without prior written approval, disclose their participation in the Study (including the names of

AbbVie or AbbVie’s affiliates, name of the Study, funding source, and total funding amount) as

required by applicable Laws, court order or state regulation, as required by Section 12

(Publications and Presentations), or in (i) curriculum vitae, (ii) internal reports, (iii) grant

applications to government funding sources, (iv) required government reports and filings, (v)

Institution’s clinical trials website exactly as such information appears on clinicaltrials.gov, and (vi)

conflict of interest disclosures. Institution understands and agrees that the terms and conditions of

this Agreement and any Statement of Work and the amount of any payment made thereunder

may be disclosed and made public by AbbVie to the extent required by AbbVie to comply with

applicable Laws. As AbbVie reasonably requests, Institution shall cooperate in good faith with

AbbVie to promptly provide accurate and complete information that is not already in AbbVie’s

possession in connection with such disclosures related to the Study. The parties understand that

the terms and conditions of this Agreement may be disclosed and made public by AbbVie and/or

Institution to the extent required by Law.

11. Intellectual Property.

(a) Each party hereto retains all right, title and interest in any patent, patent application, trade secret,

know-how and other intellectual property that was owned by such party prior to the Effective

Date. No license grant or assignment, express or implied, by estoppel or otherwise, is intended

by, or shall be inferred from this Agreement, except as specifically set forth herein.

(b) Any invention, or discovery (whether patentable or not), conceived, reduced to practice, made,

generated or developed by Institution or Institution Personnel that is made from use of the Study

Materials provided hereunder or made in the conduct of the Study (collectively, “Intellectual

Property”) shall be promptly disclosed to AbbVie, and Institution hereby assigns to AbbVie all of

Institution’s rights, title, and interest in and to such Intellectual Property. Upon AbbVie’s request

and at AbbVie’s expense, Institution shall require Institution Personnel to execute, or cause to

have executed such documents and to take such other reasonable actions to obtain, record or

enforce patents, assignments or other proprietary protection in AbbVie’s name covering any such

Intellectual Property. Subject to Section 8 (Confidentiality) and Section 12 (Publications and

Presentations), AbbVie grants to Institution a free, non-transferable, non-sublicensable, non-

exclusive license to use any Intellectual Property solely for its internal and non-commercial

research, teaching, patient care purposes and for publication purposes.

12. Publications and Presentations. For purposes of this Agreement, “Scientific Publication” means any

scientific publication or medical communication regarding Study results in any form that is intended

The University of Texas System

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for disclosure to third parties, including, without limitation, manuscripts, abstracts, posters, slides or

other materials used for presentations.

(a) AbbVie is committed to fostering the highest standard of conduct related to Scientific Publications

and transparency, while at the same time, protecting its Confidential Information provided

hereunder. Authorship related to Scientific Publications shall be determined in accordance with

and governed by the criteria defined by the International Committee of Medical Journal Editors

(ICMJE) “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly

Work in Medical Journals”, and Institution shall require that AbbVie’s role in support of the Study

be appropriately disclosed in any Institution Publications (as defined below).

(b) Institution acknowledges that, as the Study sponsor, AbbVie retains the right to disclose the

Study data and results first in a Scientific Publication based on the Study data and results from all

appropriate sites (“Summary Publication”).

completion, abandonment or termination of the Study at all Study sites, Institution and Institution

Personnel shall have the right to prepare and submit for public disclosure Institution’s Study data

through a Scientific Publication or other public disclosure (an “Institution Publication”). Institution

shall provide AbbVie with a draft of any proposed Institution Publication at least thirty (30) days

prior to submission of such publication for AbbVie to ascertain whether any patentable Intellectual

Property or AbbVie Confidential Information (other than the data and/or results of the Study

generated hereunder) are disclosed therein. AbbVie shall return comments to Institution within

thirty (30) days after receipt of the draft Institution Publication (“Review Period”). Institution shall

delay any proposed Institution Publication an additional sixty (60) days in addition to the Review

Period in the event AbbVie so requests to enable AbbVie to secure patent or other proprietary

protection for any Intellectual Property contained within such Institution Publication (“Delay

Period”). Institution agrees to (A) keep the proposed Institution Publication confidential until

expiration of the Review Period and, if elected by AbbVie, any Delay Period, and (B) delete

AbbVie Confidential Information (other than data and/or results of the Study generated

hereunder) from any Institution Publication. In the event that Institution or Institution Personnel

and AbbVie differ in their conclusions or interpretation of Study data in the Institution Publication,

the parties shall, during the Review Period, use good faith efforts to attempt to resolve such

differences through appropriate scientific debate. Subject to Institution’s and Institution

Personnel’s removal of AbbVie Confidential Information (other than data and/or results of the

Study generated hereunder), Institution or Institution Personnel, as applicable, shall retain control

over the final version of the Institution Publication.

13. Representations and Certifications.

(a) Institution represents and certifies that during the Term of this Agreement, to the best of

Institution’s knowledge:

(i) the terms of this Agreement and Statement of Work are valid and binding obligations of

Institution, and are not inconsistent with (A) any other contractual or legal obligation it may

have; or B) policies and procedures of Institution;

(ii) Institution’s and Institution Personnel’s performance of the activities hereunder is in

compliance with all policies and procedures of Institution, and Principal Investigator’s

performance of such activities does not present a conflict of interest with Principal

Investigator’s official duties;

(iii) Institution and Principal Investigator have, as applicable, adequate facilities, resources,

training and expertise to conduct the Study in accordance with the Protocol and applicable

Laws; and

(iv) Principal Investigator has a current and valid medical license in the jurisdiction in which the

Study is being performed.

The University of Texas System

September 27, 2016

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Institution shall notify AbbVie promptly if at any time during the Term, Institution learns that

Institution would no longer be able to truthfully make any of the representations and certifications

in this Section 13(a) and AbbVie shall have the right to immediately terminate this Agreement.

(b) Institution represents and certifies that neither Institution nor Institution Personnel are Debarred

or, to the best of Institution’s knowledge, have been Debarred or are the subject of a proceeding

that could lead to Institution or any Institution Personnel becoming Debarred. For purposes of this

Agreement, “Debarred” means (A) debarred by the FDA under 21 U.S.C. § 335a; (B) excluded,

debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or

in Federal procurement or nonprocurement programs; (C) listed on the FDA’s Disqualified and

Restricted Lists for clinical investigators; or (D) convicted of a criminal offense that falls within the

scope of 42 U.S.C. § 1320a-7(a), but has not yet been excluded, debarred, suspended, or

otherwise declared ineligible. In the event Institution receives notice of, or otherwise becomes

aware of, the Debarment, proposed Debarment of itself or any Institution Personnel, Institution

shall notify AbbVie immediately and AbbVie shall have the right to immediately terminate this

Agreement. The obligations of this Section 13(b) shall survive termination or expiration of the

Agreement for a period of one (1) year.

manufactured in accordance with current Good Manufacturing Practices and will meet the product

specification identified in the product label at the time of delivery to Institution.

14. Term and Termination.

(a) Unless terminated earlier as provided in Section 14(b) below, this Agreement shall be effective

on the Effective Date and shall continue for five (5) years following the Effective Date (“Term”).

(b) This Agreement may be terminated:

(i) by either AbbVie or Institution upon written notice to the other party if the other party has

breached a material term of this Agreement and fails to cure such breach within fifteen (15)

days of receiving notice of such breach; or

(ii) by either party without cause upon thirty (30) days prior written notice to the other party; or

(B) as otherwise permitted in this Agreement.

(i) by either AbbVie or Institution upon written notice to the other party if: (A) the other party has

breached a material term of this Agreement or Statement of Work and fails to cure such

breach within fifteen (15) days of receiving notice of such breach; (B) the Study is terminated

or suspended by the IRB, FDA or any other governmental or regulatory authority; (C) if the

Principal Investigator leaves Institution or is otherwise unable to continue to participate in the

Study, and the parties are unable to find a mutually acceptable replacement principal

investigator within thirty (30) days; or (D) if either AbbVie or an Institution, in its sole

judgment, believes an adverse safety concern with respect to Study Product makes

continued testing unadvisable, provided that if Institution terminates for this reason, it shall be

after the Suspension Period (defined below) in accordance with Section 14(d).

(ii) by AbbVie (A) without cause upon thirty (30) days prior written notice to Institution; or (B) as

otherwise permitted in the Statement of Work.

(d) In the event Institution or Principal Investigator have concerns about the health, safety and

welfare of the Study subject(s), Institution shall give prompt notice to AbbVie of such concerns,

and may suspend enrollment of Study subjects for a period not to exceed thirty (30) calendar

days (“Suspension Period”). During such Suspension Period, the parties shall evaluate the

concerns raised by Institution or Principal Investigator to determine whether the Statement of

Work should be terminated. In any event, Institution and Principal Investigator shall continue

The University of Texas System

September 27, 2016

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monitoring and follow-up in strict adherence to the Protocol for currently enrolled Study subjects

during the Suspension Period. After the Suspension Period and following written notice including

a detailed written explanation, to AbbVie, Institution may terminate a Statement of Work if Study

subject health, safety, and welfare remain a concern to Institution of such magnitude to support

such termination.

(e) Termination or expiration of this Agreement or Statement of Work shall not affect any rights or

obligations which have accrued prior thereto or any other rights or remedies provided at law or

equity which either party may otherwise have. If the Study Term of a Statement of Work extends

beyond the termination or expiration date of this Agreement, the applicable terms and conditions

of this Agreement shall extend automatically for such Statement of Work until such Statement of

Work’s termination or expiration date. In the event of premature termination of a Statement of

Work, Institution shall (i) appropriately withdraw and discontinue all then-enrolled subjects if

medically permissible (ii) complete the Study for then-enrolled Study subjects where required by

accepted medical practice, or (iii) reasonably cooperate with AbbVie to arrange for then-enrolled

Study subjects to enroll at an alternative Study site.

15. Subject Injury; Indemnification.

(a) If under a Study any injury or illness occurs to a Study subject as a result of (i) the administration

of the Study Materials or (ii) the performance of Protocol- mandated procedures on Study

subjects that such Study subjects would not have received but for their participation in the Study

(“Procedures”) in each case in accordance with the Protocol (“Study Injury”), AbbVie agrees to

pay all reasonable medical expenses necessary to treat such Study Injury, provided that such

Study Injury is not due to the natural progression of any pre-existing disease or any underlying

illness. Institution shall not submit claims for such medical expenses for a Study Injury paid by

AbbVie to a third party payor.

(b) AbbVie shall indemnify, defend and hold harmless Institution, System, their Regents, officers,

agents employees, Institution Personnel and Institution’s officers, trustees, and IRB members

(“Indemnitees”) in the conduct of a Study, for any liability, loss, and expense resulting from

judgments or claims against them (collectively, “Losses”) as a result of any claim or lawsuit made

by a third party as a result of (i) a Study Injury; (ii) AbbVie’s or its representatives negligent acts

or omissions, recklessness, or intentional misconduct during and/or in connection with the Study;

(iii) AbbVie’s use of the Study data and results (including Records); or (iv) AbbVie’s breach of any

provision of this Agreement. AbbVie’s indemnification obligation applies only if (A) Study

Materials are administered by Institution Personnel and Procedures are performed during the

Study in accordance with the Protocol (provided, however, that actions (including deviations from

the Protocol) taken by Institution or Institution Personnel that are based on generally accepted

standards of clinical research and medical practice, necessary to treat a condition that poses an

immediate risk to the safety, life or well-being of a Study subject shall not, in and of themselves,

constitute a violation of the Protocol), with accepted medical practice, and with any other

reasonable written instructions furnished by AbbVie, and (B) Study data and results

communicated to AbbVie by Institution Personnel are not intentionally misleading or, inaccurate.

upon the following obligations of Indemnitees to:

(i) advise AbbVie of any claim or lawsuit, in writing addressed to AbbVie Inc., Attention: Risk

Management, Dept. 317, Bldg. AP34, 1 N. Waukegan Road, North Chicago, Illinois 60064-

3500, with a copy to Attention: Legal R&D, Alliance Management and Transactions, Dept.

V323, Bldg. AP34, 1 N. Waukegan Road, North Chicago, Illinois 60064, promptly after

Indemnitees has received notice of said claim or lawsuit within such time frame so that

AbbVie’s ability and rights to defend or settle such claim or lawsuit are not materially

prejudiced, provided, however, the failure to promptly notify AbbVie shall not relieve AbbVie

of its indemnification obligations unless the AbbVie is materially adversely affected by such

failure;

The University of Texas System

September 27, 2016

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(ii) reasonably assist AbbVie and its representatives in the investigation and defense of any

lawsuit or claim for which indemnification is provided; and

(iii) not compromise or otherwise settle any such claim or lawsuit without AbbVie's prior written

consent.

(d) AbbVie’s obligations to pay reasonable medical expenses in connection with a Study Injury or to

indemnify, defend, or hold harmless shall not apply in the event any Losses or Study Injury,

respectively, are attributable to (i) the negligence, recklessness or willful misconduct of, or failure

to follow the Protocol (provided, however, that actions (including deviations from the Protocol)

taken by Institution or Institution Personnel that are based on generally accepted standards of

clinical research and medical practice, necessary to treat a condition that poses an immediate

risk to the safety, life or well-being of a Study subject shall not, in and of themselves, constitute a

violation of the Protocol), by, any of the Indemnitees or (ii) Institution’s or Institution Personnel’s

breach of any obligations under this Agreement or Statement of Work.

(e) Section 15 is subject to the statutory duties of the Texas Attorney General.

16. Insurance. Each party shall maintain a policy or program of insurance or self-insurance with policy

limits sufficient to support its obligations under this Agreement. Upon request by a party, the other

party shall furnish evidence of such party’s applicable insurance. Each party’s insurance coverage

shall comply with applicable Laws and insurance guidelines. Each member of The University of Texas

System is self-insured pursuant to The University of Texas Professional Medical Liability Benefit Plan

under the authority of Chapter 59, Texas Education Code.

17. Independent Contractor. Each party’s relationship to the other party is that of an independent

contractor, and neither party has authority to bind or act on behalf of the other party.

18. Assignment. Neither party may assign this Agreement to any other party without the other party’s

prior written consent; provided, however, that upon prior written notice to the other party, either party

may assign this Agreement without consent to any successor by merger, de-merger or sale of

substantially all of the assets to which this Agreement relates; provided further that any successor of

Institution is a hospital or other health care facility or patient treatment center. Any attempted

assignment except in accordance with this Section 18 shall be null and void and shall constitute a

material breach of this Agreement.

19. Subcontracting. In the event Institution subcontracts any aspect of Study performance to a

subcontractor, Institution shall (a) ensure each subcontractor’s compliance with the requirements of

this Agreement and Statement of Work, and (b) be responsible for any subcontractor’s non-

compliance with the terms and conditions of this Agreement and Statement of Work to the same

extent that Institution would be responsible if Institution were performing the subcontracted services

directly. If a subcontractor does not strictly adhere to the provisions of this Agreement and Statement

of Work, Institution shall promptly notify AbbVie and AbbVie may immediately terminate this

Agreement or relevant Statement of Work.

20. Notices.

(a) Routine communications regarding the conduct of the Study shall be sent to the AbbVie individual

identified to Institution by AbbVie as the primary contact for the Study (“AbbVie Study Contact”)

set forth in the Statement of Work.

(b) Communications related to the assignment of this Agreement shall be made by email, mail or

recognized national or international courier and shall be sent to the AbbVie notice address set

forth below.

recognized national or international overnight courier or registered or certified mail, postage

prepaid, return receipt requested, or delivered by hand to the legal notice address set forth below.

The University of Texas System

September 27, 2016

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Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

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Includes StemCentrx as Affiliate

If to Institution:

See Appendix A for the name and address of an

administrative contact for each Institution

With a copy to:

The University of Texas System

Office of General Counsel

201 West 7

Street

Austin, TX 78701

ATTN: OGC Intellectual Property Assistant

General Counsel and IP Legal Expert

If to AbbVie:

If to AbbVie (legal notices)

Director, Contract Management

Dept. R479, Bldg. AP04-2

AbbVie Inc.

1 N Waukegan Road

North Chicago, IL 60064

Divisional Vice President and

Associate General Counsel, Legal R&D, Alliance

Management and Transactions

AbbVie Inc.

Dept. V323, Bldg. AP34

1 North Waukegan Road

North Chicago, IL 60064-6011

Legal notices under this Agreement shall be deemed to be duly given: (i) when delivered by hand; (ii)

two (2) days after deposit with a recognized national or international courier; or (iii) on the delivery

date indicated in the return receipt for registered or certified mail. A party may change its legal notice

address immediately by sending written notice to the other party’s legal notice address as set forth in

this Section 20.

21. Survival. Any other terms which by their intent or meaning are intended to survive termination or

expiration of this Agreement shall so survive, including, without limitation, the parties’ obligations with

respect to financial disclosure reporting and conflict of interest disclosure and management, record

retention and audit rights, confidentiality, publicity, intellectual property, publications, notification

requirements with respect to such party’s representations and certifications as set forth in Section

13(b), indemnification, and Study Injuries.

22. Severability. If any provision, right or remedy provided for herein or any Statement of Work is held to

be unenforceable or inoperative by a court of competent jurisdiction, the validity and enforceability of

the remaining provisions shall not be affected thereby.

23. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall

be deemed to be an original, and all of which together shall constitute one and the same agreement.

Each party acknowledges that an original signature or a copy thereof transmitted by facsimile or by

PDF shall constitute an original signature for purposes of this Agreement.

24. Entire Agreement. This Agreement including, without limitation, all Exhibits hereto, contains the entire

understanding of the parties with respect to the subject matter herein and supersedes all previous

agreements and undertakings with respect thereto. In the event of a purchase order is issued to

provide for payment of the services under a Statement of Work, the terms and conditions of this

Agreement and relevant Statement of Work shall control over any conflict between terms and

conditions of the purchase order and this Agreement or Statement of Work. In the event of a conflict

between provisions of the Protocol and this Agreement or any Exhibits hereto, the Protocol shall

control with respect to matters of science, medical practice, and Study subject safety. In all other

matters, the provisions of this Agreement shall control. In the event of any conflict between the terms

and provisions of this Agreement and those in the Exhibits hereto or any Statement of Work, the

provisions of this Agreement shall control, unless a particular Statement of Work specifically

acknowledges the conflict and expressly states that the conflicting term or provision found in the

Statement of Work controls for that Statement of Work only (but then only with respect to that

particular Statement of Work and with respect only to such matter). Neither this Agreement nor any of

The University of Texas System

September 27, 2016

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its terms, including any attachment or Exhibit hereto, may be amended, restated or otherwise altered

except by written agreement signed by the parties.

25. State Agency. Institution is an agency of the State of Texas and under the Constitution and the laws

of the State of Texas possesses certain rights and privileges, is subject to certain limitations and

restrictions, and only has such authority as is granted to it under the Constitution and laws of the

State of Texas. Notwithstanding any provision hereof, nothing in this Agreement is intended to be, nor

will it be construed to be, a waiver of the sovereign immunity of the State of Texas or a prospective

waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas.

Moreover, notwithstanding the generality or specificity of any provision hereof, the provisions of this

Agreement as they pertain to Institution are enforceable only to the extent authorized by the

Constitution and laws of the State of Texas; accordingly, to the extent any provision hereof conflicts

with the Constitution or laws of the State of Texas or exceeds the right, power or authority of

Institution to agree to such provision, then that provision will not be enforceable against Institution or

the State of Texas.

26. Clinical Trials Xpress (“CTX”) [www.clinicaltrialsxpress.org], a wholly-owned initiative of the System,

is the central coordinating office and team established to promote efficient and streamlined study

start-up processes of multi-institutional clinical trials. More specifically, the CTX network operating

model accelerates study implementation by negotiating a single, common clinical trial study budget;

using pre-approved master clinical trial agreements; and by adopting the System IRB Reciprocity

model or central IRBs for regulatory oversight. AbbVie may engage the services of the CTX central

coordinating office when the applicable Study contemplated by this Agreement will be considered for

participation by more than one Institution.

This space intentionally left blank

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September

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CONFIDENTIAL

Template: Masler Clinical Study Agreement - 04MAR2015

Document Title: C103262 • Final

Version:

9127/20168:56 AM, 66,985

Five

Year Teon

Includes

StemCen\rx

Affiliate

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The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

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APPENDIX A

Administrative contact person and address for each Institution named in Agreement between AbbVie Inc.

and the System.

David Hawkins

Associate Director, Office of Sponsored Projects

The University of Texas at Austin

P.O. Box 7726

Austin, Texas 78713-7726

Phone: 512-471-6424

Fax: 512-471-6564

Tax ID: 74-600023

Angela R. Charboneau Wishon, J.D.

Vice President for Research Administration

The University of Texas Southwestern Medical

Center

5323 Harry Hines Blvd.

Dallas, TX 75390-9105

Phone: 214-648-6449

Fax: 214-648-4474

Tax ID: 75-6002868

Chris G. Green, CPA

Director, Office of Sponsored Programs

The University of Texas Health Science

Center at San Antonio

7703 Floyd Curl Dr, Mail Code 7828

San Antonio, TX 78229-3900

Phone: 210-567-2340

Fax: 210-567-8107

Email: [email protected]

Tax ID: 74-1586031

Christopher Denman

Assistant Director, Contracts

The University of Texas Health Science Center at

Houston

P.O. Box 20036

Houston, TX 77225

Phone: 713-500-3166

Fax: 713-383-3746

Tax ID: 74-1761309

Overnight address is:

7000 Fannin Street, Suite UCT 1007-2

Houston, TX 77030

David Anderson

Director, Office of Pre-Award Services

The University of Texas Health Science

Center at Tyler

11937 U.S. Hwy. 271

Tyler, TX 75708-3154

Phone: 903-877-7585

Fax: 903-877-7558

Email: [email protected]

Tax ID: 75-6001354

Toni D’Agostino

Associate VP for Research, Office of Sponsored

Projects

The University of Texas Medical Branch at

Galveston

301 University Boulevard

4.40 Rebecca Sealy Hospital

Galveston, TX 77555-0156

Phone: 409-266-9413

Fax: 409-266-9469

Tax ID: 74-6000949

Glorimar Colon

Research Liaison Officer

Office of the Senior VP for Research,

Innovation, and Economic Development

The University of Texas Rio Grande Valley

1201 West University Drive

Edinburg, TX 78539

Phone: 965-665-3008

Fax: 956-665-2940

Email: [email protected]

Tax ID: 46-5292740

The University of Texas System

September 27, 2016

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Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

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EXHIBIT A-1

STANDARD STATEMENT OF WORK TEMPLATE

This Statement of Work (“Statement of Work”), effective as of the full execution hereof (“Effective Date”) is

entered into by and between Insert Name of UT Campus(es) (“Institution”) and Insert Name of AbbVie

Legal Entity (“Sponsor”), and is issued under that certain Master Clinical Study Agreement (AbbVie

Contract Number C103262) effective Insert Date MCSA was fully executed (the “Agreement”) by and

between AbbVie Inc. (“AbbVie”) and The University of Texas Health Science Center at Houston; The

University of Texas Health Science Center at San Antonio, The University of Texas Health Science

Center at Tyler; The University of Texas Medical Branch at Galveston; The University of Texas

Southwestern Medical Center; The University of Texas Rio Grande Valley and The University of Texas at

Austin. This Statement of Work includes the terms and conditions of the Agreement, which are hereby

incorporated herein by reference.

WHEREAS, for purposes of this Statement of Work, the defined term “AbbVie” in the Agreement shall

refer to and mean “Sponsor,” as defined in this Statement of Work.

1. Protocol. The Study is to be conducted in relation to the Sponsor product Insert Sponsor Study

Product (individually and collectively, the “Study Product”) pursuant to Protocol No. Insert Protocol

No. entitled “Insert Protocol Title,” which may be amended from time to time (the “Protocol”), the

terms of the Agreement and this Statement of Work.

2. Principal Investigator. Sponsor is entering into this Statement of Work with the understanding that

Insert Investigator's Name (“Principal Investigator”), an employee of the Insert Campus, shall be

responsible on Institution's behalf for the conduct of the Study.

3. Equipment. Sponsor will provide Institution with the equipment described in Exhibit B (Equipment to

be provided by Sponsor) (“Equipment”) in accordance with the terms of the Agreement.

4. Compensation. Sponsor shall pay Institution in accordance with the Budget attached hereto and

incorporated herein as Exhibit A (Budget Summary and Payment Schedule) and with the terms of

the Agreement.

5. Study Term. This Statement of Work shall be effective upon the Effective Date and shall terminate on

the earlier of: (i) one (1) year from the Effective Date, if there is no subject enrollment at Institution

under this Statement of Work; or (ii) upon completion of the Study at Institution (the “Study Term”),

unless terminated earlier pursuant to the terms of the Agreement.

6. Notices.

(a) Routine communications regarding the conduct of the Study shall be sent to the Sponsor

individual identified by Institution to Sponsor as the primary contact for the Study (“Sponsor Study

Contact”).

(b) Communications related to the replacement of the individuals identified on FDA Form 1572 shall

be made by email, mail, or recognized national or international courier and shall be sent to the

Sponsor Study Contact [If AbbVie is the party, please include the following; otherwise

please delete or include the appropriate name] with a copy to Assistant Director, Outsourcing,

AbbVie Research and Development, Dept. R479, Bldg. AP04, 1 N. Waukegan Road, North

Chicago, Illinois 60064, email: pamela.[email protected].]

and be sent by recognized national or international overnight courier or registered or certified

mail, postage prepaid, return receipt requested, or delivered by hand to the legal notice address

set forth below.

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

If to Institution: If to Principal Investigator:

See Appendix A for the name and address of an

administrative contact for each Institution.

With a copy to:

The University of Texas System

Office of General Counsel

201 West 7th Street

Austin, TX 78701

ATTN: OGC Intellectual Property Assistant

General Counsel and IP Legal Expert

Insert Name

Insert Title

Insert Address

Insert City, State Zip

If to Sponsor:

If to Sponsor (legal notices):

[If AbbVie is the Sponsor, include the

following. Otherwise, insert applicable

notices recipient.]

Assistant Director, Outsourcing

Dept. R479, Bldg. AP04

AbbVie Inc.

1 N Waukegan Road

North Chicago, IL 60064

[If AbbVie is the Sponsor, include the

following. Otherwise, insert applicable

notices recipient.]

Divisional Vice President and

Associate General Counsel, Legal R&D, Alliance

Management and Transactions

AbbVie Inc.

Dept. V323, Bldg. AP34

1 North Waukegan Road

North Chicago, IL 60064-6011

Legal notices under this Statement of Work shall be deemed to be duly given: (i) when delivered

by hand; (ii) two (2) days after deposit with a recognized national or international courier; or (ii) on

the delivery date indicated in the return receipt for registered or certified mail. A party may change

its legal notice address immediately by sending written notice to the other party’s legal notice

address as set forth in this Section 6 of this Statement of Work.

7. Counterparts. This Statement of Work may be executed in any number of counterparts, each of which

shall be deemed to be an original, and all of which together shall constitute one and the same

agreement. Each party acknowledges that an original signature or a copy thereof transmitted by

facsimile or by PDF shall constitute an original signature for purposes of this Statement of Work.

8. Entire Agreement. This Statement of Work including, without limitation, all Exhibits hereto and the

Agreement contain the entire understanding of the parties with respect to the subject matter herein

and supersedes all previous agreements and undertakings with respect thereto. In the event of a

conflict between the provisions of the Protocol and the terms and provisions of this Statement of Work

or any Exhibits hereto, the Protocol shall control with respect to matters of science, medical practice

and Study subject safety. In all other matters, the terms and provisions of this Statement of Work

shall control. In the event of any conflict between the terms and provision of this Statement of Work

and those of the Agreement, the terms and provisions of the Agreement shall control, unless this

Statement of Work specifically acknowledges the conflict and expressly states that the conflicting

term or provision found in this Statement of Work controls for this Statement of Work only. This

Statement of Work may be modified only by written agreement signed by the parties to this Statement

of Work.

IN WITNESS WHEREOF, the parties have caused this Statement of Work to be executed by their duly

authorized representatives.

INSERT ABBVIE LEGAL ENTITY NAME INSERT CAMPUS

By: By: DRAFT – NOT FOR SIGNATURE

Name: Name:

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

Title: Title:

Date: Date:

I have read the Agreement and this Statement o

Work and acknowledge the obligations under the

provisions of the Agreement and this Statement o

Work.

By: DRAFT – NOT FOR SIGNATURE

Name:

Insert Name of Principal Investigator

Title: Principal Investigator

Date:

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

EXHIBIT A TO STATEMENT OF WORK

BUDGET SUMMARY AND PAYMENT SCHEDULE

(See accompanying PDF attachment)

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

EXHIBIT B TO STATEMENT OF WORK

EQUIPMENT TO BE PROVIDED BY SPONSOR

Manufacturer Model # Basic Description Replacement Value

Intentionally omitted – Sponsor will not be providing any equipment for this Study

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

EXHIBIT A-2

ABT-199 STATEMENT OF WORK TEMPLATE

This Statement of Work (“Statement of Work”), effective as of the full execution hereof (“Effective Date”) is

is entered into by and between Insert Name of UT Campus(es) (“Institution”) and AbbVie Inc. (“AbbVie”),

and is issued under that certain Master Clinical Study Agreement (AbbVie Contract Number C103262)

effective Insert Date MCSA was fully executed (the “Agreement”) by and between AbbVie and The

University of Texas Health Science Center at Houston; The University of Texas Health Science Center at

San Antonio, The University of Texas Health Science Center at Tyler; The University of Texas Medical

Branch at Galveston; The University of Texas Southwestern Medical Center; The University of Texas Rio

Grande Valley and The University of Texas at Austin. This Statement of Work includes the terms and

conditions of the Agreement, which are hereby incorporated herein by reference.

WHEREAS, Institution acknowledges that AbbVie has advised Institution that AbbVie has a collaboration

agreement with Genentech Inc. (“Genentech”) relating to the AbbVie product ABT-199 (the “Study

Product”) and the Study will involve use of the Study Product. This AbbVie-Genentech collaboration

agreement imposes certain non-negotiable conditions on conduct of the Study and use of the Study

Product as set forth below. Retention by AbbVie of Institution to conduct the Study described below is

conditioned on Institution's agreement to these conditions. Genentech is an intended third party

beneficiary of this Statement of Work and, for purposes of this Statement of Work, the Agreement.

NOW, THEREFORE, the parties hereby agree as follows:

1. Protocol. The Study is to be conducted in relation to the Study Product pursuant to Protocol No. Insert

Protocol No. entitled “Insert Protocol Title,” which may be amended from time to time (the “Protocol”),

the terms of the Agreement and this Statement of Work.

2. Principal Investigator. AbbVie is entering into this Statement of Work with the understanding that

Insert Investigator's Name (“Principal Investigator”), an employee of the Insert Campus, shall be

responsible on Institution's behalf for the conduct of the Study.

3. Equipment. AbbVie will provide Institution with the equipment described in Exhibit B (Equipment to

be provided by AbbVie) (“Equipment”) in accordance with the terms of the Agreement.

4. Compensation. AbbVie shall pay Institution in accordance with the Budget attached hereto and

incorporated herein as Exhibit A (Budget Summary and Payment Schedule) and with the terms of

the Agreement.

5. Pursuant to Section 24 of the Agreement and only with respect to this Statement of Work, the first

two sentences of Section 10(b) (Publicity) of the Agreement shall be replaced in its entirety and

superseded by the following language:

“Neither party shall use the trademark, servicemark, or logo of the other party or the other party’s

affiliates or of Genentech in any publicity, advertising, or other information intended to be

disseminated to any third person or to the general public without the prior written consent of such

other party or of Genentech, as applicable. Neither party shall use the name of the other party or

the other party’s affiliates or of Genentech in any publicity, advertising, or other information

intended to be used for commercial or promotional purposes without the prior written consent of

such other party or of Genentech, as applicable.”

6. Pursuant to Section 24 of the Agreement and only with respect to this Statement of Work, Section

11(b) (Intellectual Property) shall be superseded and replaced in its entirety by the following

language:

“Any invention, discovery (whether patentable or not), conceived or first reduced to practice,

made, generated or developed by Institution or Institution Personnel that is made in the conduct

of the Study or made from use of any of the Study Materials provided hereunder, or from using

biological samples obtained from the Study subjects as part of the Study (collectively, “Intellectual

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

Property”) shall be promptly disclosed to AbbVie, and Institution hereby assigns to AbbVie all of

Institution’s rights, title, and interest in and to such Intellectual Property. Inventorship of

Intellectual Property constituting inventions shall be determined according to U.S. patent laws.

Upon AbbVie’s request and at AbbVie’s expense, Institution shall require Institution Personnel to

execute, or cause to have executed such documents and to take such other reasonable actions

to obtain, record or enforce patents, assignments or other proprietary protection in AbbVie’s and

Genentech’s name covering such Intellectual Property. Subject to Section 8 (Confidentiality) and

Section 12 (Publications and Presentations), AbbVie grants to Institution a free, non-transferable,

non-sublicensable, non-exclusive license to use any Intellectual Property solely for its internal and

non-commercial research, teaching, patient care purposes and for publication purposes.”

7. Pursuant to Section 24 of the Agreement and only with respect to this Statement of Work, the first

sentence of Section 12(c) (Publications and Presentations) of the Agreement shall be superseded

and replaced in its entirety by the following sentence:

“Following the earliest of: (i) AbbVie’s Summary Publication; or (ii) eighteen (18) months after

completion, abandonment or termination of the Study at all Study sites, Institution and Institution

Personnel shall have the right to prepare and submit for public disclosure Institution’s Study data

through a Scientific Publication or other public disclosure (an “Institution Publication”).”

8. Study Term. This Statement of Work shall be effective upon the Effective Date and shall terminate on

the earlier of: (i) one (1) year from the Effective Date, if there is no subject enrollment at Institution

under this Statement of Work; or (ii) upon completion of the Study at Institution (the “Study Term”),

unless terminated earlier pursuant to the terms of the Agreement.

9. Notices.

(a) Routine communications regarding the conduct of the Study shall be sent to the AbbVie individual

identified by Institution to AbbVie as the primary contact for the Study (“AbbVie Study Contact”).

(b) Communications related to the replacement of the individuals identified on FDA Form 1572 shall

be made by email, mail, or recognized national or international courier and shall be sent to the

AbbVie Study Contact with a copy to Assistant Director, Outsourcing, AbbVie Research and

Development, Dept. R479, Bldg. AP04, 1 N. Waukegan Road, North Chicago, Illinois 60064,

email: [email protected]m.

and be sent by recognized national or international overnight courier or registered or certified

mail, postage prepaid, return receipt requested, or delivered by hand to the legal notice address

set forth below.

If to Institution: If to Principal Investigator:

See Appendix A for the name and address of an

administrative contact for each Institution.

With a copy to:

The University of Texas System

Office of General Counsel

201 West 7th Street

Austin, TX 78701

ATTN: OGC Intellectual Property Assistant

General Counsel and IP Legal Expert

Insert Name

Insert Title

Insert Address

Insert City, State Zip

If to AbbVie:

If to AbbVie (legal notices):

Assistant Director, Outsourcing

Dept. R479, Bldg. AP04

AbbVie Inc.

1 N Waukegan Road

North Chicago, IL 60064

Divisional Vice President and

Associate General Counsel, Legal R&D, Alliance

Management and Transactions

AbbVie Inc.

Dept. V323, Bldg. AP34

The University of Texas System

September 27, 2016

CONFIDENTIAL

Template: Master Clinical Study Agreement – 04MAR2015

Document Title: C103262 - Final

Version: 9/27/2016 8:56 AM, 66,985

Five Year Term

Includes StemCentrx as Affiliate

1 North Waukegan Road

North Chicago, IL 60064-6011

Legal notices under this Statement of Work shall be deemed to be duly given: (i) when delivered by

hand; (ii) two (2) days after deposit with a recognized national or international courier; or (ii) on the

delivery date indicated in the return receipt for registered or certified mail. A party may change its

legal notice address immediately by sending written notice to the other party’s legal notice address as

set forth in this Section 9 of this Statement of Work.

10. Counterparts. This Statement of Work may be executed in any number of counterparts, each of which

shall be deemed to be an original, and all of which together shall constitute one and the same

agreement. Each party acknowledges that an original signature or a copy thereof transmitted by

facsimile or by PDF shall constitute an original signature for purposes of this Statement of Work.

11. Entire Agreement. This Statement of Work including, without limitation, all Exhibits hereto and the