The Non-UM Institution Or Individual

SUBCONTRACT 1

SUBCONTRACT between The University of Miami And

[the non-UM Institution or individual]

This subcontract shall constitute an agreement if all of the following apply:

a) the [non-UM institution or investigator] is engaged in UM research; and b) the study is supported, at least in part, by extramural grants or sponsors; and c) UM is the prime awardee of the extramural funds; and d) the [non-UM institution] has its own FWA on file with OHRP and has its own IRB

This is an agreement to engage in collaborative research and a cost-reimbursement agreement between The University of Miami, hereinafter, “Miami,” and hereinafter, “Subcontractor,” for the performance of services on a project entitled, hereinafter, “Project.” This Agreement is funded under the authority of Prime Award Number appended hereto as Exhibit A. The Prime Award CFDA (Federal) number (if applicable) is: The Prime Award CSFA (Florida) number (if applicable) is: If this agreement is awarded from American Recovery and Reinvestment Act (ARRA) funds it will be indicated here

I. SCOPE OF AGREEMENT. The Subcontractor shall provide the necessary personnel, equipment, facilities and supplies to perform the services described in the Statement of Work and appended hereto as Exhibit B. The Principal Investigator at Miami shall be . Subcontractor agrees that it or persons under its employ or its agents, including the Principal Investigator at the Subcontractor (collectively the “Subcontractor”) will be the only persons performing services under this Agreement.

II. REPORTS AND DELIVERABLES. Subcontractor shall submit performance reports as mutually agreed between Miami’s Principal Investigator and Subcontractor’s Principal Investigator and incorporated in the Statement of Work, appended as Exhibit B. Final performance, invention, property, invoices and/or financial reports shall be submitted within 60 days of the end date stated in section III.

III. PERIOD OF PERFORMANCE. Performance of this Subcontract shall begin and shall not extend beyond the estimated completion date of unless further extended by amendment of the Subcontract, which shall be in writing and signed by all parties to this Agreement.

IV. COST PRINCIPLES AND ALLOWABLE COSTS. Subcontractor costs under this agreement must comply with the following principles:

of 18 International Subcontract (7/17/09) SUBCONTRACT 1

 Allowability – costs must be reasonable and necessary for the performance of the project.  Allocability – costs must bear a direct relationship and directly benefit the performance of the Project.  Consistency – costs must be given consistent treatment through application of those generally accepted accounting principles appropriate to the circumstances.  Conformance – costs must conform to any limitations or exclusions set forth in federal circulars (see Attachment 1), Federal laws, State or local laws, sponsored agreements or other governing regulations as to types or amounts of cost items.  Cost must be net of applicable credits.  Costs must be documented in accordance with US Office of Management and Budget (OMB) Circular A-110, “Uniform Administrative Requirements” for non-profit organizations, including institutions of Higher Education, Hospitals and Other Nonprofit Organizations or the A-102, “Common Rule for State and Local Governments,” as applicable.

V. METHOD OF PAYMENT. The total of this subcontract shall not exceed $______for the period stated in Section III. Reimbursement by Miami will be in accordance with the Subcontract budget as submitted by Subcontractor and approved by Miami and attached hereto as Exhibit C and provided that:

1. Total costs does not exceed the total amount stipulated in this Agreement, and;

2. Such costs are incurred in accordance with the applicable cost principles and Subcontractor’s established policies and procedures.

Miami shall not, in the absence of a formal amendment to this Subcontract, be obligated to reimburse the Subcontractor for costs in excess of the total amount specified in this section and the budget attached as Exhibit C.

Subcontractor shall submit invoices to Miami for reimbursement at least quarterly, but no more often than monthly. Costs must be identified on each invoice by cost category similar to the budget in Exhibit C, in sufficient detail for post audit review. Invoices, in duplicate, shall be submitted on Subcontractor’s billing forms to the Miami Principal Investigator for review, approval and subsequent submission to Miami’s Accounts Payable Office for payment.

The Miami account number, , assigned to this agreement must be included in the invoice.

Miami will make payment on all invoices submitted in accordance with the terms of this Agreement. The final invoice, clearly marked FINAL, must be submitted within 60 days after the termination of this Agreement. Miami’s payment of the final invoice shall constitute complete satisfaction of all of Miami’s obligations under this Agreement and releases and discharges Miami from all further claims and obligations under this Agreement. In the event that Subcontractor does not submit a final invoice within 60 days of the end of this agreement, any remaining dollar balance in the agreement will revert to Miami.

VI. REBUDGETING OF FUNDS. All applicable provisions for rebudgeting of the Prime Award, Exhibit A, shall be binding upon the Subcontractor and the Subcontractor agrees to comply with same as follows:

(i) Where the prime award is from Federal sources and awarded under Federal Demonstration Partnership (FDP) terms, Subcontractors entitled to the authorities under the FDP as listed in the web site http://thefdp.org/, are subject to the same rebudgeting authorities allowed by the Prime Award.

(ii) Where the Subcontractor is not entitled to the authorities under the FDP, or the prime award is not from Federal sources; Subcontractor is authorized to rebudget funds between the cost categories reflected in the budget (Exhibit C) up to an amount equal to ten percent (10%) of the total approved budget. Revisions in excess of this limit or involving the addition of budget categories require the prior written permission of Miami.

VII. GRANT-RELATED INCOME. The Subcontractor agrees to utilize any grant-related income received in connection with this agreement to offset expenditures of the Project unless the Prime Award specifies a different method of use. The Subcontractor further agrees to maintain appropriate records on the receipt and utilization of such income and to include this information in the invoices submitted to Miami in order to enable Miami to fulfill its responsibility under the Prime Award.

VIII. PRINCIPAL INVESTIGATOR and AUTHORIZED OFFICIAL

For Miami

i. Principal Investigator Address Telephone City, State Fax Zip Email Address:

ii. Authorized Institutional Official Address Telephone City, State Fax Zip Email Address:

For Subcontractor

i. Principal Investigator * Address Telephone City, State Fax Zip Email Address:

*A change in the Subcontractor’s Principal Investigator requires prior written approval of Miami.

ii. Authorized Institutional Official Address Telephone City, State Fax Zip Email Address:

IX. ACCOUNTS, RECORDS and AUDITS. The Subcontractor shall maintain records and accounts necessary to assure a proper accounting of the funds awarded under this subcontract. Miami, and/or the Prime Awarding agency, or any of their duly authorized representatives, shall have access to any books, documents, computer and paper records of Subcontractor which are directly pertinent to this subcontract. Such access to documents and records will be for the purpose of conducting audits,

examinations, excerpts and transcriptions until the expiration of three years after the end of the budget period, or longer, if stipulated in the Prime Award. If an audit begins, such documents and records must be maintained until the audit is completed and all resulting questions are resolved.

The Subcontractor assumes sole responsibility for reimbursement to Miami, or to the federal, state, local government or private agency, whichever is appropriate, of a sum of money equivalent to the amount of any expenditures disallowed or rescinded plus any penalties or fines related to the disallowance. Disallowances can be the result of an adverse finding due to an audit, examination or inquiry performed under current regulations or requested by Miami, the funding agency, or any other authorized agency. Adverse findings are generally due to expenditures made not deemed in compliance with the applicable cost principles and/or regulations of the funding agency, the provisions of the Subcontract and/or the Prime Award. Amounts rescinded can be the result of actions of the Prime Awarding agency, or Miami.

As a condition of receiving this Subcontract, Subcontractor acknowledges that federal or state awarding agency, their audit agencies, and Miami’s auditors and/or internal auditors may be granted access to records and documents of Subcontractor and Subcontractor’s independent auditors workpapers as necessary to comply with audit requirements as stated in the next section.

Audits

Federal Prime Awards

Subcontractors who expend $500,000 or more in Federal awards in a fiscal year, are required to have an audit performed in accordance with the provisions of Office of Management and Budget (OMB) Circular A-133, as revised “Audits of States, Local Governments, and Non-Profit Organizations.” The Subcontractor agrees to provide Miami with copies of its independent A133 auditors’ report. A certification signed by the Subcontractor that an A- 133 audit was completed and stating that there were no material findings in the audit report, or if immaterial findings were found, that they had no effect on this Subcontract can be substituted for the audit report. If there are material findings, or if an immaterial finding affects this subcontract, the Subcontractor will provide the full audit report, including the specific audit finding(s), the Subcontractor’s response to the auditor’s finding including the plan for future corrective action and a follow-up letter after six months indicating the status of the corrective action plan. Either the independent auditors’ report, or the substitute certification will be sent within 30 days of completion of the audit to: Director, Sponsored Programs-Financial Administration, Controller’s Office, P.O. Box 248106, Miami, Florida, 33124-1424, or fax to 305-284-4850.

State of Florida Prime Awards: Subcontractors who expend $300,000 or more of State of Florida financial assistance in a fiscal year, are required to have a Fl. State single or project-specific audit for such fiscal year in accordance with Section 215.97, Florida Statutes; applicable rules of the Executive Office of the Governor and the Comptroller; and Chapter 10.650 (nonprofit and for-profit organizations), Rules of the Auditor General. The Subcontractor agrees to provide Miami with copies of its independent Single Audit auditors’ report. In cases of non-compliance with State of Florida laws and regulations, the Subcontractor will provide the specific audit finding(s) together with the Subcontractor’s response to the auditors’ finding including the plan for future corrective action and a follow-up letter after six months indicating the status of the corrective action plan. The independent auditors’ report, will be sent within 30 days of receipt to: Director, Sponsored Programs-Financial Administration, Controller’s Office, P.O. Box 248106, Miami, Florida, 33124-1424, or fax to 305-284-4850.

X. TERMINATION. If at any time the Primary Agency terminates the Primary Award, this Subcontract shall also be terminated upon receipt by the Authorizing Official of the Subcontractor of written notice to that effect from Miami.

Either party may terminate this agreement upon thirty (30) days written notice to the other. Miami may immediately terminate this Agreement in the event that Subcontractor fails to comply with the terms of the study protocol or otherwise breaches any terms or provisions of the Agreement in any manner.

This Agreement may also be terminated on prior written notice if any of the following conditions occur:

(a) By either party, if authorization and approval to perform the study in the United States is withdrawn by the FDA;

(b) By Miami, if animal, human and/or toxicological test results, in the opinion of Miami, support termination of the study;

(c) By either party, if the emergence of any adverse reaction or side effect with the study drug administered in the study is of such magnitude or incidence, in the opinion of either party, to support termination;

(d) By Miami, if during the course of this Agreement, the Subcontractor, its Principal Investigator or any employee, agent or representative of the Subcontractor or its Principal Investigator performing services hereunder is debarred or delisted or receives notice of

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 any action or threat with respect to its debarment or delisting action under the provisions of the Generic Drug Enforcement Act or by the FDA; or

(e) By Miami, if during the course of this Agreement it determines in its opinion that the study is not worth pursuing in view of its corporate objectives.

Upon receipt of notice of termination of the study or the Agreement from Miami or the Subcontractor, the Subcontractor and its Principal Investigator shall immediately cease enrolling patients in the applicable study(ies) and, to the extent medically and psychologically permissible, cease administering the study drugs and/or conducting interventions on patients already enrolled in the study(ies). The Subcontractor and its Principal Investigator shall use all reasonable efforts upon the request of Miami, to prepare case report forms for all patient participants who have been enrolled in any terminated study. In the event of termination for any reason, Subcontractor and its Principal Investigator agree to abide by and perform any procedures as may be required by Miami or the Sponsor to follow or treat patients once the study has been terminated.

In the event of such terminations, Subcontractor shall take all reasonable steps to cancel further costs in connection with this Project. Subcontractor shall be entitled to reimbursement for costs and non-cancelable obligations incurred prior to the effective date of termination, except in no event shall such reimbursement exceed the total amount stipulated in section V.

Within sixty (60) days after termination, Subcontractor shall submit a final invoice to Miami for review and upon approval by the Miami Principal Investigator and subsequent submission of the invoice to the Accounts Payable Office, Miami shall promptly make payment to Subcontractor of the amount due.

XI. ASSIGNMENT. This Subcontract may not be assigned by the Subcontractor in whole or in part without the prior written consent of Miami.

XII. LIABILITY AND INSURANCE.

(a) The Subcontractor shall be solely responsible for the payment of any and all claims for loss, personal injury, death, property damage, or otherwise, arising out of any act or omission of its employees or agents in connection with the performance of this work. (b) Miami and Subcontractor agree to indemnify, defend and hold harmless Miami, its trustees, IRB members, officers, directors, faculty, agents, and employees, from and against any and all liabilities, claims, losses, lawsuits and judgments and/or expenses including attorney’s fees through the appellate levels, which may be incurred by or brought against Miami or its trustees, IRB members, officers, directors, faculty, agents, and employees (1) as a result of, arising out of, or in connection with any decisions, actions or omissions taken by the Miami IRB while acting as an IRB of record for the research conducted hereunder or (2) arising directly or indirectly from or reasonably attributable to any negligent act or omission or intentional wrongdoing of Subcontractor, persons under its control, its agents or employees.

(c) In the event any such claim is made or lawsuit is initiated, Subcontractor agrees to immediately notify Miami in writing, and to cooperate fully in the defense of such lawsuit.

(d) Miami agrees to indemnify, defend and hold harmless the Subcontractor, its trustees, officers, directors, faculty, agents, and employees from and against any and all liabilities, claims, losses, lawsuits and judgments and/or expenses, including attorney’s fees through the appellate levels, which may be incurred by or brought against the Subcontractor, arising directly from any negligent act or omission or intentional wrongdoing of University or employees.

(e) Insurance

(i) Miami and Subcontractor each agree to carry and keep in force, each at its own expense, professional liability insurance or a self insurance plan with limits not less than $1,000,000 per occurrence, $3,000,000 aggregate to cover liability for damages on account of bodily or personal injury or death to any person, or damage to property of any person. Such professional liability insurance or self insurance plan shall include coverage for clinical research related services and medical services.

(ii) Subcontractor and Miami each agree to carry and keep in force, each at its expense, general liability insurance or a self insurance plan with limits not less than $1,000,000 per occurrence, $2,000,000 aggregate. Subcontractor’s general liability insurance shall include product liability insurance coverage. Subcontractor’s general liability insurance shall contain an endorsement naming Miami as an additional insured with respect to this Agreement.

(iii) Subcontractor and Miami shall furnish evidence of such insurance prior to execution of this Agreement.

(iv) Such insurance shall not be cancelled for any cause without at least thirty (30) days prior written notice to the other party.

(v) The Subcontractor’s insurance shall be primary to any insurance or self insurance plan which Miami may have.

(vi) Each party shall be responsible for maintaining worker’s compensation coverage in accordance with applicable law.

(f) Limitation of Liability. NO PARTY TO THIS AGREEMENT SHALL, IN ANY EVENT, BE LIABLE TO ANY OTHER PARTY FOR INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, COSTS, EXPENSES, CHARGES OR CLAIMS, EXCEPT TO THE EXTENT THAT INDEMNIFIABLE LOSSES RESULTING FROM A THIRD PARTY CLAIM INCLUDE INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES, COSTS, EXPENSES, CHARGES OR CLAIMS OF THE THIRD PARTY AND THEN, ONLY TO THE EXTENT OF SUCH INDEMNIFIABLE LOSSES, SUBJECT HOWEVER, TO ALL OF THE LIMITATIONS SET FORTH ELSEWHERE IN THIS AGREEMENT.

(g) The provisions of this Section XII shall survive termination of this Agreement.

XIII. INDEPENDENT CONTRACTOR. The Subcontractor agrees that it is an independent contractor and not an agent, employee of, partner, or joint venture with Miami.

XIV. CLASSIFIED, RESTRICTED AND PROPRIETARY DATA. Miami agrees to apprise Subcontractor in writing as to any information or items made available as part of this Subcontract which are classified, restricted or proprietary data either in United States Government classifications or according to Miami’s classification. The Subcontractor agrees that any such classified, restricted or proprietary data will not be disclosed to other parties without express approval, in writing, from Miami. The Subcontractor further agrees that any such material, if furnished, will be returned to Miami at its request or upon termination of this agreement.

During the course of the study, certain confidential information and materials may be disclosed to the Subcontractor or its Principal Investigator. It is agreed that such materials, information and data, except that which is or becomes public knowledge through means other than the unauthorized

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 disclosure by the Subcontractor or its Principal Investigator, constitutes the property of Miami, and that neither the Subcontractor nor its Principal Investigator will disclose such information during or after the term of the study without the prior written consent of Miami. All such materials, information, and data in Subcontractor’s or its Principal Investigator’s custody shall be promptly delivered to Miami at its request or upon termination of the study. Subcontractor and Its Principal Investigator shall ensure that all employees or agents of Subcontractor shall be bound by the terms of this paragraph.

XV. CHOICE OF LAW, JURISDICTION AND VENUE. This Agreement shall be considered as having been entered into in the State of Florida, United States of America, and shall be construed and interpreted in accordance with the laws of that state. In any action or proceeding arising out of or relating to this Agreement (an “Action”), each of the parties hereby irrevocably submits to the jurisdiction of any federal or state court sitting in Miami, Florida, and further agrees that any Action shall be heard and determined in such Florida federal court or in such state court. Each party hereby irrevocably waives, to the fullest extent it may effectively do so, the defense of an inconvenient forum to the maintenance of any Action in Miami, Florida.

XVI. INVENTIONS AND DISCOVERIES 1. Definitions

a. "Intellectual Property" means all forms of intellectual property under the laws of any state or country including, but not limited to, patentable inventions, patentable plants, copyrightable works, mask works, novel plant varieties, trademarks, service marks and trade secrets.

b. "Subcontractor Intellectual Property" means Intellectual Property invented, developed, created or discovered solely by one or more employees of Subcontractor in connection with the performance of this Agreement.

c. "Miami Intellectual Property" means Intellectual Property invented, developed, created or discovered solely by one or more employees of Miami in connection with the performance of this Agreement.

d. "Joint Intellectual Property" means Intellectual Property invented, developed, created or discovered jointly by one or more employees of Subcontractor in connection with the performance of this Agreement and one or more employees of Miami in connection with the performance of this Agreement.

2. Ownership

a. Subject to the rights of the United States Government or any other sponsor and any limitations imposed by any applicable law or regulation, all right and title to Subcontractor Intellectual Property shall belong to Subcontractor and shall be subject to the terms and conditions of this Agreement; however, Miami shall have an irrevocable, fully paid up, royalty free non-exclusive license to use such Subcontractor Intellectual Property for Miami's internal research and educational purposes only.

b. Subject to the rights of the United States Government or any other granting agency, all right and title to Miami Intellectual Property shall belong to Miami and shall not be subject to the terms and conditions of this Agreement.

c. Subject to the rights of the United States Government or any other granting agency, all right and title to Joint Intellectual Property shall belong jointly to Subcontractor and Miami. Subcontractor and Miami shall enter into good faith negotiations to agree on the

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 procedure to be used for the protection of Joint Intellectual Property and commercialization of the Joint Intellectual Property.

d. Nothing in this agreement shall affect the ownership rights either party may have to Intellectual Property previously owned by each party or not conceived or reduced to practice under this Agreement

Subcontractor shall provide Miami with written notice immediately upon discovering an Invention and Discovery made under this Agreement.

XVII. PROVISIONS OF THE PRIME AWARD. All applicable provisions including representations, certifications and flow down clauses of the Prime Award, and those included in Attachment 1 shall be binding upon the Subcontractor and the Subcontractor agrees to comply with the same. All required assurances of the Prime Award are incorporated herein by reference.

XVIII. ENTIRE AGREEMENT, WAIVERS AND AMENDMENTS, THIRD PARTY BENEFICIARY. This Agreement and attachments hereto contain the entire Agreement between the two parties. All modifications must be in writing and signed by the Principal Investigators AND the Authorized Officials of Miami and Subcontractor. No oral agreements or conversation with an officer or employee of either party shall affect or modify any of the terms and conditions of this Agreement. This Agreement is entered into by and between the parties hereto and for their benefit. There is no intent by either party to create or establish a third-party beneficiary status or rights in any third party to this Agreement.

XIX. STUDY CONDITIONS AND STANDARDS. Research will be conducted in accordance with the protocol attached hereto as Exhibit D, incorporated herein by reference, and hereafter referred to as the “study” or the “protocol”. The parties agree to comply with (and to cause their agents and investigators to comply with) the terms of the protocol, the Statement of Investigator (Form 1573) and any and all federal, international, state, local and institutional laws, rules, regulations and policies that may be applicable to the conduct of this study or that may provide additional protection for human subjects participating in research conducted hereunder, including but not limited to the United States Food and Drug Administration (“FDA”) Regulations 21 CFR Parts 50 and 56 and the United States Miami and Subcontractor (including its Principal Investigators), as the case may be, each agree to abide by all decisions, determinations and conditions imposed by its own reviewing institutional review board (“IRB”), as may be amended from time to time, and to accept the final authority and decisions of such IRB with respect to its own conduct of research hereunder, including but not limited to directives to terminate participation in designated research activities conducted hereunder. The Subcontractor and its Principal Investigator shall be responsible for complying with any locally required authorizations and institutional policies and regulations applicable to their participation in the study and in accordance with the Subcontractor’s federal-wide assurance (if applicable).

The Subcontractor and its Principal Investigator has reviewed: (1) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (see http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm) or other internationally recognized equivalent (see section B.1. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm); (2) DHHS regulations for the protection of human subjects at 45 CFR 46 (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) or other procedural standards designated by a non-U.S. institution under its FWA (see section B.3. of the Terms of the Federalwide Assurance (FWA) for International (Non-U.S.) Institutions on the OHRP website at http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm); (3) The Federal-Wide Assurance (FWA) of Miami (see https://hsro.med.miami.edu/eprost/Rooms/DisplayPages/LayoutInitial? Container=com.webridge.entity.Entity%5BOID%5BD3CCE8B6FAEDB94FA19B59C42C04A85B

%5D%5D); and (4) Miami’s Policies and Procedures for the protection of human participants (see https://hsro.med.miami.edu/eprost/Rooms/DisplayPages/LayoutInitial? Container=com.webridge.entity.Entity%5BOID%5B332A415E0D2156419EF987EAAF32757D%5D %5D).

The Subcontractor and its Principal Investigator understand and accept the responsibility to comply with the standards and requirements stipulated in the documents referenced in the preceding paragraph and to protect the rights and welfare of human subjects involved in the research conducted hereunder. The Subcontractor and its Principal Investigator acknowledge that the subjects’ rights and welfare must take precedence over the goals and requirements of the research.

The Subcontractor and its Principal Investigator represent that, to the best of its knowledge, it is not now under any agreement to conduct clinical research studies or interventions or any other agreement which could conflict with its obligations hereunder, and the Subcontractor and its Principal Investigator agree not to knowingly enter into any conflicting agreements during the term of this Agreement.

XX. TREATMENT AND RECORDS. If applicable, Subcontractor and its Principal Investigator shall obtain required clinical information, obtain tissues, and complete all medical records as necessary in the usual treatment of the patient participant and as may be required by the terms of the protocol. Any deviation from the protocol must be approved by Miami prior to such deviation. Subcontractor and its Principal Investigator shall make available all medical records and original source documentation to Miami or its Principal Investigator as may be requested by Miami or its Principal Investigator.

XXI. INSTITUTIONAL REVIEW BOARD AND TRAINING. Unless the University of Miami has previously agreed to act as the sole IRB of record for the research in which the [non-UM institution] is engaged pursuant to an IRB Authorization Agreement, or unless the University of Miami has previously agreed to designate the IRB for the 'non-UM institution' as the IRB of record for the research, the following conditions shall apply.

Each of the Subcontractor and Miami shall be responsible for designating its own IRB under its own FWA, in accordance with the DHHS Office for Human Research Protections (“OHRP”) and FDA regulations and administrative guidance, as the IRB of record for the study, and shall share oversight of the research undertaken hereunder. For the avoidance of doubt, the Miami IRB shall not be the IRB of record for any research conducted at or by the Subcontractor or its Principal Investigator other than the study conducted pursuant to this Agreement. Each such IRB shall be responsible for reviewing the research undertaken hereunder (including reviewing and approving the consent form, the protocol, and other aspects of the research and providing continuing oversight of the research for the duration of the study) in accordance with such regulations and guidance and other applicable federal and state laws and regulations governing IRBs and research with human beings, and abiding by the terms of its assurance and its responsibilities as set forth in 45 CFR 46. Miami and Subcontractor (including its Principal Investigator), as the case may be, each agree to abide by all decisions, determinations and conditions imposed by its own reviewing IRB (including assuring that such IRB approval does not lapse), as may be amended from time to time, and to accept the final authority and decisions of such IRB with respect to its own conduct of research hereunder, including but not limited to directives to terminate participation in designated research activities conducted hereunder.

The Subcontractor and its Principal Investigator shall ensure, and certify to Miami, that all investigators and personnel conducting research hereunder receive proper initial and continuing education on the requirements related to human subjects protection. Subcontractor and its Principal Investigator shall ensure that the investigators and other staff at Subcontractor who are conducting studies are appropriately qualified and meet Miami’s standards for eligibility to conduct research and have read Miami’s policies and procedures for conducting human subjects research. Consider provision whereby Miami is compensated for sending representatives to monitor study under

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 local conditions (OHRP requirement to monitor study). Payment terms such as monthly billings, last invoice after X days, etc. (as in paragraph V) would need to be added.

XXII. COOPERATION. The Subcontractor and its Principal Investigator acknowledge and agree to cooperate in Miami IRB’s dual responsibility for initial and continuing review, record keeping, reporting, and certification for the research conducted hereunder (notwithstanding that the Miami IRB shares oversight with an IRB for the Subcontractor). The Subcontractor and its Principal Investigator will provide all information requested by the Miami IRB within 15 business days of receipt of the request. Subcontractor and its Principal Investigator agree to allow the appropriate Miami IRB to inspect its facilities, the progress of the study and any and all documentation or material as may be deemed necessary by the Miami IRB. Miami, through its authorized representatives, has the right at all reasonable times, to inspect or otherwise evaluate the work performed or being performed by Subcontractor and its Principal Investigator and the information and results derived from or relating to it. All documentation from each study (including case report forms, source documents and clinical information generated as a result of the study) will be promptly and fully disclosed, as permitted hereunder, to Miami by the Subcontractor upon reasonable request and also shall be made available at the Subcontractor’s site upon request for inspection, copying, review and audit at reasonable times by representatives of Miami and the FDA or other regulatory agencies.

The Subcontractor and its Principal Investigator agree to notify Miami of all communications to and from the FDA, OHRP and other applicable federal and state regulatory agencies regarding the protocol or in reference to any matter that directly impacts Miami’s review of protocols. The Subcontractor and its Principal Investigator will promptly notify Miami of any proposed regulatory inspection relating to the research conducted hereunder, permit representatives of Miami to be present during the inspection and promptly provide Miami with a copy of any report issued after the inspection. The Subcontractor and its Principal Investigator agree to take any reasonable steps requested by Miami as a result of a regulatory audit to cure any deficiencies in the case report forms or other documentation from the study. Documentation from each study, as further delineated in this Section and in the applicable protocol, shall be retained by the Subcontractor in accordance with applicable laws and regulations relating to clinical trial records, but for a minimum period of 5 years after the Miami IRB approval of the final report.

The Subcontractor and its Principal Investigator agree to promptly notify Miami (and provide supporting documentation and explanation, if applicable) of any of the following: the Subcontractor’s IRB’s (if applicable) approval, disapproval, termination, suspension or recommendations for modification of research conducted at the Subcontractor; instances of serious or continuing noncompliance with the federal regulations or the requirements and determinations of such IRB; and any other matter, including but not limited to site adverse events, subject complaints, unanticipated problems involving risks to subjects or deviations reported to such IRB by the investigators, that comes to the attention of such IRB that may adversely affect Miami’s compliance with applicable regulations and laws governing human subjects research.

XXIII. ENROLLMENT OF SUBJECTS AND INFORMED CONSENT. The Subcontractor and its Principal Investigator will not enroll subjects in research under this Agreement prior to review and approval by all IRBs of record. Prior to conducting any research under this study, Subcontractor and its Principal Investigator shall, when responsible for enrolling subjects, obtain, document and maintain records of informed consent for each such subject or each subject’s legally authorized representative as required under DHHS regulations at 45 CFR part 46 (or any other international or national procedural standards selected in the FWA for the Subcontractor) and stipulated by the IRB (unless the IRB has granted a waiver of informed consent). Such informed consent shall be in the form reviewed and approved by and on file with the Miami IRB.

XXIV. ADVERSE REACTIONS AND UNANTICIPATED PROBLEMS. Subcontractor and its Principal Investigator agree to promptly notify the Miami Principal Investigator and the Miami IRB by telephone or in writing as appropriate in the event of any serious adverse reaction of any participant

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 in this study or any unanticipated problems involving risks to subjects or others in research covered under this Agreement, but in no event later than five (5) days after such adverse reaction or unanticipated problem has occurred.

XXV. CHANGES TO THE RESEARCH. The Subcontractor and its Principal Investigator will report promptly to the Miami IRB any proposed changes in the research conducted under this Agreement, including but not limited to changes in personnel involved in the study. The Subcontractor and its Principal Investigator will not initiate changes in the research without prior Miami IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.

XXVI. HIPAA. The Subcontractor and its Principal Investigator agree to comply with all provisions of the Health Insurance Portability and Accountability Act of 1996 and regulations promulgated thereunder, as such law and regulations may be amended from time to time. The Subcontractor and its Principal Investigator agree to not use or further disclose protected health information (“PHI”), as defined under HIPAA, other than as permitted or required by an underlying agreement or as required by law. The Subcontractor and its Principal Investigator agree to use appropriate safeguards to prevent use or disclosure of PHI other than as provided for by this Agreement. Consider whether the Subcontractor is providing any services or otherwise accessing PHI so that the following sentence should be included: Simultaneous with the execution of this Agreement, the Subcontractor and its Principal Investigator shall enter into a Business Associate Agreement with Miami pursuant to the rules and regulations promulgated under HIPAA.

XXVII. ELIGIBILITY FOR FEDERAL HEALTH CARE PROGRAM. The Subcontractor represents and warrants that neither it nor any of its agents, employees or persons providing services for the study, including its Principal Investigator, has been convicted of a criminal offense related to health care and/or related to the provision of services paid for by Medicare, Medicaid or another federal health care program or excluded from participation in any federal health care program, including Medicare and Medicaid. Subcontractor and its Principal Investigator shall immediately notify Miami if Subcontractor or any such persons are at any time convicted or excluded. Miami reserves the right to terminate this Agreement immediately upon notification by Subcontractor or its Principal Investigator, or discovery by Miami, that Subcontractor or any such persons, including its Principal Investigator, has been so convicted or excluded. The Subcontractor and its Principal Investigator shall provide a certification to Miami that it has not been debarred under the Generic Drug Enforcement Act or delisted by the FDA or otherwise disqualified from participating in the research. The Subcontractor and its Principal Investigator hereby certify that it has not and will not use in any capacity the services of any individual, corporation, partnership or association which has been debarred or delisted. In the event that during the term of this Agreement, the Subcontractor or its Principal Investigator or its key personnel (i) becomes debarred or delisted, or (ii) receives notice of an action or threat of an action with respect to its debarment or delisting action, the Subcontractor or its Principal Investigator shall notify Miami immediately and immediately cease all activities relating to the study, and Miami shall have the right to automatically terminate the Agreement or agree with the Institution, in Miami’s sole discretion, on a substitute investigator who will assume full responsibility and perform all remaining activities under this Agreement.

XXVIII. MATERIALS TRANSFER. During the course of a study, Miami may transfer to the Subcontractor compounds, drugs, samples, reagents, devices, and related materials (collectively, “Materials”). Such transfer will be subject to the following conditions:

(a) The Materials shall be used by the Subcontractor and its Principal Investigator solely for purposes of such study and only as specified in the applicable protocol and this Agreement.

(b) The Subcontractor will not chemically modify the Materials.

(c) The Subcontractor accepts the Materials with the understanding that their pharmacological properties have not been completely investigated and therefore are not fully understood. The Subcontractor will handle the Materials accordingly and will inform Miami in writing of any life threatening or adverse reactions or effects experienced by persons administered or handling the Materials. In addition, the Subcontractor will promptly inform Miami of any test or study results which suggest: (1) a significant risk for humans, (2) mutagenicity, (3) teratogenicity or (4) carcinogenicity.

(d) In handling the Materials, the Subcontractor will comply with all applicable national and local laws and regulations including those governing disposal of hazardous substances.

(e) Each party shall comply with all applicable laws and regulations, including obtaining any applicable licenses, when transferring materials internationally.

(f) All sites sending samples to the University of Miami will obtain proper authorization under HIPAA from each participant in the research prior to sending protected health information to the University of Miami. Each site shall inform participants (either specifically or through a general reference to collaborators) of the University of Miami’s involvement and the fact that the University of Miami will be accessing their protected health information. The University of Miami (either specifically or through a general reference to collaborators) shall be authorized on each site’s HIPAA Authorization forms and Informed Consent documents to access the participants’ protected health information.

XXIX . COMPLIANCE

(a) The parties shall comply with all applicable laws and regulations in providing services or performing any act arising under or related to this Agreement.

(b) The parties are familiar with the U.S. Foreign Corrupt Practices Act (the “FCPA”), its prohibitions and purposes, and will not undertake any actions that may violate the FCPA. Accordingly, the parties hereby agree that:

(i) The parties will not employ/retain a person who is a governmental official or employee, including employees of government owned or government controlled corporations, agencies or bodies (such as health or medical institutions which are owned or controlled by the government), unless services retained are bona fide consulting work and – where required – retained official has obtained necessary approvals by competent authorities/employer to be retained for said consulting services;

(ii) The parties will not, directly or indirectly, make any payment, offer or promise to make any payment or transfer of anything of value to a governmental official or employee, or to any political party or any candidate for political office, with the purpose of influencing decisions favorable to either party and its business in contravention of the FCPA.

(iii) The parties will immediately advise the other party in writing in the event that any person employed by or associated with such party becomes such government official, political party official or candidate, unless services retained are bona fide consulting work and – where required –

retained official has obtained necessary approvals by competent authorities/employer to be retained for said consulting services;

(iv) The parties shall maintain true and accurate records necessary to demonstrate compliance with the Agreement (including the requirements of this Annex), and shall provide a written certification of such compliance upon simple request.

(v) Each party shall provide the other party or its representatives, with access to such records (financial and otherwise) and supporting documentation related to the subject matter of this Agreement as may be requested by such party in order to document or verify compliance with the provisions of this Agreement (including, but not limited to, the provisions of this Annex).

(c) Export Regulations. It is understood that the University is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities (including the Arms Export Control Act as amended and the Export Administration Act of 1979), and that its obligations hereunder are contingent on compliance with applicable United States export laws and regulations. Each Party shall adhere to the U.S. Export Administration Laws and regulations and shall not export or re-export any technical data or products of such technical data to any proscribed country listed in the U.S. export Administration Regulations, unless properly authorized by the U.S. Government. The transfer of certain technical data and commodities may require a license from the cognisant agency of the United States government and/or written assurances by the collaborating institution that the collaborating institution shall not export data or commodities to certain foreign countries without prior approval of such agency. The University neither represents that a license shall not be required, nor that if required, it shall be issued.

XXX. NOTICES. Any notices required to be given pursuant to the terms and provisions of this Agreement shall be in writing and shall be sent by certified mail, return receipt requested, by delivering the same personally, by courier or Federal Express (or comparable overnight courier), or by facsimile (with confirmation by any other method accepted herein) to such other party. All notices shall be sent to the addresses specified below.:

University: Richard Bookman, Ph.D. Vice Provost for Research Administration University of Miami Medical Campus, 2017 Sewell Building Miami, FL 33136

Myron Rosenthal, Ph.D. Vice Provost for Human Subject Research Human Subject Research Office University of Miami 1500 NW 12 Avenue, Suite 1002 Miami, FL 33136

University of Miami Department of

Subcontractor:

Either party may, at any time, designate any other address in place of those given above by written notice to the other party.

XXXI. USE OF MIAMI NAME. Subcontractor agrees that it shall not use the name of the University of Miami without the express written approval from the Vice President for Business Services at Miami, nor will it state or indicate that Miami endorses or approves any event(s) or products. Subcontractor shall not issue any press release or other public statement that uses Miami’s name or trademarks, without the express written consent of Miami. Furthermore, Miami’s name shall not be used in any recruitment material related to the study without prior approval from the Miami IRB. Any publication initiated by the Subcontractor shall be co-authored by Miami if appropriate under standard scientific ethics.

XXXII. SEVERABILITY. If any provision of this Agreement or the application of any provision hereof to any person or circumstance is held invalid, the remainder of this Agreement and the application of such provisions to other persons or circumstances shall not be affected unless the invalid provision substantially impairs the benefits of the remaining portions of this Agreement. It is further agreed that in the event any section or other provision is determined to be unenforceable, the parties shall use their best efforts to agree on an amendment to the Agreement to supersede the severed section or provision.

XXXIII. WAIVER. The waiver by either party of a breach or violation of any provision of this Agreement shall not operate as, or be construed to be, a waiver of any subsequent breach of the same or other provision hereof.

XXXIV. HEADINGS. The heading of each section or subsection of this Agreement is for reference purposes only and will not affect in any way the meaning or interpretation of this Agreement.

XXXV. WARRANTIES. MIAMI MAKES NO WARRANTIES, EXPRESS OR IMPLIED AND HEREBY DISCLAIMS ALL SUCH WARRANTIES, AS TO ANY MATTER WHATSOEVER INCLUDING, WITHOUT LIMITATION, THE CONDITION OF THE PROTOCOLS OR STUDY(IES); RESEARCH OR ANY INVENTION(S) OR PRODUCT(S), WHETHER TANGIBLE OR INTANGIBLE, CONCEIVED, DISCOVERED, OR DEVELOPED UNDER THIS AGREEMENT; OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY SUCH INVENTION OR PRODUCT. MIAMI SHALL NOT BE LIABLE FOR ANY DIRECT OR INDIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY ANY SUBCONTRACTOR, SPONSOR OR ANY THIRD PARTIES RESULTING FROM THE USE OF THE PROTOCOLS, RESEARCH OR ANY SUCH INVENTION OR PRODUCT.

IN WITNESS WHEREOF, the parties have executed this Agreement the day and date written above by their duly authorized officers.

______SUBCONTRACTOR signature date

______Subcontractor Name and Title -- Institution

______PRINCIPAL INVESTIGATOR Signature date

______Principle Investigator name and title

______AUTHORIZING UM OFFICIAL SIGNATURE date

______Authorizing Official Name and title

______VICE PROVOST FOR HUMAN SUBJECT RESEARCH date

______Vice Provost Name

Please send a copy to the Human Subjects Research Office.

Subcontract 1 - Attachment 1 - Page 1

Applicability of US Office of Management and Budget (OMB) Cost Principles and Circulars The following OMB circulars prescribe the cost accounting policies associated with the administration of Federal awards by non-profit organizations, States, local governments, and Indian tribal governments. Federal awards include Federal programs and cost-type contracts and may be in the form of grants, contracts, and other agreements.  OMB Circular A-87, “Cost Principles for State, Local and Indian Tribal Governments”  OMB Circular A-21, “Cost Principles for Educational Institutions”  OMB Circular A-122, “Cost Principles for Non-Profit Organizations” The cost principles applicable to a non-Federal entity apply to all Federal awards received by the entity, regardless of whether the awards are received directly from the Federal Government or indirectly through a pass-through entity.

Grants/Contracts Most Common Required Provisions The following provisions are incorporated in the Subcontract and the Subcontractor agrees to abide by them. Although these are the most common of the governmental provisions, there may be others that are applicable and must be followed by the Subcontractor. If Subcontractor issues any grants or contracts under this Agreement, the following provisions must be incorporated in those grants or contracts.

1. Equal Employment Opportunity – Executive Order (E.O.) 11246, "Equal Employment Opportunity," as amended by E.O. 11375, "Amending Executive Order 11246 Relating to Equal Employment Opportunity," and as supplemented by regulations at 41 CFR part 60, "Office of Federal Contract Compliance Programs, Equal Employment Opportunity, Department of Labor."

2. Rights to Inventions Made Under a Contract or Agreement – If this Subcontract is for the performance of experimental, developmental, or research work and it is funded by federal funds, the rights of the Federal Government to any invention prevail in accordance with 37 CFR part 401, "Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements," and any implementing regulations issued by the awarding agency.

3. Clean Air Act (42 U.S.C. 7401 et seq.) and the Federal Water Pollution Control Act (33 U.S.C. 1251 et seq.), as amended – If this Subcontract is for amounts in excess of $100,000 the recipient agrees to comply with all applicable standards, orders or regulations issued pursuant to the Clean Air Act (42 U.S.C. 7401 et seq.) and the Federal Water Pollution Control Act as amended (33 U.S.C. 1251 et seq.). Violations shall be reported to the Federal awarding agency and the Regional Office of the Environmental Protection Agency (EPA).

4. Byrd Anti-Lobbying Amendment (31 U.S.C. 1352) - If this Subcontract is for $100,000 or more, Subcontractor affirms and certifies that it will not and has not used Federal appropriated funds to pay any person or organization for influencing or attempting to influence an officer or employee of any federal or state agency, a member of Congress, officer of employee of Congress, or an employee of a member of Congress in connection with obtaining any Federal or State contract, grant or any other award covered by 31 U.S.C. 1352. In addition, Subcontractor agrees to disclose to Miami any lobbying with non-federal or non-State of Florida funds in connection with obtaining the attached agreement.

5. Debarment and Suspension (E.O.s 12549 and 12689) – The Subcontractor affirms that none of its principal employees have been disbarred or suspended in accordance with EO12549 and 12689. In addition, Subcontractor will not issue a contract under this Agreement to parties listed on the U.S. General Services Administration (GSA) “List of Parties Excluded from Federal Procurement or Nonprocurement Programs”. This list contains the names of parties debarred,

of 18 International Subcontract (7/17/09) SUBCONTRACT 1 suspended, or otherwise excluded by agencies, and contractors declared ineligible under statutory or regulatory authority other than EO 12549.

6. Contract Work Hours and Safety Standards Act (40 U.S.C. 327-333) - Where applicable, all contracts awarded by recipients in excess of $2,000 for construction contracts and in excess of $2,500 for other contracts that involve the employment of mechanics or laborers shall include a provision for compliance with Sections 102 and 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than 1 ½ times the basic rate of pay for all hours worked in excess of 40 hours in the work week. Section 107 of the Act is applicable to construction work and provides that no laborer or mechanic shall be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market, or contracts for transportation or transmission of intelligence.

The following sections are applicable to construction and renovations grants and contracts:

1. Copeland "Anti-Kickback" Act (18 U.S.C. 874 and 40 U.S.C. 276c) – If the attached agreement is in excess of $2,000 and for the purposes of construction or repair Subcontractor agrees to comply with the Copeland "Anti-Kickback" Act (18 U.S.C. 874), as supplemented by Department of Labor regulations (29 CFR part 3, "Contractors and Subcontractors on Public Building or Public Work Financed in Whole or in Part by Loans or Grants from the United States"). The Act prohibits from inducing, by any means, any person employed in the construction, completion, or repair of public work, to give up any part of the compensation to which he is otherwise entitled.

2. Davis-Bacon Act, as amended (40 U.S.C. 276a to a-7) - When required by Federal program legislation, all construction contracts of more than $2,000 must comply with the Davis-Bacon Act (40 U.S.C. 276a to a-7) and as supplemented by Department of Labor regulations (29 CFR part 5, "Labor Standards Provisions Applicable to Contracts Governing Federally Financed and Assisted Construction"). Under this Act, contractors are required to pay wages to laborers and mechanics at a rate not less than the minimum wages specified in a wage determination made by the Secretary of Labor. In addition, contractors shall be required to pay wages not less than once a week.

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