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STANFORD UNIVERSITY CLINICAL STUDY AGREEMENT

This Agreement is entered into by and between ("SPONSOR"), a _________ corporation, with offices at __________, and THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY ("STANFORD"), a body having corporate powers under the laws of the State of California of the United States of America. SPO Number: *[SPO NUMBER] Project Title: *[PROJECT TITLE] Principal Investigator: *[PI NAME-4] BACKGROUND 1. WHEREAS, SPONSOR conducts business in the development of therapeutic products,

compounds, and reagents (or medical devices) ; and WHEREAS, SPONSOR has entered an agreement with CRO to act as an agent on

behalf of the Sponsor to conduct clinical research services on SPONSOR’s behalf; and

WHEREAS, SPONSOR has developed a protocol and desires STANFORD to conduct a clinical research study (hereinafter “Clinical Trial”) pursuant to the terms of this Agreement and the study protocol entitled_______________________ as set forth in Appendix A attached hereto and incorporated herein by reference (hereinafter “Protocol”); and

2. The performance of the Clinical Trial is of mutual interest to SPONSOR and STANFORD,

and is consistent with the educational, scholarship, and research objectives of STANFORD as a nonprofit, tax-exempt, educational institution.

1. STATEMENT OF WORK STANFORD agrees to use reasonable efforts to perform the Clinical Trial described in Exhibit A.

Both Parties agree to conduct the Clinical Trial based upon the terms and conditions contained in this Agreement

(i) SPONSOR shall conduct an evaluation of the Study Site before the performance of the Clinical Trial and before implementation of clinical testing.

(ii) Because such Studies have implications for the commitment of resources by both parties, there should be frequent and full interchange between the personnel of the SPONSOR and STANFORD.

Use of CRO. SPONSOR shall have the right to enlist the services of a contract research organization ("CRO") as its representative agent to design, develop, manage, oversee, and otherwise perform functions related to sponsor responsibilities for Studies as permitted by applicable law. The parties agree that if SPONSOR elects to utilize a CRO as its representative agent, the terms and

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conditions of this Agreement shall still apply to the CRO and the CRO is bound by the responsibilities, liabilities and obligations of SPONSOR. Compliance. Each Study shall be conducted in accordance with the Study Protocol, SPONSOR’s written instructions, and all Laws and Regulations applicable to performance of a Study including but not limited to 21 CFR §50, 54, 56 and 812 and the requirements of the Federal Food, Drug, and Cosmetic Act or any similar or successor legislation (the FDCA). STANFORD shall conduct a Study in accordance with any conditions imposed by FDA or the Institutional Review Board (IRB). In the event that SPONSOR’s written instructions are inconsistent with the Protocol, the Protocol approved by the IRB shall take precedence. 2. PERIOD OF PERFORMANCE The Clinical Trial will be effective on the ____ day of ______, 200_ and continue until the study is completed at STANFORD. The parties agree that no patient enrollment will occur until there is IRB approval of the Protocol at STANFORD. 3. REIMBURSEMENT OF COSTS/PAYMENT

3.1 SPONSOR shall reimburse STANFORD for all direct and indirect costs incurred by STANFORD in connection with the Clinical Trial up to ____________ ("Cost"). SPONSOR shall pay start-up costs which includes a non-refundable IRB fee, pharmacy set-up fee, and/or clinical administration fees in the amount of $___________ plus an IDC of ___% which is payable upon the signing of this Agreement. In addition, SPONSOR agrees to reimburse STANFORD the costs for advertising which shall not exceed $_____________. The Reimbursement Schedule for this clinical trial is as follows: 3.2 The parties agree that the Cost is based upon the reasonable costs for similar studies at like institutions in the same geographic area and STANFORD has not been induced to participate in this Clinical Trial based on inducements from SPONSOR. The parties estimate that the Cost is sufficient to support the Clinical Trial, but if certain patient care costs are expected to be covered by insurance or another third party payers and such patient care costs are denied, SPONSOR agrees to reimburse STANFORD for the patient care costs not covered by insurance or third party payer which are necessary to conduct the Clinical Trial. STANFORD may submit to SPONSOR a revised budget requesting additional funds at such time as costs may reasonably be projected to exceed the Cost. SPONSOR will not be liable for any payment in excess of the Cost except upon SPONSOR's written agreement. 3.3 SPONSOR shall make payments to STANFORD in accordance with the Payment Schedule attached as Exhibit B and incorporated herein. 3.4 SPONSOR will pay by wire transfer to:

Wells Fargo Bank 420 Montgomery Street San Francisco, CA 94163

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Account No. 4001-047349 ABA No. 121000248

or by checks, which will be made payable to Stanford University and will be sent to: By first class mail: By Express Mail Stanford University Stanford University Lockbox 44253

P.O. Box 44253 C/O Regulus San Francisco, CA 94144-4253 42840 Christy Street, Suite 100 Attn: SPO # xxxx/PI Fremont, CA 94538

Tel: 510-492-6759

All checks should reference the Principal Investigator’s name and SPO Number for reference purposes.

4. INTELLECTUAL PROPERTY 4.1 SPONSOR will own as its sole property any invention developed under the Exhibit A, Clinical Trial Protocol ("SPONSOR Technology"). 4.2 STANFORD’s Office of Technology Licensing (“OTL”) will promptly disclose to SPONSOR all SPONSOR Technology after OTL receives such disclosure(s) from the Principal Investigator. 4.3 STANFORD will retain rights to use SPONSOR Technology for internal research, educational and archival purposes. 4.4 STANFORD will obtain patent and copyright agreements to effectuate the purposes of this

Agreement from all individuals who perform any part of the Clinical Trial. 5. DATA AND BIOLOGICAL MATERIAL 5.1 The data generated as a result of this Clinical Trial shall be jointly owned by the Parties to use

for purposes identified in the patient authorization/informed consent and this Agreement. Stanford may maintain a copy of all study results and data for research, teaching, educational, archival, auditing and patient care purposes. If data is entered into any pre-existing STANFORD database, SPONSOR does not acquire any rights to the STANFORD database.

5.2 If Biologic Materials will be used or obtained in performance of the Clinical Trial, SPONSOR agrees to

reimburse STANFORD for the cost of shipping such Biological Materials to SPONSOR. The term "Biologic Materials" shall include the materials derived from subjects enrolled in the Study and used pursuant to the protocol, including, but not limited to, blood, bone marrow, urine, sera, and other biological materials. At no time shall any Biologic Materials be used for any purpose other than as described in the Protocol or transferred to any third party without STANFORD’s prior written consent. Upon completion of the Study, any early termination thereof or any termination or expiration of this Agreement, whichever is earliest, all unused Biologic Materials shall be destroyed as required under any law or regulation or stored in accordance with the Protocol.

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6. COMPLIANCE WITH LAW 6.1 STANFORD, Principal Investigator and SPONSOR will comply with all applicable federal,

state, and local laws, regulations and guidelines including, but not limited to, the Federal Food, Drug, and Cosmetic Act, as amended, and regulations promulgated thereunder ("the Act") and the United States Food and Drug Administration ("FDA") regulations governing the protection of human subjects and regulations governing clinical investigators.

6.2 STANFORD certifies that neither STANFORD nor any person employed or engaged by

STANFORD in the Study has been debarred pursuant to sections 306(a) or (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 335(a) and 335(b)) and that no debarred person will in the future be employed or engaged by STANFORD in connection with services to be performed by STANFORD for SPONSOR. STANFORD further certifies that it will notify SPONSOR immediately in the event of any debarment or threat of debarment occurring during the period of this Agreement.

6.3 HIPAA: In connection with research studies, STANFORD may collect “Protected Health

Information” (“PHI”) as defined in 45 C.F.R. section 164.501 or medical information as defined under Cal. Civil Code section 56.06,. STANFORD shall obtain a patient authorization/informed consent from study subjects to allow STANFORD to disclose the PHI and medical information to SPONSOR. SPONSOR shall use the PHI or medical information in accordance with the patient authorization/informed consent. If either party de-identifies PHI in accordance with the standards as set forth in 45 C.F.R. section 164.514, either Party may use and disclose the de-identified information as allowed by law.

7. ACCESS 7.1 Either SPONSOR or FDA, as required by FDA regulations, shall have reasonable access to

Principal Investigator and other project personnel, project facilities, drug records, subject records, case reports, and other records, subject to applicable laws and regulations. SPONSOR agrees to provide at least twenty four hours notice prior to a Site visit and will schedule such visit during normal business hours upon STANFORD’s consent. SPONSOR or CRO on behalf of SPONSOR shall limit the number of Site visits to those outlined in the Protocol. If SPONSOR exceeds the number of reasonable Site visits, SPONSOR agrees to reimburse STANFORD for reasonable costs and expenses to make Study personnel available.

7.2 If there is a FDA audit, STANFORD agrees to provide SPONSOR with prompt notice of the

FDA audit and SPONSOR may be present during such audit but SPONSOR agrees not to interfere or alter, change or amend any documentation of STANFORD. STANFORD shall be free to respond to any FDA inquiries and will provide SPONSOR with a copy of any final response or documentation to the FDA regarding the Clinical Trial. SPONSOR agrees to reimburse STANFORD for the reasonable costs incurred by Study personnel in responding to a FDA audit or investigation.

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7.3 SPONSOR shall provide Principal Investigator with all SPONSOR’s relevant information pertaining to the Clinical Trial, including potential adverse reactions of subjects to study drug , control drug and/or study device.

8. CONFIDENTIAL INFORMATION 8.1 SPONSOR understands that free dissemination of information is an essential and long-

standing STANFORD policy. A Clinical Trial that requires secrecy may not be conducted by STANFORD. In addition, STANFORD researchers must be able to publish the final results of the Clinical Trial from all participating sites.

8.2 SPONSOR and Principal Investigator recognize that the conduct of this project may require

the transfer of confidential or proprietary information between the parties. All documents, information, materials and data provided to STANFORD by SPONSOR shall be considered confidential information of the SPONSOR ("Sponsor Confidential Information"). All documents, information, materials and data provided by STANFORD to SPONSOR shall be considered information of STANFORD ("Stanford Confidential Information"). In consideration of the disclosure of any Confidential Information to the other, SPONSOR and STANFORD agree that, for a period of five years from the date of this Agreement, they will:

(a) Make no use of Sponsor’s Confidential Information so designated in writing as

confidential or proprietary by the disclosing party except as allowed in this Agreement;

(b) Make no use of Stanford’s Confidential Information without an appropriate patient authorization and/or consent and as allowed in this Agreement.

(b) Not disclose to third parties any of the Confidential Information belonging to the other party without express written consent of the disclosing party except in accordance with paragraph 10; and

(c) Take precautions as normally taken with the receiving party's own confidential and proprietary information to prevent disclosure to third parties.

The obligation of confidentiality does not apply to study results, supporting data or to information that:

(a) Is publicly available through no fault of recipient; (b) Is disclosed to the recipient by a third party; (c) Is already known to the recipient at the time of disclosure; or (d) Is developed by the recipient without reference to the Confidential Information.

9. SUPPLIES, CASE REPORT FORMS,EQUIPMENT 9.1 STUDY DRUG. The Study Drug for this Clinical Trial is _____________ which does/does not

have FDA approval. SPONSOR will provide to STANFORD at no cost with a sufficient quantity of Study Drug to conduct the Clinical Trial, as well as any other compounds, materials, equipment, and information which the Protocol specifies SPONSOR will deliver

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or which SPONSOR deems necessary to conduct the Clinical Trial. All such Study Drug, compounds, materials, and equipment are the sole property of SPONSOR and will be returned to SPONSOR, if applicable, at SPONSOR’s expense at the end of the Clinical Trial

9.2 STUDY DEVICE. The Study Device for this Clinical Trial is ________________which

does/does not have FDA approval. SPONSOR shall provide STANFORD a sufficient number of Study Devices to conduct the Clinical Trial, as well as any other compounds, materials, equipment, and information which the Protocol specifies SPONSOR will deliver or which SPONSOR deems necessary to conduct the Clinical Trial. All such Study Devices, compounds, materials, and equipment are the sole property of SPONSOR. SPONSOR shall provide STANFORD with X number of Study Devices at the beginning of the Clinical Trial or STANFORD shall issue a Purchase Order for each device which will be reimbursed at $____________ per Study Device. Study Devices will be shipped at SPONSOR’s expense FOB destination. SPONSOR shall promptly replace or repair any Study Device which is outdated or not in proper working condition. If insurance or a third party payer does not cover the cost of the Study Device, the SPONSOR shall reimburse STANFORD the cost of the device paid by STANFORD.

9.3 SPONSOR will provide STANFORD with a sufficient quantity of Case Report Forms

("CRF's") and necessary questionnaires or documentation to conduct the Clinical Trial. All original CRF's will be the sole property of SPONSOR. All other original records of the work completed under this Agreement, including patient medical records, laboratory records and reports, scans, films and information on pre-existing STANFORD databases will be STANFORD property. STANFORD will retain a copy of all Study documents for internal research, teaching and archival purposes.

9.4 If SPONSOR is providing any equipment to STANFORD to conduct this Clinical Trial,

SPONSOR shall be responsible for maintaining service/maintenance agreements for the equipment and shall be liable for all taxes and insurance. STANFORD will return the equipment to SPONSOR at the conclusion of the Clinical Trial less normal wear and tear at SPONSOR’s expense.

10. PUBLICATION 10.1 The basic objective of research activities at STANFORD is the generation of new

knowledge and its expeditious dissemination for the public's benefit. SPONSOR will provide all reasonable cooperation with STANFORD in meeting this objective.

10.2 As a matter of basic academic policy, STANFORD retains the right at its discretion to

publish freely any results of the Clinical Trial. STANFORD agrees to provide SPONSOR a copy of any manuscript at least 30 days prior to its submission for publication. SPONSOR may review the manuscript:

(a) To ascertain whether SPONSOR's Confidential Information would be disclosed

by the publication;

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(b) To identify potentially patentable technology so that appropriate steps may be taken to protect such technology; and

(c) To confirm that the privacy rights of the individuals are adequately protected.

SPONSOR will provide comments, if any, within 30 days of receipt of manuscript. If STANFORD patentable technology is disclosed in the manuscript, SPONSOR will promptly advise STANFORD whether it requests STANFORD to file and prosecute a patent application pursuant to Paragraph 4.

10.3 In the case of a multicenter Clinical Trial, Principal Investigator understands that a multicenter publication will be prepared and published, with a committee comprised of participating Principal Investigators responsible for such multicenter publication. Principal Investigator understands and agrees not to publish the results of STANFORD's participation in the Clinical Trial until after the completion of the Clinical Trial at all participating sites, allowing for the review and analysis of the Clinical Trial results and the preparation and publication of the multicenter results. Should a multicenter publication not materialize within twelve months after the multicenter study is completed at all participating sites, Principal Investigator may publish/present the individual Clinical Trial results as stated in Paragraph 10.2. SPONSOR shall provide to STANFORD a copy of all study results from participating sites upon written request for purposes of publication.

10.4 STANFORD will give SPONSOR the option of receiving an acknowledgment in such

publication for its sponsorship of the Clinical Trial. 10.5 If SPONSOR elects to publish the results from STANFORD’s participation, SPONSOR

agrees to provide STANFORD with a copy of the proposed publication at least thirty (30) days prior to publication and agrees to acknowledge STANFORD’s participation in the Clinical Trial as appropriate for peer review publications.

11. WIND DOWN Either party may terminate this Agreement upon 30 days written notice. In the event of any termination of this Agreement prior to the End Date, SPONSOR shall pay the reasonable costs incurred by STANFORD in winding down and terminating the Clinical Trial, including the costs of the Clinical Trial during the wind down period and all costs and non-cancelable commitments made prior to termination. 12. NOTICES Any notices given under this Agreement will be in writing and delivered by mail, by hand, or by facsimile addressed to the parties as follows: STANFORD SPONSOR (Name) *[SPONSOR COGNIZANT OFFICIAL] Office of Sponsored Research *[SPONSOR NAME-3] Stanford University 1215 Welch Road, #B

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Stanford, CA 94305-5401 650-498-4167 (fax)

13. PUBLICITY Neither party will identify the other in any promotional advertising or other promotional materials to be disseminated to the public or use the name of any faculty member, employee, or student or any trademark, service mark, trade name, or symbol of the other, including Stanford Hospital and clinics, without the other's prior written consent. Notwithstanding anything to the contrary, Sponsor agrees to allow the following information to appear on Institution’s Clinical Trials Directory website: study title, study status, trial type, study phase, study category and subcategory, study objectives and designs, conditions treated, treatment(s) or intervention(s), key eligibility criteria and exclusion criteria. In addition, as part of Institution’s application to become a NCI comprehensive cancer center, Sponsor agrees to allow Institution to release the following information to NCI for NCI’s internal use only: The disease site (ICD-O Code), whether this is a single site or multicenter trial, sponsor type, name of sponsor, anatomic site, protocol ID, PI name, program type, period of performance, study phase, study type, protocol title, target accrual, other participating sites, twelve (12) months accrual for all sites, to date accrual for each site if available, and the gender, ethnicity, race of study subjects. 14. INDEMNIFICATION 14.1 SPONSOR hereby agrees to indemnify, defend, and hold harmless STANFORD,

STANFORD Hospital and Clinics, Lucile Salter Packard Children’s Hospital, their respective trustees, directors, employees, agents, subcontractors, and students ("Stanford Indemnitees") from any liability, damage, loss, or expense (including reasonable attorneys' fees and expenses of litigation) incurred by or imposed upon the Stanford Indemnitees or any one of them in connection with any claims, suits, actions, demands, or judgments arising out of or connected with this Agreement, the Clinical Trial done under this Agreement, use of Study results/data or breach of any law or regulation by SPONSOR and employees, agents and/or representatives of SPONSOR, except to the extent that such liability is due to the negligence of STANFORD or breach of any law or regulation by STANFORD.

14.2 STANFORD will promptly notify SPONSOR of any such claim and will cooperate with

SPONSOR in the defense of the claim. SPONSOR agrees, at its own expense, to provide attorneys reasonably acceptable to STANFORD to defend against any claim with respect to which SPONSOR has agreed to provide indemnification hereunder. SPONSOR agrees not to settle any claim against STANFORD with an admission of liability against STANFORD without STANFORD’s written consent. This indemnity shall not be deemed excess coverage to any insurance or self-insurance STANFORD may have covering a claim. SPONSOR's indemnity shall not be limited by the amount of SPONSOR's insurance.

14.3 (If Sponsor insists on indemnification from Stanford)

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STANFORD hereby agrees to indemnify, defend, and hold harmless SPONSOR, its respective employees and agents ("Sponsor Indemnitees") from any liability, damage, loss, or expense (including reasonable attorneys' fees and expenses of litigation) incurred by or imposed upon the Sponsor Indemnitees or any one of them in connection with any claims, suits, actions, demands, or judgments arising out of or connected with the negligence or intentional misconduct of STANFORD in performing the Clinical Trial or the use of Study results/data or breach of any law or regulation by STANFORD, except to the extent that such liability is due to the negligence of SPONSOR indemnitees or breach of any law or regulation by SPONSOR indemnitees.

14.4 SPONSOR will promptly notify STANFORD of any such claim and will cooperate with STANFORD in the defense of the claim. STANFORD agrees, at its own expense, to provide attorneys reasonably acceptable to SPONSOR to defend against any claim with respect to which STANFORD has agreed to provide indemnification hereunder. STANFORD agrees not to settle any claim against SPONSOR with an admission of liability against SPONSOR without SPONSOR’s written consent. This indemnity shall not be deemed excess coverage to any insurance or self-insurance STANFORD may have covering a claim. STANFORD's indemnity shall not be limited by the amount of STANFORD's insurance.

14.5 The provisions of this clause shall survive termination of this Agreement. 15. INSURANCE 15.1 STANFORD will maintain Worker's Compensation insurance or other coverage on its

employees as required by California law, and will self-insure or maintain insurance covering its liability under this Agreement.

15.2 SPONSOR shall procure and maintain during the term of this Agreement comprehensive

liability, clinical trial and product liability insurance to the full amount of SPONSOR’s insurance limits, but in no event less than $5,000,000 per occurrence and $10,000,000 annual aggregate, with a reputable and financially secure insurance carrier. Insurance should be placed with carriers with ratings with at least A-, X as rated by A.M. Best.

15.3 Such insurance shall include STANFORD, Stanford Hospital and Clinics, Lucile Salter

Packard Children’s Hospital, their trustees, directors, employees, agents, subcontractors, and students as additional insureds with respect to this Agreement. This insurance shall be written to cover claims incurred, discovered, manifested, or made during or after the expiration of this Agreement.

15.4 Prior to the effective date of this agreement, SPONSOR shall provide STANFORD with a

Certificate of Insurance evidencing primary coverage and advise STANFORD of any deductibles to SPONSOR’s insurance.

15.5 SPONSOR shall provide STANFORD with thirty (30) days written notice of cancellation or

material change. SPONSOR will advise STANFORD, in writing, that it maintains excess

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liability coverage (following form) over primary insurance for at least the minimum limits set forth above. Conditions of the Certificate of Insurance will be subject to approval in advance by STANFORD's Office of Risk Management.

15.6 SPONSOR's insurance will be primary coverage with respect to its indemnification

responsibilities under paragraph 14. STANFORD's insurance or self-insurance will be excess and noncontributory.

15.7 If SPONSOR'S insurance is written on a claims made basis, as opposed to an occurrence

basis, SPONSOR shall guarantee that it will purchase "tail" coverage and/or a retrospective coverage provision to provide continuation and uninterruption of coverage of all claims.

15.8 SPONSOR and STANFORD hereby waive any rights of subrogation. 16. NO WARRANTIES STANFORD MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, THE RESULTS OF THE CLINICAL TRIAL OR ANY INVENTION, PROCESS OR PRODUCT, WHETHER TANGIBLE OR INTANGIBLE, CONCEIVED, DISCOVERED, OR DEVELOPED UNDER THIS AGREEMENT. STANFORD SHALL NOT BE LIABLE FOR ANY INDIRECT, CONSEQUENTIAL, OR OTHER DAMAGES SUFFERED BY SPONSOR, ANY LICENSEE, OR ANY OTHERS INCLUDING, BUT NOT LIMITED TO, DAMAGES ARISING FROM LOSS OF DATA OR DELAY OR TERMINATION OF THE CLINICAL TRIAL, OR FROM THE USE OF THE RESULTS OF THE CLINICAL TRIAL, OR ANY SUCH INVENTION OR PRODUCT. THE PROVISIONS OF THIS CLAUSE SHALL SURVIVE TERMINATION OF THIS AGREEMENT. 17. FORCE MAJEURE STANFORD will not be liable for any failure to perform as required by this Agreement, if the failure to perform is caused by circumstances reasonably beyond STANFORD's control, such as labor disturbances or labor disputes of any kind, accidents, failure of any governmental approval required for full performance, civil disorders or commotions, acts of aggression, acts of God, energy or other conservation measures, explosions, failure of utilities, mechanical breakdowns, material shortages, disease, thefts, or other such occurrences. 18. ADVERSE REACTIONS The SPONSOR agrees that it, and not STANFORD, is responsible for the costs of diagnosis, care and treatment of any undesirable side effects, adverse reactions, illness or injury to a participant in the Clinical Trial which in the reasonable judgment of the Principal Investigator or STANFORD are determined to result from participation in the Clinical Trial, except for such costs that arise directly from (i) the negligent activities, reckless misconduct or intentional misconduct of STANFORD, the Principal Investigator or his/her staff or (ii) their failure to adhere to the terms of the Protocol. This

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section is not intended to create any third-party contractual benefit for any participants in the Clinical Trial. 19. HUMAN RESEARCH PROTECTION PROGRAM 19.1 SPONSOR acknowledges that STANFORD has a human research protection program

(“HRPP”) established in accordance with the principles and standards of the Association for the Accreditation of Human Research Protection Programs that is applicable to all clinical research studies, including the Clinical Trial, that includes: (i) their submittal for prospective and continuing review to STANFORD’s institutional review board (“IRB”) as required by the FDA regulations governing the protection of human research subjects, (ii) obtaining of consent from human research subjects as required by the FDA regulations governing the protection of human research subjects, (iii) conducting them in accordance with ethical standards such as the Belmont Report.

19.2 In furtherance of STANFORD’s HRPP, SPONSOR agrees:

(a) to promptly notify the Principal Investigator and/or the IRB directly, of (i) non-compliance with the study protocol in Exhibit A or applicable laws, particularly those laws related to human research subjects, that could impact the safety or welfare of participating subjects, (ii) serious adverse events that have been reported to the FDA or other governmental agency in relation to the Clinical Trial at Stanford or any other site, (iii) unanticipated problems in the Clinical Trial at Stanford or any other site that could relate to risks to participating subjects, and (iv) circumstances that could affect subjects’ willingness to continue to participate in the Clinical Trial or the IRB’s continuing approval of the Clinical Trial, and

(b) to develop a plan of communication to subjects with the Principal Investigator that is acceptable to the IRB when new findings or results of the Clinical Trial might impact the willingness of subjects to continue to participate in the Clinical Trial or directly affect their current or future safety or medical care.

20. MISCELLANEOUS 20.1 Any dispute between the parties in connection with this Agreement which cannot be

resolved by mutual agreement will be finally settled through arbitration under the Commercial Arbitration Rules of the American Arbitration Association by one or more arbitrators appointed in accordance with those Rules. Arbitration will be held in Palo Alto, California, or at any other mutually agreeable location.

20.2 Neither party may assign this Agreement without the prior written consent of the other

party. 20.3 If any provision of this Agreement becomes or is declared illegal, invalid, or unenforceable,

such provision will be divisible from this Agreement and will be deemed to be deleted from this Agreement. If such deletion substantially alters the basis of this Agreement, the parties

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will negotiate in good faith to amend the provisions of this Agreement to give effect to the original intent of the parties.

20.4 STANFORD and SPONSOR are independent contractors and neither is an agent, joint

venturer, or partner of the other. 20.5 This Agreement is not to be construed to limit the freedom of individuals participating in

this Clinical Trial to engage in any other Clinical Trial. 20.6 This Agreement is governed by the laws of the State of California without regard to conflict

of law principles. Any legal action involving this Agreement or the Clinical Trial under it will be adjudicated in the State of California at a mutually agreeable location.

20.7 In the event of any inconsistency between the terms of this Agreement and the documents

referenced or incorporated herein or any other agreement concerning this Clinical Trial between the Parties and their employees, the terms of this Agreement will prevail.

20.8 This Agreement represents the entire agreement and understanding between the parties and

their employees with respect to its subject matter and supersedes any prior and/or contemporaneous discussions, representations, or agreements, whether written or oral, of the parties regarding this subject matter.

20.9 Amendments or changes to this Agreement must be in writing and signed by duly authorized

representatives of the parties.

IN WITNESS WHEREOF, these duly authorized representatives of the parties hereby execute this

Agreement, including all the terms and conditions which follow.

THE BOARD OF TRUSTEES OF THE SPONSOR LELAND STANFORD JUNIOR UNIVERSITY Signature Signature

Name Name

Title Title

Date Date

The Principal Investigator acknowledges his/her responsibilities to carry out this Agreement. By: [INSERT NAME]

Principal Investigator

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EXHIBIT A

Clinical Trial Protocol