Clinical Trial Agreement Sample Contracts

Y-mAbs Therapeutics, Inc. – Investigator-Sponsored Master Clinical Trial Agreement (August 24th, 2018)

THIS INVESTIGATOR-SPONSORED TRIAL AGREEMENT (together with Appendix A, the Agreement) is made as of the date last signed below (the Effective Date) by and among Y-mAbs Therapeutics, Inc, a corporation with offices at 750 Third Avenue, 9th floor, New York, NY 10017 (Company), on the one hand; and MEMORIAL SLOAN KETTERING CANCER CENTER, a New York not-for-profit corporation with principal offices at 1275 York Avenue, New York, New York 10065, on behalf of Memorial Hospital for Cancer and Allied Diseases, its Regional Network sites, MSK Alliance Clinical Trial Sites, and its Cancer Health Equity Research Program Sites (MSK), and on behalf of itself and its employee specified in the applicable Study Addendum (Investigator-Sponsor), on the other hand. The parties agree that INVESTIGATOR-SPONSOR is not a party to this Agreement.

Magenta Therapeutics, Inc. – Clinical Trial Agreement (May 24th, 2018)

This Clinical Trial Agreement (including any exhibits or appendices attached hereto, this Agreement) is made as of the date of last signature below (the Effective Date) by and between Regents of the University of Minnesota, a non-profit, educational, research and healthcare institution (Institution) with an address at 450 McNamara Alumni Center, 200 Oak Street SE, Minneapolis, MN 55455, and Magenta Therapeutics, Inc., a corporation having its principal place of business at 50 Hampshire Street, Cambridge, MA 02139 (Sponsor). Sponsor and Institution are herein referred to collectively as Parties. Individually, each of Sponsor and Institution is a Party.

Y-mAbs Therapeutics, Inc. – Investigator-Sponsored Master Clinical Trial Agreement (April 3rd, 2018)

THIS INVESTIGATOR-SPONSORED TRIAL AGREEMENT (together with Appendix A, the Agreement) is made as of the date last signed below (the Effective Date) by and among Y-mAbs Therapeutics, Inc, a corporation with offices at 750 Third Avenue, 9th floor, New York, NY 10017 (Company), on the one hand; and MEMORIAL SLOAN KETTERING CANCER CENTER, a New York not-for-profit corporation with principal offices at 1275 York Avenue, New York, New York 10065, on behalf of Memorial Hospital for Cancer and Allied Diseases, its Regional Network sites, MSK Alliance Clinical Trial Sites, and its Cancer Health Equity Research Program Sites (MSK), and on behalf of itself and its employee specified in the applicable Study Addendum (Investigator-Sponsor), on the other hand. The parties agree that INVESTIGATOR-SPONSOR is not a party to this Agreement.

Magenta Therapeutics, Inc. – Clinical Trial Agreement (March 28th, 2018)

This Clinical Trial Agreement (including any exhibits or appendices attached hereto, this Agreement) is made as of the date of last signature below (the Effective Date) by and between Regents of the University of Minnesota, a non-profit, educational, research and healthcare institution (Institution) with an address at 450 McNamara Alumni Center, 200 Oak Street SE, Minneapolis, MN 55455, and Magenta Therapeutics, Inc., a corporation having its principal place of business at 50 Hampshire Street, Cambridge, MA 02139 (Sponsor). Sponsor and Institution are herein referred to collectively as Parties. Individually, each of Sponsor and Institution is a Party.

Syndax Pharmaceuticals Inc – Amendment No. 9 to Clinical Trial Agreement Between (March 8th, 2018)

This Amendment No. 9 to Clinical Trial Agreement (the "Amendment" or "Amendment 9") is entered into as of November 22, 2017 (the "Effective Date"), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the "Group," "ECOG" or "ECOG-ACRIN"), and Syndax Pharmaceuticals, Inc. ("Company" or "Syndax").

Celcuity LLC – Clinical Trial Agreement FB-12 Phase II Study (August 23rd, 2017)

This Clinical Trial Agreement (together with Appendices as incorporated hereunder, the "Agreement") is entered into and effective as of May 8, 2017 (the "Effective Date"), by and between NSABP Foundation, Inc., a 501(c)(3) non-profit Pennsylvania membership corporation with its principal office and place of business located at Nova Tower 2, Two Allegheny Center, Suite 1200; Pittsburgh, PA 15212-5234 ("NSABP"), and Celcuity, LLC, with its principal office and place of business located at 16305 - 36th Avenue North, Suite 450; Minneapolis, MN 55446 ("Celcuity") (each, a "Party" and, collectively, the "Parties").

Celcuity LLC – Clinical Trial Agreement FB-12 Phase II Study (July 14th, 2017)

This Clinical Trial Agreement (together with Appendices as incorporated hereunder, the "Agreement") is entered into and effective as of May 8, 2017 (the "Effective Date"), by and between NSABP Foundation, Inc., a 501(c)(3) non-profit Pennsylvania membership corporation with its principal office and place of business located at Nova Tower 2, Two Allegheny Center, Suite 1200; Pittsburgh, PA 15212-5234 ("NSABP"), and Celcuity, LLC, with its principal office and place of business located at 16305 - 36th Avenue North, Suite 450; Minneapolis, MN 55446 ("Celcuity") (each, a "Party" and, collectively, the "Parties").

Clinical Trial Agreement (May 15th, 2017)

This Clinical Trial Agreement ("Agreement"), effective this 1st day of June 2017 ("Effective Date"), is made by and between Southern California Permanente Medical Group, with its offices at 100 South Los Robles, 2nd Floor, Pasadena, California 91101 (hereinafter "Institution"), and Enteromedics, Inc., with its offices at 2800 Patton Road, St. Paul, MN 55113 (hereinafter "Sponsor"), to have the Institution conduct a clinical trial (the "Study") at several sites.

Syndax Pharmaceuticals Inc – Amendment No. 8 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (May 9th, 2017)

This Amendment No. 8 to Clinical Trial Agreement (the Amendment or Amendment 8) is entered into as of January 18, 2017 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Syndax Pharmaceuticals Inc – Amendment No. 7 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (May 9th, 2017)

This Amendment No. 7 to Clinical Trial Agreement (the Amendment or Amendment 7) is entered into as of January 9, 2017 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Jolley Marketing Inc – Clinical Trial Agreement (November 10th, 2016)

This Clinical Trial Agreement ("Agreement") is made as of this 19th day of September, 2016 ("Effective Date") by and between Creative Medical Technologies, Inc. with a place of business at 2017 W. Peoria Avenue, Phoenix, AZ, 85029 ("CMT") and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, a non-profit biomedical research and education institute located at 1124 W. Carson Street, Building N-14, Torrance, CA 90502 ("Institution").

Jolley Marketing Inc – Clinical Trial Agreement (October 12th, 2016)

This Clinical Trial Agreement ("Agreement") is made as of this 19th day of September, 2016 ("Effective Date") by and between Creative Medical Technologies, Inc. with a place of business at 2017 W. Peoria Avenue, Phoenix, AZ, 85029 ("CMT") and Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, a non-profit biomedical research and education institute located at 1124 W. Carson Street, Building N-14, Torrance, CA 90502 ("Institution").

Syndax Pharmaceuticals Inc – Amendment No. 4 to Clinical Trial Agreement E2112 Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (August 15th, 2016)

This Amendment No. 4 (the Amendment or Amendment 4) to Clinical Trial E2112 entered into on March 14, 2014 (the Agreement) is entered into as of April 20, 2016 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Syndax Pharmaceuticals Inc – Amendment No. 5 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (August 15th, 2016)

This Amendment No. 5 to Clinical Trial Agreement (the Amendment or Amendment 5) is entered into as of April 20, 2016 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Syndax Pharmaceuticals Inc – Amendment No. 3 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (August 15th, 2016)

This Amendment No. 3 to Clinical Trial Agreement (the Amendment or Amendment 3) is entered into as of April 20, 2016 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Syndax Pharmaceuticals Inc – Amendment No. 6 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (August 15th, 2016)

This Amendment No. 6 to Clinical Trial Agreement (the Amendment or Amendment 6) is entered into as of April 25, 2016 (the Effective Date), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the Group, ECOG or ECOG-ACRIN), and Syndax Pharmaceuticals, Inc. (Company or Syndax).

Syndax Pharmaceuticals Inc – Amendment No. 2 to Clinical Trial Agreement E2112 Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (February 22nd, 2016)

This Amendment No. 2 (the "Amendment" or "Amendment 2") to Clinical Trial E2112 entered into on March 14, 2014 (the "Agreement") is entered into as of July 31, 2015 (the "Effective Date"), by and between ECOG-ACRIN Cancer Research Group, on behalf of itself and its member hospitals, institutions and physicians (the "Group," "ECOG" or "ECOG-ACRIN"), and Syndax Pharmaceuticals, Inc. ("Company" or "Syndax").

Syndax Pharmaceuticals Inc – Clinical Trial Agreement (January 4th, 2016)

This Clinical Trial Agreement ("Agreement") is entered into as of March 14, 2014 ("Effective Date") by and between EASTERN COOPERATIVE ONCOLOGY GROUP, an organization with its executive office at 1818 Market St., Suite 1100, Philadelphia, PA 19103-3602, and its principal place of business at ECOG Coordinating Center, Frontier Science, 900 Commonwealth Avenue, Boston, MA 02215 ("Group") and Syndax Pharmaceuticals, Inc., a Delaware corporation, with its principal office and place of business located at 400 Totten Pond Road, Suite 140, Waltham, Massachusetts 02451 ("Company").

Syndax Pharmaceuticals Inc – Amendment No. 1 to Clinical Trial Agreement Between Ecog-Acrin Cancer Research Group and Syndax Pharmaceuticals, Inc. (January 4th, 2016)

This Amendment No. 1 to Clinical Trial Agreement (the "Amendment" or "Amendment 1") is entered into as of January 30, 2015 (the "Effective Date") by and between ECOG-ACRIN Cancer Research Group, successor entity to the Eastern Cooperative Oncology Group, on behalf of itself and its member hospitals, institutions and physicians (the "Group," "ECOG" or "ECOG-ACRIN"), and Syndax Pharmaceuticals, Inc. ("Company" or "Syndax").

IND SPONSOR: InCHOIR CLINICAL TRIAL AGREEMENT BETWEEN THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) AND Mesoblast, Inc. Protocol # CTSNLVAD02 Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients (November 2nd, 2015)

This Clinical Trial Agreement (the Agreement), effective as of July 28th, 2014 (the Effective Date) is made by and between the National Heart, Lung, and Blood Institute (NHLBI), an institute of the National Institutes of Health (NIH), which is part of the United States Government Department of Health and Human Services (HHS), and Mesoblast, Inc. (Company), located at 505 Fifth Ave., 3rd Floor, New York, NY 10017 (individually referred to as the Party and collectively referred to as the Parties) for a Clinical Trial designated as Protocol # CTSNLVAD02 entitled Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients.

Syndax Pharmaceuticals Inc – Clinical Trial Agreement (October 2nd, 2015)

This Clinical Trial Agreement (Agreement) is entered into as of March 14, 2014 (Effective Date) by and between EASTERN COOPERATIVE ONCOLOGY GROUP, an organization with its executive office at 1818 Market St., Suite 1100, Philadelphia, PA 19103-3602, and its principal place of business at ECOG Coordinating Center, Frontier Science, 900 Commonwealth Avenue, Boston, MA 02215 (Group) and Syndax Pharmaceuticals, Inc., a Delaware corporation, with its principal office and place of business located at 400 Totten Pond Road, Suite 140, Waltham, Massachusetts 02451 (Company).

IND SPONSOR: InCHOIR CLINICAL TRIAL AGREEMENT BETWEEN THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) AND Mesoblast, Inc. Protocol # CTSNLVAD02 Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients (September 21st, 2015)

This Clinical Trial Agreement (the Agreement), effective as of July 28th, 2014 (the Effective Date) is made by and between the National Heart, Lung, and Blood Institute (NHLBI), an institute of the National Institutes of Health (NIH), which is part of the United States Government Department of Health and Human Services (HHS), and Mesoblast, Inc. (Company), located at 505 Fifth Ave., 3rd Floor, New York, NY 10017 (individually referred to as the Party and collectively referred to as the Parties) for a Clinical Trial designated as Protocol # CTSNLVAD02 entitled Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients.

Clinical Trial Agreement (July 9th, 2015)

This Clinical Trial Agreement ("Agreement") is made as of the 29th day of April, 2010 ("Effective Date") between Putney Drug Corp., a Nevada corporation, having a principal place of business at 3930 Varsity Drive, Ann Arbor, MI 48109 ("Company"), and The Regents of the University of California, a constitutional California corporation, on behalf of its Los Angeles campus, with an address at David Geffen School of Medicine UCLA Clinical Trials Contracts Unit, 10911 Weyburn Avenue, 3rd Floor, Los Angeles, CA 90095-7170 ("Institution"), each referred to herein individually as a "Party" and collectively as the "Parties."

Amendment to Clinical Trial Agreement (July 9th, 2015)

This Amendment To Clinical Trial Agreement (the "CTA Amendment") is made and entered into effective as of July 8, 2015 (the "CTA Amendment Effective Date") by and between Putney Drug Corp., a Nevada corporation having a place of business at 617 Detroit Street, Suite 100, Ann Arbor, MI, 48104 ("Company"), and The Regents of the University of California, a constitutional California corporation, on behalf of its Los Angeles campus, with an address at David Geffen School of Medicine UCLA Clinical Trials Administration Office, 10911 Weybeurn Avenue, 3rd Floor, Los Angeles California 90095-7170 ("Institution" or "The Regents"), to amend the terms of that certain Clinical Trial Agreement between Company and Institution, originally dated as of April 29, 2010 (the "CTA"). Company and Institution may be referred to herein individually as a "Party", and collectively as the "Parties".

TEKMIRA PHARMACEUTICALS Corp – Manufacturing and Clinical Trial Agreement Between the Chancellor Masters and Scholars of the University of Oxford and Tekmira Pharmaceuticals Corporation on Behalf of Itself and Its Wholly Owned Affiliate, Protiva Biotherapeutics Inc. Dated December 18th, 2014 (May 1st, 2015)

This MANUFACTURING AND CLINICAL TRIAL AGREEMENT is made as of this 18th day of December, 2014) (the "Effective Date") between Tekmira Pharmaceuticals Corporation, on behalf of itself and its wholly owned Affiliate, Protiva Biotherapeutics, Inc. (collectively "Tekmira"), each a B.C. corporation having its principal place of business at 100-8900 Glenlyon Way, Burnaby, B.C.V5J 5J8, Canada, and The Chancellor Masters and Scholars of the University of Oxford ("OXFORD") whose administrative address is University Offices, Wellington Square, Oxford, OX1 2JD.

Aethlon Medical – Clinical Trial Agreement No. Ami-201951 (April 15th, 2015)

This clinical trial agreement ("Agreement") is entered into this 24th day of March 2015, by and between The Regents of the University of California, on behalf of its Irvine campus, a California corporation with a place of business at 5171 California Avenue, Suite 150, Irvine, CA 92697-7600 (hereinafter referred to as the "Institution") and Aethlon Medical, Inc. and its subsidiaries, a Nevada corporation with a place of business at 9635 Granite Ridge Drive, Suite 100, San Diego, CA. 92123, (hereinafter referred to as the "Sponsor"), the Institution and Sponsor each being a "party" and hereinafter collectively referred to as the "Parties".

Galmed Pharmaceuticals Ltd. – Investigator-Initiated Clinical Trial Agreement (March 31st, 2015)

This Clinical Trial Agreement ("Agreement") is made and entered into effective as of the full execution hereof ("Effective Date"), by and between The Regents of the University of California, a California constitutional corporation, on behalf of its San Diego campus, located at 9500 Gilman Drive, La Jolla, CA 92093, California ("Institution"), and Galmed Research and Development Ltd., a private company having its principal place of business at 8, Shaul Hamelech Blvd., Tel Aviv, 6473307, Israel ("Company"), (each may be individually referred to as a "Party" and collectively, as "the Parties").

TEKMIRA PHARMACEUTICALS Corp – Manufacturing and Clinical Trial Agreement Between the Chancellor Masters and Scholars of the University of Oxford and Tekmira Pharmaceuticals Corporation on Behalf of Itself and Its Wholly Owned Affiliate, Protiva Biotherapeutics Inc. Dated December 18th, 2014 (March 13th, 2015)

This MANUFACTURING AND CLINICAL TRIAL AGREEMENT is made as of this 18th day of December, 2014) (the "Effective Date") between Tekmira Pharmaceuticals Corporation, on behalf of itself and its wholly owned Affiliate, Protiva Biotherapeutics, Inc. (collectively "Tekmira"), each a B.C. corporation having its principal place of business at 100-8900 Glenlyon Way, Burnaby, B.C.V5J 5J8, Canada, and The Chancellor Masters and Scholars of the University of Oxford ("OXFORD") whose administrative address is University Offices, Wellington Square, Oxford, OX1 2JD.

IND SPONSOR: InCHOIR CLINICAL TRIAL AGREEMENT BETWEEN THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) AND Mesoblast, Inc. Protocol # CTSNLVAD02 Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients (December 10th, 2014)

This Clinical Trial Agreement (the Agreement), effective as of July , 2014 (the Effective Date) is made by and between the National Heart, Lung, and Blood Institute (NHLBI), an institute of the National Institutes of Health (NIH), which is part of the United States Government Department of Health and Human Services (HHS), and Mesoblast, Inc. (Company), located at 505 Fifth Ave., 3rd Floor, New York, NY 10017 (individually referred to as the Party and collectively referred to as the Parties) for a Clinical Trial designated as Protocol # CTSNLVAD02 entitled Safety and Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients.

Prana Biotechnology Ltd – AMENDMENT to the Clinical Trial Agreement Between Prana Biotechnology Limited and the University of Rochester (November 3rd, 2014)

WHEREAS, The University of Rochester ("Institution") and Prana Biotechnology Limited ("Sponsor") have entered into a Clinical Trial Agreement dated October 7, 2011 relating to clinical trial services with regard to the product PBT2 ("Agreement"), and

E-Qure Corp. – E-Qure Clinical Trial Agreement (September 5th, 2014)

Austen Bio lnnovation Institute in Akron Address: 47 North Main Street, Akron, Ohio 44308 COMPANY/SPONSOR: Name: ADB International Group Inc. (E-QURE Corp.) Address: 1440 West Bitters Road, San Antonio TX 78248 STUDY DEVICE: PROTOCOL: E-QURE Bioelectrical Signal Therapy ("BST") Device EFFECTIVE DATE: Study Evaluation of the E-QURE BST Device in the treatment of chronic wounds, as an adjunct to standard of care, June 6, 2014. THIS CLINICAL TRIALS AGREEMENT (together with Appendices A Protocol and 8 Payment Schedule must be attached), the "Agreement" is made as of the Effective Date stated above by and among Austen Biolnnovation Institute in Akron having a place of business at 47 N. Main Street, Akron, Ohio 44308, who is acting as a Clinical Research Organization (CRO) ("Institution" or "CRO" or "ABIA") with ADB International Group, Inc., a Delaware corporation (E-QURE Corp.) based in Israel, (the "Sponsor") whose principal address is 1440 West Bitters Road San Antonio TX 78248. Th

Vascular Biogenics Ltd. – CLINICAL TRIAL AGREEMENT a Randomized, Double-Blind, 24-Week, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis (The Study) Protocol No. VB-201-079 EudraCT No. 2012-002763-10 (July 18th, 2014)

This means any untoward medical occurrence in a patient or clinical trial subject administered with a medicinal product and which does not necessarily have a causal relationship with the Project.

Vascular Biogenics Ltd. – CLINICAL TRIAL AGREEMENT a Randomized, Double-Blind, 24-Week, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis (The Study) Protocol No. VB-201-079 EudraCT No. 2012-002763-10 (June 6th, 2014)

This means any untoward medical occurrence in a patient or clinical trial subject administered with a medicinal product and which does not necessarily have a causal relationship with the Project.

Vascular Biogenics Ltd. – CLINICAL TRIAL AGREEMENT a Randomized, Double-Blind, 24-Week, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients With Moderate to Severe Plaque Psoriasis (The Study) Protocol No. VB-201-079 EudraCT No. 2012-002763-10 (May 22nd, 2014)

This means any untoward medical occurrence in a patient or clinical trial subject administered with a medicinal product and which does not necessarily have a causal relationship with the Project.

Cytodyn Inc – Clinical Trial Agreement (April 11th, 2014)

This Clinical Trial Agreement, effective on the last date of signature, is by and between Philadelphia Health & Education Corporation d/b/a Drexel University College of Medicine (Institution) located at 1601 Cherry Street, Suite 10627, Philadelphia, PA 19102 and CytoDyn Inc. (the Company), located at 1111 Main Street, Suite 660, Vancouver, Washington 98660 (individually referred to as the Party and collectively referred to as the Parties).