Study Performance. 1.1 PROTOCOL Subject to approval of the Study pursuant to Section 1.2 below, Principal Investigator agrees to conduct to the extent funds are made available hereunder a clinical study of a 308nm Excimer Laser manufactured by Acculase, Inc., a subsidiary of Laser Photonics, Inc. (hereinafter referred to as the "Study Device") in accordance with the study protocol entitled "308 nm Excimer Laser for the Treatment of Plaque Psoriasis (High Fluence Study)", a copy of which is attached hereto as Exhibit A (hereinafter referred to as the "Study"). In the event of any conflict between Exhibit A and the provisions of this Agreement, the provisions of this Agreement shall govern.
Study Performance. 1.1 PROTOCOL Subject to approval by General’s Institutional Review Board (“IRB”) Principal Investigator agrees to conduct a clinical study of a ruby laser device furnished by Palomar (hereinafter referred to as the “Study Device, and together with any other devices provided by Palomar in accordance with paragraph 1.4, as the “Study Device(s)”) in accordance with the study protocol attached hereto as Schedule A and including any changes to such protocol as may be required by General’s IRB (which protocol and any other protocol added hereto in accordance with paragraph 1.4 are hereinafter referred individually to as the “Study” and collectively as the “Studies.”). In the event of any conflict between Schedule A and the provisions of this Agreement, the provisions of this Agreement shall govern.
Study Performance. The VTL Parties hereby engage ColumbiaGrid to coordinate a technical analysis and study to calculate the Variable Transfer Limits of the Northwest AC Intertie, Bonneville’s internal network, and, if practicable, other Bonneville interties (“the Study”). The Study will be performed pursuant to a detailed study methodology and statement of work (together, the “Statement of Work”) established collaboratively between ColumbiaGrid, the VTL Parties, members of NTTG, the Pacific Northwest Generating Cooperative, and the California Independent System Operator. The VTL Parties authorize ColumbiaGrid to engage third-party contractors to assist or perform the Study work, as necessary. It is the intention of the Parties that third-party contractors will be accountable for performing the Statement of Work and for producing the final products pursuant to the Statement of Work. ColumbiaGrid shall post the Statement of Work and a final report of the Study results on its Website.
Study Performance. 1.1 Conduct of Study in Accordance with Protocol; Priority of Terms. Subject to the initial and continuing approvals described in Section 1.2 below, Institution, through Principal Investigator, agrees to conduct an ex-vivo study of Cytolin(R) brand of S6FI monoclonal antibodies ("Study Drug") in accordance with the study protocol entitled "An observational study to determine the in-vitro immunologic and virology activity of Cytolin," attached to this Agreement as Exhibit A and herein incorporated by reference ("Study"). The Parties agree that the Study will be performed in strict accordance with the Study protocol entitled above, and any subsequent amendments thereto (the" Study Protocol"). In the event of any conflict between the Protocol and the provisions of the main body of this Agreement, the Protocol shall govern with respect to scientific and subject consent issues, and the provisions of the main body of this Agreement shall govern with respect to all other issues. In the event of any conflict between the Study informed consent form and the provisions of this Agreement with respect to any commitment by Company to cover costs associated with subject injuries, the broader commitment (the commitment that is more protective of human subjects) shall control.
Study Performance. Covance shall use commercially reasonable efforts in accordance with industry and industry standards to provide facilities, supplies and staff necessary to complete the Study as provided in the Protocol, as it may be modified as provided herein, and in accordance with the terms of this Agreement.
Study Performance. I. I Conduct of Study in Accordance with Protocol: Priority of Terms. Subject to the initial and continuing approvals described in Section 1.2 below. Institution, through Principal Investigator, agrees to conduct a clinical study of GDC-0084 (“Study Drug”) in accordance with the study protocol entitled “Phase II Trial of GDC-0084 in combination with Trastuzumab for Patients with HER2-Positive Breast Cancer Brain Metastases,” attached to this Agreement as Exhibit A and herein incorporated by reference (“Study”). The Parties to this agree that the Study will be performed in strict accordance with the Study protocol entitled above, and any subsequent amendments thereto (the “Protocol”), applicable federal, state, and local laws, regulations and guidelines, and good clinical practices as required under FDA regulations (“GCPs”). In the event of any conflict between the Protocol and the provisions of the main body of this Agreement, the Protocol shall govern with respect to scientific. Study management and reporting and subject consent issues, and the provisions of the main body of this Agreement shall govern with respect to all other issues.
Study Performance. 1.1 Protocol Subject to approval of the Study pursuant to Section 1.2 below, DFPCC agrees to conduct a clinical study of Defibrotide (hereinafter referred to as the "Study Drug") in accordance with the study protocol entitled "Defibrotide for Hematopoietic Stem Cell Transplant (SCT) Patients with Severe Hepatic Xxxx-Occlusive Disease (VOD): A Phase I/II Study to Determine Minimal Effective Dose", a copy of which is attached hereto as Exhibit A (hereinafter referred to as the "Study"). In the event of any conflict between Exhibit A and the provisions of this Agreement, the provisions of this Agreement shall govern. The Study will be conducted by Xxxx Xxxxxxxxxx, M.D. (the "Principal Investigator") at General/Xxxxxxx/DFCI and Xxxxxx Xxxxxxx, M.D. at General/Xxxxxxx/DFCI (the "CoInvestigator") and sub-investigators at other sites within the United States (Sub-Investigators) (who shall be referred to herein each as an "Investigator" and, collectively as "Investigators").
Study Performance. 2.1 The Study shall be performed by the Study Center in accordance with Protocol Number VAX 004 entitled "A Phase Ill Trial to Determine the Efficacy of AIDSVAX(TM) B/B Vaccine in Adults at Risk of Sexually Transmitted HIV-1 Infection in the United States," attached hereto as Exhibit A, and any subsequent amendments made thereto in accordance with Article 16.0 (the "Protocol"). The Protocol is subject to approval by the IRB. The Informed
Study Performance. 1.1 Protocol PI and SPONSOR both agree to conduct, to the extent funds are made available xxxxxxxxx, a clinical study entitled “[title of the clinical trial study as submitted to the Research Advisory Council]” (hereinafter referred to as “STUDY”) in accordance with study protocol #: [RAC #], as approved by the Research Advisory Council, a copy of which is attached hereto as Exhibit A.
Study Performance. 1.1 Conduct of Study in Accordance with Protocol; Priority of Terms. Subject to the initial and continuing approvals described in Section 1.2 below, Institution, through Principal Investigator, agrees to conduct the Study in accordance with the Protocol, which is attached to this Agreement as Exhibit A and herein incorporated by reference. In the event of any conflict between the Protocol and the provisions of this Agreement, the Protocol shall govern with respect to scientific issues, and the provisions of this Agreement shall govern with respect to all other issues. The Study shall be conducted in accordance with all applicable federal, state and local laws relating to the conduct of clinical studies, including Food and Drug Administration (“FDA”) Good Clinical Practice (“GCP”), the Health Insurance Portability and Accountability Act of 1996 (together with any regulations promulgated thereunder, “HIPAA”), and the California Confidentiality of Medical Information Act (“CMIA”) (collectively “Applicable Laws”).
