Provision and Use of Study Drug Sample Clauses

Provision and Use of Study Drug. Company shall be responsible for providing and will ship directly to each of the Institution and the Study subsites, at no charge, sufficient quantities of the Study Drug and placebo as may be required for the Study in accordance with the Study schedule. Company understands that Institution is relying on timely delivery of the Study Drug in order for Institution and the subsites to conduct the Protocol. Institution, through Principal Investigator, will safeguard such Study Drug in accordance with all Applicable Laws and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance with Company’s instructions and at Company’s expense. Institution shall not use any Study Drug for any purpose other than the conduct of the Study. Company represents and warrants that it is in compliance with federal, state, and local laws and regulations relating to the manufacture and formulation of any investigational drug and to other materials supplied, and with other applicable legal requirements. Company shall ensure that the supplies of the Study Drug and placebo shall be from the same vendor in order to ensure consistency throughout the term of the Study and that the method of overencapsulation will also remain constant throughout the Study. Company is not providing funding for the Study or other support other than the Study Drug and placebo.
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Provision and Use of Study Drug. Company shall be responsible for providing and delivering to the research pharmacy of each site of Institution, at no charge, sufficient quantities of the Study Drug (GDC-0084 15mg Capsules, bottled and identified with lot number) as may be required for the Study in accordance with the Study schedule. Institution, through Principal Investigator, will safeguard such Study Drug with the degree of care used for its own property and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance with Company’s instructions and Institution’s pharmacy’s Standard Operating Procedures (SOP’s) for drug destruction. Institution and Principal Investigator shall not use any Study Drug for any purpose other than the Study, unless otherwise agreed. Company represents and warrants that it is in compliance with federal, state, and local laws and regulations relating to the manufacture and formulation of any investigational drug and to any other materials supplied, and with all applicable legal requirements. Responsibilities between the Parties are provided in Exhibit x
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Provision and Use of Study Drug. Company shall be responsible for providing and delivering to Institution, at no charge, such quantities of the Study Drug in bags for in vitro use as needed for conducting the Study in accordance with the Study Protocol, along with the results of safety testing for the lot of Study Drug provided, and conducted according to currently published standards. Institution acknowledges receipt of the latter. Company understands that Institution and Principal Investigator are relying on timely delivery of the Study Drug in order for Institution to perform its obligations under this Agreement. Institution understands that the ability of the Company to provide the drug depends upon Institution providing shipping and delivery requirements. Institution, through Principal Investigator, will safeguard such Study Drug with the degree of care used for its own property and shall return or otherwise dispose of any remaining Study Drug at the Study Conclusion in accordance with the Study Protocol. Institution and Principal Investigator shall not use any Study Drug for any purpose other than the Study, unless otherwise agreed. Company represents and warrants that it is in compliance with federal, state, and local laws and regulations relating to the manufacture and formulation of any investigational drug and to other materials supplied, and with other applicable legal requirements.,
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Related to Provision and Use of Study Drug

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  • Formation and Purpose Promptly following the Effective Date, the Parties shall confer and then create the Committees listed in the chart below, each of which shall have the purpose indicated in the chart. To the extent that after conferring both Parties agree that a given Committee need not be created until a later date, the Parties may agree to defer the creation of the Committee until one Party informs the other Party of its then desire to create the so-deferred Committee, at which point the Parties will thereafter promptly create the so-deferred Committee and schedule a meeting of such Committee within one (1) month. Committee Purpose Joint Steering Committee (“JSC”) Establish projects for the Anti-Infectives Program and establish the priorities, as well as approve budgets for such projects. Approve all subcommittee projects and plans. The JSC shall establish budgets not less than on a quarterly basis. Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans and review and approve activities and budgets for chemistry, manufacturing, and controls under the Anti-Infectives Program. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Committee Purpose Clinical/Regulatory Committee (“CRC”) Review and approve all research and development plans, clinical projects and publications, and regulatory filings and correspondence under the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing. Commercialization Committee (“CC”) Establish project plans and review and approve activities and budgets for commercialization activities under the Anti-Infectives Program. Intellectual Property Committee (“IPC”) Evaluate intellectual property issues in connection with the Anti-Infectives Program; review and approve itemized budgets with respect to the foregoing.

  • Authorization of Agreement This Agreement has been duly authorized, executed and delivered by the Company.

  • Inspection of Agreement A copy of this Agreement shall be available at all reasonable times at the principal corporate trust office of the Warrant Agent for inspection by the holder of any Warrant Certificate. The Warrant Agent may require such holder to submit his Warrant Certificate for inspection by it.

  • Construction of Agreement The parties mutually acknowledge that they and their attorneys have participated in the preparation and negotiation of this Agreement. In cases of uncertainty this Agreement shall be construed without regard to which of the parties caused the uncertainty to exist.

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