Protocol Development Sample Clauses

Protocol Development. 31. The Parties shall, with the advice of expert consultants, and under the supervision of the Monitor, develop a Protocol to accomplish this system of evaluation. This Protocol (hereafter, the “Evaluation Protocol”) shall be developed within 90 days of the Court approval of this Agreement, and implementation shall be commenced not more than 60 days thereafter.
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Protocol Development. 6.1.1 OXFORD and TEKMIRA will mutually agree upon the OXFORD Protocol, which will be designed utilizing the TEKMIRA Protocol for instructions related to Product administration.
Protocol Development. Beginning Q1- 2002, all protocols being developed will be at ca. * and will include HPLC purification as the *. In order to assure the development of approximately * protocols for the first year, there will be approximately * each quarter. This level of development activity requires maintaining * with the appropriate references, reaction schemes, monomer lists and at minimum development quantities of template.
Protocol Development i. By January 1, 2012 CMS will provide sample cost report protocols to the Commonwealth for physician, clinic and hospital services as well as any other provider receiving payments for services under the SNCP provider payments for uncompensated care.
Protocol Development. 6.1 The Parties agree that enrollment in the Clinical Trial will not start until the version of the Protocol to be used has been reviewed in advance by the Protocol Team; approved (stipulations met/resolved) by the relevant IRB(s) and NHLBI in writing; and submitted to the FDA, the thirty (30) calendar day wait period has been satisfied and any FDA clinical hold issues have been responded to satisfactorily. The Protocol is a product of NHLBI and will be deemed NHLBI Confidential Information, as defined in Section 11 (Confidential Information) of this Agreement.
Protocol Development. An exposure protocol was developed in order to allow direct quantitative comparisons between the oxidative potential of PM10 and the gases. The potential effect of extraction processes in altering the physical and chemical properties of particles [295- 298], along with an increased sensitivity of these filters to sonication (physical destruction) prompted the development of an in vitro protocol that directly exposed PM to the RTLF model.
Protocol Development. 6.1. The Parties agree that enrollment in the Clinical Trial will not start until the version of the Protocol to be used has been reviewed in advance by the Protocol Team; approved (stipulations met/resolved) by the relevant IRB(s) and NIAID in writing; and submitted to the FDA, the thirty (30) calendar day wait period has been satisfied and any FDA clinical hold issues have been responded to satisfactorily. The Protocol is a product of Company and will be deemed its Confidential Information, as defined in Section 11 (Confidential Information) of this Agreement. The Parties agree that any alteration in or amendment to the Protocol must be accepted by the Protocol Team, approved in writing by the relevant IRB(s), and submitted to the FDA, if appropriate, prior to such alteration or amendment becoming effective.
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Protocol Development. 6.1 The Parties agree that enrollment in the Clinical Trial will not start until the version of the Protocol to be used has been reviewed in advance by the Protocol Team; approved (stipulations met/resolved) by the relevant IRB(s) and the NIAID in writing; and submitted to the FDA, the thirty (30) calendar day wait period has been satisfied and any FDA clinical hold issues have been responded to satisfactorily. The Protocol is a product of NIAID and will be deemed NIAID Confidential Information, as defined in Section 11 (Confidential Information) of this Agreement. The Parties agree that any alteration in or amendment to the Protocol must be accepted by the Protocol Team, and approved in writing by the relevant IRB(s) and the NIAID and submitted to the FDA, if appropriate, prior to such alteration or amendment becoming effective. The Company will have the right to review any amendments or alterations to the Protocol and NIAID will consider such comments in good faith in finalizing such amendments or alterations.
Protocol Development. 6.1 The Parties agree that enrollment in the Clinical Trial will not start until the version of the Protocol to be used has been reviewed in advance by the Protocol Team; approved (stipulations met/resolved) by the relevant IRB(s) and the NIAID in writing; and submitted to the FDA, the thirty (30) calendar day wait period has been satisfied and any FDA clinical hold issues have been responded to satisfactorily. The Protocol is a product of NIAID and will be deemed NIAID Confidential Information, as defined in Section 11 (Confidential Information) of this Agreement. The Protocol will be posted to CxxxxxxxXxxxxx.xxx, as required by DMID, NIAID, the Final Rule for FDAAA 801, issued in September 2016, and the NIH Policy on the Dissemination of NIH-funded Clinical Trial Information, also issued in September 2016. The Parties agree that any alteration in or amendment to the Protocol must be accepted by the Protocol Team, and approved in writing by the relevant IRB(s) and the NIAID and submitted to the FDA, if appropriate, prior to such alteration or amendment becoming effective.
Protocol Development. Protocol development, the reduction of an idea to a synthetic procedure capable of making * compounds, will be the responsibility of *. The number of automated synthetic and workup steps per protocol is anticipated to average no more than * and *, respectively. Since the expected final quantity is *, the reaction scale may be adjusted accordingly, ca. *. If * desires to *. For selected protocols, up to * selected by *, meeting the *, and having a minimum quantity of * would be * the appropriate information in an SD file. These samples *.
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