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.
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. By the beginning of 2003, all protocols being developed will be at * and will include HPLC purification as the *. In order to assure the development of approximately * protocols for the second year and prepare for the * the third 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 necessary 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 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. 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.
Protocol Development. Merck will develop and propose to Xxxxxx a protocol for performing (i) an in vivo clinical study to investigate "raw data" correlation between radiographic absorptiometry ("RA") and the Device for measuring phalange bone density, (ii) an in vivo clinical study to establish a normative database for use in connection with the Device, and (iii) a cadaver study to measure precision and accuracy of the Device, and "raw data" correlation between RA and the Device, in each case as it pertains to measurement of phalange bone density. Merck agrees that it will deliver to Xxxxxx the protocols referred to in clauses (i)-(iii) on or before September 30, 1996, provided that if Merck shall fail to make such deliveries by that date, the June 30, 1997 date referred to in Sections 5(e)(vi) and 10(c) shall be extended one day for each day that such protocols are so delayed. Merck shall make good faith efforts in the performance of its obligations under this Section 10(a), but shall not be responsible for outcomes, implementation, scope, methodology or design deficiencies.
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. Each Party shall provide the other Party with access to the protocol for human clinical trials and pre-clinical animal trials of the Principal Products or Injection Catheter and access to and use of the clinical trial data and results, in each case on an ongoing basis, solely for use in connection with seeking necessary Approvals for use of the Principal Product. The Representatives shall meet to discuss any comments and proposals BSC has with respect to the protocol, and the Company Representative Group shall make a good faith endeavor to incorporate the comments and proposals made by BSC. To the extent that BSC’s comments and proposals relate to the Injection Catheter, the Company shall incorporate all such comments and proposals into the protocol; provided, however, BSC shall be responsible for all costs arising from its comments relating primarily to the development of the Injection Catheters.
