Protocol Development Sample Clauses
Protocol Development. 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.
6.1.2 Once the parties have mutually agreed upon the OXFORD Protocol, if OXFORD wishes to make further changes to the OXFORD Protocol after TEKMIRA’s approval has been granted, TEKMIRA shall again have the right receive, review, comment and approve in writing each new change. In this latter case, TEKMIRA may only withhold approval of the OXFORD Protocol for reasons relating to patient safety or data integrity, as determined by changes in mode or rate of drug administration, dosage, method of tracking and/or reporting patient adverse events, frequency or nature of safety monitoring, inclusion criteria, exclusion criteria, use of concomitant medications, randomization, stopping rules, use of placebo, or other elements relating to patient care.
6.1.3 TEKMIRA may, subject to Section 11.3.6 (return of Wellcome Trust funding), decline to ship Investigational Medicinal Product and terminate this Agreement in the event that the OXFORD Protocol or any further change thereto is not approved by TEKMIRA. If after shipment of the Investigational Medicinal Product, the OXFORD Protocol or any further change thereto is not approved by TEKMIRA, the Parties shall mutually terminate the Agreement, and subject to Section 11.3.6 (return of Wellcome Trust funding) OXFORD shall promptly return all Investigational Medicinal Product to TEKMIRA or destroy same and confirm destruction in writing, at TEKMIRA’s sole election.
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. In order to assure the development of approximately * protocols for the third year and prepare for *, 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. 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 *.
Protocol Development. 1.1.1. Institute and Company shall collaborate in the development and drafting of a protocol designed to advance the Research which protocol, when final, (the “Protocol”) will include, among other things, those elements described in Exhibit A hereto (the “Protocol Outline”). Each Party will supply those resources and furnish those deliverables enumerated in the Protocol Outline to the extent required in the final Protocol.
1.1.2. To that end, Institute and Company will collaborate and regularly communicate in good faith through each Party’s primary point of contact, identified in Exhibit A. Institute and Company shall take reasonable efforts to complete the Protocol for submission to the institutional review board of record for Institute (the “IRB”) within sixty (60) calendar days from the Effective Date hereof or such longer period as and to which the Parties may agree in writing (the “Protocol Development Period”).
1.1.3. The Protocol shall be considered the Confidential Information of each Party.
1.1.4. In the event the Parties are unable to agree on a protocol within the Protocol Development Period, the Parties may mutually agree to terminate this Agreement or either Party may terminate this Agreement by providing the other Party with ten (10) calendar days’ notice and, following termination, subject to Article 5 and Section 9.5 hereto (including the provisions referenced therein), neither Party shall be restricted or prevented in any way from pursuing similar activities, work or research on its own or with any third party collaborator(s).
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.
ii. By March 30, 2012, the Commonwealth must provide CMS for CMS approval a cost protocol development tool that includes a description of all specific data including data sources it proposes to include in the cost-limit protocol, including the scope of services and costs for each provider type (e.g. inpatient, outpatient, physician services, clinic services, non-hospital services, etc.). Massachusetts must use the same definition for inpatient and outpatient services as described in its approved Medicaid State plan for an initial framework and identify other uncompensated care costs that are not included in the State plan definitions. The Commonwealth must also identify any costs that would not be captured using Medicare cost principles but for which it will seek reimbursement under the SNCP (an example would be unreimbursed translation services associated with Medicaid or uninsured individuals).
iii. By May 31, 2012, CMS will approve this cost protocol development tool. This approval will inform the scope of services and costs in subparagraph
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.
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. 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.