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. 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. 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. 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.
6.2 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 NHLBI and submitted to the FDA, if appropriate, prior to such alteration or amendment becoming effective. Company will review any amendments or alterations to the Protocol and NHLBI 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 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.
6.2 The NIAID, through its contractors, will be responsible for performing the randomization. […***…] will determine who will have access to the randomization codes.
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.
6.2 The NIAID, through its contractors, will be responsible for performing the randomization. NIAID will determine who will have access to the randomization codes.
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.
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.
