Protocol and Statistical Analysis Plan Sample Clauses

Protocol and Statistical Analysis Plan. (a) Attached as Appendix A is a synopsis of the protocol for the Gilead Arm. Company shall (i) within [***] days after the Effective Date, provide to Gilead a draft of the full protocol for the Gilead Arm (“Protocol”) and consider in good faith any comments provided by Gilead thereon and (ii) not adopt the Protocol unless and until Gilead has approved the Protocol in writing, such approval not to be unreasonably withheld, conditioned or delayed. (b) Company shall (i) reasonably (and in any event not less than [***] days) prior to adopting the statistical analysis plan for the Gilead Arm (“Statistical Analysis Plan”), provide to Gilead a draft thereof and consider in good faith any comments provided by Gilead thereon, and (ii) not adopt the Statistical Analysis Plan unless and until Gilead has approved the Statistical Analysis Plan in writing, such approval not to be unreasonably withheld, conditioned or delayed. (c) Company shall have the right to amend the Protocol or the Statistical Analysis Plan (in each case, after its adoption) from time to time; provided, however, that (i) without limiting clause (ii) below, Company shall, reasonably (and in any event not less than [***] Business Days) prior to adopting any such amendment, provide to Gilead a draft of such amendment and consider in good faith any comments thereon provided by Gilead, and (ii) if such amendment is material (i.e., substantive) or otherwise related to the Gilead Compound (whether alone or as part of the Combination Therapy), including any such amendment that (A) relates to, or otherwise would have an adverse impact on, the Gilead Compound (including the dose or dosing regimen thereof), (B) would increase the supply obligations of Gilead under the Agreement, or (C) relates to any patient that receives or would receive the Gilead Compound (whether alone or as part of the Combination Therapy), then such amendment shall not be adopted unless Gilead approves such amendment in writing, such approval not to be unreasonably withheld, conditioned or delayed. (d) Gilead may from time to time propose amendments to the Protocol or the Statistical Analysis Plan (in each case, after its adoption), and the Parties shall discuss in good faith any such amendments proposed by Gilead. To the extent any such amendment proposed by Gilead relates solely to the Gilead Compound (including the dose or dosing regimen thereof), the Parties shall adopt in writing such amendment. To the extent any such amendment pro...

Protocol and Statistical Analysis Plan. A synopsis of the initial Protocol for the Study has been agreed to by the Parties as of the Effective Date and is attached hereto as Exhibit A. Through the JDC, Rexahn shall (a) provide any draft versions of the Protocol or statistical analysis plan (and any subsequent revisions thereof) to Merck for Merck’s review and comment, (b) consider in good faith any changes to the draft Protocol or statistical analysis plan requested by Merck, and (c) incorporate any changes requested by Merck with respect to the Merck Compound. Any proposed final version of the Protocol [***] having any amendment from that of Exhibit A related to the Merck Compound) or statistical analysis plan shall be submitted by Rexahn to the JDC for final approval. To the extent the JDC cannot agree unanimously on the Protocol or statistical analysis submitted for final approval: (i) Rexahn shall have final decision-making authority with respect to matters in the Protocol or statistical analysis plan related to [***] (ii) Merck shall have final decision-making authority with respect to matters in the Protocol or statistical analysis plan related to [***] and (iii) all other matters in respect of the Protocol or statistical analysis plan on which the JDC cannot agree shall be resolved in accordance with Section 3.10.4. Once the final Protocol has been approved in accordance with this Section 4.1, any material changes to such approved final Protocol or statistical analysis plan (other than material changes relating solely to the Rexahn Compound) and any changes to the final Protocol (whether or not material) or statistical analysis plan relating to the Merck Compound shall require Merck’s prior written consent. Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager. Merck will provide such consent, or a written explanation for why such consent is being withheld, [***] of receiving a copy of Rexahn’s requested changes. 4.1.1 Notwithstanding anything to the contrary contained herein, Merck, in its sole discretion, shall have the sole right to determine the dose and dosing regimen for the Merck Compound and shall have the final decision on all matters relating to the Merck Compound (including quantities of Merck Compound to be supplied pursuant to Article 8) and any information regarding the Merck Compound included in the Protocol. 4.1.2 Notwithstanding anything to the contrary contained herein, Rexahn, in its sole discretion, shall have the sol...

Protocol and Statistical Analysis Plan. A Protocol and the draft statistical analysis plan for the Study have been agreed to by the Parties as of the Effective Date and are attached hereto as Appendix A. Through the JDC, Company shall (a) provide any subsequent revisions of the Protocol to MSD for MSD’s review and comment, (b) consider in good faith any changes to the Protocol requested by MSD, and (c) incorporate any changes requested by MSD with respect to MSD Compound. To the extent the JDC cannot agree unanimously regarding the contents of the revised Protocol for final approval the matter shall be resolved in accordance with Section 3.9.