Protocol and Statistical Analysis Plan Sample Clauses

Protocol and Statistical Analysis Plan. An initial Protocol and a 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, FLX shall (a) provide any proposed revisions to the then current Protocol or statistical analysis plan to Merck for Merck’s review and comment, (b) consider in good faith any changes requested by Merck, and (c) incorporate any changes requested by Merck with respect to Merck Compound. FLX shall then submit the proposed revised Protocol or statistical analysis plan, as applicable, to the JDC for approval. To the extent the JDC cannot agree unanimously regarding the Protocol or statistical analysis plan for final approval: (i) [***] shall have final decision-making authority with respect to matters related to [***] (including with respect to [***]); (ii) [***] shall have final decision-making authority with respect to matters related to [***] (including with respect to [***]); and (iii) all other matters on which the JDC cannot agree shall be resolved in accordance with Section 3.11.3. Once the final Protocol or statistical analysis plan has been approved in accordance with this Section 4.1, Merck’s prior written consent shall be required for: (i) any [***] changes to such approved final Protocol or statistical analysis plan (other than [***] changes relating [***]); or (ii) any changes to such approved final Protocol or statistical analysis plan [***] relating to [***]. Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager. 4.1.1. Notwithstanding anything to the contrary contained herein, [***], in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to [***] (including [***]) and any information regarding [***]. 4.1.2. Notwithstanding anything to the contrary contained herein, [***], in its sole discretion, shall have the sole right to determine [***] and shall have the final decision on all matters relating to [***] (including [***]), [***], and any information regarding [***].
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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...
Sample 1
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...
Sample 1
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.
Sample 1

Related to Protocol and Statistical Analysis Plan

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • Statistical, Demographic or Market-Related Data All statistical, demographic or market-related data included in the Registration Statement, the Disclosure Package or the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate and all such data included in the Registration Statement, the Disclosure Package or the Prospectus accurately reflects the materials upon which it is based or from which it was derived.

  • Statistical and Marketing-Related Data All statistical or market-related data included or incorporated by reference in the Registration Statement, the Time of Sale Disclosure Package or the Final Prospectus, or included in the Marketing Materials, are based on or derived from sources that the Company reasonably believes to be reliable and accurate, and the Company has obtained the written consent to the use of such data from such sources, to the extent required.

  • Statistical Data The statistical, industry-related and market-related data included in the Registration Statement, the Sale Preliminary Prospectus, and/or the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes are reliable and accurate, and such data materially agree with the sources from which they are derived.

  • Statistical and Market Data Nothing has come to the attention of the Company that has caused the Company to believe that the statistical and market-related data included in the Registration Statement, the Pricing Disclosure Package and the Prospectus is not based on or derived from sources that are reliable and accurate in all material respects.

  • Statistical and Market-Related Data Any statistical and market-related data included in the Registration Statement, the General Disclosure Package or the Prospectus are based on or derived from sources that the Company believes, after reasonable inquiry, to be reliable and accurate and, to the extent required, the Company has obtained the written consent to the use of such data from such sources.

  • Statistical Information Any third-party statistical and market-related data included in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate in all material respects.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

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