Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “Phase 1b/2 Study of VX15/2503 in combination with avelumab in patients with advanced non-small cell lung cancer”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Vaccinex and Merck shall agree on the contents of the Protocol; any changes to the Protocol that would require the approval of a Regulatory Authority or Institutional Review Board shall require prior written approval of all Parties. The contents of the Protocol and any proposed changes to the Protocol will be sent in writing to Merck’s Team Leader and Merck’s Manager. In the event that the Parties cannot agree in writing on the final Protocol, the matter shall be elevated in accordance with Section 3.8 for final resolution. In the event that the Managers cannot reach agreement on changes or amendments to the Protocol after elevating the matter in accordance with Section 3.8, Vaccinex shall have the final decision on any Protocol amendments solely related to the dosing of Vaccinex Compound, and Merck shall have the final decision on any Protocol amendments solely related to the dosing of Merck Compound. For clarity, Vaccinex may implement any change to the Protocol that would not require the approval of a Regulatory Authority or Institutional Review Board; provided, that Vaccinex gives prompt notice thereof to Merck.
4.2 Vaccinex shall prepare the patient informed consent forms for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with Merck) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to Merck Compound will be provided to Vaccinex by Merck). Any changes to such form that relate to the Sample Testing or Merck Compound or the sharing of data shall be subject to Merck’s review and prior written consent to be provided to Vaccinex in a timely manner. Any such proposed changes will be sent in writing to Merck’s Team Leader and Merck’s Manager. Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “Protocol Summary”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Context shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol materially impacting the Menarini Compound shall require Menarini's prior written consent, not to be unreasonably withheld, conditioned or delayed. Any such proposed changes will be sent in writing to Menarini's Project Manager and Menarini's Alliance Manager. Menarini will provide such consent, or a written explanation for why such consent is being withheld, within [***] days of receiving a copy of Context's requested changes; provided that if Menarini fails to provide such written explanation within such [***] day period, then Menarini shall be deemed to have consented to such change or changes.
4.2 Context shall prepare the patient informed consent form for the Study (which shall include any required consent for the Sample Testing) in consultation with Menarini (it being understood and agreed that the portion of the informed consent form relating to the Menarini Compound will be timely provided to Context by Menarini). Any changes to such form that relate to the Menarini Compound shall be subject to Menarini's review and prior written consent, not to be unreasonably withheld, conditioned or delayed. Any such proposed changes will be sent in writing to Menarini's Project Manager and Menarini's Alliance Manager. Menarini will provide such consent, or a written explanation for why such consent is being withheld, within [***] days of receiving a copy of Context's requested changes; provided that if Menarini fails to provide such written explanation within such [***] day period, then Menarini shall be deemed to have consented to such change or changes.
4.3 Within a reasonable time after the Effective Date, the Parties shall enter into an agreement related to the collection of financial disclosure information from “clinical investigators” involved in the Study and the certification and/or disclosure of the same in accordance with all Applicable Law, including, but not limited to, Part 54 of Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA guidance documents. Among other things, such agreement will provide (a) for Context to track and collect from all “clinical investigators” involved in the Stu...
Protocol and Related Documents. A summary of the initial Protocol, entitled “Randomized Phase 2 Study of Darovasertib + Crizoitnib in Patients with Metastatic Uveal Melanoma”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Ideaya shall have the final decision regarding the contents of the Protocol; provided, however, that any [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. material changes to the Protocol relating to the Study (other than relating solely to the Ideaya Compound), and any changes (whether or not material) relating to the Pfizer Compound, shall require Pfizer’s prior written consent. Any such proposed changes will be sent in writing to Pfizer’s Project Manager and Pfizer’s Alliance Manager. Pfizer will provide such consent, or a written explanation for why such consent is being withheld, within [***] Business Days of receiving a copy of Ideaya’s requested changes; provided that if Pfizer fails to provide such written explanation within such [***] Business Day period, then Pfizer shall be deemed to have consented to such change or changes.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “PROTOCOL SUMMARY FOR ENCORE 603 TRIAL”, has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. Syndax and the Alliance shall agree on the contents of the Protocol; any changes of the Protocol require prior written approval of all Parties. The contents of the Protocol and any proposed changes to the Protocol will be sent in writing to the Alliance’s Project Manager and the Alliance’s Alliance Manager. In the event that the Parties cannot agree in writing on the final Protocol the matter is elevated in accordance with Section 3.8 for final resolution. In the event that the Alliance Managers cannot reach agreement on changes or amendments to the Protocol after elevating the matter in accordance with Section 3.8, Syndax shall have the final decision on ***, and the Alliance shall have the final decision on ***.
4.2 Syndax shall prepare the patient informed consent forms for the Study (which shall include any required consent for the Sample Testing and sharing of patient data with the Alliance) in consultation with the Alliance (it being understood and agreed that the portion of the informed consent form relating to the Alliance Compound will be provided to Syndax by the Alliance). Any changes to such form that relate to the Sample Testing or the Alliance Compound or the sharing of data shall be subject to the Alliance’s review and prior written consent. Any such proposed changes will be sent in writing to the Alliance’s Project Manager and the Alliance’s Alliance Manager.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “***” has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. The final Protocol must be accepted by both Parties. Athenex shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol (other than relating solely to the Athenex Compound), and any changes (whether or not material) relating to the Lilly Compound, shall require Lilly’s prior written consent. Any such proposed changes will be sent in writing to Lilly’s Project Manager. Lilly will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days of receiving a copy of Athenex’s requested changes; provided that if Lilly fails to provide such written explanation within such 15 Business Day period, then Lilly shall be deemed to have consented to such change or changes. Athenex will provide a copy of the final approved protocol and any subsequent protocol amendments.
Protocol and Related Documents. 11 Section 4.1. Protocol ........................................................................................................11 Section 4.2. Patient Informed Consent ..........................................................................12 Section 4.3. Sunshine Reporting .....................................................................................12 Article 5.
Protocol and Related Documents. 4.1 A summary of the initial Protocol, entitled “A phase Ib study of Oraxol in combination with Ramucirumab in patients with Gastric, Gastro-esophageal, or Esophageal Cancers” has been agreed to by the Parties as of the Effective Date, and is attached as Appendix A. The final Protocol must be accepted by both Parties. Athenex shall have the final decision regarding the contents of the Protocol; provided, however, that any material changes to the Protocol (other than relating solely to the Athenex Compound), and any changes (whether or not material) relating to the Lilly Compound, shall require Lilly’s prior written consent. Any such proposed changes will be sent in writing to Lilly’s Project Manager. Lilly will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days of receiving a copy of Athenex’s requested changes; provided that if Lilly fails to provide such written explanation within such 15 Business Day period, then Lilly shall be deemed to have consented to such change or changes. Athenex will provide a copy of the final approved protocol and any subsequent protocol amendments.
Protocol and Related Documents. 4.1 A protocol and statistical analysis plan for the Study, has been agreed to by the Parties as of the Effective Date and is attached hereto as Appendix A (“Protocol”). The Protocol may be amended with the approval of the JDC, subject to each Party’s decision-making rights as set forth below.
4.2 Notwithstanding Section 4.1, Merck, in its sole discretion, will determine the dose and dosing regimen for the Merck Compound and will have the final decision on all matters relating to the Merck Compound and any information regarding the Merck Compound included in the Protocol.
4.3 Notwithstanding Section 4.1, Advaxis in its sole discretion, will determine the dose and dosing regimen for the Advaxis Compound and will have the final decision on all matters relating to the Advaxis Compound and any information regarding the Advaxis Compound included in the Protocol. Certain portions of this document have been marked “[C.I.]” to indicate that confidential treatment has been requested for such confidential information. The confidential portions have been omitted and submitted separately with the Securities and Exchange Commission.
4.4 Advaxis shall prepare the patient informed consent form for the Study in consultation with Merck (it being understood that the portion of the informed consent form relating to the Merck Compound will be provided by Merck). Any changes to such form that relate to the Merck Compound shall be subject to Merck’s written consent. Merck will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days of receiving Advaxis’ request therefor.
Protocol and Related Documents. 4.1 A synopsis of each initial Protocol, entitled (i) for the Indication CRC “A Phase Ib/II dose seeking study of VXM01 in combination with the anti-PD-L1 antibody Avelumab in advanced solid malignancies with expansion cohort in colorectal cancer” and
Protocol and Related Documents
