Common use of Protocol and Statistical Analysis Plan Clause in Contracts

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 proposed by Gilead does not relate solely to the Gilead Compound (including the dose or dosing regimen thereof), such amendment shall not be adopted unless Company approves such amendment in writing, such approval not to be unreasonably withheld, conditioned or delayed. Subject to the foregoing, if Company has concerns regarding any such amendment proposed by Gilead, Company may raise such [***] 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. concerns at any meeting of the JSC and, to the extent any such concerns are so raised, Gilead shall consider such concerns in good faith; provided that, if after such good faith consideration, Gilead notifies the Company that Gilead requires that such amendment be adopted, the Company may terminate this Agreement upon [***] days written notice provided to Gilead within [***] days of the notice of such requirement from Gilead. (e) Company shall prepare the template patient informed consent form for the Gilead Arm in consultation with Gilead; provided, however, that Gilead shall be solely responsible for, and shall provide Company with, the portion of the template informed consent form that relates to the Gilead Compound. Any proposed changes to the template informed consent form requested by an institutional review board or Gilead Arm site that would alter language relating to the Gilead Compound shall require ▇▇▇▇▇▇’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed, (and Company shall provide any such proposed changes to Gilead for its review at least [***] Business Days prior to the date on which Company requests ▇▇▇▇▇▇’s response thereto). Company shall ensure that each informed consent form for the Gilead Arm includes any required consent for use of the applicable patient’s Samples pursuant to the Sample Analysis Plan and authorizes Company to provide to Gilead, and Gilead to use and disclose as permitted hereby, any Clinical Data or Sample Analysis Results relating to the applicable patient.

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 [***] 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. 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 proposed by Gilead ▇▇▇▇▇▇ does not relate solely to the Gilead Compound (including the dose or dosing regimen thereof), such amendment shall not be adopted unless Company approves such amendment in writing, such approval not to be unreasonably withheld, conditioned or delayed. Subject to the foregoing, if Company has concerns regarding any such amendment proposed by Gilead, Company may raise such [***] 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. concerns at any meeting of the JSC and, to the extent any such concerns are so raised, Gilead shall consider such concerns in good faith; provided that, if after such good faith consideration, Gilead notifies the Company that Gilead requires that such amendment be adopted, the Company may terminate this Agreement upon [***] days written notice provided to Gilead within [***] days of the notice of such requirement from Gilead. (e) Company shall prepare the template patient informed consent form for the Gilead Arm in consultation with Gilead; provided, however, that Gilead shall be solely responsible for, and shall provide Company with, the portion of the template informed consent form that relates to the Gilead Compound. Any proposed changes to the template informed consent form requested by an institutional review board or Gilead Arm site that would alter language relating to the Gilead Compound shall require ▇▇▇▇▇▇’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed, (and Company shall provide any such proposed changes to Gilead for its review at least [***] Business Days prior to the date on which Company requests ▇▇▇▇▇▇’s response thereto). Company shall ensure that each informed consent form for the Gilead Arm includes any required consent for use of the applicable patient’s Samples pursuant to the Sample Analysis Plan and authorizes Company to provide to Gilead, and Gilead to use and disclose as permitted hereby, any Clinical Data or Sample Analysis Results relating to the applicable patient.