Common use of Medical Affairs Plan Clause in Contracts

Medical Affairs Plan. Kyowa Kirin will prepare and submit to the JSC for JSC’s review a plan containing the strategy and proposed Medical Affairs Activities (described generally) in the Territory with respect to Licensed Products for use in the Field (as updated pursuant to this Section 6.7, the “Medical Affairs Plan”). Kyowa Kirin will submit a proposed draft of the Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product and will submit an updated Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product. Kyowa Kirin will deliver an update of the relevant sections of the Medical Affairs Plan from time to time during the Term, and in no case less than [***] following the First Commercial Sale. Updates to the Medical Affairs Plan will reflect, among other things, each new Indication in the Field for which the Licensed Product has received Commercialization Regulatory Approval and countries within the Territory in which Medical Affairs Activities will be conducted for Licensed Product. The Medical Affairs Plan and all updates will be reviewed and discussed by the JSC. Kyowa Kirin will in good faith consider the reasonable comments provided by Reata to the Medical Affairs Plan in light of potential risks that such Medical Affairs Plan; and if such risks could have, or are having, a material adverse scientific, clinical, medical, regulatory or commercial impact on (a) obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or (b) commercialization of Licensed Product outside of the Territory, then subject to Section 3.4, the JSC may decide to revise the applicable Medical Affairs Plan to address such concerns and resubmit it to the JSC for review in the same manner. Kyowa Kirin will make Commercially Reasonable Efforts to carry out and perform the plan, strategy and activities set forth in the Medical Affairs Plan within any applicable timelines contained therein. Kyowa Kirin will not engage in any Medical Affairs Activities with respect to Licensed Product in a manner that is inconsistent with or outside the scope of the Medical Affairs Plan.

Medical Affairs Plan. Kyowa Kirin will prepare and submit to the JSC for JSC’s review a plan containing the strategy and proposed Medical Affairs Activities (described generally) in the Territory with respect to Licensed Products for use in the Field (as updated pursuant to this Section 6.7, the ““ Medical Affairs PlanPlan ”). Kyowa Kirin will submit a proposed draft of the Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product and will submit an updated Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product. Kyowa Kirin will deliver an update of the relevant sections of the Medical Affairs Plan from time to time during the Term, and in no case less than [***] following the First Commercial Sale. Updates to the Medical Affairs Plan will reflect, among other things, each new Indication in the Field for which the Licensed Product has received Commercialization Regulatory Approval and countries within the Territory in which Medical Affairs Activities will be conducted for Licensed Product. The Medical Affairs Plan and all updates will be reviewed and discussed by the JSC. Kyowa Kirin will in good faith consider the reasonable comments provided by Reata to the Medical Affairs Plan in light of potential risks that such Medical Affairs Plan; and if such risks could have, or are having, a material adverse scientific, clinical, medical, regulatory or commercial impact on (a) obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or (b) commercialization of Licensed Product outside of the Territory, then subject to Section 3.4, the JSC may decide to revise the applicable Medical Affairs Plan to address such concerns and resubmit it to the JSC for review in the same manner. Kyowa Kirin will make Commercially Reasonable Efforts to carry out and perform the plan, strategy and activities set forth in the Medical Affairs Plan within any applicable timelines contained therein. Kyowa Kirin will not engage in any Medical Affairs Activities with respect to Licensed Product in a manner that is inconsistent with or outside the scope of the Medical Affairs Plan.

Medical Affairs Plan. Kyowa Kirin will prepare and submit The Parties shall coordinate with respect to the JSC for JSC’s review a plan containing the strategy and proposed implementation of the Medical Affairs Activities (described generally) in the Territory with respect to Licensed Products each Collaboration Product in each Indication [*] for use such Indication, and such coordination will be set forth in the Field Medical Affairs Plan. No later than [*] Collaboration Product, Astellas shall prepare and provide to the JMAC for review and discussion a written plan for the Medical Affairs Activities for such Collaboration Product (as updated pursuant to this Section 6.7, the “Medical Affairs Plan”), subject to Section 10.5 below. Kyowa Kirin will The Medical Affairs Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Medical Affairs Activities with respect to such Collaboration Product. The Medical Affairs Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ MSLs’ activities during [*] such Collaboration Product (and thereafter if Cytokinetics exercises its Co-Promotion option for such Collaboration Product or if such Collaboration Product is Developed in [*] Indication), as well as a budget therefor, which shall be consistent with Section 10.5 below. Astellas shall periodically (at least on an annual basis) prepare updates and amendments to the Medical Affairs Plan to reflect changes in its plans, subject to Section 10.5. Astellas shall submit a proposed draft of all updates and amendments to the Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date JMAC for review and discussion. Astellas shall be solely responsible for all costs incurred by or on behalf of the First Commercial Sale of each Licensed Product and will submit an updated Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product. Kyowa Kirin will deliver an update of the relevant sections of either Party in performing their respective obligations under the Medical Affairs Plan from time to time during the Term, and in no case less than shall pay [***] following the First Commercial Sale. Updates to the Medical Affairs Plan will reflect, among other things, each new Indication in the Field for which the Licensed Product has received Commercialization Regulatory Approval and countries within the Territory in which Medical Affairs Activities will be conducted for Licensed Product. The Medical Affairs Plan and all updates will be reviewed and discussed by the JSC. Kyowa Kirin will in good faith consider the reasonable comments provided by Reata to the Medical Affairs Plan in light of potential risks that such Medical Affairs Plan; and if such risks could have, or are having, a material adverse scientific, clinical, medical, regulatory or commercial impact on (a) obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or (b) commercialization of Licensed Product outside of the Territory, then subject to Section 3.4, the JSC may decide to revise the applicable Medical Affairs Plan to address such concerns and resubmit it to the JSC for review in the same manner. Kyowa Kirin will make Commercially Reasonable Efforts to carry out and perform the plan, strategy and activities as set forth in the Medical Affairs Plan within any applicable timelines contained thereinPlan, except as set forth in Section 10.5(b)(ii)(1). Kyowa Kirin will not engage in any For clarity, [*] Medical Affairs Activities with respect [*] each Indication will be determined by the JMAC, subject to Licensed Product in a manner that is inconsistent with or outside [*]. If and when [*] MSL support for the [*] Indications [*] for the [*] Indications and/or [*] Indications. Cytokinetics may perform additional activities within the scope of its responsibilities under the Medical Affairs Plan, in addition to those funded in the JMAC-approved budget, [*] for the [*] Indication and/or [*] Indications in the Shared Territory.

Medical Affairs Plan. Kyowa Kirin will prepare and submit The Parties shall coordinate with respect to the JSC for JSC’s review a plan containing the strategy and proposed implementation of the Medical Affairs Activities (described generally) in the Territory with respect to Licensed Products each Collaboration Product in each Indication [ * ] for use such Indication, and such coordination will be set forth in the Field Medical Affairs Plan. No later than [ * ] Collaboration Product, Astellas shall prepare and provide to the JMAC for review and discussion a written plan for the Medical Affairs Activities for such Collaboration Product (as updated pursuant to this Section 6.7, the “Medical Affairs Plan”), subject to Section 10.5 below. Kyowa Kirin will The Medical Affairs Plan shall include a reasonably detailed description of and anticipated timeline [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. for the Parties’, their respective Affiliates’ and sublicensees’ Medical Affairs Activities with respect to such Collaboration Product. The Medical Affairs Plan shall also include a reasonably detailed description of and anticipated timeline for Cytokinetics’ MSLs’ activities during [ * ] such Collaboration Product (and thereafter if Cytokinetics exercises its Co-Promotion option for such Collaboration Product or if such Collaboration Product is Developed in [ * ] Indication), as well as a budget therefor, which shall be consistent with Section 10.5 below. Astellas shall periodically (at least on an annual basis) prepare updates and amendments to the Medical Affairs Plan to reflect changes in its plans, subject to Section 10.5. Astellas shall submit a proposed draft of all updates and amendments to the Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date JMAC for review and discussion. Astellas shall be solely responsible for all costs incurred by or on behalf of the First Commercial Sale of each Licensed Product and will submit an updated Medical Affairs Plan to the JSC no later than [***] prior to the anticipated date of the First Commercial Sale of each Licensed Product. Kyowa Kirin will deliver an update of the relevant sections of either Party in performing their respective obligations under the Medical Affairs Plan from time to time during the Term, and in no case less than [***shall pay [ * ] following the First Commercial Sale. Updates to the Medical Affairs Plan will reflect, among other things, each new Indication in the Field for which the Licensed Product has received Commercialization Regulatory Approval and countries within the Territory in which Medical Affairs Activities will be conducted for Licensed Product. The Medical Affairs Plan and all updates will be reviewed and discussed by the JSC. Kyowa Kirin will in good faith consider the reasonable comments provided by Reata to the Medical Affairs Plan in light of potential risks that such Medical Affairs Plan; and if such risks could have, or are having, a material adverse scientific, clinical, medical, regulatory or commercial impact on (a) obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or (b) commercialization of Licensed Product outside of the Territory, then subject to Section 3.4, the JSC may decide to revise the applicable Medical Affairs Plan to address such concerns and resubmit it to the JSC for review in the same manner. Kyowa Kirin will make Commercially Reasonable Efforts to carry out and perform the plan, strategy and activities as set forth in the Medical Affairs Plan within any applicable timelines contained thereinPlan, except as set forth in Section 10.5(b)(ii)(1). Kyowa Kirin will not engage in any For clarity, [ * ] Medical Affairs Activities with respect [ * ] each Indication will be determined by the JMAC, subject to Licensed Product in a manner that is inconsistent with or outside [ * ]. If and when [ * ] MSL support for the [ * ] Indications [ * ] for the [ * ] Indications and/or [ * ] Indications. Cytokinetics may perform additional activities within the scope of its responsibilities under the Medical Affairs Plan, in addition to those funded in the JMAC-approved budget, [ * ] for the [ * ] Indication and/or [ * ] Indications in the Shared Territory.