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. Ji Xing shall conduct all Medical Affairs Activities for the Product in the Field in the Territory pursuant to a written Medical Affairs Activities plan that set forth the timeline and details of all Medical Affairs Activities to be conducted by or on behalf of Ji Xing for the Product in the Field in the Territory (the “Medical Affairs Plan”), which plan shall, [*]. No later than [*] before the planned initiation of the first Clinical Trial of the Product in the Field in the Territory, Ji Xing [*]. Thereafter, from time to time, but at least [*], Ji Xing shall prepare updates or amendments to the Medical Affairs Plan [*].
Medical Affairs Plan. At an appropriate time to be agreed by the Development Committee, the Development Committee shall agree upon the initial joint plan and budget for Medical Affairs activities, including:
(1) medical education plan which shall set forth medical science liaison (“MSL”) and medical affairs strategies and activities, including meetings with key opinion leaders, consultancy meetings or programs, non-promotional activities, conferences, budgets and strategies for grant disbursements, medical information services, managing relationships with cooperative groups, and establishing and implementing risk, evaluation and mitigation strategies;
(2) MSL and other medical affairs personnel responsibilities shall be allocated between the Parties by the JCC in an equitable manner, taking into consideration all reasonable factors; and
(3) investigator initiated studies.
Medical Affairs Plan. No later than [***] days prior to the anticipated date of performance of the Medical Affairs activities for the Licensed Product in the Territory, and in no event later than [***] days prior to the anticipated commercial launch of the Licensed Product in the Territory, the JDC will develop, review, and discuss an initial draft of the Medical Affairs Plan for the Licensed Product and provide such initial draft to the JSC to review, discuss, and determine whether to approve. The Medical Affairs Plan will contain a high level summary of the major Medical Affairs activities to be undertaken for the Licensed Product in the Territory and the estimated timelines for performing such activities. Thereafter, from time to time, but at least annually, the JDC will propose updates to the Medical Affairs Plan for the Licensed Product to reflect changes in such plans, including to account for relevant factors that may influence such plan and the Medical Affairs activities set forth therein and provide each such update to the JSC to review, discuss, and determine whether to approve. To the extent relevant to the conduct of Medical Affairs activities for the Licensed Product in the Territory by Partner in accordance with the Medical Affairs Plan, the Parties will discuss, through the JSC, Kiniksa’s Medical Affairs activities outside of the Territory, including medical publications, real world study data, symposium, and conference presentations.
Medical Affairs Plan. No less than fifteen (15) months prior to the reasonably anticipated date for a First Commercial Sale, ADCT shall prepare and present at a JSC meeting for discussion a strategy containing the worldwide strategy, activities and timeline with respect to the medical affairs activities in support of the Products in the Field (such strategy, as may be amended by ADCT from time to time, the “Global Medical Affairs Strategy”). No less than nine (9) months prior to the reasonably anticipated date for a First Commercial Sale, MTPC shall prepare and present at a JSC meeting a plan containing the strategy, activities and timeline with respect to the medical affairs activities in support of the Products in the MTPC Territory for the JSC to review and approve (such plan, as may be amended with approval of the JSC during the Term, the “MTPC Medical Affairs Plan”) that will, to the extent possible and subject to the Governance Mechanism, be aligned with the Global Medical Affairs Strategy.
Medical Affairs Plan. Evelo has developed a global Medical Affairs strategy (including a strategy for managing communications with key opinion leaders), and no later than one year following the Effective Date, in collaboration with Evelo through the PCC, ALJ will prepare a reasonably detailed medical affairs plan for the Territory that will be consistent with Evelo’s global Medical Affairs strategy (the “Medical Affairs Plan”). The PCC will review, discuss, and determine whether to approve the initial Medical Affairs Plan so submitted by ALJ. The Medical Affairs Plan will be compliant with all Applicable Laws and each Party’s written compliance policies and procedures, and each Medical Affairs Plan will include:
7.1.1 the Medical Affairs activities to be undertaken by each Party for the Products in the Territory and an allocation between the Parties for all such activities;
7.1.2 the qualification requirements for each Party’s medical science liaisons;
7.1.3 medical science liaison resource planning; and
7.1.4 a written budget of the expected FTE Costs and Out-of-Pocket Expenses for all activities under the Medical Affairs Plan on a Calendar Year basis for the subsequent Calendar Year (as may be updated pursuant to this Section 7.1 (Medical Affairs Plan), the “Medical Affairs Budget”). At least once each Calendar Year, ALJ will provide to the PCC an update to the then-current Medical Affairs Plan and Medical Affairs Budget, and may provide additional updates thereto from time to time, and the PCC will review, discuss, and determine whether to approve any proposed amendment or updates to the Medical Affairs Plan (including any amendments to the Medical Affairs Budget) in accordance with Section 3.3 (Decision-Making). ALJ will not perform any Medical Affairs activities for the Products for the Territory that is not in accordance with the Medical Affairs Plan.
Medical Affairs Plan. Kyowa shall prepare and submit to the JSC a plan containing the strategy and proposed activities for Medical Affairs Activities (as updated pursuant to this Section 6.7, the “Medical Affairs Plan”). Kyowa shall submit a proposed draft of the Medical Affairs Plan to the JSC no later than * prior to the anticipated Commercial Launch of Licensed Product and shall submit an updated Medical Affairs Plan to the JSC no later than * prior to the anticipated Commercial Launch of Licensed Product. Kyowa shall 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 once per Calendar Year. Updates to the Medical Affairs Plan shall reflect, among other things, each new Indication in the Cancer Field, and Additional Field if applicable, and countries within the Territory in which Medical Activities will be conducted for Licensed Product. The Medical Affairs Plan and all updates shall be reviewed and discussed by the JSC. Kyowa will in good faith consider the reasonable comments provided by the ArQule JSC members but will only be required to revise a Medical Affairs Plan if, in ArQule’s sole but reasonable opinion, an aspect of such Medical Affairs Plan would have, or is having, a material adverse scientific, clinical, medical, regulatory or commercial impact on obtaining regulatory approval for the manufacture, use or sale of Licensed Product outside the Territory, or commercialization of Licensed Product outside of the Territory, in which event Kyowa will revise the applicable Medical Affairs Plan and resubmit it to the JSC for review in the same manner. Kyowa shall make commercially reasonable best efforts to carry out and perform the plan, strategy and activities set forth in the Medical Affairs Plan as in effect from time to time within the timelines contained therein. All decisions regarding the day-to-day conduct of Medical Affairs Activities in accordance with the Medical Affairs Plan shall be Kyowa Decisions. Kyowa shall not engage in any Medical Affairs Activities with respect to Licensed Product unless such activity is described in the Medical Affairs Plan.
Medical Affairs Plan. (a) The Parties shall coordinate with respect to the strategy and implementation of the Medical Affairs Activities with respect to the Product in Cytokinetics Territory and Astellas Territory under a written plan for the Medical Affair Activities for the Product (the “Medical Affairs Plan”). 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 the Product.
(b) No later than [*], or promptly after the Effective Date (if the Effective Date occurs during such [*] period), the JMAC shall prepare and approve the initial Medical Affairs Plan. Thereafter, the JMAC shall periodically (at least on an annual basis) prepare and approve updates and amendments to the Medical Affairs Plan.
(c) Each Party shall provide the other Party with at least [*] days advance notification of key in-person meeting or teleconference of advisory panels with key opinion leaders that relates to the Development or Commercialization of Tirasemtiv and Product. Such other Party shall have the right, but not the obligation, to have its representatives attend (but, unless otherwise requested by the Party responsible for such meeting, not participate in) such meetings; provided however that Astellas shall not have the right to attend any such meeting in the Cytokinetics Sole Territory.
Medical Affairs Plan. Each Party will prepare and provide to the JMAC for its review a Medical Affairs Plan with respect to the Licensed Product no later than […***…] after the Effective Date with respect to the Licensed Product with respect to (i) in Novartis’s case, the initial Indication with respect to which a BLA for Licensed Product is filed in the United States and (ii) in BeiGene’s case, any Indication in respect of which BeiGene has received Regulatory Approval or has filed a MAA in the BeiGene Territory. Thereafter, no later than […***…] prior to the expected date of First Commercial Sale of any other Licensed Product, each Party shall provide to the JMAC for its review a Medical Affairs Plan with respect to such Licensed Product. Each Party shall provide the JMAC with updates regarding the conduct of each such Medical Affairs Plan not less than […***…] thereafter. Any amendments or modifications to the Medical Affairs Plan for the Licensed Product shall be prepared by the applicable Party and delivered promptly to the JMAC.
Medical Affairs Plan. Subject to Section 5.5.4, each Party will prepare and provide to the JMAC for its review a Medical Affairs Plan with respect to the Licensed Product in its respective Territory. No later than […***…] prior to the expected date of First Commercial Sale of any Licensed Product, each Party shall provide to the JMAC for its review a Medical Affairs Plan with respect to such Licensed Product. Each Party shall provide the JMAC with updates regarding the conduct of each such Medical Affairs Plan not less than […***…] thereafter. Any amendments or modifications to the Medical Affairs Plan for the Licensed Product shall be prepared by the applicable Party and delivered promptly to the JMAC.
