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:
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. The Medical Affairs Activities in support of Products in the Territory shall be described in a reasonably comprehensive plan (the “Medical Affairs Plan”) that describes the Medical Affairs Activities throughout in the Territory, key tactics and strategies for implementing those activities, the relative responsibilities of the Parties and the associated budget for such activities (the “Medical Affairs Budget”). The JMAC shall prepare an initial Medical Affairs Plan (with input from the JDC and JCC) for review and approval by the JSC, no later than [**]. On an annual basis thereafter, the JMAC shall meet no later than [**] of each Calendar Year to update the Medical Affairs Plan and shall submit all such updates to the JSC for review and approval, such that JSC preliminary approval would occur no later than [**] of such Calendar Year. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC no later than [**] of such Calendar Year, at which time such Medical Affairs Plan shall be amended accordingly. The JMAC shall also reasonably consider for approval any proposed updates and amendments to the Medical Affairs Plan presented by either Party. The JSC shall review such proposed amendments presented by the JMAC and may approve such proposed amendments or any other proposed amendments that the JSC may consider from time to time and, upon such approval by the JSC, the Medical Affairs Plan shall be amended accordingly.
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:
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. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Medical Affairs Plan. Licensee shall conduct the Licensee Medical Affairs Activities pursuant to a Medical Affairs Activities plan, prepared by Licensee in consultation with Company through the JDC (as amended from time to time, the “Medical Affairs Plan”), which shall include a description of all Medical Affairs Activities conducted in the Licensed Territory for such Product. Licensee shall submit the initial Medical Affairs Plan and any amendments thereto to the JDC for review and approval in accordance with Article VI.
Medical Affairs Plan. Akebia has developed a global Medical Affairs strategy (including a strategy for managing communications with key opinion leaders), and in collaboration with Licensee through the JDC, will prepare a reasonably detailed medical affairs plan for the Territory that will be consistent with Akebia’s global Medical Affairs strategy (the “Medical Affairs Plan”). 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:
Medical Affairs Plan. No later than [***] prior to the anticipated date of performance of the Medical Affairs activities for the Licensed Products in the Territory, and in no event later than [***], Partner will develop for the JDC to review, and discuss an initial draft of the Medical Affairs Plan for the Licensed Products and provide such initial draft to the JSC to review, discuss, and determine whether to approve. The Medical Affairs Plan will contain [***] of the [***] Medical Affairs activities to be undertaken for the Licensed Products in the Territory and [***]. Thereafter, from time to time, but at least annually, the JDC will propose updates to the Medical Affairs Plan for the Licensed Products 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. ImmunoGen will assist Partner in Partner’s conduct of Medical Affairs activities in the Territory in accordance with the Medical Affairs Plan and transfer to Partner applicable Medical Affairs materials developed outside of the Territory, including medical publications, real world study data, symposium, and conference presentations.
