Medical Affairs Plans. NVS will prepare a reasonably detailed, annual plan for global Medical Affairs with respect to In-Vivo [***] Products (the “Global Medical Affairs Plan”), and HMI will prepare a reasonably detailed, annual plan for Medical Affairs with respect to In-Vivo [***] Products in the U.S. (the “U.S. Medical Affairs Plan”), in each case, no later than [***] for an In-Vivo [***] Product. The strategic objectives in the U.S. Medical Affairs Plan will be consistent with the strategic objectives in the Global Medical Affairs Plan, unless otherwise agreed by the Parties. In order to ensure consistency between the Global Medical Affairs Plan and the U.S. Medical Affairs Plan and coordination and alignment between the Parties with respect to the Medical Affairs to be conducted by NVS with respect to In-Vivo [***] Products pursuant to the Global Medical Affairs Plan and by HMI with respect to U.S. [***] Products pursuant to the U.S. Medical Affairs Plan (including with respect to each Party’s communications with key opinion leaders in the Territory), the Global Medical Affairs Plan and the U.S. Medical Affairs Plan, and any material amendments or updates thereto will be reviewed and discussed by the JSC, with the first such review and discussion occurring no later than [***] for an In-Vivo [***] Product. Any subsequent review and discussion, to the extent required, will occur annually thereafter at an appropriate time as agreed by the JSC, or more frequently as may be required during the Term.
Medical Affairs Plans. [***] the Effective Date, Zai shall develop and provide a preliminary draft of the Medical Affairs Plan for the Licensed Product to the JSC’s subcommittee represented solely by medical affairs personnel for its review, discussion and approval. Upon approval and thereafter, Zai shall (a) undertake the major Medical Affairs activities for the Licensed Products in the Territory and the estimated timelines for performing such activities pursuant to the Medical Affairs Plan; and (b) from time to time but no less frequent than [***] propose updates or amendments to the Medical Affairs Plan for the JSC subcommittee’s review, discussion and approval.
Medical Affairs Plans. No later than [***] before the submission of the first Regulatory Filing seeking the first Regulatory Approval for a DT Co-Co Product, the Medical Affairs Working Group shall prepare and submit to the JDC a Medical Affairs Plan for such DT Co-Co Product in the Territory for the following [***], including the corresponding Medical Affairs Budget. The Medical Affairs Plan shall contain a [***] rolling annual plan for the Medical Affairs activities for the DT Co-Co Product in the Territory. Subject to comments and proposed changes by the other Party, each Party will be responsible for the Medical Affairs Plan for its respective Region. The Medical Affairs Plans for each Region will be incorporated into the overall Medical Affairs Plan. The JDC shall prepare, review, discuss and determine whether to present each Medical Affairs Plan and Medical Affairs Budget, including the allocation of activities between the Parties set forth therein, to the JSC for approval. On an annual basis during the Term (or more frequently as may be required), the JDC shall review and update, or have a Party review and update, each Medical Affairs Plan and Medical Affairs Budget based on the currently available information and data, including for any applicable new formulations or Indications that that were added to a Development Plan pursuant to Section 6.4.7(b) (JDC and JSC Decision Regarding New Development Activities) or new Combination Products approved by the JSC in accordance with Section 6.4.8 (Combination Products), in each case, that are not included in the then-current Medical Affairs Plan for the applicable DT Co-Co Product. The JDC shall review and discuss and determine whether to present any such update to the Medical Affairs Plans and Medical Affairs Budgets to the JSC for approval. Each such update to a Medical Affairs Plan and corresponding Medical Affairs Budget shall become effective and shall supersede the previous Medical Affairs Plan and corresponding Medical Affairs Budget upon approval thereof by the JSC.
Medical Affairs Plans. Akebia will prepare a reasonably detailed, [***] plan for global Medical Affairs (the “Global Medical Affairs Plan”), and Licensee will prepare a reasonably detailed, [***] plan for Medical Affairs in the Territory (the “Local Medical Affairs Plan”), in each case, no later than [***] following the Effective Date. The strategic objectives in the Local Medical Affairs Plan will be consistent with the strategic objectives in the Global Medical Affairs Plan, unless otherwise agreed by the Parties. In order to ensure consistency between the Global Medical Affairs Plan and the Local Medical Affairs Plan and coordination and alignment between the Parties with respect to the Medical Affairs to be conducted by Akebia in the Territory pursuant to the Global Medical Affairs Plan and by Licensee in the Territory pursuant to the Local Medical Affairs Plan (including with respect to each Party’s communications with key opinion leaders in the Territory), the Global Medical Affairs Plan and the Local Medical Affairs Plan, and any amendments or updates thereto, will be [***] simultaneously by the JDC as provided in Section 3.2.3(l) (Specific Responsibilities of the JDC), with the first such [***] occurring no later than [***] following the Effective Date. Any subsequent [***], to the extent required, will occur [***] thereafter at an appropriate time as agreed by the JDC, or more frequently as may be required during the Term.
Medical Affairs Plans. At such time as the Parties agree, Aurinia will prepare a reasonably detailed, annual plan for global Medical Affairs (the “Global Medical Affairs Plan”), and Otsuka will prepare one or more reasonably detailed, annual plan(s) for Medical Affairs in the Otsuka Territory or in any country or region in the Otsuka Territory (the “Local Medical Affairs Plan”). The Local Medical Affairs Plan and, to the extent the Global Medical Affairs Plan will include any Medical Affairs Activities in the Otsuka Territory (including any conventions, seminars and interaction with KOLs and the like, including medical professional organizations and associations in the Otsuka Territory), the Global Medical Affairs Plan, shall at all times conform to Professional Requirements and Applicable Laws (including compliance requirements) in the Otsuka Territory. In order to ensure consistency between the Global Medical Affairs Plan and the Local Medical Affairs Plan(s) and coordination and alignment between the Parties with respect to Medical Affairs to be conducted by Aurinia in the Otsuka Territory pursuant to the Global Medical Affairs Plan and the Medical Affairs to be conducted by Otsuka in the Otsuka Territory pursuant to the Local Medical Affairs Plan(s), the Global Medical Affairs Plan and the Local Medical Affairs Plan(s), and any amendments or updates thereto, will be reviewed and discussed jointly by the Medical Affairs Subcommittee and the Local JCCs (jointly).
Medical Affairs Plans. [***] the Effective Date, Zai shall develop and provide a preliminary draft of the Medical Affairs Plan for the Licensed Product to the JSC’s subcommittee represented solely by medical affairs personnel for its review, discussion and approval. Upon approval and thereafter, Zai shall (a) undertake the major Medical Affairs activities for the Licensed Products in the Territory and the estimated timelines for performing such activities pursuant to the Medical Affairs Plan; and (b) from time to time but no less frequent than [***], propose updates or amendments to the Medical Affairs Plan for the JSC subcommittee’s review, discussion and approval. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Medical Affairs Plans. [***] CStone will develop and provide an initial draft of the Medical Affairs Plan for such Collaboration Product to the JPT for its review and discussion. The Medical Affairs Plan for a Collaboration Product will contain a [***] of the major Medical Affairs activities to be undertaken for such Collaboration Product in the Territory and the estimated timelines for performing such activities. The JPT will have the right to comment on each such Medical Affairs Plan and each update thereto, and CStone will consider such comments [***] and incorporate such comments [***] prior to finalizing each such Medical Affairs Plan (or any update thereto). Thereafter, from time to time[***] CStone will propose updates to the Medical Affairs Plan for each Collaboration Product in consultation with the JPT 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.
Medical Affairs Plans. [****] Zai will develop and provide an initial draft of the Medical Affairs Plan for such Licensed Product to the JPT for its review and discussion. The Medical Affairs Plan for a Licensed Product will contain a [****] of the major Medical Affairs activities to be undertaken for such Licensed Product in the Territory and the estimated timelines for performing such activities, including all key opinion leaders that Xxx plans to engage. The JPT will have the right to comment on each such Medical Affairs Plan and each update thereto, and Xxx will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Medical Affairs Plan (or any update thereto). Thereafter, from time to time, [****] Zai will propose updates to the Medical Affairs Plan for each Licensed Product in consultation with the JPT 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. Zai submit each initial Medical Affairs Plan and each such proposed updated Medical Affairs Plan to the JSC. The JSC will review, discuss, and determine whether to approve each initial Medical Affairs Plan for each Licensed Product and each update thereto. Once approved by the JSC, each update to a Medical Affairs Plan for a Licensed Product will become effective and supersede the then-current Medical Affairs Plan for such Licensed Product.
Medical Affairs Plans. Licensee will prepare a reasonably detailed, [**] plan of the Medical Affairs activities to be undertaken for the Licensed Product in the Field in the Territory (the “Local Medical Affairs Plan”), in each case, starting no later than [**] following the Effective Date. The Local Medical Affairs Plan, and any amendments or updates thereto, will be reviewed and discussed by the JSC as provided in Section 3.1.4(e) (Specific Responsibilities of the JSC). Any subsequent review and discussion, to the extent required, will occur [**] thereafter at an appropriate time as agreed by the JSC, or more frequently as may be required during the Term.
Medical Affairs Plans
