As further described in this Section 8.3, the tactics and strategy for the Commercialization of each Product in the Territory will be described in a comprehensive plan (each such plan, a Joint Commercialization Plan) that describes the pre-launch, launch and subsequent Commercialization of such Product in the Shared Territory (including anticipated activities relating to messaging, branding, Pricing Matters (to the extent not prohibited by Applicable Law), advertising, planning, marketing, sales force training and allocation, detailing, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a Joint Commercialization Budget).
Joint Commercialization Plan. Any expenses incurred by a Party for Commercialization activities in the Shared Territory related to a Product that do not fall within the definitions of Joint Commercialization Costs will be borne solely by such Party unless the JCC determines otherwise. In addition, any expenditure or cost that exceeds the amount set forth in the applicable Joint Commercialization Plan by more than for a calendar year or any unbudgeted cost that is incurred by either Party will be borne by such Party; provided that the JCC will have the discretion to review such expenditures or costs and propose to the JSC that they be designated as Joint Commercialization Costs.
Committee means the Joint Steering Committee, Joint Development Committee, Joint Commercialization Committee or Joint Manufacturing Committee, or any other subcommittee established under Article 4, as applicable.
Joint Development Committee. In accordance with Section 6.6(c), the JDC will act as an information-sharing forum with respect to the Research and Development of each Reversion Product. The Continuing Party will provide such information and data regarding the Development of the Reversion Product as the JDC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the ACTR platform technology and, if SGI is the Opt-Out Party, the applicable SGI Antibody. In addition, the Continuing Party will provide summaries of all other material information and data regarding the Development of such Reversion Product. The Parties acknowledge and agree that the Joint Development Committee will have no decision-making authority or approval rights with respect to a Reversion Product.
Joint Manufacturing Committee. The JMC will act as an information-sharing forum with respect to the Manufacture of clinical and commercial supplies of ACTR T-cells and SGI Antibodies for a Reversion Product. The Continuing Party will provide such information and data regarding the Manufacture of the Reversion Product as the JMC would customarily receive regarding a Product to the extent that it specifically relates to, if Unum is the Opt-Out Party, ACTR T-cells or the INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED
Joint Steering Committee. Promptly following the Effective Date, the Parties shall establish a joint steering committee (the JSC) to provide for the exchange of information and ideas regarding the continued research and development of the Licensed Compounds, to plan and monitor the conduct of such research and activities during the Term and to provide and receive updates regarding the invention or development of any Improvements. The JSC shall not have any decision-making authority and is not authorized to or to . Each of the Parties shall designate in writing representatives to the JSC. Each Party shall have the right at any time to substitute individuals, on a permanent or temporary basis, for any of its previously designated representatives to the JSC by giving written notice to the other Party. The JSC shall establish a schedule of times for regular meetings to be conducted by teleconference or in person as it shall determine. The Parties shall each bear all expenses of their respective JSC representatives related to their participation on the JSC and attendance at JSC meetings; provided that if Spero reimburses any of its, or its Affiliates, officers, directors or employees for such participation it shall so notify Northern and it shall reimburse Northern for the participation of any of its, or its Affiliates, officers, directors or employees for such participation on the same terms.
Section # Development and Commercialization; Joint Steering Committee.
Joint Commercialization Committee or JCC means the committee formed by the Parties as described in Section 4.4(a).
Commercialization. By of each calendar year during the Term, the Continuing Party will provide to the other Party a report on the Commercialization of the applicable Reversion Product. Such report will describe in reasonable detail the Commercialization efforts for the preceding calendar year for such Reversion Product (including the past calendar year and projected budgets for such Commercialization). Further, the Continuing Party will provide such additional information regarding the Commercialization of such Reversion Product as the other Party may reasonably request, and further will meet (in person at the Continuing Partys site) with such other Party after providing such report upon such other Partys request to discuss same. Subject to Applicable Law, all Pricing Matters for Reversion Products will be determined by the Continuing Party, except to the extent they constitute an ACTR Matter, in which event such Pricing Matter will be determined by mutual agreement of the JSC, subject to the dispute resolution process set forth in [Section 4.5(c)]. The Parties will comply with Section 7.3 for each Reversion Product, with the Continuing Party being responsible for the global safety database for such Reversion Product.
Without limiting any other provision of this Agreement ACADIA (or its Affiliate or Sub-Licensee, as applicable) shall be solely responsible for:
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