Joint Commercialization Committee. Upon a decision by the JSC to activate the joint Commercialization committee, but in no case later than eighteen (18) months prior to the projected First Commercial Sale (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish the JCC. The JCC shall hold its initial meeting within thirty (30) days of its establishment. Following its initial meeting, the JCC will meet in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. The JCC will be responsible for the communication, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and [***], in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing and consulting with Coherus on the Commercialization Plan prior to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product in the Territory; (f) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Laws and industry best practices; (g) overseeing the trademark and publication strategies for the Territory; and (h) communicating with the Parties regarding all of the foregoing.
Appears in 4 contracts
Samples: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)
Joint Commercialization Committee. Upon (a) The JCC will oversee the Commercialization of the Licensed Products in the Field in the Territory and the European Territory. Prior to the commencement of the Commercialization of the Licensed Products in the Territory or the European Territory, at a decision time agreed to by the JSC Parties, each Party shall designate its initial three (3) representatives on the JCC, and each of such representatives will be an employee of such Party and will have sufficient seniority within the applicable Party to activate make decisions arising within the joint Commercialization committee, but in no case later than eighteen scope of the JCC’s responsibilities.
(18b) months prior Each Party shall appoint a person from among its representatives on the JCC to the projected First Commercial Sale (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish serve as a co-chairperson of the JCC. The co-chairpersons will not have any greater authority than any other representative on the JCC and shall hold its initial conduct the following activities of the JCC: (i) calling meetings of the JCC; (ii) preparing and issuing minutes of each such meeting within thirty (30) days of its establishment. Following its initial thereafter; (iii) preparing and circulating an agenda for the upcoming meeting, ; and (iv) ensuring that any decision-making delegated to the JCC will meet is carried out in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. accordance with Section 3.5.
(c) The JCC will be responsible for the communication, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and [***], in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible have responsibility for: (ai) reviewing and consulting with Coherus on overseeing the Commercialization Plan prior to adoption of the Commercialization Plan or changes by LicenseeLicensed Products; (bii) recommending the setting overall strategic objectives and plans (including pricing and reimbursements) related to Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product Licensed Products in the Field in the Territory and the European Territory; (fiii) establishing appropriate processes developing and submitting to the JSC for coordinating review the annual Marketing Plan in the Territory at least ninety (90) days prior to the start of promotional materials each Calendar Year; (iv) developing and submitting to the JSC for review and approval the annual Marketing Budget in the Profit Share Territory in accordance with Section 6.1.7; (v) reviewing marketing plans for the European Territory and proposed material amendments or updates thereto submitted to ensure compliance the JCC by KHK in accordance with Applicable Laws and industry best practicesSection 6.1.8; (gvi) overseeing the trademark and publication strategies reviewing Commercialization issues for the Licensed Products in the Field in the Territory and the European Territory; (vii) providing a forum for the Parties to discuss the Commercialization of the Licensed Products in the Field in the Territory and the European Territory; and (hviii) communicating with such other responsibilities as may be assigned to the JCC pursuant to this Agreement or as may be mutually agreed upon by the Parties regarding all of the foregoingfrom time to time.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.)
Joint Commercialization Committee. Upon a decision by the JSC to activate the joint Commercialization committee, but in no case later than eighteen (18) months prior to the projected First Commercial Sale committee (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish the JCC, but in no case later than eighteen (18) months prior to the first projected launch of a Product in the Territory. The JCC shall hold will be composed of an equal number of representatives from each of BioGenerics and Licensee, except the case of BioGenerics’ withdrawal set forth in Section 3.5 (BioGenerics’ Membership in Committees). For clarity, either Party may invite its initial meeting within thirty (30) days employees to the JCC. The JCC will be responsible for the communication, review and discussion of its establishmentthe Commercialization Plans and other Commercialization matters, including but not limited to marketing strategy and planning, pricing, commercial manufacture, and medical affairs support. Following its initial meetingWithout limiting the foregoing, the JCC shall be responsible for: (a) reviewing Commercialization Plans (and changes thereto) for the Products in the Territory prior to adoption of such plans or changes by a Licensee; (b) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization of the Products in the Territory; (c) reviewing and monitoring the activities and progress against the Commercialization Plans; (d) monitoring and reporting on the competitive landscape for the Products in the Territory; (e) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Law and industry best practices; (f) overseeing the trademark and publication strategies for the Territory; and (g) communicating with the Parties regarding all of the foregoing. The JCC will report to the JSC, and any disagreement between the Parties’ members on the JCC will be submitted for resolution to the JSC in accordance with Section 3.1(c) (Decision-Making; Limitations on JSC); provided, however, that if the Executive Officers are unable to reach resolution in accordance with Section 14.2 (Resolution by Executive Officers), then no further escalation of dispute resolution under Article 14 (DISPUTE RESOLUTION) shall apply and [***] shall have the final deciding vote, unless [***]. The JCC will meet in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. The JCC will be responsible for the communicationsuch activities, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and with a first meeting no later than [***] prior to [***], . [***] Certain information in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing this document has been omitted and consulting with Coherus on the Commercialization Plan prior to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating filed separately with the JDC regarding Securities and Exchange Commission. Confidential treatment has been requested with respect to the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product in the Territory; (f) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Laws and industry best practices; (g) overseeing the trademark and publication strategies for the Territory; and (h) communicating with the Parties regarding all of the foregoingomitted portions.
Appears in 3 contracts
Samples: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)