Common use of Joint Commercialization Committee Clause in Contracts

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

Sources: 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

Sources: 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

Sources: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)

Joint Commercialization Committee. Upon As of the Effective Date, the Parties have established 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 commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Parties Commercialization of Products at the operational level. Each JCC representative shall establish have knowledge and expertise in the JCCcommercialization of products similar to Products. The JCC shall hold its initial meeting within thirty in particular: [ * ] = 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. (30a) days review and recommend the Commercialization Plans and related activities with respect to the Commercialization of its establishment. Following its initial meetingProducts in the Collaborator Territory, and report to the JCC will meet JEC on all significant Commercialization activities in personthe Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, by teleconference or by video-teleconference at least [***] per [***] discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss material decisions and key activities that relate the major findings of Collaborator’s market research with respect to any Product in the matters set forth below. The JCC will be responsible for the communicationCollaborator Territory, if any; (f) review and discussion of oversee the Commercialization Plan branding and other Commercialization matters, including marketing product positioning strategy and planning, pricing, commercial manufacture, and [***], in each case for Products in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing Collaborator Territory 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 evaluate Collaborator’s brand strategy for the Product in the Territory; (f) establishing appropriate processes Collaborator Territory for coordinating review of promotional materials consistency with the then-current global brand strategy for the Territory to ensure compliance with Applicable Laws and industry best practices; Product; (g) overseeing discuss Product list price and status of reimbursement in the trademark and publication strategies for the Collaborator Territory; and and (h) communicating perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties regarding all arising from the deliberations of the foregoingJCC, or as otherwise directed by the JEC.

Appears in 1 contract

Sources: Collaboration and License Agreement (Exelixis, Inc.)

Joint Commercialization Committee. Upon As of the Effective Date, the Parties have established 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 commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Parties Commercialization of Products at the operational level. Each JCC representative shall establish have knowledge and expertise in the JCCcommercialization of products similar to Products. 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: particular: (a) reviewing and consulting with Coherus on the Commercialization Plan prior report to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption on all significant Commercialization activities in the Licensee Territory, including implementation of the Commercialization Plan, and on the activities of the JCC; (b) review, discuss and approve the Commercialization Plans and related activities with respect to the Commercialization of Products in the Licensee Territory; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. (c) communicating provide a forum for and facilitate communications and coordination between the Parties with respect to the JDC regarding Commercialization of Products in the interrelationship between Development activities Licensee Territory and potential Commercialization activities; the Exelixis Territory; (d) reviewing on an annual basis, review and monitoring the activities and progress against the Commercialization Plan; approve Licensee’s Sales Forecast prepared pursuant to Section 6.3(b) as well as any corrective plans submitted thereunder; (e) monitoring review and reporting on approve any recommendation by Licensee not to launch (or to significantly delay the competitive landscape for launch of) any Product in any country of the Licensee Territory; (f) review and discuss the major findings of Licensee’s market research with respect to any Product in the Licensee 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 provide input to the trademark JDC on the global publication strategy with respect to the Products and publication strategies for implement such strategy under supervision of the Territory; and JDC once it has been established; (h) communicating review and oversee the branding and product positioning strategy for Products in the Licensee Territory; (i) establish pricing corridors for Products in the Licensee Territory for the purpose of reimbursement and potential international pricing reference by relevant Regulatory Authorities; (j) define and coordinate medical messaging worldwide with respect to the Products; (k) oversee and facilitate the Parties’ communications and activities with respect to publications under Section 14.4; (l) design a global brand strategy for the Licensee Territory (e.g., a four-year brand plan, resource plan, , etc.) and submit such strategy to the JSC for review and approval; (m) discuss and coordinate the manufacture and supply of the Products to Licensee for Commercial use; and (n) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties regarding all arising from the deliberations of the foregoingJCC, or as otherwise directed by the JSC.

Appears in 1 contract

Sources: Collaboration and License Agreement (Exelixis, Inc.)