Specific Responsibilities of the JCC. Subject to any limitations under applicable Law, including Antitrust Laws, the JCC has the following responsibilities:
2.5.3.1. discuss, prepare and approve for submission to the JSC the Commercialization Plan for each Regional Licensed Product, including, in each case, any amendments thereto;
2.5.3.2. oversee implementation of each Commercialization Plan for a Regional Licensed Product;
2.5.3.3. review and discuss Commercialization activities with respect to Regional Licensed Products;
2.5.3.4. facilitate the flow of information between the Parties with respect to the Commercialization of T1 Antibody Candidates, T1 Licensed Products, Regional Antibody Candidates, Regional Licensed Products, Global Antibody Candidates or Global Licensed Products;
2.5.3.5. allocate between the Parties primary responsibility for tasks relating to Commercialization of Regional Licensed Products in their respective Territory in a manner consistent with Section 6;
2.5.3.6. oversee forecasting and market planning with respect to Regional Licensed Products;
2.5.3.7. review and discuss strategies with respect to Pricing Matters for Regional Licensed Products in the Territory, to the extent operationally feasible and not prohibited by applicable Law;
2.5.3.8. review, discuss and oversee Manufacturing for the Commercialization of Regional Licensed Products, including the supply chain for Regional Licensed Products;
2.5.3.9. manage Trademarks as contemplated by Section 14.9; and
2.5.3.10. perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC in accordance with Section 2.2.3.12 or as expressly provided in this Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Specific Responsibilities of the JCC. In support of its responsibilities as described in clause (a) above, the JCC shall, subject to Sections 2.1(b) and 2.7(c), perform the following activities solely with respect to Co-Promotion Products:
(i) prepare the Global Commercialization Strategy and the U.S. Commercialization Plan, and any updates thereto;
(ii) review the allocation of Commercialization responsibilities between the Parties to ensure consistency with the terms of this Agreement, the Global Commercialization Strategy, and the U.S. Commercialization Plan;
(iii) coordinate and oversee the Parties’ plans for labeling, branding and selecting trademarks for each Product;
(iv) review life cycle management opportunities;
(v) review pricing and reimbursement strategies with respect to Products in the Royalty Territory and
(vi) With respect to Co-Promotion Products in the U.S. only:
(1) review and approve advertising materials and strategies and promotional materials developed by a Party for the Parties’ Sales Representatives;
(2) approve the selection of major or key marketing vendors (e.g., public relations and advertising agencies and medical education agencies);
(3) approve pricing and reimbursement, patient assistance, vendor return and co-pay strategies;
(4) design, in collaboration with the JDC, pharmacoeconomic studies or Phase IV Clinical Trials;
(5) approve market research plans;
(6) approve and coordinate all sales force activities, including training, number, proportion of time to be devoted to promotion, and territory alignment;
(7) approve packaging designs, and oversee educational and professional symposia, and speaker and peer-to-peer activity programs;
(8) discuss a range of suggested prices at which a Co-Promotion Product will be sold to unaffiliated Third Parties and any discount strategies for such Co-Promotion Product (it being understood that BMS will determine all pricing and reimbursement terms for Co-Promotion Products sold to customers);
(9) review of each Party’s reports pertaining to its Sales and Marketing Costs; and
(10) review early access and compassionate use programs.
Specific Responsibilities of the JCC. In addition to its general responsibilities, the JCC shall in particular:
(a) discuss, prepare and approve for submission to the JSC all US Commercialization Plans (including the Commercialization Budget), including any amendments thereto;
(b) review and update revenue forecasts and review the Commercialization Budget for Collaboration Products in the Collaboration Territory at least on a [**] basis to ensure actual and anticipated expenditure is within the approved Commercialization Budget for the relevant Calendar Year, and make recommendations to the JCC for approval regarding any variances before such additional expenditure is incurred;
(c) review and discuss the Commercialization activities (including Co-Promotion) of Beam and Verve with respect to Collaboration Products in the Collaboration Territory;
(d) prepare forecasts of relevant Collaboration Products to be shared with the JMC for planning of inventory levels of such Products;
(e) subject to the terms and conditions of Section 13.6.1, discuss and approve for submission to the JSC the appropriate timing for selection of trademarks, and discuss, review and approve for submission to the JSC all proposed trademarks cleared by the Parties selected to be used to identify Collaboration Products in the Collaboration Territory and all proposed trademarks, logos, taglines, trade dress, packaging configuration, domain names or indicia of origin, in each case, cleared by the Parties for use in connection with the sale or marketing of Collaboration Products in the Collaboration Territory;
(f) review, discuss, coordinate and approve for submission to the JSC, in the Collaboration Territory, the Parties’ medical affairs activities with respect to the Collaboration Products; and
(g) perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC or as specified in this Agreement.
Specific Responsibilities of the JCC. In addition to its general responsibilities, the JCC shall in particular:
Specific Responsibilities of the JCC. The JCC shall, in particular, in accordance with the decision-making principles set forth in Section 2.5(c):
(i) discuss the Commercialization activities of the Parties with respect to the Co-Developed Product in the Major Markets;
(ii) with input and in consultation with the JDC, make recommendations to the JEC concerning whether to seek new indications for the Co-Developed Product;
(iii) make recommendations to the JDC concerning scientific publication plans relating to the Co-Developed Product, and review and discuss scientific presentation and publication plans related to the Co-Developed Product;
(iv) discuss a global commercialization strategy for the Co-Developed Product, including (A) brand positioning, messaging and branding strategies, (B) a global pricing band, and (C) advertising, marketing and promotional strategies;
(v) review and coordinate activities of the Parties with respect to key opinion leaders and global meetings in connection with the Co-Developed Product;
(vi) review packaging designs and trademarks (in accordance with Article 10) for the Co-Developed Product;
(vii) review on an annual basis Medical Education Activities for Co-Developed Product in the U.S. and Major European Countries;
(viii) review on an annual basis, through a subcommittee of the JCC (A) content of any messages to be provided by Medical Liaisons or medical information to be provided in response to medical inquiries relating to a Co-Developed Product communicated via sales representatives or received by letter, phone call or email, and (B) grants to support continuing medical education, symposia or Third Party clinical research related to Co-Developed Product;
(ix) perform such other duties as are expressly assigned to the JCC in this Agreement or as may be properly assigned to it by the JEC; and
(x) provide quarterly updates on its activities to the JEC.
Specific Responsibilities of the JCC. Subject to any limitations under applicable Law, the JCC will have the following responsibilities:
2.4.2.1. facilitating the provision of information by Licensee to Eureka with respect to the status of, and activities for, the Commercialization of Licensed Products by or on behalf of Licensee or its Related Parties in the Licensee Territory, including information as to pricing for the Licensed Products;
2.4.2.2. discussing and providing input on the commercial positioning with respect to target patients of the Licensed Products in the Licensee Territory, including any proposed material changes thereto, for approval by the JSC;
2.4.2.3. discussing and providing input on the key promotional message with respect to the Licensed Products in the Licensee Territory, including any proposed material changes thereto, for approval by the JSC; and
2.4.2.4. discussing and providing input on the Licensee Territory Commercialization Plan for each Licensed Product, including, in each case, any amendments thereto, for approval by the JSC.
Specific Responsibilities of the JCC. In addition to its general responsibility to manage, monitor, review and coordinate the commercialization of the Product in the Territory according to the Marketing Plan and to ensure a regular flow of development information among the Parties, the JCC shall in particular:
(i) Oversee the activities of Amersham in marketing, selling and distributing Product in the Territory, including pre-launch and post-launch activities;
(ii) Review and comment on the Marketing Plan and all updates thereto, as provided in Section 7.1;
(iii) Monitor Amersham's compliance with the Marketing Plan; and
(iv) Perform any other responsibilities set forth for the JDC in this Agreement.
Specific Responsibilities of the JCC. The responsibilities of the JCC shall be to:
(a) [***] the CAN Plan and [***] any amendments or updates thereto (other than material amendments or updates, which will be subject to JSC [***]), and [***] Non-Promotional Activities and Commercialization activities and progress under the CAN Plan, including through each Party’s updates of the status of Commercialization and Non-Promotional Activities in the Territory, as described in Section 7.3 (CAN Reports);
(b) [***] to be provided by each Party with respect to the Licensed Products in each country of the Territory in accordance with [***];
(c) [***], as described in [***];
(d) [***] actually contributed by each Party in that calendar year (including any [***] as applicable), as described in [***];
(e) prepare updates to the CAN Plan to reflect any [***], as described in [***];
(f) [***]as described in Section 7.8.3(b) (Failure to Agree on Additional Details) and [***];
(g) [***] the Promotional Data to be provided by each Party as described in Section 7.16.3 (Reporting);
(h) [***] the global brand name for each Licensed Product and the applicable Product Marks for each such Licensed Product in the Territory, as described in Section 7.21.1 (Product Marks);
(i) [***] the Manufacturing Plan related to Commercialization and [***] any amendments or updates thereto related to Commercialization (other than material amendments or updates, which will be subject to JSC [***]), and [***] activities under the Manufacturing Plan related to manufacture and supply of the Licensed Products for Commercialization purposes, as described in Section 8.1 (Manufacturing Plan);
(j) [***] following Regulatory Approval in the U.S. of a Licensed Product;
(k) [***] (except to the extent otherwise reviewed and discussed by the JDC) [***], which will be led by [***], as described [***];
(l) [***] related to the Licensed Products; and
(m) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties.
Specific Responsibilities of the JCC. Each JCC shall have the following responsibilities with respect to the applicable Pillar:
(a) review capital investment activities of each of the Parties and coordinate the activities of each of the Parties under such Pillar as set forth in the applicable Collaboration Plan, Project Plans and Project Contracts;
(b) discuss and attempt to address any scientific or technical issues arising in the course of each Party’s Development and Commercialization activities with respect to any deliverables in connection with or arising under such Pillar;
(c) evaluate, review and propose any amendments to the Collaboration Plan for such Pillar for review and approval by the JSC;
(d) determine the scope of each separate and distinct Project to be entered into by the applicable Parties with respect to the Pillar, including any subsequent expansion or other modification of such Project;
(e) determine the applicable Participating Parties, to be included in the applicable Project;
(f) review, discuss, and determine whether to approve the Projects proposed to the JCC by any one of the Parties and accompanying budgets prepared by the applicable Participating Parties for a Project, and any amendments to the Project Plans or accompanying budgets;
(g) determine when the Project Managers should be appointed for a particular Project and appoint the Project Managers;
(h) for each Project, establish and delegate specifically defined duties to the Project Managers for such Project;
(i) review, discuss, and determine whether to approve any Project Contracts to be entered into by the Participating Parties as contemplated under the Collaboration Plan;
(j) review, discuss, and determine whether to approve each Project Plan developed by the applicable Project Managers for a Project;
(k) review, discuss, and determine whether to propose to the JSC any amendments to the Collaboration Plan for its Pillar;
(l) review the progress reports on the collaboration activities submitted by the Project Managers in accordance with Clause 3.3.2(e);
(m) address any issues or disputes arising from the conduct of the activities with respect to the Pillar;
(n) establish such additional Working Groups as it deems necessary to achieve the objective and intent of the applicable Project; and
(o) perform such other functions as appropriate to further the purposes of this MRCA as determined by the Parties.
Specific Responsibilities of the JCC. Subject to Section 2.3(f), the JCC shall have the following responsibilities:
(i) review the Global Commercialization Strategy and Global Pricing Strategy and updates thereto, provide feedback to the Parties, and submit the final Global Commercialization Strategy and Global Pricing Strategy for approval by the JSC;
(ii) review the plan prepared by Gilead for the Licensed Product brand in the United States and progress against plan after launch;
(iii) review and discuss uses of the Marks with respect to Licensed Products in the Territory;
(iv) attempt to resolve issues presented to it by, and disputes within, the Shared Territory JCC; and
(v) manage any activities related to adherence by the Parties to the corporate compliance programs required to be maintained pursuant to Section 5.2(b)(ix).
