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. The JCC has the following responsibilities:
(i) discuss, prepare and approve for submission to the JSC the Joint Commercialization Plan for each Product, including, in each case, any amendments thereto;
(ii) oversee implementation of each Joint Commercialization Plan;
(iii) review and discuss Commercialization activities with respect to Products;
(iv) allocate between the Parties primary responsibility for tasks relating to Commercialization of Products in the Shared Territory in a manner consistent with Article 8;
(v) coordinate the Co-Promotion activities of Unum and SGI with respect to Products in the Shared Territory;
(vi) oversee long-range forecasting and market planning with respect to Products;
(vii) review and discuss strategies with respect to Pricing Matters in the Shared Territory and make determinations with respect thereto, to the extent not prohibited by Applicable Law;
(viii) manage Marks as contemplated by Section 12.8;
(ix) oversee the conduct of Voluntary Phase 4 Clinical Trials and the results thereof;
(x) allocate budgeted resources and determine priorities for each Voluntary Phase 4 Clinical Trial included under the Joint Commercialization Plan;
(xi) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to the Products in the Territory;
(xii) review and facilitate discussion of proposed Publications and resolve disputes with respect thereto taking into consideration the factors set forth in Section 15.4(c); and
(xiii) perform such other functions as appropriate to further the purposes of this Agreement, as directed by the JSC in accordance with Section 4.2(c)(xvi) or as expressly provided in this Agreement.
Specific Responsibilities of the JCC. In addition to its general responsibilities, the JCC shall in particular:
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. 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. 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. 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. Subject to Section 2.3(f), the JCC shall have the following responsibilities:
(i) discuss the Global Commercialization Strategy;
(ii) review the Shared Territory Commercialization Plan prepared by Gilead and approve the Shared Territory Commercialization Budget for submission to the JSC;
(iii) review the plan prepared by Gilead for the Licensed Product brand in the United States and progress against plan after launch;
(iv) review and discuss uses of the Marks with respect to Licensed Products in the Territory;
(v) review the Co-Promotion Plan prepared by the JCPT that covers the Co-Promotion of a Licensed Product or applicable Gilead Combination Product in the Shared Territory (and annual amendments thereto).
(vi) Oversee the implementation of the Co-Promotion Plan and make changes as needed; * Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission.
(vii) Manage any activities related to adherence by the Parties to Gilead’s Business Conduct Policies as provided by Gilead to Galapagos from time to time;
(viii) Review progress of the Parties versus the Co-Promotion Plan, including […***…]; and
(ix) Review the costs associated with Distribution Costs on an annual basis and propose changes to the JSC, if any, to […***…].
Specific Responsibilities of the JCC. The Joint Commercializa- tion Committee shall have the following responsibilities subject to oversight of the JSC and in accordance with Section 3.1:
(A) reviewing the progress of Commercial activities (whether under this Agreement or otherwise) of the Eisai Collaboration Molecule, including Commercial Plan progress and Initial Launch Plan progress, no less than quarterly;
(B) preparing and recommending to the JSC for review and approval, overall strategic objectives, plans and progress related to Commercialization of the Eisai Collaboration Products;
(C) discussing, preparing and submitting to the JSC for review and approval the Global Branding Strategy for the Eisai Collaboration Products and any updates or amendments thereto;
(D) discussing, preparing and submitting to the JSC for review and approval each Commercialization Plan and Commercialization Plan Budget (including each Initial Launch Plan and Initial Launch Plan Budget) and any updates or amendments thereto; provided that Company shall prepare any such Commercialization Plan and Commercialization Plan Budget (including any amendments or updates thereto) for both the E2609 Eisai Collaboration Product and the BAN2401 Eisai Collaboration Product;
(E) overseeing, coordinating and implementing the Commercialization Plans for the E2609 Eisai Collaboration Product and the BAN2401 Eisai Collaboration Product;
(F) providing a forum for the Parties to discuss the Commercialization of the Eisai Collaboration Products;
(G) preparing and recommending to the JSC a procedure for monitoring the rate of spending for Commercialization compared to the applicable Commercialization Plan Budget (including budget overspends or underspends);
(H) providing a forum for the Parties to discuss, but not determine, the appropriate allocation of costs and expenses under this Agreement for Commercialization of Eisai Collaboration Products; 132539616_1
(I) reporting to the JSC on financial matters;
(J) overseeing the Commercialization Plan Budget;
(K) overseeing the Parties in the development and implementation of co-Promotion terms with respect to the promotion of each Eisai Collaboration Product in the Territory;
(L) setting the FTE rates for Commercialization activities and Commercialization Costs; and
(M) performing such other functions as may be appropriate to further the purposes of the Collaboration and this Agreement with respect to Commercialization of the Eisai Collaboration Products.
