Responsibilities of JCC. The JCC shall perform the following functions: (i) oversee and coordinate the overall strategic direction of the Promotion of the Combination Therapy in accordance with Article 7 (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein); (ii) review and discuss the Combination Therapy Promotion Plan and any material updates or amendments thereto, in accordance with Section 7.2; (iii) review the Promotional Materials for the Combination Therapy generated by Affimed pursuant to Section 7.3(c)(ii) and, only to the extent the Promotional Materials contain statements relating to the Artiva Product (e.g., relating to its efficacy, safety or use) as a monotherapy or as part of the Combination Therapy (and not the Affimed Product), approve such statements within such Promotional Materials (but no other aspect of such Promotional Materials such as layout and design), taking into account any guidance and assessments presented by functional representatives of either Party (who may attend the respective JCC meeting in accordance with Section 3.4), provided that the review and, if applicable, approval process shall be completed in any event within ten (10) Business Days from the date the Promotional Materials are submitted to the JCC; (iv) review and approve each Party’s use of the other Party’s trademarks, logos, Promotional Materials, trade dress, copyrights, corporate logos, corporate names, visual identity and branding elements, in each case, in connection with the Promotion of the Combination Therapy as set forth in Section 7.3(c)(iv); (v) review and discuss, as necessary, the Demand Projection in accordance with Section 8.1(a), the In-Scope Adjusted Revenue Tracking Methodology as set forth in Section 9.2(a), and the Agreement Payment as set forth in Section 9.2(c); (vi) exchange information with respect to each Party’s activities with respect to the Commercialization of such Party’s Product as relevant and necessary to the commercialization of the Combination Therapy pursuant to this Agreement (at all times to the extent such information exchange is permitted by Applicable Law); and (vii) perform such other functions as are assigned to the JCC in this Agreement, or otherwise delegated to the JCC by the JEC (within the authority of the JEC) or agreed by the Parties in writing.
Appears in 4 contracts
Samples: Collaboration Agreement (Artiva Biotherapeutics, Inc.), Collaboration Agreement (Artiva Biotherapeutics, Inc.), Collaboration Agreement (Affimed N.V.)
Responsibilities of JCC. (a) The purpose of the JCC shall perform the following functions:
be to (i) oversee the Commercialization of Collaboration Products in the Co-Promotion Territory, including the annual budgeting and coordinate the overall strategic direction forecasting, commercial manufacturing, pre- marketing, medical affairs, Phase IIIB Clinical Trials, Phase IV Clinical Trials, Post Launch Product R&D, liaison, marketing, sales and distribution of the Promotion of the Combination Therapy in accordance with Article 7 (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein);
Collaboration Products, (ii) monitor, review and discuss comment on costs incurred by the Combination Therapy Parties in the commercial manufacture, marketing, sale and distribution of Collaboration Products in the Co-Promotion Plan and any material updates or amendments theretoTerritory (including, in accordance with Section 7.2;
without limitation, Cost of Goods Sold), (iii) review and comment on the Promotional Materials Commercialization Plans and Launch Plans and the selection of trademarks for Collaboration Products in the Combination Therapy generated by Affimed pursuant to Section 7.3(c)(ii) andCo-Promotion Territory, only to the extent the Promotional Materials contain statements relating to the Artiva Product (e.g., relating to its efficacy, safety or use) as a monotherapy or as part of the Combination Therapy (and not the Affimed Product), approve such statements within such Promotional Materials (but no other aspect of such Promotional Materials such as layout and design), taking into account any guidance and assessments presented by functional representatives of either Party (who may attend the respective JCC meeting in accordance with Section 3.4), provided that the review and, if applicable, approval process shall be completed in any event within ten (10) Business Days from the date the Promotional Materials are submitted to the JCC;
(iv) review receive and approve each Party’s use provide to the Parties all sales, pricing, and financial reports pertaining to Pre- Marketing and Commercialization of Collaboration Products in the other Party’s trademarksCo-Promotion Territory, logos, Promotional Materials, trade dress, copyrights, corporate logos, corporate names, visual identity and branding elements, in each case, in connection with the Promotion of the Combination Therapy as set forth in Section 7.3(c)(iv);
(v) review the principal indications and discussdelivery routes recommended by JDC for all Collaboration Products in the Co-Promotion Territory, as necessary, the Demand Projection in accordance with Section 8.1(a), the In-Scope Adjusted Revenue Tracking Methodology as set forth in Section 9.2(a), and the Agreement Payment as set forth in Section 9.2(c);
(vi) exchange information with respect to each Party’s activities review and comment on ORTHO's pricing recommendations in the Co-Promotion Territory, and (vii) facilitate the flow of Information with respect to the Commercialization of each Collaboration Product in the Co-Promotion Territory. Subject to the provisions of Section 7.01(b) regarding Excepted Commercialization Matters, ORTHO shall make the final decision on all matters relating to the Commercialization of any Collaboration Product including all day-to-day decisions. Each party will disclose to the other proposed agenda items reasonably in advance of each meeting of the JCC. Each party shall bear its own costs for participation in the JCC.
(b) Decisions shall be reached by the JCC by consensus after an open discussion of the matters as to which decisions are being made. If the JCC fails to reach consensus as to any matter involving Commercialization, the decision of ORTHO will be final and determinative, so long as such Party’s decision does not contradict or modify the terms of this Agreement, except with regard to (i) a decision to recall a Collaboration Product, which shall be decided pursuant to Section 7.12, (ii) a dispute related to pricing of a Collaboration Product as relevant in the Co-Promotion Territory, which shall be referred to the executive officers of the Parties pursuant to Section 7.11, or (iii) increasing a Commercialization Budget in any material respect ("Excepted Commercialization Matters"). If CTI committee members believe that a JCC decision is seriously detrimental to Collaboration Product Development or Commercialization or to CTI's interests, they may present this viewpoint in written form simultaneously to ORTHO's JCC members and necessary to the Steering Committee for review. If the Steering Committee does not unanimously agree with CTI's view, ORTHO's view shall prevail and be followed.
(c) The JCC will have the power to form subcommittees with appropriate representation from CTI, ORTHO and appropriate Third Parties.
(d) During clinical trials for any Collaboration Products, the JCC in full collaboration with the JDC shall coordinate activities to assure a smooth transition from Development to Commercialization.
(e) The JCC shall not be involved with the commercialization of (i) Independent Products or (ii) Royalty Bearing Products in the Combination Therapy pursuant to this Agreement (at all times to the extent such information exchange is permitted by Applicable Law); and
(vii) perform such other functions as are assigned to the JCC in this Agreement, or otherwise delegated to the JCC by the JEC (within the authority of the JEC) or agreed by the Parties in writingRoyalty Bearing Territory.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Cell Therapeutics Inc), Collaboration and License Agreement (Cell Therapeutics Inc)