Formation; Purpose. 8 3.1.2 Membership.............................................................................8 3.1.3 Meetings...............................................................................9 3.1.4 Chairpersons...........................................................................9 3.1.5 Decision-Making........................................................................9 3.1.6 Dispute Resolution.....................................................................9
Formation; Purpose. Within ten (10) days after the Effective Date, AeroGen and Pathogenesis shall establish the Joint Development Team ("JDT"). The general purposes of the JDT shall be (i) to determine the overall technical strategy for the development of the Inhaler and Adapter (and the way in which they coact or interfit with the Ampoule), (ii) to oversee and coordinate the parties' activities in the development of the Inhaler and Adapter pursuant to the specifications and the timelines set forth in Exhibits A and B, and (iii) to develop and propose for the parties' approval the final specifications for the Inhaler and Adapter, all based on the principles of prompt and diligent development, consistent with good pharmaceutical and medical device practices. The JDT shall perform such other functions as appropriate to further the purposes of the this Agreement as determined by the parties, including the periodic evaluation of performance against goals.
Formation; Purpose. Within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be:
(i) to review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of Licensed Products in the Terns Territory, including related regulatory activities;
(ii) to discuss and approve the inclusion of additional Indications within the Field for the Development and Commercialization of Licensed Products in the Terns Territory, including approval of the relevant Development Plan for such Indications;
(iii) to review, discuss and approve any proposed amendments or revisions to the Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.3(b);
(iv) to review and discuss (but not approve) the Commercialization Plan and any proposed amendments or revisions to such plan, and review and discuss (but not approve) the Commercialization of Licensed Products in the Terns Territory;
(i) to coordinate the Commercialization of Licensed Products in the Terns Territory and Genfit Territory to ensure consistent global marketing of Licensed Products;
(v) to review and discuss whether to pursue either Party’s proposals for Development collaboration, and the scope and allocation of rights and obligations relating thereto, as set forth in Section 2.7; and
Formation; Purpose. Within [***] ([***]) days of the Effective Date, Pieris and AstraZeneca shall each appoint three (3) members each to the joint steering committee (the “JSC”). The JSC shall be responsible for managing the overall collaboration between the Parties and AstraZeneca and resolving any disputed matters that may arise in any subcommittee(s) created by the JSC.
Formation; Purpose. Within [***] ([***]) days of the Effective Date, Pieris and AstraZeneca shall each appoint two (2) members each to a joint development committee (the “JDC”). The JDC shall be a subcommittee of the JSC and shall be responsible for implementing the Lead Product Development Plans and Collaboration Product Development Plan subject to the terms and conditions of this Agreement.
Formation; Purpose. Within thirty (30) days of the Effective Date, the Parties will establish a Joint Steering Committee (the “Joint Steering Committee” or “JSC”), which (i) shall oversee, coordinate and review recommendations and approve decisions for the Development, Regulatory Approval, Manufacture and Commercialization of Product to Physician Targets for use in the Field in the Territory. The JSC shall coordinate the co-promotion of Product by the Parties and all budgets for such activities in the Field in the Territory. Within ten (10) Business Days of the Effective Date, each of MAP and ALLERGAN shall designate an individual who shall initially serve as a co-chair for the JSC. The JSC shall have the authority to set up joint teams, committees and subcommittees as necessary to Commercialize Product.
Formation; Purpose. (a) The formation of the Company, a single employer separate and apart from any other entity, without limitation, as a Delaware limited liability company under the Delaware Limited Liability Company Act of 1992, as amended (the “Act”), and all actions taken by the Person who executed and filed its certificate of formation are hereby adopted and ratified, such Person being an “authorized person” within the meaning of the Act.
(b) The Company is organized to (i) be a holding company for various automotive interiors systems components businesses, including the Lear North American ISD Business, and (ii) engage in all such other lawful transactions and business activities as may be determined by the Board, subject to Section 3.4(c).
Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint coordination committee (the “Joint Coordination Committee” or “JCC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JCC shall be to:
(i) review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of Licensed Products in the Hansoh Territory, including planning and executing of any Clinical Trials, regulatory filings and/or registration in the Territory;
(ii) review, discuss and approve (subject to Section 3.3) the inclusion of Additional Indications within the Field for the Development and Commercialization of Licensed Products in the Hansoh Territory, including approval of the relevant Development Plan for such Indications;
(iii) review, discuss and approve (subject to Section 3.3) any proposed amendments or revisions to the Development Plan, including those with respect to clinical Development activities set forth in Section 4.3, and to review, discuss and approve (subject to Section 3.3) the conduct of any Development activities by Hansoh;
(iv) review and discuss (but not approve) any Global Clinical Trial Plan and any proposed amendments or revisions thereto;
(v) review and discuss (but not approve) any Local Clinical Trial Plan and any proposed amendments or revisions thereto;
(vi) oversee the initial transfer of the Keros Technology and Development activities related to the Licensed Products from Keros to Hansoh in accordance with the terms of this Agreement;
(vii) review and coordinate the Manufacture of Licensed Products and the transfer thereof by Keros to Hansoh;
(viii) coordinate the schedule for reporting safety data related to Licensed Products in the Hansoh Territory and any other expected and unrelated serious adverse events and adverse events related to Licensed Products;
(ix) facilitate the exchange of Data pursuant to Section 4.7;
(x) review, coordinate, and discuss the conduct of any combination studies involving Licensed Products in the Hansoh Territory; and
(xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
Formation; Purpose. Simultaneously with the execution of this Agreement, the Parties shall establish a Steering Committee (the “Steering Committee”) which shall: (a) oversee the activities to be undertaken by the Parties during the Pre-Commencement Period as described in Article II of this Agreement, (b) oversee the Co-Promotion activities to be under taken by the Parties during the Co-Promotion Term; (c) endeavor to resolve disputes of the Co-Promotion and Marketing Committee referred to the Steering Committee pursuant to Section 13.1.1.
Formation; Purpose. Prior to the commencement of the Co-Promotion Term, the Steering Committee shall establish a Co-Promotion and Marketing Committee (the “Co-Promotion and Marketing Committee”) which shall be responsible for (a) the development, implementation and oversight of the activities of the Parties under the Co-Promotion Plan, (b) sharing relevant market information (e.g., market research) with each other to the extent permissible under Applicable Laws, (c) assessing and recommending mutually advantageous propositions for the Parties that MLNM may adopt in its sole discretion, and (d) ensuring consistent messaging regarding the combination of the Product with Doxil® consistent with the terms of Section 3.1.2, and discussing the messaging regarding the combination of the Product with doxorubicin in relapsed multiple myeloma. OBI and MLNM shall share all proposed messaging and market research regarding the combined use of the Product with Doxil® with the committee to enable it to discharge its responsibility pursuant to subpart (d) above.