Responsibility; Diligence. After the exercise of the Liquidia Respiratory Option or the Inhaled Option, GSK will be solely responsible for, and use Commercially Reasonable Efforts to, commercialize the Liquidia Respiratory Product and each Inhaled Product in the applicable Exercised Field in countries in which Regulatory Approval is obtained. Such commercialization may include the following activities, conducted by or on behalf of GSK, in GSK’s sole discretion; provided, nothing in this Agreement obligates GSK to conduct any of the following specific commercialization activities with respect to the Liquidia Respiratory Product or any Inhaled Product: (a) developing and executing a commercial launch strategy and plan for the Liquidia Respiratory Product and each such Inhaled Product; (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of the Liquidia Respiratory Product and Inhaled Product; (c) marketing and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; and (f) providing customer support, including handling medical queries, and performing other related functions. GSK shall keep Liquidia reasonably informed on the commercialization of the Liquidia Respiratory Product and each Inhaled Product, including annual written reports summarizing significant commercialization activities for the Liquidia Respiratory Product and each Inhaled Product.
Responsibility; Diligence. Subject to Section 5.6.2, Xxxxxxx shall have the sole right and authority, at its sole cost and expense, to Commercialize the Licensed Compounds and Licensed Products in the Field in the Territory. Xxxxxxx shall use Commercially Reasonable Efforts to Commercialize each Licensed Product in each of the Major Market Countries following receipt of Marketing Approval of such Licensed Product in the applicable country. Xxxxxxx shall conduct all such Commercialization in accordance with the terms and conditions of this Agreement and in compliance with Applicable Law.
Responsibility; Diligence. Company (directly and through Company Sublicensees) will be responsible, at its own expense, for further Development of Compounds and Products in the Field in the Territory. Company (directly and through Company Sublicensees) shall use Commercially Reasonable Efforts to Develop […***…] through Marketing Authorization in […***…]. For the avoidance of doubt, the foregoing diligence requirement shall not be construed so as to necessitate that Company seek Marketing Authorization in all […***…] simultaneously.
Responsibility; Diligence. Company (directly and through Company Sublicensees) will be responsible, at its own expense, for Commercialization of Compounds and Products in the Field in the Territory. Company (directly and through its Company Sublicensees) shall use Commercially Reasonable Efforts to Commercialize Products in countries where Marketing Authorization has been obtained.
Responsibility; Diligence. (a) Protagonist shall be solely responsible for conducting the Phase 1 Activities at its sole cost and expense. Protagonist shall use Diligent Efforts to conduct and complete the Phase 1 Activities in accordance with the Clinical Development Plan (including the timeline set forth therein). Protagonist shall have day-to-day operational control over the conduct of the Phase 1 Activities.
Responsibility; Diligence. (a) Xxxxxxx shall be solely responsible for conducting the Phase 2 Activities. The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. Xxxxxxx shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the Clinical Development Plan (including the timeline set forth therein). Xxxxxxx shall have day-to-day operational control over the conduct of the Phase 2 Activities.
Responsibility; Diligence. Xxxxxxx shall have the sole right and authority, at its sole cost and expense (other than with respect to the Collaboration Activities), to Develop Licensed Compounds and Licensed Products in the Field in the Territory. Xxxxxxx shall use Commercially Reasonable Efforts to Develop and obtain Marketing Approval for one (1) Licensed Product for each of CD and UC (which may be the same Licensed Product) in each of the Major Market Countries. Xxxxxxx shall conduct all Development of Licensed Compounds and Licensed Products in accordance with the terms and conditions of this Agreement, in good scientific manner and in compliance with Applicable Law including, as applicable, those relating to GLP, GCP, pharmacovigilance and safety reporting, and requirements for the protection of human subjects.
Responsibility; Diligence. (a) Protagonist shall be solely responsible for conducting the Phase 1 Activities for the Phase 1 Clinical Trial set forth in the Clinical Development Plan (which Clinical Trial has been completed as of the First Amendment Effective Date), [*] Phase 1 Clinical Trial for [*] 2nd Generation Products set forth in the 2nd Generation Development Plan and, if Protagonist agrees in writing to [*] any further Phase 1 Activities for [*] 2nd Generation Products set forth in the 2nd Generation Development Plan, such further Phase 1 Activities. Xxxxxxx shall be solely responsible for conducting any Xxxxxxx Xxxxx 0 Clinical Trials. The costs of such Phase 1 Activities shall be borne in accordance with Section 7.2.
Responsibility; Diligence. (a) Xxxxxxx shall be solely responsible for conducting the Phase 2 Activities. The costs and expenses of the Phase 2 Activities shall be shared by the Parties in accordance with Section 7.2. Xxxxxxx shall use Diligent Efforts to conduct and complete the Phase 2 Activities in accordance with the applicable Development Plan (including the timeline set forth therein). Xxxxxxx shall have day-to-day operational control over the conduct of the Phase 2 Activities. For clarity, it shall not be a breach of this Section 3.4.3 for Xxxxxxx to cease Developing the Initial Product provided that: (i) the Research Term is ongoing and Xxxxxxx is fulfilling its obligations under Section 3.9.6, or (ii) if the Research Term has terminated or expired, a Development Candidate has been selected and Xxxxxxx is fulfilling its obligations under this Section 3.4.3 with respect to a 2nd Generation Product.
Responsibility; Diligence. (a) Each Party shall use Diligent Efforts to conduct and complete the Research Activities in accordance with the Research Plan (including the timeline set forth therein). Protagonist shall have primary responsibility for the conduct of the Research Activities during the Funded Research Term (as defined below).
