Novartis Development Activities Sample Clauses
The "Novartis Development Activities" clause defines the responsibilities and scope of work that Novartis undertakes in relation to the development of a product or technology under the agreement. It typically outlines the specific research, testing, regulatory, and clinical activities that Novartis is obligated to perform, as well as any timelines, milestones, or reporting requirements associated with these tasks. By clearly delineating these development obligations, the clause ensures that both parties understand Novartis's role and commitments, thereby reducing ambiguity and helping to manage expectations and project timelines.
Novartis Development Activities. For clarity, nothing in this Agreement shall limit in any way Novartis’ right to conduct Development or any other activities with respect to the Exploitation of Licensed Products [***].
Novartis Development Activities. (a) Novartis shall use Commercially Reasonable Efforts to timely and diligently conduct all Novartis Development Activities and will be responsible for conducting all other activities in connection with any other research and Development activities with respect to the Array Compounds and/or Products not delegated to Array under the Development Plan.
(b) Novartis will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval, and to perform its obligations under Sections 5.1, 5.3 and 5.5, for at least one (1) Product in a Major Indication, unless the data does not support a Major Indication, in which case Novartis will use Commercially Reasonable Efforts towards a Minor Indication.
(c) No less than five (5) Business Days prior to each scheduled meeting of the JDC, Novartis will provide the Array members of the JDC with a written report on the status and progress of its activities under Section 5.3(a), which reports shall be consistent in format and content with the reports Novartis normally prepares in connection with JDC meetings and may include, as applicable, information on progress versus plan, spend versus budget (quarterly), protocol deviations, notable safety and efficacy findings (including serious adverse events and events of interest from risk management perspective), inspection, audit findings, and summaries of all interactions, and copies of all correspondence, with Regulatory Authorities since the previous report.
(d) The status, progress and results of the Novartis Development Activities under Section 5.3(a), shall be discussed in reasonable detail at meetings of the JDC.
(e) In addition, Novartis shall make available to Array (i) information about Novartis Development Activities, and (ii) any data generated by Novartis during the conduct of Novartis Development Activities, in each case as may be reasonably requested by Array from time to time.
(f) Novartis shall notify Array promptly upon scheduling, and provide Array with five (5) Business Days prior notice, of any Regulatory Authority meetings with FDA or EMEA held by Novartis or its Affiliate for a Product or Compound, and Array, at its option, may attend such meetings.
(g) Novartis shall promptly inform Array in writing about any unforeseen and/or material results, problems, difficulties or issues in connection with the Novartis Development Activities with respect to the Array Compounds and/or Products.
Novartis Development Activities. For clarity, except as set forth in the last sentence of Section 5.1 (General), nothing in this Agreement shall limit in any way Novartis’ right to conduct Development or any other activities after the Effective Date with respect to the Exploitation of Licensed Compounds or Licensed Products during Licensor’s conduct of the Licensor Clinical Trial Activities.
Novartis Development Activities. For clarity, nothing in this Article 4 shall limit in any way Novartis’ right to conduct Development or any other activities with respect to the Exploitation of Licensed Products during Arvinas’ conduct of the Arvinas Clinical Trial Activities. ARTICLE 5
Novartis Development Activities. 32 ARTICLE 6 REGULATORY ....................................................................................... 33 ARTICLE 7